The Antes B+ Study: an Open-Label, Pragmatic, Randomized, Controlled Trial of Triple Therapy Versus Laba-Lama Combination to Improve Clinical Control in High-Risk Gold B Patients (B+)

2023-507304-32-00 Protocol ANTES B+ Therapeutic use (Phase IV) Ended

Start 9 Feb 2024 · End 23 Jan 2025 · Status Ended · 1 EU/EEA countries · 39 sites · Protocol ANTES B+

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Ended
Participants planned 1,028
Countries 1
Sites 39

Chronic Obstructive Pulmonary Disease

To determine the efficacy of Trelegy® vs. LABA-LAMA treatment in improving clinical control (CC), a validated composite endpoint that includes two domains, stability, and impact, in COPD B+ patients

Key facts

Sponsor
Fundacio Privada Mon Clinic Barcelona
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Respiratory Tract Diseases [C08]
Trial duration
9 Feb 2024 → 23 Jan 2025
Decision date (initial)
2023-11-22
Transition trial
No
Low-intervention
Yes
Rare-disease indication
No
Vulnerable population
No
Funding sources
GlaxoSmithKline Research&Development Limited

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To determine the efficacy of Trelegy® vs. LABA-LAMA treatment in improving clinical control (CC), a validated composite endpoint that includes two domains, stability, and impact, in COPD B+ patients

Secondary objectives 3

  1. To determine the efficacy of Trelegy® vs. LABA-LAMA treatment in improving Clinical Important deterioration (CID-CAT), another validated composite endpoint, in COPD B+ patients, that includes occurrence of moderate/severe exacerbations, lung function decline (≥100 mL decrease from baseline in trough forced expiratory volume in 1 s (FEV1) and deterioration in health status symptoms (≥2.0 units in COPD Assessment Test (CAT) score).
  2. To evaluate the impact of Trelegy® vs. LABA-LAMA combination on several health status domains (including but not limited to domains and variables of CC and CID) in COPD B+ patients.
  3. To determine independent predictors for permanently vs intermittently vs never CC status over the study period.

Conditions and MedDRA coding

Chronic Obstructive Pulmonary Disease

VersionLevelCodeTermSystem organ class
21.1 PT 10009033 Chronic obstructive pulmonary disease 100000004855

Study design 1 period

#TitleAllocationBlindingRoles blindedArms
1 Triple Therapy/LABA-LAMA Therapy
Phase IV, open-label, prospective, pragmatic, interventional, randomized (1:1), multicenter, controlled, 12-month duration study.
 Randomised Controlled None Interventional Arm: Triple Therapy
Control Arm: LABA-LAMA Therapy

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

  1. Female or male
  2. 40-80 yrs. of age
  3. Current/former smokers ≥10 pack-year
  4. Diagnosis of COPD according to GOLD 2023 (post-BD FEV1/FVC<0.7 in the appropriate clinical context) with FEV1 post-BD 30-70% of the reference value
  5. B+ phenotype 1. CAT≥10 despite being on LABA-LAMA for ≥3 months, and 2. 1 moderate ECOPD in the previous year (treated with a short course of oral steroids and/or antibiotics), and 3. ≥150 blood Eos/L (as determined by a single Eos measurement in the previous 12 months available in the medical record of the patient)
  6. A signed and dated written informed consent prior to study participation.

Exclusion criteria 18

  1. GOLD E (≥2 moderate or 1 severe ECOPD in the previous year)
  2. ICS treatment (or oral steroid for whatever reason) during the last 8 weeks
  3. ECOPD during the last 8 weeks
  4. Current diagnosis of asthma or documented history of asthma in the medical record of the patient according to the 2023 Global Initiative for Asthma (GINA) guidelines or other accepted guidelines
  5. Other concomitant respiratory disease (e.g., bronchiectasis, lung fibrosis, lung neoplasm)
  6. Use of domiciliary long-term oxygen therapy or non-invasive ventilation
  7. Alpha-1 antitrypsin deficiency
  8. Unstable or life-threatening cardiac disease, including: 1. Myocardial infarction or unstable angina in the last 6 months 2. Unstable or life-threatening cardiac arrhythmia requiring intervention in the last 3 months. 3. NYHA Class IV Heart failure.
  9. Participation on Pulmonary Rehabilitation Program within 4 weeks prior to Screening or subjects who plan to enter the acute phase of a Pulmonary Rehabilitation Program during the study.
  10. Long term antibiotic therapy (antibiotics are allowed for the short-term treatment of an exacerbation or for short term treatment of other acute infections during the study).
  11. Systemic, oral, parenteral corticosteroids used for COPD and/or other diseases in the last 8 weeks before entering in the study (oral/systemic corticosteroids may be used to treat COPD exacerbations during the study).
  12. Active neoplasm
  13. Life expectancy < 1 yr.
  14. Current participation in other RCTs
  15. Non-compliance: subjects at risk of non-compliance, or unable to comply with the study procedures.
  16. Any disease, disability, or geographic location that would limit compliance for scheduled visits.
  17. Known allergy to Trelegy® components (vilanterol, umeclidinium and/or fluticasone furoate) or inability to use the Ellipta® device.
  18. Women who are pregnant or lactating or are planning to become pregnant during the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. To determine the existence of an association between the use of Trelegy® vs. LABA-LAMA treatment with being a patient persistently controlled by CC at all study visits (a subject to be a categorize as having clinical control they must meet the criteria at month 3, 6, 9 and 12).

