Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
1,590
Countries
9
Sites
67
Pneumonia
To provide reliable estimates of the effect of study treatments on mortality and time to discharge from hospital
Key facts
- Sponsor
- University Of Oxford
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02], Diseases [C] - Bacterial Infections and Mycoses [C01], Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 29 Feb 2024 → ongoing
- Decision date (initial)
- 2024-11-28
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- NIHR Clinical Trials Unit Support Funding (core funding) · Health Data Research UK (core funding) · The Bill and Melinda Gates Foundation (core funding) · NIHR Oxford Biomedical Research Centre (core funding) · UK Foreign, Commonwealth and Development Office (core funding) · Flu Lab · Wellcome (core funding) · MRC Population Health Research Unit at the University of Oxford (core funding)
External identifiers
- EU CT number
- 2023-507441-29-00
- ClinicalTrials.gov
- NCT04381936
- ISRCTN
- ISRCTN50189673
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
To provide reliable estimates of the effect of study treatments on mortality and time to discharge from hospital
Secondary objectives 1
- To assess the effect of study treatment on progression to invasive mechanical ventilation or extracorporeal membrane oxygenation
Conditions and MedDRA coding
Pneumonia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10035664 | Pneumonia | 100000004862 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Hospitalised patients aged ≥18 years
- Pneumonia syndrome (clinical diagnosis, in general based on a) typical symptoms of new respiratory infection, b) objective evidence of acute lung disease [e.g. hypoxia or compatible imaging or clinical examination], and c) alternative causes considered unlikely
- One of the following diagnoses: a) Confirmed influenza A or B infection b) Community-acquired pneumonia with planned antibiotic treatment (without suspected or confirmed SARS-CoV-2, influenza, active pulmonary tuberculosis, or Pneumocystis pneumonia)
- No medical history that might, in the opinion of the patient’s doctor, put the patient at significant risk if he/she were to participate in the trial
- No reason that the trial treatment definitely should, or should not, be given in the opinion of the patient’s doctor (this only affects eligibility for the relevant comparison)
Exclusion criteria 1
- No exclusion criteria
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- 28 day all-cause mortality
- Time to discharge alive from hospital within 28 days (patients with influenza only)
Secondary endpoints 2
- Time to discharge alive from hospital within 28 days (patients without influenza)
- Progression to invasive mechanical ventilation (including extracorporeal membrane oxygenation) or death within 28 days
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
PRD2154676 · Product
- Active substance
- Oseltamivir
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 1500 mg milligram(s)
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- J05AH02 — OSELTAMIVIR
- Marketing authorisation
- EU/1/02/222/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Hydrocortisone 100 mg, powder for solution for injection/infusion
PRD5848761 · Product
- Active substance
- Hydrocortisone Sodium Succinate
- Substance synonyms
- HYDROCORTISONE 21-(SODIUM SUCCINATE)
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 160 mg milligram(s)
- Max total dose
- 1600 mg milligram(s)
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB09 — HYDROCORTISONE
- Marketing authorisation
- PL 44124/0020
- MA holder
- PANPHARMA
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD4940399 · Product
- Active substance
- Prednisolone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB06 — PREDNISOLONE
- Marketing authorisation
- PL 00142/0843
- MA holder
- ACCORD-UK LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Dexamethasone Tablets BP 2.0mg
PRD3570594 · Product
- Active substance
- Dexamethasone Ph. Eur.
