Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
304
Countries
1
Sites
15
Ulcerative Colitis
To evaluate the biological recurrence rate at 24 months of follow-up after discontinuation of thiopurines in patients with quiescent Ulcerative Colitis in prolonged remission and advanced age compared to those who continue treatment.
Key facts
- Sponsor
- Grupo Espanol De Trabajo En Enfermedad De Crohn y Colitis Ulcerosa
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Decision date (initial)
- 2026-04-30
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-524675-23-00
- ClinicalTrials.gov
- NCT07248644
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To evaluate the biological recurrence rate at 24 months of follow-up after discontinuation of thiopurines in patients with quiescent Ulcerative Colitis in prolonged remission and advanced age compared to those who continue treatment.
Secondary objectives 5
- Identify factors associated with clinical and biological recurrence and colectomy after withdrawal of thiopurines.
- Clinical and biological remission rate after discontinuation of thiopurines.
- Describe the time to clinical recurrence and biological recurrence.
- Compare the safety of both strategies based on the rate of adverse effects, rate of hospitalisation due to disease flare-ups or complications, rate of hospitalisation due to adverse effects, rate of colectomy, disease-related mortality, and mortality associated with adverse effects.
- Long-term passive follow-up to determine the introduction of advanced therapies or immunosuppressants, colectomy, AA, and AAG.
Conditions and MedDRA coding
Ulcerative Colitis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10045365 | Ulcerative colitis | 10017947 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 9
- 1. Age 60 years or older.
- 2. Established diagnosis of ulcerative colitis according to ECCO criteria.
- 3. Treatment with azathioprine (AZA; 1–2.5 mg/kg/day) or mercaptopurine (MP; 0.75–1.5 mg/kg/day) for ≥5 consecutive years, at stable doses (minimum effective dose without adverse effects) during the last 12 months.
- 4. In the case of concomitant treatment with oral mesalazine, stable doses for the last 12 months.
- 5. Clinical remission maintained for ≥3 years, in the investigator's opinion, defined as: i. Absence of flare-ups requiring systemic corticosteroids (oral or IV) or biological agents. ii. The use of stable oral mesalazine and/or topical rectal treatments is permitted if the dose has remained stable over the last 12 months.
- 6. Objective clinical remission at the inclusion visit: (1) Partial Mayo index ≤2 (with rectal bleeding subindex equal to 0).
- 7. Endoscopic remission confirmed by colonoscopy performed within 12 months prior to study inclusion with endoscopic Mayo subindex=0 according to clinical practice.
- 8. Subclinical inflammatory remission: Baseline faecal calprotectin ≤150 mg/kg, measured approximately 1 month (+/- 1 week) prior to randomisation.
- 9. Written informed consent.
Exclusion criteria 10
- 1. Ulcerative proctitis (maximum extent observed <25 cm during the course of the disease).
- 2. Total or segmental colectomy
- 3. Ileoanal reservoir
- 4. History of complex perianal disease
- 5. Intolerance to oral 5-ASA
- 6. Current or previous treatment with any selective immunomodulator or advanced therapy approved for the treatment of ulcerative colitis for any indication.
- 7. Cessation of topical treatment (mesalazine or steroids) in the 3 months prior to inclusion
- 8. CRF with creatinine ≥2mg/dl (glomerular filtration rate ≤ 30mL/min/1.73m2)
- 9. Abnormal liver function tests (AST, ALT, alkaline phosphatase or GGT elevated >2 times the upper limit of normal) at the time of inclusion
- 10. Neutrophil count <1500x10⁶ cells/mm³, lymphocytes <500x10⁶ cells/mm³, platelets <120,000x10⁶ cells/mm³, haemoglobin <12 g/dL (women) or 13 g/dL (men) at the time of inclusion.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Biological recurrence: faecal calprotectin >250 µg/g confirmed in two consecutive samples OR clinical recurrence requiring intensification of treatment within 24 months.