Secondary endpoints 15

  1. To determine the existence of an association between the use of Trelegy® vs. LABA-LAMA treatment with being a patient persistently non deteriorated by CID-CAT at all study visits.(a subject to be a categorize as having control by CID-CAT they must meet the criteria a month 3, 6, 9 and 12).
  2. To compare several Health status related endpoints between study arms including the existence of an association between the use of Trelegy vs. LABA-LAMA treatment with being a patient persistenly controlled (at all visits) throughout the study between the two study arms as per CC - Stability Domain (1.General status since the last visit and 2. Exacerbations in the last 3 months)
  3. To compare several Health status related endpoints between study arms including the existence of an association between the use of Trelegy vs. LABA-LAMA treatment with being a patient persistenly controlled (at all visits) throughout the study between the two study arms as per CC - Impact Domain (1.Sputum color, 2. Rescue Medication, 3. Minute walked per day and 4. Dyspnea (mMRC)))
  4. To compare several Health status related endpoints between study arms including the existence of an association between the use of Trelegy vs. LABA-LAMA treatment with being a patient persistenly controlled (at all visits) throughout the study between the two study arms as per CID-CAT – Exacerbations
  5. To compare several Health status related endpoints between study arms including the existence of an association between the use of Trelegy vs. LABA-LAMA treatment with being a patient persistenly controlled (at all visits) throughout the study between the two study arms as per CID-CAT – PROs
  6. To compare several Health status related endpoints between study arms including the existence of an association between the use of Trelegy vs. LABA-LAMA treatment with being a patient persistenly controlled (at all visits) throughout the study between the two study arms as per CID-CAT – Lung function
  7. To compare several Health status related endpoints between study arms including: To evaluate time to first not being CC or suffer CID-CAT
  8. To compare several Health status related endpoints between study arms including evaluate the time to first not achievement event for CC - Stability Domain (1. General status since the last visit and 2. Exacerbations in the last 3 months)
  9. To compare several Health status related endpoints between study arms including evaluate the time to first not achievement event for CC - Impact Domain (1. Sputum color, 2. Rescue medication use, 3. Minutes walked per day and 4. Dyspnea (mMRC))
  10. To compare several Health status related endpoints between study arms including evaluate the time to first not achievement event for CID-CAT Exacerbations
  11. To compare several Health status related endpoints between study arms including evaluate the time to first not achievement event for CID-CAT Spirometry
  12. To compare several Health status related endpoints between study arms including to evaluate the mean and annual rate of: 1. Moderate exacerbations (ECOPD), 2. Severe ECOPD (hospitalized) and 3. Moderate and Severe ECOPD
  13. To compare several Health status related endpoints between study arms including to evaluate time to first ECOPD including: 1. Moderate ECOPD, 2. Severe ECOPD (hospitalized) and 3. Moderate to Severe ECOPD
  14. To compare several Health status related endpoints between study arms including to assess annual FEV1 and FVC changes (ml/year)
  15. To identify independent predictors with a potential negative impact on achieving the CC, each of its domains and each of its variables at each study visit.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Trelegy Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed

PRD5572207 · Product

Active substance
Umeclidinium Bromide
Pharmaceutical form
INHALATION POWDER, PRE-DISPENSED
Route of administration
INHALATION
Max daily dose
92 µg microgram(s)
Max total dose
92 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL08 — -
Marketing authorisation
EU/1/17/1236/002
MA holder
GLAXOSMITHKLINE TRADING SERVICES LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Trelegy Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed

PRD5572206 · Product

Active substance
Umeclidinium Bromide
Pharmaceutical form
INHALATION POWDER, PRE-DISPENSED
Route of administration
INHALATION
Max daily dose
92 µg microgram(s)
Max total dose
92 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL08 — -
Marketing authorisation
EU/1/17/1236/001
MA holder
GLAXOSMITHKLINE TRADING SERVICES LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Trelegy Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed

PRD5572208 · Product

Active substance
Umeclidinium Bromide
Pharmaceutical form
INHALATION POWDER, PRE-DISPENSED
Route of administration
INHALATION
Max daily dose
92 µg microgram(s)
Max total dose
92 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL08 — -
Marketing authorisation
EU/1/17/1236/003
MA holder
GLAXOSMITHKLINE TRADING SERVICES LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Comparator 111

Inaspir 25 microgramos/inhalación, suspensión para inhalación en envase a presión

PRD1710775 · Product

Active substance
Salmeterol
Pharmaceutical form
PRESSURISED INHALATION, SUSPENSION
Route of administration
INHALATION
Max daily dose
200 µg microgram(s)
Max total dose
200 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AC12 — SALMETEROL
Marketing authorisation
59.527
MA holder
GLAXOSMITHKLINE, S.A.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Inaspir Accuhaler 50 microgramos/inhalación, polvo para inhalación.

PRD1710774 · Product

Active substance
Salmeterol
Pharmaceutical form
INHALATION POWDER, PRE-DISPENSED
Route of administration
INHALATION
Max daily dose
200 µg microgram(s)
Max total dose
200 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AC12 — SALMETEROL
Marketing authorisation
59.526
MA holder
ALLEN FARMACÉUTICA, S.A
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Braltus 10 microgramos/dosis liberada polvo para inhalación (cápsula dura)

PRD4402489 · Product

Active substance
Tiotropium Bromide
Substance synonyms
BA 679 BR
Pharmaceutical form
INHALATION POWDER, HARD CAPSULE
Route of administration
INHALATION
Max daily dose
10 µg microgram(s)
Max total dose
10 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB04 — TIOTROPIUM BROMIDE
Marketing authorisation
80981
MA holder
TEVA PHARMA S.L.U.,
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sirkava 18 microgramos polvo para inhalación (cápsula dura)

PRD7374930 · Product

Active substance
Tiotropium Bromide
Pharmaceutical form
INHALATION POWDER, HARD CAPSULE
Route of administration
INHALATION
Max daily dose
18 µg microgram(s)
Max total dose
18 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB04 — TIOTROPIUM BROMIDE
Marketing authorisation
84261
MA holder
MYLAN PHARMACEUTICALS S.L.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Oslif Breezhaler 300 microgram inhalation powder, hard capsules

PRD381165 · Product

Active substance
Indacaterol
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
300 µg microgram(s)
Max total dose
300 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AC18 — -
Marketing authorisation
EU/1/09/586/006
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Oslif Breezhaler 300 microgram inhalation powder, hard capsules

PRD381167 · Product

Active substance
Indacaterol
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
300 µg microgram(s)
Max total dose
300 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AC18 — -
Marketing authorisation
EU/1/09/586/008
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Oslif Breezhaler 300 microgram inhalation powder, hard capsules

PRD381168 · Product

Active substance
Indacaterol
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
300 µg microgram(s)
Max total dose
300 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AC18 — -
Marketing authorisation
EU/1/09/586/009
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Oslif Breezhaler 300 microgram inhalation powder, hard capsules

PRD381166 · Product

Active substance
Indacaterol
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
300 µg microgram(s)
Max total dose
300 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AC18 — -
Marketing authorisation
EU/1/09/586/007
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Oslif Breezhaler 300 microgram inhalation powder, hard capsules

PRD381169 · Product

Active substance
Indacaterol
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
300 µg microgram(s)
Max total dose
300 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AC18 — -
Marketing authorisation
EU/1/09/586/010
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

ANORO ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed

PRD1600826 · Product

Active substance
Umeclidinium Bromide
Pharmaceutical form
INHALATION POWDER, PRE-DISPENSED
Route of administration
INHALATION
Max daily dose
55 µg microgram(s)
Max total dose
55 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL03 — -
Marketing authorisation
EU/1/14/898/001
MA holder
GLAXOSMITHKLINE (IRELAND) LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

ANORO ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed

PRD1600827 · Product

Active substance
Umeclidinium Bromide
Pharmaceutical form
INHALATION POWDER, PRE-DISPENSED
Route of administration
INHALATION
Max daily dose
55 µg microgram(s)
Max total dose
55 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL03 — -
Marketing authorisation
EU/1/14/898/002
MA holder
GLAXOSMITHKLINE (IRELAND) LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Xoterna Breezhaler 85 micrograms/43 micrograms inhalation powder hard capsules

PRD4008814 · Product

Active substance
Glycopyrronium Bromide
Substance synonyms
CHF 5259.02, EP-101, AHR-504, CHF-5259, GLYCOPYRROLATE
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
85 µg microgram(s)
Max total dose
85 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL04 — -
Marketing authorisation
EU/1/13/863/004
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Xoterna Breezhaler 85 micrograms/43 micrograms inhalation powder hard capsules