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- PL 39699/0056
- MA holder
- ASPEN PHARMA TRADING LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Dexamethasone 3.3 mg/ml solution for injection
PRD302046 · Product
- Active substance
- Dexamethasone Sodium Phosphate
- Substance synonyms
- SODIUM DEXAMETHASONE PHOSPHATE
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- IV INFUSION
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- PL 01502 /0079
- MA holder
- HAMELN PHARMA LTD
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Xofluza 20 mg film-coated tablets
PRD8645550 · Product
- Active substance
- Baloxavir Marboxil
- Substance synonyms
- S-033188, (((12AR)-12-((11S)-7,8-DIFLUORO-6,11-DIHYDRODIBENZO(B,E)THIEPIN-11-YL)-6,8-DIOXO-3,4,6,8,12,12AHEXAHYDRO-1H-(1,4)OXAZINO(3,4-C)PYRIDO(2,1-F)(1,2,4)TRIAZIN-7-YL)OXY)METHYL METHYL CARBONATE
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 160 mg milligram(s)
- Max treatment duration
- 4 Day(s)
- Authorisation status
- Authorised
- ATC code
- J05AX25 — -
- Marketing authorisation
- EU/1/20/1500/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Refer to the following document for a description of the modification: F3_ Other statements_licences_Regulatory compliance confirmation_ Roche
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
University Of Oxford
- Sponsor organisation
- University Of Oxford
- Address
- Richard Doll Building, Old Road, Headington Old Road Headington
- City
- Oxford
- Postcode
- OX3 7LF
- Country
- United Kingdom
Scientific contact point
- Organisation
- University Of Oxford
- Contact name
- Leon Peto
Public contact point
- Organisation
- University Of Oxford
- Contact name
- Leon Peto
Locations
9 EU/EEA countries · 67 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 150 | 5 |
| Estonia | Ongoing, recruiting | 120 | 4 |
| France | Ongoing, recruiting | 160 | 12 |
| Italy | Ongoing, recruiting | 160 | 13 |
| Netherlands | Ongoing, recruiting | 160 | 4 |
| Portugal | Ongoing, recruiting | 150 | 5 |
| Romania | Ongoing, recruiting | 210 | 7 |
| Spain | Ongoing, recruiting | 240 | 9 |
| Sweden | Ongoing, recruiting | 240 | 8 |
| Rest of world | — | 0 | — |
Investigational sites
Jessa Ziekenhuis
Infectious Diseases, Stadsomvaart 11, 3500, Hasselt
Universitair Ziekenhuis Gent
Dept. of Respiratory Medicine, Corneel Heymanslaan 10, 9000, Gent
CHU Saint-Pierre
Infectious Diseases, Rue aux Laines 105, 1000, Bruxelles
Cliniques Universitaires Saint-Luc
Internal Medicine and Infectious Disease, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
UZ Leuven
Respiratory Medicin, Herestraat 49, 3000, Leuven
Tartu University Hospital
Department of infection control, A006, L. Puusepa Tn 8, Tartu Linn
Laane-Tallinna Keskhaigla AS
Infectious Diseases, Paldiski Mnt 68, 10617, Pohja-Tallinna Linnaosa
North Estonia Medical Centre Foundation
Department of infection control, J. Sutiste Tee 19, Mustamae Linnaosa, Tallinn
Sihtasutus Parnu Haigla
Internal Medicine, Ristiku Tn 1, 80010, Parnu Linn
Hôpital Bichat Claude-Bernard AP-HP
Infectious diseases and tropical diseases, 46 Rue Henri Huchard, cedex Paris 18, Paris
Hopital Saint Antoine
Infectious diseases, 184 Rue Du Faubourg Saint Antoine, 75571, Paris Cedex 12
Hospital Edouard Herriot
Emergency Department, 5 Place D Arsonval, 69437, Lyon Cedex 03
Centre Hospitalier Regional D'Angers
Emergency Department, 4 Rue Larrey, 49100, Angers
Centre Hospitalier Universitaire De Nice
ICU/Infectious and Tropical Diseases, 151 Route De Saint Antoine, 06200, Nice
Pellegrin Hospital
Infectious Diseases, Place Amelie Raba Leon, 33000, Bordeaux
Raymond Poincare Hospital
Infectious Diseases, 104 Boulevard Raymond Poincare, 92380, Garches
University Of Strasbourg
Infectious diseases, 1 Place De L Hopital, 67000, Strasbourg
Centre Hospitalier Universitaire De Lille
Infectious Diseases, Rue Michel Polonovski, 59037, Lille Cedex
Centre Hospitalier Regional Universitaire De Tours
Emergency Department, 2 Boulevard Tonnelle, 37044, Tours Cedex 9
Centre Hospitalier Et Universitaire De Limoges
Emergency Department, 2 Avenue Martin Luther King, 87000, Limoges
Centre Hospitalier Universitaire De Toulouse
Infectious diseases and tropical diseases, 1 Place Du Docteur Joseph Baylac, 31300, Toulouse
Azienda Ospedaliero Universitaria Pisana
Infectious Diseases Unit, Via Paradisa 2, 56124, Pisa
Azienda Ospedaliera Dei Colli
Internal Medicine, Via Leonardo Bianchi, 80131, Naples
Azienda Ospedaliera Universitaria Integrata Verona
Infectious and Tropical Diseases Unit, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Azienda Ospedaliero Universitaria Delle Marche
Gastroenterolgy and Transplantation, Via Conca 71, 60126, Ancona
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Infectious Diseases, Via Del Vespro 129, 90127, Palermo
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Infectious Diseases, Largo Francesco Vito 1, 00168, Rome
Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo
Infectious and Tropical Diseases, Via Antonio Di Rudini' 8, 20142, Milan
ASST Fatebenefratelli Sacco
Infectious Diseases, Via Giovanni Battista Grassi 74, 20157, Milan
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Pathophysiology and Transplantation, Via Francesco Sforza 28, 20122, Milan
Azienda Provinciale Per I Servizi Sanitari - Ospedale Civile Santa Chiara
Infectious Disease Unit, Largo Medaglie D’Oro 9, 38122, Trento
Istituto San Raffaele
Infectious Diseases, Via Stamira D'ancona 20, 20127, Milan
Humanitas Mirasole S.p.A.
