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List of centrally authorised products with safety-relat...

Feb 28, 2025 0

List of centrally authorised products with safety-related changes to the product...

Procedural advice on CHMP/CAT/PRAC Rapporteur/Co-Rappor...

Feb 28, 2025 0

Procedural advice on CHMP/CAT/PRAC Rapporteur/Co-Rapporteur appointment principl...

Human medicines European public assessment report (EPAR): Fluenz, influenza vaccine (live attenuated, nasal), Date of authorisation: 03/06/2024, Revision: 3, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 28, 2025 0

Human medicines European public assessment report (EPAR): Fluenz, influenza vacc...

Clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome - Scientific guideline

Clinical investigation of medicinal products in the tre...

Feb 28, 2025 0

Clinical investigation of medicinal products in the treatment of patients with a...

Orphan designation: Overview

Orphan designation: Overview

Feb 28, 2025 0

Orphan designation: Overview

Draft guideline on the clinical investigation of medici...

Feb 28, 2025 0

Draft guideline on the clinical investigation of medicinal products in the treat...

Minutes of the CAT meeting 22-24 January 2025

Feb 27, 2025 0

Minutes of the CAT meeting 22-24 January 2025

Union product database: webinar for veterinary marketing authorisation holders on an industry dedicated read API, Online, from 27 February 2025, 11:00 (CET) to 27 February 2025, 12:00 (CET)

Union product database: webinar for veterinary marketin...

Feb 27, 2025 0

Union product database: webinar for veterinary marketing authorisation holders o...

Human medicines European public assessment report (EPAR): Comirnaty, COVID-19 mRNA vaccine,tozinameran,riltozinameran and tozinameran,famtozinameran and tozinameran,raxtozinameran, Date of authorisation: 21/12/2020, Revision: 52, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 27, 2025 0

Human medicines European public assessment report (EPAR): Comirnaty, COVID-19 mR...

Human medicines European public assessment report (EPAR): Zavicefta, ceftazidime,avibactam, Date of authorisation: 23/06/2016, Revision: 18, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 27, 2025 0

Human medicines European public assessment report (EPAR): Zavicefta, ceftazidime...

Human medicines European public assessment report (EPAR): Nuvaxovid, COVID-19 Vaccine (recombinant, adjuvanted), Date of authorisation: 20/12/2021, Revision: 17, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 27, 2025 0

Human medicines European public assessment report (EPAR): Nuvaxovid, COVID-19 Va...

Human medicines European public assessment report (EPAR): mResvia, Single-stranded 5' capped mRNA encoding the Respiratory syncytial virus glycoprotein F stabilized in the prefusion conformation, Date of authorisation: 22/08/2024, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 27, 2025 0

Human medicines European public assessment report (EPAR): mResvia, Single-strand...

Human medicines European public assessment report (EPAR): Advagraf, tacrolimus, Date of authorisation: 23/04/2007, Revision: 29, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 27, 2025 0

Human medicines European public assessment report (EPAR): Advagraf, tacrolimus, ...

Human medicines European public assessment report (EPAR): Omlyclo, omalizumab, Date of authorisation: 16/05/2024, Revision: 2, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 27, 2025 0

Human medicines European public assessment report (EPAR): Omlyclo, omalizumab, D...

Human medicines European public assessment report (EPAR): Remicade, infliximab, Date of authorisation: 13/08/1999, Revision: 67, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 27, 2025 0

Human medicines European public assessment report (EPAR): Remicade, infliximab, ...

Human medicines European public assessment report (EPAR): Litfulo, ritlecitinib, Date of authorisation: 15/09/2023, Revision: 4, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 27, 2025 0

Human medicines European public assessment report (EPAR): Litfulo, ritlecitinib,...

Human medicines European public assessment report (EPAR): Welireg, belzutifan, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 27, 2025 0

Human medicines European public assessment report (EPAR): Welireg, belzutifan, S...

Guidance on the details of the classification of variat...

Feb 27, 2025 0

Guidance on the details of the classification of variations requiring assessment...

Infographic - Orphan Medicines in the EU

Feb 27, 2025 0

Infographic - Orphan Medicines in the EU

Human medicines European public assessment report (EPAR): Soliris, eculizumab, Date of authorisation: 20/06/2007, Revision: 38, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 27, 2025 0

Human medicines European public assessment report (EPAR): Soliris, eculizumab, D...

Human medicines European public assessment report (EPAR): Spinraza, nusinersen, Date of authorisation: 30/05/2017, Revision: 18, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 27, 2025 0

Human medicines European public assessment report (EPAR): Spinraza, nusinersen, ...

Human medicines European public assessment report (EPAR): Xalkori, crizotinib, Date of authorisation: 23/10/2012, Revision: 37, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 27, 2025 0

Human medicines European public assessment report (EPAR): Xalkori, crizotinib, D...

Addendum to the Guideline on clinical development of va...

Feb 27, 2025 0

Addendum to the Guideline on clinical development of vaccines to address clinica...

Clinical Trial Information System (CTIS) evaluation tim...

Feb 27, 2025 0

Clinical Trial Information System (CTIS) evaluation timelines

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