PRD4008817 · Product

Active substance
Glycopyrronium Bromide
Substance synonyms
CHF 5259.02, EP-101, AHR-504, CHF-5259, GLYCOPYRROLATE
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
85 µg microgram(s)
Max total dose
85 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL04 — -
Marketing authorisation
EU/1/13/863/007
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Xoterna Breezhaler 85 micrograms/43 micrograms inhalation powder hard capsules

PRD4008811 · Product

Active substance
Glycopyrronium Bromide
Substance synonyms
CHF 5259.02, EP-101, AHR-504, CHF-5259, GLYCOPYRROLATE
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
85 µg microgram(s)
Max total dose
85 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL04 — -
Marketing authorisation
EU/1/13/863/001
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Xoterna Breezhaler 85 micrograms/43 micrograms inhalation powder hard capsules

PRD4008813 · Product

Active substance
Glycopyrronium Bromide
Substance synonyms
CHF 5259.02, EP-101, AHR-504, CHF-5259, GLYCOPYRROLATE
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
85 µg microgram(s)
Max total dose
85 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL04 — -
Marketing authorisation
EU/1/13/863/003
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Xoterna Breezhaler 85 micrograms/43 micrograms inhalation powder hard capsules

PRD4008812 · Product

Active substance
Glycopyrronium Bromide
Substance synonyms
CHF 5259.02, EP-101, AHR-504, CHF-5259, GLYCOPYRROLATE
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
85 µg microgram(s)
Max total dose
85 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL04 — -
Marketing authorisation
EU/1/13/863/002
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Xoterna Breezhaler 85 micrograms/43 micrograms inhalation powder hard capsules

PRD4008818 · Product

Active substance
Glycopyrronium Bromide
Substance synonyms
CHF 5259.02, EP-101, AHR-504, CHF-5259, GLYCOPYRROLATE
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
85 µg microgram(s)
Max total dose
85 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL04 — -
Marketing authorisation
EU/1/13/863/008
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Xoterna Breezhaler 85 micrograms/43 micrograms inhalation powder hard capsules

PRD4008815 · Product

Active substance
Glycopyrronium Bromide
Substance synonyms
CHF 5259.02, EP-101, AHR-504, CHF-5259, GLYCOPYRROLATE
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
85 µg microgram(s)
Max total dose
85 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL04 — -
Marketing authorisation
EU/1/13/863/005
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Xoterna Breezhaler 85 micrograms/43 micrograms inhalation powder hard capsules

PRD4008816 · Product

Active substance
Glycopyrronium Bromide
Substance synonyms
CHF 5259.02, EP-101, AHR-504, CHF-5259, GLYCOPYRROLATE
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
85 µg microgram(s)
Max total dose
85 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL04 — -
Marketing authorisation
EU/1/13/863/006
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Beglan 25 microgramos/inhalación, suspensión para inhalación en envase a presión

PRD1710779 · Product

Active substance
Salmeterol Xinafoate
Substance synonyms
2-(HYDROXYMETHYL)-4-[1-HYDROXY-2-[6-(4-PHENYLBUTOXY)HEXYLAMINO]ETHYL]PHENOL, 1-HYDROXYNAPHTHALENE-2-CARBOXYLIC ACID, SALMETEROL 1-HYDROXY-2-NAPHTHOATE, LIPO-202
Pharmaceutical form
PRESSURISED INHALATION, SUSPENSION
Route of administration
INHALATION
Max daily dose
200 µg microgram(s)
Max total dose
200 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AC12 — SALMETEROL
Marketing authorisation
59.523
MA holder
GLAXO S.A.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Beglan Accuhaler 50 microgramos/inhalación, polvo para inhalación.

PRD1710778 · Product

Active substance
Salmeterol Xinafoate
Substance synonyms
2-(HYDROXYMETHYL)-4-[1-HYDROXY-2-[6-(4-PHENYLBUTOXY)HEXYLAMINO]ETHYL]PHENOL, 1-HYDROXYNAPHTHALENE-2-CARBOXYLIC ACID, SALMETEROL 1-HYDROXY-2-NAPHTHOATE, LIPO-202
Pharmaceutical form
INHALATION POWDER, PRE-DISPENSED
Route of administration
INHALATION
Max daily dose
200 µg microgram(s)
Max total dose
200 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AC12 — SALMETEROL
Marketing authorisation
59.522
MA holder
GLAXO S.A.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Onbrez Breezhaler 300 microgram inhalation powder, hard capsules

PRD381155 · Product

Active substance
Indacaterol
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
300 µg microgram(s)
Max total dose
300 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AC18 — -
Marketing authorisation
EU/1/09/593/006
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Onbrez Breezhaler 300 microgram inhalation powder, hard capsules

PRD381157 · Product

Active substance
Indacaterol
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
300 µg microgram(s)
Max total dose
300 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AC18 — -
Marketing authorisation
EU/1/09/593/008
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Onbrez Breezhaler 300 microgram inhalation powder, hard capsules

PRD381158 · Product

Active substance
Indacaterol
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
300 µg microgram(s)
Max total dose
300 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AC18 — -
Marketing authorisation
EU/1/09/593/009
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Onbrez Breezhaler 300 microgram inhalation powder, hard capsules

PRD381156 · Product

Active substance
Indacaterol
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
300 µg microgram(s)
Max total dose
300 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AC18 — -
Marketing authorisation
EU/1/09/593/007
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Onbrez Breezhaler 300 microgram inhalation powder, hard capsules

PRD381159 · Product

Active substance
Indacaterol
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
300 µg microgram(s)
Max total dose
300 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AC18 — -
Marketing authorisation
EU/1/09/593/010
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Spiolto Respimat 2,5 microgramos/2,5 microgramos, solución para inhalación

PRD2960858 · Product

Active substance
Tiotropium
Pharmaceutical form
INHALATION SOLUTION
Route of administration
INHALATION
Max daily dose
5 µg microgram(s)
Max total dose
5 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL06 — -
Marketing authorisation
79967
MA holder
BOEHRINGER INGELHEIM INTERNATIONAL GMBH
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Formoterol Aldo-Unión 12 microgramos polvo para inhalación (cápsulas duras)

PRD326421 · Product

Active substance
Formoterol Fumarate Dihydrate
Pharmaceutical form
INHALATION POWDER, HARD CAPSULE
Route of administration
INHALATION
Max daily dose
48 µg microgram(s)
Max total dose
48 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AC13 — FORMOTEROL
Marketing authorisation
66.558
MA holder
LABORATORIO ALDO-UNIÓN, S.L.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Gregal 10 microgramos/dosis liberada polvo para inhalación (cápsula dura)