Pulmonology, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Sanitaria Universitaria Giuliano Isontina
Pulmonology, Strada Di Fiume 447, 34149, Trieste
Södersjukhuset
Infektionskliniken/Venhälsan, Sjukhusbacken 10, 118 83, Stockholm
Amphia Hospital
Pulmonology, Molengracht 21, 4818 CK, Breda
Jeroen Bosch Ziekenhuis
General Internal Medicine and Endocrinology, Henri Dunantstraat 1, 5223 GZ, 's-Hertogenbosch
Amsterdam UMC
Infectious Diseases, Meibergdreef 9, 1105 AZ, Amsterdam
Unidade Local de Saude de Sao Joao E.P.E.
Internal medicine, Alameda Professor Hernani Monteiro, 4200-319, Porto
Hospital Da Luz Arrabida S.A.
Internal medicine, Praceta Henrique Moreira 150, 4400-346, Vila Nova De Gaia
Hospital Da Luz S.A.
Internal medicine, Avenida Lusiada 100, 1500-650, Lisbon
Hospital Pedro Hispano
Internal medicine, Rua Doutor Eduardo Torres 1, 4450-113, Matosinhos
CCAB Centro Clinico Academico Braga Associacao
Intensive care medicine, Lugar De Sete Fontes S Victor, 4710-243, Braga
Spitalul Clinic De Boli Infectioase Constanta
Infectious Diseases and Epidemiology, Bulevardul Ferdinand 100, 900709, Constanta
Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu
Boli Infectioase, 149th Ic Bratianu Street, 077015, Balotesti
Spitalul Clinic Judetean De Urgenta Targu Mures
Clinica Boli Infectioase, Strada Marinescu Gheorghe 50, 540136, Targu Mures
Spitalul Clinic De Boli Infectioase Sf. Parascheva Iasi
Infectious Disease, Strada Botez Octav Nr 2, 700116, Jassi
Institutul National De Boli Infectioase Prof.Dr.Matei Bals
Infectious Diseases, Strada Dr. Calistrat Grozovici Nr. 1, 021105, Bucharest
Clinical Hospital Of Infectious Diseases And Pneumophysiology Dr.Victor Babes Timisoara
Infectious Disease, Strada Adam Gheorghe Nr. 13, 300310, Timisoara
Fundatia Dr. Victor Babes
Infectious Diseases, Soseaua Mihai Bravu 281, 030303, Bucharest
Hospital Universitario Central De Asturias
Intensive care, Avenida De Roma S/n, 33011, Oviedo
Hospital Universitario Virgen De La Macarena
Unidad Clinica de Engermedades Infecciosas y Microbioligia, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Clinico Universitario Lozano Blesa
Infectious Diseases, Avenida De San Juan Bosco 15, 50009, Zaragoza
Complexo Hospitalario Universitario De Vigo
Servicio de Medicina Interna, Unidad de infecciosas, Estrada Clara Campoamor N 341, 36312, Vigo
Hospital Universitario Y Politecnico La Fe
Pneumology Department, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital De La Santa Creu I Sant Pau
Infection control unit, Carrer De San Quinti 89, 08041, Barcelona
Hospital Universitari Vall D Hebron
Infectious Diseases, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Germans Trias I Pujol
Pulmonology Department, Carretera Canyet 1a Planta, 08916, Badalona
Hospital Del Mar
Infectious Diseases Department, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Norrlands University Hospital
Infektionskliniken, DanieL Naezens Vag, 90737, Umea
Karolinska University Hospital
Infectious Diseases, Halsovagen, Flemingsberg, Huddinge
Region Oestergoetland
Infektionskliniken, Universitetssjukhuset I, 58185, Linkoping
Örebro University Hospital
Infectious Diseases, Universitetssjukhuset Örebro, Department of Internal Medicine, Örebro
Länsjukhuset Kalmar
Infektionskliniken, Länsjukhuset, 39185, Kalmar
Region Skane Skanes Universitetssjukhus
Infektionskliniken, Halsogatan 3, Lunds Allhelgonafors., Lund
University of Gothenburg and Sahlgrenska University Hospital (SU)
Infectious Diseases, Diagnosvägen 21, 41650, Gothenburg
Capio S:t Goerans Sjukhus AB
medicinkliniken, Sankt Goransplan 1, Vastermalm, Stockholm
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 |
|---|---|---|---|---|---|
| Belgium | 2025-01-27 | 2025-01-29 | |||
| Estonia | 2025-06-12 | 2025-07-15 | |||
| France | 2024-02-29 | 2024-03-22 | |||
| Italy | 2024-06-12 | 2024-06-28 | |||
| Netherlands | 2024-04-03 | 2024-05-29 | |||
| Portugal | 2025-05-08 | 2025-06-16 | |||
| Romania | 2025-03-26 | 2025-06-11 | |||
| Spain | 2025-02-18 | 2025-03-03 | |||
| Sweden | 2025-01-29 | 2025-02-05 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 40 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Core Protocol_2023-507441-29-00 | 28.0 |