Secondary endpoints 7
- Time to relapse
- Clinical recurrence rate
- Colectomy rate
- Safety and adverse events
- Mortality
- Hospitalisation rate (due to activity or adverse events)
- Treatment adherence (Morisky-Green scale)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 21
Asacol 1600 mg comprimidos gastrorresistentes
PRD9295822 · Product
- Active substance
- Mesalazine
- Substance synonyms
- 5-ASA-MMX, 5-Aminosalicylic acid, MESALAMINE, 5-ASA
- Pharmaceutical form
- GASTRO-RESISTANT TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 4 g gram(s)
- Max total dose
- 2920 g gram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- A07EC02 — MESALAZINE
- Marketing authorisation
- 86315
- MA holder
- TILLOTTS PHARMA SPAIN S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PENTASA 500 mg comprimidos de liberación prolongada
PRD12526485 · Product
- Active substance
- Mesalazine
- Substance synonyms
- 5-ASA-MMX, 5-Aminosalicylic acid, MESALAMINE, 5-ASA
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 4 g gram(s)
- Max total dose
- 2920 g gram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- A07EC02 — MESALAZINE
- Marketing authorisation
- 60.152
- MA holder
- FERRING S.A.U.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Asacol 1600 mg comprimidos gastrorresistentes
PRD9295821 · Product
- Active substance
- Mesalazine
- Substance synonyms
- 5-ASA-MMX, 5-Aminosalicylic acid, MESALAMINE, 5-ASA
- Pharmaceutical form
- GASTRO-RESISTANT TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 4 g gram(s)
- Max total dose
- 2920 g gram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- A07EC02 — MESALAZINE
- Marketing authorisation
- 86315
- MA holder
- TILLOTTS PHARMA SPAIN S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Asacol 800 mg comprimidos gastrorresistentes
PRD2688405 · Product
- Active substance
- Mesalazine
- Substance synonyms
- 5-ASA-MMX, 5-Aminosalicylic acid, MESALAMINE, 5-ASA
- Pharmaceutical form
- GASTRO-RESISTANT TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 4 g gram(s)
- Max total dose
- 2920 g gram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- A07EC02 — MESALAZINE
- Marketing authorisation
- 78448
- MA holder
- TILLOTTS PHARMA SPAIN S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PENTASA 500 mg comprimidos de liberación prolongada
PRD12526515 · Product
- Active substance
- Mesalazine
- Substance synonyms
- 5-ASA-MMX, 5-Aminosalicylic acid, MESALAMINE, 5-ASA
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 4 g gram(s)
- Max total dose
- 2920 g gram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- A07EC02 — MESALAZINE
- Marketing authorisation
- 60.152
- MA holder
- FERRING S.A.U.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PENTASA 500 mg comprimidos de liberación prolongada
PRD474857 · Product
- Active substance
- Mesalazine
- Substance synonyms
- 5-ASA-MMX, 5-Aminosalicylic acid, MESALAMINE, 5-ASA
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 4 g gram(s)
- Max total dose
- 2920 g gram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- A07EC02 — MESALAZINE
- Marketing authorisation
- 60.152
- MA holder
- FERRING S.A.U.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Salofalk 3 g granulado de liberación prolongada
PRD833421 · Product
- Active substance
- Mesalazine
- Substance synonyms
- 5-ASA-MMX, 5-Aminosalicylic acid, MESALAMINE, 5-ASA
- Pharmaceutical form
- PROLONGED-RELEASE GRANULES
- Route of administration
- ORAL USE
- Max daily dose
- 4 g gram(s)
- Max total dose
- 2920 g gram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- A07EC02 — MESALAZINE
- Marketing authorisation
- 74791
- MA holder
- DR. FALK PHARMA G.M.B.H.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Pentasa 4 g granulado de liberación prolongada
PRD12529103 · Product
- Active substance
- Mesalazine
- Substance synonyms
- 5-ASA-MMX, 5-Aminosalicylic acid, MESALAMINE, 5-ASA
- Pharmaceutical form
- PROLONGED-RELEASE GRANULES
- Route of administration
- ORAL USE
- Max daily dose
- 4 g gram(s)