PRD4402490 · Product

Active substance
Tiotropium Bromide
Substance synonyms
BA 679 BR
Pharmaceutical form
INHALATION POWDER, HARD CAPSULE
Route of administration
INHALATION
Max daily dose
10 µg microgram(s)
Max total dose
10 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB04 — TIOTROPIUM BROMIDE
Marketing authorisation
80980
MA holder
TEVA PHARMA S.L.U.,
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tavulus 18 microgramos polvo para inhalación (cápsula dura)

PRD10069953 · Product

Active substance
Tiotropium
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
18 µg microgram(s)
Max total dose
18 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB04 — TIOTROPIUM BROMIDE
Marketing authorisation
85978
MA holder
ZENTIVA, K.S.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Serevent® Accuhaler® 50 microgramos/inhalación, polvo para inhalación

PRD402571 · Product

Active substance
Salmeterol
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
200 µg microgram(s)
Max total dose
200 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AC12 — SALMETEROL
Marketing authorisation
59.489
MA holder
GLAXOSMITHKLINE S.A.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Serevent 25 microgramos/inhalación, suspensión para inhalación en envase a presión

PRD1710773 · Product

Active substance
Salmeterol
Pharmaceutical form
PRESSURISED INHALATION, SUSPENSION
Route of administration
INHALATION
Max daily dose
200 µg microgram(s)
Max total dose
200 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AC12 — SALMETEROL
Marketing authorisation
59.490
MA holder
GLAXOSMITHKLINE S.A.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

LAVENTAIR ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed

PRD1601166 · Product

Active substance
Umeclidinium Bromide
Pharmaceutical form
INHALATION POWDER, PRE-DISPENSED
Route of administration
INHALATION
Max daily dose
55 µg microgram(s)
Max total dose
55 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL03 — -
Marketing authorisation
EU/1/14/899/001
MA holder
GLAXOSMITHKLINE (IRELAND) LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

LAVENTAIR ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed

PRD1601168 · Product

Active substance
Umeclidinium Bromide
Pharmaceutical form
INHALATION POWDER, PRE-DISPENSED
Route of administration
INHALATION
Max daily dose
55 µg microgram(s)
Max total dose
55 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL03 — -
Marketing authorisation
EU/1/14/899/003
MA holder
GLAXOSMITHKLINE (IRELAND) LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

LAVENTAIR ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed

PRD1601167 · Product

Active substance
Umeclidinium Bromide
Pharmaceutical form
INHALATION POWDER, PRE-DISPENSED
Route of administration
INHALATION
Max daily dose
55 µg microgram(s)
Max total dose
55 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL03 — -
Marketing authorisation
EU/1/14/899/002
MA holder
GLAXOSMITHKLINE (IRELAND) LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Formatris Novolizer® 12 microgramos/dosis polvo para inhalación

PRD5867933 · Product

Active substance
Formoterol Fumarate Dihydrate
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
48 µg microgram(s)
Max total dose
48 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AC13 — FORMOTEROL
Marketing authorisation
68063
MA holder
MYLAN IRE HEALTHCARE LIMITED
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Hirobriz Breezhaler 300 microgram inhalation powder, hard capsules

PRD381066 · Product

Active substance
Indacaterol
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
300 µg microgram(s)
Max total dose
300 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AC18 — -
Marketing authorisation
EU/1/09/594/008
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Hirobriz Breezhaler 300 microgram inhalation powder, hard capsules

PRD381068 · Product

Active substance
Indacaterol
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
300 µg microgram(s)
Max total dose
300 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AC18 — -
Marketing authorisation
EU/1/09/594/010
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Hirobriz Breezhaler 300 microgram inhalation powder, hard capsules

PRD381067 · Product

Active substance
Indacaterol
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
300 µg microgram(s)
Max total dose
300 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AC18 — -
Marketing authorisation
EU/1/09/594/009
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Hirobriz Breezhaler 300 microgram inhalation powder, hard capsules

PRD381064 · Product

Active substance
Indacaterol
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
300 µg microgram(s)
Max total dose
300 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AC18 — -
Marketing authorisation
EU/1/09/594/006
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Hirobriz Breezhaler 300 microgram inhalation powder, hard capsules

PRD381065 · Product

Active substance
Indacaterol
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
300 µg microgram(s)
Max total dose
300 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AC18 — -
Marketing authorisation
EU/1/09/594/007
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

FORADIL Aerolizer 12 microgramos polvo para inhalación (cápsula dura)

PRD10297853 · Product

Active substance
Formoterol Fumarate Dihydrate
Pharmaceutical form
INHALATION POWDER, HARD CAPSULE
Route of administration
INHALATION
Max daily dose
48 µg microgram(s)
Max total dose
48 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AC13 — FORMOTEROL
Marketing authorisation
62.197
MA holder
BEXAL FARMACÉUTICA S.A.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Soltel 25 microgramos/inhalación suspensión para inhalación en envase a presión

PRD7197767 · Product

Active substance
Salmeterol
Pharmaceutical form
PRESSURISED INHALATION, SUSPENSION
Route of administration
INHALATION
Max daily dose
100 µg microgram(s)
Max total dose
100 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AC12 — SALMETEROL
Marketing authorisation
83247
MA holder
CIPLA EUROPE NV
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Enurev Breezhaler 44 micrograms inhalation powder, hard capsules

PRD4008735 · Product

Active substance
Glycopyrronium Bromide
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
44 µg microgram(s)
Max total dose
44 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB06 — -
Marketing authorisation
EU/1/12/789/005
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Enurev Breezhaler 44 micrograms inhalation powder, hard capsules

PRD4008736 · Product

Active substance
Glycopyrronium Bromide
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
44 µg microgram(s)
Max total dose
44 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB06 — -
Marketing authorisation
EU/1/12/789/006
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Enurev Breezhaler 44 micrograms inhalation powder, hard capsules

PRD4008737 · Product

Active substance
Glycopyrronium Bromide
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
44 µg microgram(s)
Max total dose
44 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB06 — -
Marketing authorisation
EU/1/12/789/007
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Enurev Breezhaler 44 micrograms inhalation powder, hard capsules

PRD4008733 · Product

Active substance
Glycopyrronium Bromide
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
44 µg microgram(s)
Max total dose
44 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB06 — -
Marketing authorisation
EU/1/12/789/003
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Enurev Breezhaler 44 micrograms inhalation powder, hard capsules

PRD4008731 · Product

Active substance
Glycopyrronium Bromide
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
44 µg microgram(s)
Max total dose
44 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB06 — -
Marketing authorisation
EU/1/12/789/001
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Enurev Breezhaler 44 micrograms inhalation powder, hard capsules

PRD4008738 · Product

Active substance
Glycopyrronium Bromide
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
44 µg microgram(s)
Max total dose
44 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB06 — -
Marketing authorisation
EU/1/12/789/008
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Enurev Breezhaler 44 micrograms inhalation powder, hard capsules