| Protocol (for publication) | D1_EU Appendix to Core Protocol_2023-507441-29-00 | 2.0 |
| Recruitment arrangements (for publication) | K1_Forfarande for rekrytering och samtyckesprocess | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_BE | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_RECOVERY-EU | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_RECOVERY-EU | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_RECOVERY-EU | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_RO | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_BE-FR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_BE-NL_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_EE-EE_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_EE-RU_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_ES-ES_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_FR-AR_Clean | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_FR-FR_Clean | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_IT-IT_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_NL-NL_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_PT-PT_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_RO-RO_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_SE-EN_Clean | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_SE-SE_Clean | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Xofluxa | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_ Dexamethasone 2mg Tablets | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_ Dexamethasone 3 3mg per ml IV | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_ Hydrocortisone 100 mg Powder for Solution for InjectionInfusion | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_ Prednisolone 10mg Tablets | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_ Tamiflu hard capsules | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Water for Injections BP solvent for parenteral use | 1 |
| Synopsis of the protocol (for publication) | D1_EU Protocol Synopsis ES_2023-507441-29-00 | 2.0 |
| Synopsis of the protocol (for publication) | D1_EU Protocol Synopsis FR_2023-507441-29-00 | 2.0 |
| Synopsis of the protocol (for publication) | D1_EU Protocol Synopsis IT_2023-507441-29-00 | 2.0 |
| Synopsis of the protocol (for publication) | D1_EU Protocol Synopsis NL_2023-507441-29-00 | 2.0 |
| Synopsis of the protocol (for publication) | D1_EU Protocol Synopsis PT_2023-507441-29-00 | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_DE_2023-507441-29-00 | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_EN_2023-507441-29-00 | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_RO_2023-507441-29-00 | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_SE_2023-507441-29-00 | 2.0 |
Application history
14 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-09 | Netherlands | Acceptable 2024-02-02
|
2024-02-02 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-11 | Acceptable | 2024-08-06 | |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2024-09-11 | 2024-11-28 | ||
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2024-09-11 | Acceptable 2024-02-02
|
2024-11-28 | |
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2024-09-11 | 2024-11-07 | ||
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2024-09-11 | Acceptable | 2025-01-17 | |
| 7 | SUBSEQUENT ADDITION OF MSC | APP-7 | 2024-09-11 | Acceptable 2024-02-02
|
2024-12-04 | |
| 8 | SUBSEQUENT ADDITION OF MSC | APP-8 | 2024-09-11 | Acceptable 2024-02-02
|
2024-12-09 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-09-24 | Acceptable | 2024-10-17 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-10-01 | Acceptable | 2024-11-05 | |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-01-23 | Acceptable | 2025-01-23 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-03-24 | Acceptable | 2025-05-09 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-04-30 | Acceptable | 2025-05-30 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-07-28 | Netherlands | Acceptable 2025-09-29
|
2025-09-30 |