- Max total dose
- 2920 g gram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- A07EC02 — MESALAZINE
- Marketing authorisation
- 79555
- MA holder
- FERRING S.A.U.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Pentasa 2g granulado de liberación prolongada
PRD12526680 · Product
- Active substance
- Mesalazine
- Substance synonyms
- 5-ASA-MMX, 5-Aminosalicylic acid, MESALAMINE, 5-ASA
- Pharmaceutical form
- PROLONGED-RELEASE GRANULES
- Route of administration
- ORAL USE
- Max daily dose
- 4 g gram(s)
- Max total dose
- 2920 g gram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- A07EC02 — MESALAZINE
- Marketing authorisation
- 77.668
- MA holder
- FERRING S.A.U.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Salofalk 1000 mg granulado de liberación prolongada
PRD831725 · Product
- Active substance
- Mesalazine
- Substance synonyms
- 5-ASA-MMX, 5-Aminosalicylic acid, MESALAMINE, 5-ASA
- Pharmaceutical form
- PROLONGED-RELEASE GRANULES
- Route of administration
- ORAL USE
- Max daily dose
- 4 g gram(s)
- Max total dose
- 2920 g gram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- A07EC02 — MESALAZINE
- Marketing authorisation
- 65772
- MA holder
- DR. FALK PHARMA G.M.B.H.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Pentasa 1g granulado de liberación prolongada
PRD12529892 · Product
- Active substance
- Mesalazine
- Substance synonyms
- 5-ASA-MMX, 5-Aminosalicylic acid, MESALAMINE, 5-ASA
- Pharmaceutical form
- PROLONGED-RELEASE GRANULES
- Route of administration
- ORAL USE
- Max daily dose
- 4 g gram(s)
- Max total dose
- 2920 g gram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- A07EC02 — MESALAZINE
- Marketing authorisation
- 62.670
- MA holder
- FERRING S.A.U.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Pentasa 2g granulado de liberación prolongada
PRD474846 · Product
- Active substance
- Mesalazine
- Substance synonyms
- 5-ASA-MMX, 5-Aminosalicylic acid, MESALAMINE, 5-ASA
- Pharmaceutical form
- PROLONGED-RELEASE GRANULES
- Route of administration
- ORAL USE
- Max daily dose
- 4 g gram(s)
- Max total dose
- 2920 g gram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- A07EC02 — MESALAZINE
- Marketing authorisation
- 77.668
- MA holder
- FERRING S.A.U.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Pentasa 4 g granulado de liberación prolongada
PRD12529106 · Product
- Active substance
- Mesalazine
- Substance synonyms
- 5-ASA-MMX, 5-Aminosalicylic acid, MESALAMINE, 5-ASA
- Pharmaceutical form
- PROLONGED-RELEASE GRANULES
- Route of administration
- ORAL USE
- Max daily dose
- 4 g gram(s)
- Max total dose
- 2920 g gram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- A07EC02 — MESALAZINE
- Marketing authorisation
- 79555
- MA holder
- FERRING S.A.U.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PENTASA 500 mg comprimidos de liberación prolongada
PRD12526514 · Product
- Active substance
- Mesalazine
- Substance synonyms
- 5-ASA-MMX, 5-Aminosalicylic acid, MESALAMINE, 5-ASA
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 4 g gram(s)
- Max total dose
- 2920 g gram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- A07EC02 — MESALAZINE
- Marketing authorisation
- 60.152
- MA holder
- FERRING S.A.U.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Pentasa 1g granulado de liberación prolongada
PRD12529873 · Product
- Active substance
- Mesalazine
- Substance synonyms
- 5-ASA-MMX, 5-Aminosalicylic acid, MESALAMINE, 5-ASA
- Pharmaceutical form
- PROLONGED-RELEASE GRANULES
- Route of administration
- ORAL USE
- Max daily dose
- 4 g gram(s)
- Max total dose
- 2920 g gram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- A07EC02 — MESALAZINE
- Marketing authorisation
- 62.670
- MA holder
- FERRING S.A.U.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Claversal 500 mg comprimidos gastrorresistentes
PRD439613 · Product
- Active substance
- Mesalazine
- Substance synonyms
- 5-ASA-MMX, 5-Aminosalicylic acid, MESALAMINE, 5-ASA
- Pharmaceutical form