PRD4008732 · Product

Active substance
Glycopyrronium Bromide
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
44 µg microgram(s)
Max total dose
44 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB06 — -
Marketing authorisation
EU/1/12/789/002
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Enurev Breezhaler 44 micrograms inhalation powder, hard capsules

PRD4008734 · Product

Active substance
Glycopyrronium Bromide
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
44 µg microgram(s)
Max total dose
44 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB06 — -
Marketing authorisation
EU/1/12/789/004
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Spiriva Respimat 2,5 microgramos, solución para inhalación

PRD323503 · Product

Active substance
Tiotropium Bromide Monohydrate
Pharmaceutical form
INHALATION SOLUTION
Route of administration
INHALATION
Max daily dose
5 µg microgram(s)
Max total dose
5 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB04 — TIOTROPIUM BROMIDE
Marketing authorisation
69.589
MA holder
BOEHRINGER INGELHEIM INTERNATIONAL GMBH
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Spiriva 18 microgramos polvo para inhalación

PRD303496 · Product

Active substance
Tiotropium Bromide Monohydrate
Pharmaceutical form
INHALATION POWDER, HARD CAPSULE
Route of administration
INHALATION
Max daily dose
18 µg microgram(s)
Max total dose
18 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB04 — TIOTROPIUM BROMIDE
Marketing authorisation
64.796
MA holder
BOEHRINGER INGELHEIM INTERNATIONAL GMBH
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

OXIS TURBUHALER 9 microgramos/inhalación polvo para inhalación.

PRD395528 · Product

Active substance
Formoterol Fumarate Dihydrate
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
36 µg microgram(s)
Max total dose
36 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AC13 — FORMOTEROL
Marketing authorisation
61.667
MA holder
LABORATORIO BETA S.A.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

OXIS TURBUHALER 4,5 microgramos/inhalación polvo para inhalación.

PRD395537 · Product

Active substance
Formoterol Fumarate Dihydrate
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
36 µg microgram(s)
Max total dose
36 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AC13 — FORMOTEROL
Marketing authorisation
61.666
MA holder
LABORATORIO BETA S.A.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Seebri Breezhaler 44 micrograms inhalation powder, hard capsules

PRD4008750 · Product

Active substance
Glycopyrronium Bromide
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
44 µg microgram(s)
Max total dose
44 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB06 — -
Marketing authorisation
EU/1/12/788/004
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Seebri Breezhaler 44 micrograms inhalation powder, hard capsules

PRD4008749 · Product

Active substance
Glycopyrronium Bromide
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
44 µg microgram(s)
Max total dose
44 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB06 — -
Marketing authorisation
EU/1/12/788/003
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Seebri Breezhaler 44 micrograms inhalation powder, hard capsules

PRD4008754 · Product

Active substance
Glycopyrronium Bromide
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
44 µg microgram(s)
Max total dose
44 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB06 — -
Marketing authorisation
EU/1/12/788/008
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Seebri Breezhaler 44 micrograms inhalation powder, hard capsules

PRD4008752 · Product

Active substance
Glycopyrronium Bromide
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
44 µg microgram(s)
Max total dose
44 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB06 — -
Marketing authorisation
EU/1/12/788/006
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Seebri Breezhaler 44 micrograms inhalation powder, hard capsules

PRD4008748 · Product

Active substance
Glycopyrronium Bromide
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
44 µg microgram(s)
Max total dose
44 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB06 — -
Marketing authorisation
EU/1/12/788/002
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Seebri Breezhaler 44 micrograms inhalation powder, hard capsules

PRD4008747 · Product

Active substance
Glycopyrronium Bromide
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
44 µg microgram(s)
Max total dose
44 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB06 — -
Marketing authorisation
EU/1/12/788/001
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Seebri Breezhaler 44 micrograms inhalation powder, hard capsules

PRD4008751 · Product

Active substance
Glycopyrronium Bromide
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
44 µg microgram(s)
Max total dose
44 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB06 — -
Marketing authorisation
EU/1/12/788/005
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Seebri Breezhaler 44 micrograms inhalation powder, hard capsules

PRD4008753 · Product

Active substance
Glycopyrronium Bromide
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
44 µg microgram(s)
Max total dose
44 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB06 — -
Marketing authorisation
EU/1/12/788/007
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Eklira Genuair 322 micrograms inhalation powder

PRD10145489 · Product

Active substance
Aclidinium Bromide
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
644 µg microgram(s)
Max total dose
644 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB05 — -
Marketing authorisation
EU/1/12/778/003
MA holder
COVIS PHARMA EUROPE B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Eklira Genuair 322 micrograms inhalation powder

PRD10145488 · Product

Active substance
Aclidinium Bromide
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
644 µg microgram(s)
Max total dose
644 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB05 — -
Marketing authorisation
EU/1/12/778/002
MA holder
COVIS PHARMA EUROPE B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Eklira Genuair 322 micrograms inhalation powder

PRD10145487 · Product

Active substance
Aclidinium Bromide
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
644 µg microgram(s)
Max total dose
644 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB05 — -
Marketing authorisation
EU/1/12/778/001
MA holder
COVIS PHARMA EUROPE B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Brimica Genuair 340 micrograms /12 micrograms inhalation powder

PRD10153792 · Product

Active substance
Formoterol Fumarate
Substance synonyms
EFORMOTEROL FUMARATE, BUT-2-ENEDIOIC ACID, N-[2-HYDROXY-5-[(1S)-1-HYDROXY-2-[[(2S)-1-(4-METHOXYPHENYL)PROPAN-2-YL]AMINO]ETHYL]PHENYL]FORMAMIDE
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
680 µg microgram(s)
Max total dose
680 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL05 — -
Marketing authorisation
EU/1/14/963/003
MA holder
COVIS PHARMA EUROPE B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Brimica Genuair 340 micrograms /12 micrograms inhalation powder

PRD10153790 · Product

Active substance
Formoterol Fumarate
Substance synonyms
EFORMOTEROL FUMARATE, BUT-2-ENEDIOIC ACID, N-[2-HYDROXY-5-[(1S)-1-HYDROXY-2-[[(2S)-1-(4-METHOXYPHENYL)PROPAN-2-YL]AMINO]ETHYL]PHENYL]FORMAMIDE
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
680 µg microgram(s)
Max total dose
680 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL05 — -
Marketing authorisation
EU/1/14/963/001
MA holder
COVIS PHARMA EUROPE B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Brimica Genuair 340 micrograms /12 micrograms inhalation powder

PRD10153791 · Product

Active substance
Formoterol Fumarate
Substance synonyms
EFORMOTEROL FUMARATE, BUT-2-ENEDIOIC ACID, N-[2-HYDROXY-5-[(1S)-1-HYDROXY-2-[[(2S)-1-(4-METHOXYPHENYL)PROPAN-2-YL]AMINO]ETHYL]PHENYL]FORMAMIDE
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
680 µg microgram(s)
Max total dose
680 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL05 — -
Marketing authorisation
EU/1/14/963/002
MA holder
COVIS PHARMA EUROPE B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Formoterol STADA 12 mcg polvo para inhalación

