Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
214
Countries
1
Sites
4
Heart Failure
In patients with early breast cancer scheduled for anthracycline-containing anti-cancer therapy, to assess whether the administration of LCZ696 (sacubitril/valsartan) can prevent or is associated with attenuation of the reduction in left ventricular systolic function measured by cardiovascular magnetic resonance (CMR).
Key facts
- Sponsor
- Akershus University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14], Diseases [C] - Neoplasms [C04]
- Trial duration
- 13 Nov 2024 → ongoing
- Decision date (initial)
- 2024-11-13
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515323-11-00
- EudraCT number
- 2017-004909-41
- ClinicalTrials.gov
- NCT03760588
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Prophylaxis
In patients with early breast cancer scheduled for anthracycline-containing anti-cancer therapy, to assess whether the administration of LCZ696 (sacubitril/valsartan) can prevent or is associated with attenuation of the reduction in left ventricular systolic function measured by cardiovascular magnetic resonance (CMR).
Secondary objectives 4
- To assess whether the administration of LCZ696 is associated with prevention of reduction in left ventricular systolic function measured by echocardiography or CMR.
- To assess whether the administration of LCZ696 is associated with reduced incidence of a significant reduction in left ventricular systolic function measured by CMR or echocardiography.
- To assess whether the administration of LCZ696 is associated with reduced incidence of cardiotoxicity measured by CMR or echocardiography.
- To assess whether the administration of LCZ696 is associated with reduced early, acute and late, chronic cardiotoxic injury measured by cardiac biomarkers
Conditions and MedDRA coding
Heart Failure
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Women with histological evidence of invasive early breast cancer scheduled for neoadjuvant and/or adjuvant therapy with anti-cancer regimens that include anthracyclines.
- Eastern Cooperative Oncology Group performance status 0-1.
- Sinus rhythm.
Exclusion criteria 16
- Age <18 years
- Renal failure, i.e. serum creatinine greater than 133 micromol/L (1,5 mg/dl) or estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73m2
- Hyperkalemia, i.e. serum potassium greater than 5.0 mmol/L
- Systolic blood pressure < 100 mg Hg
- Uncontrolled hypertension
- Acute myocardial infarction within the last three months
- Contraindication to angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) or LCZ696, including previous hypersensitivity reaction, angioedema and renal artery stenosis
- ACEI, ARB, aldosterone antagonist or LCZ696 use within 4 weeks of study start
- Clear indication for ACEI, ARB, aldosterone antagonist or LCZ696 therapy, including symptomatic heart failure
- History of hemodynamically significant valvular disease
- Active liver disease, i.e. alanine aminotransferase or aspartate aminotransferase greater than 1.5 times the upper limit of normal
- Participation in another pharmaceutical clinical trial of an investigational medicinal product less than 4 weeks prior to inclusion or use of other investigational drugs within 5 half-lives of enrollment, whichever is longer
- Conditions that would affect the participants to comply with the study protocol as psychiatric or mental disorders, alcohol abuse or other substance abuse, suspected poor drug compliance, language barriers or other factors
- Contraindication or inability to undergo CMR examination
- Fertile women with inadequate birth control, pregnancy, and/or breastfeeding. Adequate contraception includes oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device or system, vasectomized partner or sexual abstinence. Fertile women are defined as following menarche and until becoming postmenopausal unless permanently sterile. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause
- Life expectancy < 12 months
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change in left ventricular ejection fraction (LVEF), as determined by CMR from randomization to end of blinded therapy (18 months).
Secondary endpoints 9
- Change in left ventricular ejection fraction (LVEF), as determined by echocardiography from randomization to end of blinded therapy (18 months).
- Change in global longitudinal strain (GLS), as determined by echocardiography from randomization to end of blinded therapy (18 months).
- Change in GLS, as determined by CMR from randomization to end of blinded therapy (18 months)
- Change in end-systolic volume measured by CMR.
- Incidence of clinically significant reduction in left ventricular systolic function expressed as an absolute reduction in LVEF >/=5% by CMR.