- GASTRO-RESISTANT TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 4 g gram(s)
- Max total dose
- 2920 g gram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- A07EC02 — MESALAZINE
- Marketing authorisation
- 58.101
- MA holder
- FAES FARMA, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Pentasa 1g granulado de liberación prolongada
PRD474830 · Product
- Active substance
- Mesalazine
- Substance synonyms
- 5-ASA-MMX, 5-Aminosalicylic acid, MESALAMINE, 5-ASA
- Pharmaceutical form
- PROLONGED-RELEASE GRANULES
- Route of administration
- ORAL USE
- Max daily dose
- 4 g gram(s)
- Max total dose
- 2920 g gram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- A07EC02 — MESALAZINE
- Marketing authorisation
- 62.670
- MA holder
- FERRING S.A.U.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Pentasa 4 g granulado de liberación prolongada
PRD12529084 · Product
- Active substance
- Mesalazine
- Substance synonyms
- 5-ASA-MMX, 5-Aminosalicylic acid, MESALAMINE, 5-ASA
- Pharmaceutical form
- PROLONGED-RELEASE GRANULES
- Route of administration
- ORAL USE
- Max daily dose
- 4 g gram(s)
- Max total dose
- 2920 g gram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- A07EC02 — MESALAZINE
- Marketing authorisation
- 79555
- MA holder
- FERRING S.A.U.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Claversal 1 g comprimidos gastrorresistentes
PRD6277732 · Product
- Active substance
- Mesalazine
- Substance synonyms
- 5-ASA-MMX, 5-Aminosalicylic acid, MESALAMINE, 5-ASA
- Pharmaceutical form
- GASTRO-RESISTANT TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 4 g gram(s)
- Max total dose
- 2920 g gram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- A07EC02 — MESALAZINE
- Marketing authorisation
- 83.162
- MA holder
- FAES FARMA, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PENTASA1 g comprimidos de liberación prolongada
PRD2020218 · Product
- Active substance
- Mesalazine
- Substance synonyms
- 5-ASA-MMX, 5-Aminosalicylic acid, MESALAMINE, 5-ASA
- Pharmaceutical form
- PROLONGED-RELEASE TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 4 g gram(s)
- Max total dose
- 2920 g gram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- A07EC02 — MESALAZINE
- Marketing authorisation
- 77022
- MA holder
- FERRING S.A.U.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Pentasa 4 g granulado de liberación prolongada
PRD3516948 · Product
- Active substance
- Mesalazine
- Substance synonyms
- 5-ASA-MMX, 5-Aminosalicylic acid, MESALAMINE, 5-ASA
- Pharmaceutical form
- PROLONGED-RELEASE GRANULES
- Route of administration
- ORAL USE
- Max daily dose
- 4 g gram(s)
- Max total dose
- 2920 g gram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- A07EC02 — MESALAZINE
- Marketing authorisation
- 79555
- MA holder
- FERRING S.A.U.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Grupo Espanol De Trabajo En Enfermedad De Crohn y Colitis Ulcerosa
- Sponsor organisation
- Grupo Espanol De Trabajo En Enfermedad De Crohn y Colitis Ulcerosa
- Address
- Gran Via 81
- City
- Bilbao
- Postcode
- 48011
- Country
- Spain
Scientific contact point
- Organisation
- Grupo Espanol De Trabajo En Enfermedad De Crohn y Colitis Ulcerosa
- Contact name
- Clinical Trial information desk
Public contact point
- Organisation
- Grupo Espanol De Trabajo En Enfermedad De Crohn y Colitis Ulcerosa
- Contact name
- Clinical Trial information desk
Locations
1 EU/EEA country · 15 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 304 | 15 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital Universitario Miguel Servet
Gastroenterology, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Hospital Clinic De Barcelona
Gastroenterology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Marques De Valdecilla
Gastroenterology, Avenida Valdecilla Sn, 39008, Santander
Hospital Santa Ana
Gastroenterology, Avenida Enrique Martin Cuevas S/N, 18600, Motril
Complejo Hospitalario Universitario De Ourense
Gastroenterology, Calle De Ramon Puga Noguerol Nº 52, 32005, Ourense
University Hospital Virgen Del Rocio S.L.