PRD394230 · Product

Active substance
Formoterol Fumarate
Pharmaceutical form
INHALATION POWDER, HARD CAPSULE
Route of administration
INHALATION
Max daily dose
48 µg microgram(s)
Max total dose
48 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AC13 — FORMOTEROL
Marketing authorisation
66.573
MA holder
LABORATORIO STADA, S.L.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ulunar Breezhaler 85 micrograms/43 micrograms inhalation powder hard capsules

PRD4008801 · Product

Active substance
Glycopyrronium Bromide
Substance synonyms
CHF 5259.02, EP-101, AHR-504, CHF-5259, GLYCOPYRROLATE
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
85 µg microgram(s)
Max total dose
85 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL04 — -
Marketing authorisation
EU/1/14/917/007
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ulunar Breezhaler 85 micrograms/43 micrograms inhalation powder hard capsules

PRD1584319 · Product

Active substance
Glycopyrronium Bromide
Substance synonyms
CHF 5259.02, EP-101, AHR-504, CHF-5259, GLYCOPYRROLATE
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
85 µg microgram(s)
Max total dose
85 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL04 — -
Marketing authorisation
EU/1/14/917/002
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ulunar Breezhaler 85 micrograms/43 micrograms inhalation powder hard capsules

PRD1584323 · Product

Active substance
Glycopyrronium Bromide
Substance synonyms
CHF 5259.02, EP-101, AHR-504, CHF-5259, GLYCOPYRROLATE
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
85 µg microgram(s)
Max total dose
85 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL04 — -
Marketing authorisation
EU/1/14/917/006
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ulunar Breezhaler 85 micrograms/43 micrograms inhalation powder hard capsules

PRD1584320 · Product

Active substance
Glycopyrronium Bromide
Substance synonyms
CHF 5259.02, EP-101, AHR-504, CHF-5259, GLYCOPYRROLATE
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
85 µg microgram(s)
Max total dose
85 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL04 — -
Marketing authorisation
EU/1/14/917/003
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ulunar Breezhaler 85 micrograms/43 micrograms inhalation powder hard capsules

PRD1584318 · Product

Active substance
Glycopyrronium Bromide
Substance synonyms
CHF 5259.02, EP-101, AHR-504, CHF-5259, GLYCOPYRROLATE
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
85 µg microgram(s)
Max total dose
85 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL04 — -
Marketing authorisation
EU/1/14/917/001
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ulunar Breezhaler 85 micrograms/43 micrograms inhalation powder hard capsules

PRD1584321 · Product

Active substance
Glycopyrronium Bromide
Substance synonyms
CHF 5259.02, EP-101, AHR-504, CHF-5259, GLYCOPYRROLATE
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
85 µg microgram(s)
Max total dose
85 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL04 — -
Marketing authorisation
EU/1/14/917/004
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ulunar Breezhaler 85 micrograms/43 micrograms inhalation powder hard capsules

PRD1584322 · Product

Active substance
Glycopyrronium Bromide
Substance synonyms
CHF 5259.02, EP-101, AHR-504, CHF-5259, GLYCOPYRROLATE
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
85 µg microgram(s)
Max total dose
85 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL04 — -
Marketing authorisation
EU/1/14/917/005
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ulunar Breezhaler 85 micrograms/43 micrograms inhalation powder hard capsules

PRD4008802 · Product

Active substance
Glycopyrronium Bromide
Substance synonyms
CHF 5259.02, EP-101, AHR-504, CHF-5259, GLYCOPYRROLATE
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
85 µg microgram(s)
Max total dose
85 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL04 — -
Marketing authorisation
EU/1/14/917/008
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Duaklir Genuair 340 micrograms /12 micrograms inhalation powder

PRD10145420 · Product

Active substance
Formoterol Fumarate Dihydrate
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
680 µg microgram(s)
Max total dose
680 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL05 — -
Marketing authorisation
EU/1/14/964/001
MA holder
COVIS PHARMA EUROPE B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Duaklir Genuair 340 micrograms /12 micrograms inhalation powder

PRD10145421 · Product

Active substance
Formoterol Fumarate Dihydrate
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
680 µg microgram(s)
Max total dose
680 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL05 — -
Marketing authorisation
EU/1/14/964/002
MA holder
COVIS PHARMA EUROPE B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Duaklir Genuair 340 micrograms /12 micrograms inhalation powder

PRD10145422 · Product

Active substance
Formoterol Fumarate Dihydrate
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
680 µg microgram(s)
Max total dose
680 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL05 — -
Marketing authorisation
EU/1/14/964/003
MA holder
COVIS PHARMA EUROPE B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Incruse Ellipta 55 micrograms inhalation powder, pre-dispensed

PRD1598608 · Product

Active substance
Umeclidinium Bromide
Pharmaceutical form
INHALATION POWDER, PRE-DISPENSED
Route of administration
INHALATION
Max daily dose
55 µg microgram(s)
Max total dose
55 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB07 — -
Marketing authorisation
EU/1/14/922/002
MA holder
GLAXOSMITHKLINE (IRELAND) LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Incruse Ellipta 55 micrograms inhalation powder, pre-dispensed

PRD1598607 · Product

Active substance
Umeclidinium Bromide
Pharmaceutical form
INHALATION POWDER, PRE-DISPENSED
Route of administration
INHALATION
Max daily dose
55 µg microgram(s)
Max total dose
55 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB07 — -
Marketing authorisation
EU/1/14/922/001
MA holder
GLAXOSMITHKLINE (IRELAND) LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Incruse Ellipta 55 micrograms inhalation powder, pre-dispensed

PRD1598609 · Product

Active substance
Umeclidinium Bromide
Pharmaceutical form
INHALATION POWDER, PRE-DISPENSED
Route of administration
INHALATION
Max daily dose
55 µg microgram(s)
Max total dose
55 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB07 — -
Marketing authorisation
EU/1/14/922/003
MA holder
GLAXOSMITHKLINE (IRELAND) LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Bretaris Genuair 322 micrograms inhalation powder

PRD10151877 · Product

Active substance
Aclidinium Bromide
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
644 µg microgram(s)
Max total dose
644 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB05 — -
Marketing authorisation
EU/1/12/781/001
MA holder
COVIS PHARMA EUROPE B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Bretaris Genuair 322 micrograms inhalation powder

PRD10151879 · Product

Active substance
Aclidinium Bromide
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
644 µg microgram(s)
Max total dose
644 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB05 — -
Marketing authorisation
EU/1/12/781/003
MA holder
COVIS PHARMA EUROPE B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Bretaris Genuair 322 micrograms inhalation powder

PRD10151878 · Product

Active substance
Aclidinium Bromide
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
644 µg microgram(s)
Max total dose
644 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB05 — -
Marketing authorisation
EU/1/12/781/002
MA holder
COVIS PHARMA EUROPE B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Rolufta Ellipta 55 micrograms inhalation powder, pre-dispensed