- Incidence of clinically significant reduction in left ventricular systolic function expressed as a relative percentage reduction of GLS > 15%
- Incidence of cardiotoxicity expressed as an absolute reduction in LVEF >/=10% to a value below 50% as measured either by CMR or Echocardiography.
- Incidence of cardiotoxicity expressed as incidence of clinical heart failure.
- Cardiotoxic injury expressed as change in circulating concentrations of cardiac troponins I and T measured by high sensitivity assays (hs-TnI and hs-TnT) and N-terminal proB-type natriuretic peptide (NT-proBNP).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 22
Entresto 24 mg/26 mg film-coated tablets
PRD5493641 · Product
- Active substance
- Valsartan
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- C09DX04 — -
- Marketing authorisation
- EU/1/15/1058/017
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Entresto 49 mg/51 mg film-coated tablets
PRD4293027 · Product
- Active substance
- Valsartan
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- C09DX04 — -
- Marketing authorisation
- EU/1/15/1058/012
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Entresto 24 mg/26 mg film-coated tablets
PRD4293014 · Product
- Active substance
- Valsartan
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- C09DX04 — -
- Marketing authorisation
- EU/1/15/1058/008
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Entresto 49 mg/51 mg film-coated tablets
PRD3417304 · Product
- Active substance
- Valsartan
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- C09DX04 — -
- Marketing authorisation
- EU/1/15/1058/004
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Entresto 49 mg/51 mg film-coated tablets
PRD7765242 · Product
- Active substance
- Valsartan
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- C09DX04 — -
- Marketing authorisation
- EU/1/15/1058/020
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Entresto 97 mg/103 mg film-coated tablets
PRD3417300 · Product
- Active substance
- Valsartan
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- C09DX04 — -
- Marketing authorisation
- EU/1/15/1058/006
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Entresto 97 mg/103 mg film-coated tablets
PRD4293039 · Product
- Active substance
- Valsartan
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- C09DX04 — -
- Marketing authorisation
- EU/1/15/1058/015
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Entresto 24 mg/26 mg film-coated tablets
PRD4293015 · Product
- Active substance
- Valsartan
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- C09DX04 — -
- Marketing authorisation
- EU/1/15/1058/009
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Entresto 24 mg/26 mg film-coated tablets
PRD4293022 · Product
- Active substance
- Valsartan
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- C09DX04 — -
- Marketing authorisation
- EU/1/15/1058/010
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Entresto 24 mg/26 mg film-coated tablets
PRD7765234 · Product
- Active substance
- Valsartan
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- C09DX04 — -
- Marketing authorisation
- EU/1/15/1058/018
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Entresto 97 mg/103 mg film-coated tablets
PRD3417301 · Product
- Active substance
- Valsartan
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- C09DX04 — -
- Marketing authorisation
- EU/1/15/1058/007
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Entresto 97 mg/103 mg film-coated tablets
PRD7765250 · Product
- Active substance
- Valsartan
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- C09DX04 — -
- Marketing authorisation
- EU/1/15/1058/022
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Entresto 97 mg/103 mg film-coated tablets
PRD7765246 · Product
- Active substance
- Valsartan
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- C09DX04 — -
- Marketing authorisation
- EU/1/15/1058/021
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Entresto 97 mg/103 mg film-coated tablets
PRD3417299 · Product
- Active substance
- Valsartan
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- C09DX04 — -
- Marketing authorisation
- EU/1/15/1058/005
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Entresto 49 mg/51 mg film-coated tablets
PRD3417302 · Product
- Active substance
- Valsartan
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- C09DX04 — -
- Marketing authorisation
- EU/1/15/1058/002
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Entresto 49 mg/51 mg film-coated tablets
PRD4293034 · Product
- Active substance
- Valsartan
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- C09DX04 — -
- Marketing authorisation
- EU/1/15/1058/013