Gastroenterology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Fundacio Assistencial De Mutua De Terrassa Fpc
Gastroenterology, Calle De San Antonio No 32, 08221, Terrassa
Hospital Universitari De Girona Doctor Josep Trueta
Gastroenterology, Avinguda De Franca S/n, 17007, Girona
Parc Tauli Hospital Universitari
Gastroenterology, Parc Del Tauli 1, 08208, Sabadell
Hospital Universitario La Paz
Gastroenterology, Paseo De La Castellana 261, 28046, Madrid
Complexo Hospitalario Universitario De Santiago
Gastroenterology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Consorci Sanitari Del Maresme
Gastroenterology, Carretera De Cirera 230, 08304, Mataro
Hospital Universitario De Burgos
Gastroenterology, Avenida De Las Islas Baleares 3, 09006, Burgos
Hospital Germans Trias I Pujol
Gastroenterology, Carretera Canyet 1a Planta, 08916, Badalona
Hospital Alvaro Cunqueiro
Gastroenterology, Estrada Clara Campoamor No 341, 36312, Vigo
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 18 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_ES_RFI-CT-2025-524675-23-00-IN-005 | 1.2 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_ES__2025-524675-23-00_RFI_IN_001 | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF adults_ ES_2025-524675-23-00 | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF adults_ ES_2025-524675-23-00-IN-002 | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_ES_RFI-CT-2025-524675-23-00-IN-004 | 1.2 |
| Subject information and informed consent form (for publication) | L2_ Other subject information_ES-2025_524675-23-00 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_Smpc_mesalazina_Asacol 1600 mg__FT_86315_ES_2025-524675-23-00 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_Smpc_mesalazina_Asacol 800 mg__FT_78448_ES_2025-524675-23-00 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_Smpc_mesalazina_Claversal 1 g_FT 83162_ES_2025-524675-23-00 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_Smpc_mesalazina_Claversal 500mg_FT 58101_ES_2025-524675-23-00 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_Smpc_mesalazina_Pentasa_1g granulado_FERRING_FT_62670_ES_2025-524675-23-00 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_Smpc_mesalazina_Pentasa_1g_FERRING_FT_77022_ES_2025-524675-23-00 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_Smpc_mesalazina_Pentasa_2g granulado_FERRING_FT_77668_ES_2025-524675-23-00 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_Smpc_mesalazina_Pentasa_4g_FERRING_FT_79555_ES_2025-524675-23-00 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_Smpc_mesalazina_Pentasa_500mg_FERRING_FT_60152_ES_2025-524675-23-00 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_Smpc_mesalazina_Salofalk_granulados_ES_2025-524675-23-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EN_RFI-CT-2025-524675-23-00-IN-005 | 1.2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_RFI-CT-2025-524675-23-00-IN-005 | 1.2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-01-13 | Spain | Acceptable 2026-04-29
|
2026-04-30 |