PRD4867000 · Product

Active substance
Umeclidinium Bromide
Pharmaceutical form
INHALATION POWDER, PRE-DISPENSED
Route of administration
INHALATION
Max daily dose
55 µg microgram(s)
Max total dose
55 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB07 — -
Marketing authorisation
EU/1/17/1174/003
MA holder
GLAXOSMITHKLINE TRADING SERVICES LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Rolufta Ellipta 55 micrograms inhalation powder, pre-dispensed

PRD4866315 · Product

Active substance
Umeclidinium Bromide
Pharmaceutical form
INHALATION POWDER, PRE-DISPENSED
Route of administration
INHALATION
Max daily dose
55 µg microgram(s)
Max total dose
55 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB07 — -
Marketing authorisation
EU/1/17/1174/001
MA holder
GLAXOSMITHKLINE TRADING SERVICES LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Rolufta Ellipta 55 micrograms inhalation powder, pre-dispensed

PRD4866501 · Product

Active substance
Umeclidinium Bromide
Pharmaceutical form
INHALATION POWDER, PRE-DISPENSED
Route of administration
INHALATION
Max daily dose
55 µg microgram(s)
Max total dose
55 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB07 — -
Marketing authorisation
EU/1/17/1174/002
MA holder
GLAXOSMITHKLINE TRADING SERVICES LIMITED
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Betamican 25 microgramos/inhalación, suspensión para inhalación en envase a presión

PRD1710777 · Product

Active substance
Salmeterol
Pharmaceutical form
PRESSURISED INHALATION, SUSPENSION
Route of administration
INHALATION
Max daily dose
200 µg microgram(s)
Max total dose
200 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AC12 — SALMETEROL
Marketing authorisation
59.676
MA holder
GLAXOSMITHKLINE, S.A.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Betamican® Accuhaler® 50 microgramos/inhalación, polvo para inhalación

PRD1710776 · Product

Active substance
Salmeterol
Pharmaceutical form
INHALATION POWDER, PRE-DISPENSED
Route of administration
INHALATION
Max daily dose
200 µg microgram(s)
Max total dose
200 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AC12 — SALMETEROL
Marketing authorisation
59.675
MA holder
GLAXOSMITHKLINE S.A.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Striverdi Respimat 2,5 microgramos, solución para inhalación

PRD1575404 · Product

Active substance
Olodaterol
Pharmaceutical form
INHALATION SOLUTION
Route of administration
INHALATION
Max daily dose
5 µg microgram(s)
Max total dose
5 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AC19 — -
Marketing authorisation
78.253
MA holder
BOEHRINGER INGELHEIM INTERNATIONAL GMBH
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Broncoral Neo 12 microgramos/pulsación, Solución para inhalación en envase a presión.

PRD317548 · Product

Active substance
Formoterol Fumarate Dihydrate
Pharmaceutical form
PRESSURISED INHALATION, SOLUTION
Route of administration
INHALATION
Max daily dose
48 µg microgram(s)
Max total dose
48 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AC13 — FORMOTEROL
Marketing authorisation
67037
MA holder
CHIESI ESPAÑA S.A.U.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Yanimo Respimat 2,5 microgramos/2,5 microgramos, solución para inhalación

PRD2958309 · Product

Active substance
Tiotropium
Pharmaceutical form
INHALATION SOLUTION
Route of administration
INHALATION
Max daily dose
5 µg microgram(s)
Max total dose
5 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL06 — -
Marketing authorisation
79966
MA holder
BOEHRINGER INGELHEIM INTERNATIONAL GMBH
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ultibro Breezhaler 85 micrograms/43 micrograms inhalation powder hard capsules

PRD4008786 · Product

Active substance
Glycopyrronium Bromide
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
85 µg microgram(s)
Max total dose
85 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL04 — -
Marketing authorisation
EU/1/13/862/008
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ultibro Breezhaler 85 micrograms/43 micrograms inhalation powder hard capsules

PRD4008784 · Product

Active substance
Glycopyrronium Bromide
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
85 µg microgram(s)
Max total dose
85 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL04 — -
Marketing authorisation
EU/1/13/862/006
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ultibro Breezhaler 85 micrograms/43 micrograms inhalation powder hard capsules

PRD4008780 · Product

Active substance
Glycopyrronium Bromide
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
85 µg microgram(s)
Max total dose
85 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL04 — -
Marketing authorisation
EU/1/13/862/002
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ultibro Breezhaler 85 micrograms/43 micrograms inhalation powder hard capsules

PRD4008779 · Product

Active substance
Glycopyrronium Bromide
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
85 µg microgram(s)
Max total dose
85 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL04 — -
Marketing authorisation
EU/1/13/862/001
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ultibro Breezhaler 85 micrograms/43 micrograms inhalation powder hard capsules

PRD4008782 · Product

Active substance
Glycopyrronium Bromide
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
85 µg microgram(s)
Max total dose
85 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL04 — -
Marketing authorisation
EU/1/13/862/004
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ultibro Breezhaler 85 micrograms/43 micrograms inhalation powder hard capsules

PRD4008785 · Product

Active substance
Glycopyrronium Bromide
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
85 µg microgram(s)
Max total dose
85 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL04 — -
Marketing authorisation
EU/1/13/862/007
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ultibro Breezhaler 85 micrograms/43 micrograms inhalation powder hard capsules

PRD4008781 · Product

Active substance
Glycopyrronium Bromide
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
85 µg microgram(s)
Max total dose
85 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL04 — -
Marketing authorisation
EU/1/13/862/003
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ultibro Breezhaler 85 micrograms/43 micrograms inhalation powder hard capsules

PRD4008783 · Product

Active substance
Glycopyrronium Bromide
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
85 µg microgram(s)
Max total dose
85 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03AL04 — -
Marketing authorisation
EU/1/13/862/005
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tovanor Breezhaler 44 micrograms inhalation powder, hard capsules

PRD4008764 · Product

Active substance
Glycopyrronium Bromide
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
44 µg microgram(s)
Max total dose
44 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB06 — -
Marketing authorisation
EU/1/12/790/002
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tovanor Breezhaler 44 micrograms inhalation powder, hard capsules

PRD4008769 · Product

Active substance
Glycopyrronium Bromide
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
44 µg microgram(s)
Max total dose
44 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB06 — -
Marketing authorisation
EU/1/12/790/007
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tovanor Breezhaler 44 micrograms inhalation powder, hard capsules

PRD4008765 · Product

Active substance
Glycopyrronium Bromide
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
44 µg microgram(s)
Max total dose
44 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB06 — -
Marketing authorisation
EU/1/12/790/003
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tovanor Breezhaler 44 micrograms inhalation powder, hard capsules

PRD4008768 · Product

Active substance
Glycopyrronium Bromide
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
44 µg microgram(s)
Max total dose
44 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB06 — -
Marketing authorisation
EU/1/12/790/006
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tovanor Breezhaler 44 micrograms inhalation powder, hard capsules