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Entresto 97 mg/103 mg film-coated tablets
PRD4293046 · Product
- Active substance
- Valsartan
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- C09DX04 — -
- Marketing authorisation
- EU/1/15/1058/016
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Entresto 49 mg/51 mg film-coated tablets
PRD4293026 · Product
- Active substance
- Valsartan
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- C09DX04 — -
- Marketing authorisation
- EU/1/15/1058/011
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Entresto 49 mg/51 mg film-coated tablets
PRD3417303 · Product
- Active substance
- Valsartan
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- C09DX04 — -
- Marketing authorisation
- EU/1/15/1058/003
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Entresto 49 mg/51 mg film-coated tablets
PRD7765238 · Product
- Active substance
- Valsartan
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- C09DX04 — -
- Marketing authorisation
- EU/1/15/1058/019
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Entresto 24 mg/26 mg film-coated tablets
PRD3417298 · Product
- Active substance
- Valsartan
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- C09DX04 — -
- Marketing authorisation
- EU/1/15/1058/001
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Entresto 97 mg/103 mg film-coated tablets
PRD4293038 · Product
- Active substance
- Valsartan
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- C09DX04 — -
- Marketing authorisation
- EU/1/15/1058/014
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 3
Placebo to sacubitril/valsartan (lcz696) 200 mg film coated tablet
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Placebo to sacubitril/valsartan (lcz696) 100mg film coated tablet
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Placebo to sacubitril/valsartan (lcz696) 50 mg film coated tablet
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Akershus University Hospital
- Sponsor organisation
- Akershus University Hospital
- Address
- Sykehusveien 25
- City
- Loerenskog
- Postcode
- 1474
- Country
- Norway
Scientific contact point
- Organisation
- Akershus University Hospital
- Contact name
- Torbjørn Omland
Public contact point
- Organisation
- Akershus University Hospital
- Contact name
- Geeta Gulati
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Ongoing, recruitment ended | 214 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Akershus University Hospital
Division of Medicine, Sykehusveien 27, 1478, Lorenskog
Stavanger University Hospital HF
Department of Cardiology, Helse Stavanger HF, Postboks 8100, Stavanger
St. Olavs Hospital HF
Clinic of Cardiology, Prinsesse Kristinas G. 3, 7030, Trondheim
University Hospital of North Norway
Department of Oncology, Postboks 100, 9038, Tromsø
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Norway | 2024-11-13 | 2024-11-13 | 2024-11-13 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 13 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_EU CT 2024-515323-11-00_uten sign | 0.11 |
| Recruitment arrangements (for publication) | Recruitment arrangements_Study-name Blank document for CTR transferral | 1 |
| Subject information and informed consent form (for publication) | Graviditetstestdagbok_v2_021219 | 2.0 |
| Subject information and informed consent form (for publication) | Medikamentdagbok_versjon 3_0_220121 | 3.0 |
| Subject information and informed consent form (for publication) | Pasientprosedyre Graviditetstest InstAlert v2_071218 | 2.0 |
| Subject information and informed consent form (for publication) | Pasientprosedyre Medikamentopptrapping_v1_0_271118 | 1.0 |
| Subject information and informed consent form (for publication) | Samtykke frisk frivillig_AHUS_V3_0_030521_clean | 3.0 |
| Subject information and informed consent form (for publication) | Samtykkeskjema_Ahus_v2_4_150221_clean | 2.4 |
| Subject information and informed consent form (for publication) | Samtykkeskjema_StOlavs_v2_4_150221_clean | 2.4 |
| Subject information and informed consent form (for publication) | Samtykkeskjema_SUS_v2_4_150221_clean | 2.4 |
| Subject information and informed consent form (for publication) | Samtykkeskjema_UNN_v2_4_150221_clean | 2.4 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_entresto | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EU CT 2024-515323-11-00_Blank document for CTR transferral | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-17 | Norway | Acceptable 2024-11-12
|
2024-11-13 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-11-19 | Norway | Acceptable 2024-11-12
|
2025-11-19 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-02-04 | Norway | Acceptable 2024-11-12
|
2026-02-04 |