PRD4008766 · Product

Active substance
Glycopyrronium Bromide
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
44 µg microgram(s)
Max total dose
44 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB06 — -
Marketing authorisation
EU/1/12/790/004
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tovanor Breezhaler 44 micrograms inhalation powder, hard capsules

PRD4008767 · Product

Active substance
Glycopyrronium Bromide
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
44 µg microgram(s)
Max total dose
44 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB06 — -
Marketing authorisation
EU/1/12/790/005
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tovanor Breezhaler 44 micrograms inhalation powder, hard capsules

PRD4008763 · Product

Active substance
Glycopyrronium Bromide
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
44 µg microgram(s)
Max total dose
44 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB06 — -
Marketing authorisation
EU/1/12/790/001
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Tovanor Breezhaler 44 micrograms inhalation powder, hard capsules

PRD4008770 · Product

Active substance
Glycopyrronium Bromide
Pharmaceutical form
INHALATION POWDER
Route of administration
INHALATION
Max daily dose
44 µg microgram(s)
Max total dose
44 µg microgram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
R03BB06 — -
Marketing authorisation
EU/1/12/790/008
MA holder
NOVARTIS EUROPHARM LIMITED
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacio Privada Mon Clinic Barcelona

Sponsor organisation
Fundacio Privada Mon Clinic Barcelona
Address
Recinte Escola Industrial, Calle Del Comte D'urgell 187 Calle Del Comte D'urgell 187
City
Barcelona
Postcode
08036
Country
Spain

Scientific contact point

Organisation
Fundacio Privada Mon Clinic Barcelona
Contact name
Regulatory Affairs Manager

Public contact point

Organisation
Fundacio Privada Mon Clinic Barcelona
Contact name
Regulatory Affairs Manager

Locations

1 EU/EEA country · 39 investigational sites

By country

CountryMS statusPlanned subjectsSites
Spain Ended 1,028 39
Rest of world — 0 —

Investigational sites

Spain

39 sites · Ended
Consorci D'atencio Primaria De Salut Barcelona Esquerra
Servicio de Neumología, Calle De Mejia Lequerica S/n, 08028, Barcelona
University Hospital Son Espases
Servicio de Neumología, Carretera Valldemossa 79, 07120, Palma
Hospital Arnau De Vilanova De Valencia
Servicio de Neumología, Calle De San Clemente 12, 46015, Valencia
Servei De Salut De Les Illes Balears
Servicio de Neumología, Carretera Valldemossa 79, 07120, Palma
Servei De Salut De Les Illes Balears
Servicio de Neumología, Carretera Valldemossa 79, 07120, Palma
Clinica Universidad De Navarra
Servicio de Neumología, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitario Nuestra Senora De Candelaria
Servicio de Neumología, Carretera De Rosario 145, Resto, Santa Cruz De Tenerife
Complexo Hospitalario Universitario De Vigo
Servicio de Neumología, Estrada Clara Campoamor N 341, 36312, Vigo
Clinica Universidad De Navarra
Servicio de Neumología, Avenue Pio XII 36, 31008, Pamplona
Hospital Universitario Virgen De Las Nieves
Servicio de Neumología, Avenida De Las Fuerzas Armadas 2, 18014, Granada
Hospital Clinic De Barcelona
Instituto Respiratorio, Calle Villarroel 170, 08036, Barcelona
Servei De Salut De Les Illes Balears
Servicio de Neumología, Carretera Valldemossa 79, 07120, Palma
Hospital Universitario Quironsalud Madrid
Servicio de Neumología, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitari Vall D Hebron
Servicio de Neumología, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Unviersitario Miguel Servet
Medicina/Respiratorio, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Hospital Universitario De La Princesa
Pulmonología, Calle De Diego De Leon 62, 28006, Madrid
Hospital Universitario De Guadalajara SESCAM
Neumología, Calle De Los Donantes De Sangre S/n, 19002, Guadalajara
University Hospital Virgen Del Rocio S.L.
Pulmonología, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Marques De Valdecilla
Pulmonología, Avenida Valdecilla Sn, 39008, Santander
Hospital Universitario Fundacion Jimenez Diaz
Pneumology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Neumología, Avinguda De L'alcalde Rovira Roure 80, 25196, Lleida
Hospital San Pedro De Alcantara
Pulmonología, Avenida De Pablo Naranjo Porras S/n, 10002, Caceres
Hospital Universitario Regional De Malaga
Unidad de Gestión Clínica Médico-Quirúrgica de Enfermedades Respiratorias, Avenida De Carlos De Haya Sn, 29010, Malaga
Hospital Universitario Central De Asturias
Pneumology, Avenida De Roma S/n, 33011, Oviedo
Hospital Universitario Rio Hortega
Neumología, Calle Dulzaina 2, 47012, Valladolid
Hospital Universitario La Paz
Neumologia, Paseo De La Castellana 261, 28046, Madrid
Hospital El Bierzo
Neumología, Calle Medicos Sin Fronteras 7, Poligono Industrial El Bierzo, Ponferrada
Hospital Universitario De Salamanca
Neumología, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitario De Burgos
Neumología, Avenida De Las Islas Baleares 3, 09006, Burgos
Hospital Universitario Infanta Leonor
Neumología, Avenida Gran Via Del Este 80, 28031, Madrid
Hospital Clinico Universitario Lozano Blesa
Pulmonary, Avenida De San Juan Bosco 15, 50009, Zaragoza
Hospital Universitario De Navarra
Neumología, Irunlarrea Kalea 3, 31008, Pamplona
Hospital Universitario Y Politecnico La Fe
Neumología, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Clinico San Carlos
Pulmonología, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Hospital Universitario Dr Peset Aleixandre
Pneumology, Avinguda De Gaspar Aguilar 90, 46017, Valencia
Hospital De Galdakao Usansolo
Pneumology, Leku Barrio Labeaga 46 A, 48960, Galdakao
Bellvitge University Hospital
Respiratory, Carrer De La Feixa Llarga S/n, 08907, L'hospitalet De Llobregat
Hospital Universitario Puerta De Hierro De Majadahonda
Pulmonología, Calle De Joaquin Rodrigo 2, 28222, Majadahonda
Centro de Salud Francia
Medicina General, Calle de Francia, 38, Fuenlabrada

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Spain 2024-02-09 2024-02-29

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

TitleSubmission dateStatusType
ANTES B_Summary of Results
SUM-116085
 2026-01-22T17:53:38 Submitted Summary of Results

Layperson summary Annex V

TitleSubmission dateStatusType
ANTES B_Lay Summary of Results 2026-01-22T17:54:20 Submitted Laypersons Summary of Results

Documents 2 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Laypersons summary of results (for publication) Lay Summary Results 1
Summary of results (for publication) Summary of Results 1

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-08-11 Spain Acceptable
2023-11-10
 2023-11-22
2 SUBSTANTIAL MODIFICATION SM-1 2024-03-12 Spain Acceptable 2024-04-04

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