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Product Management Service (PMS) questions and aswers clinic - April 2025, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 29 April 2025, 11:00 (CEST) to 29 April 2025, 12:00 (CEST)

Product Management Service (PMS) questions and aswers c...

Mar 7, 2025 0

Product Management Service (PMS) questions and aswers clinic - April 2025, Onlin...

Opinion/decision on a Paediatric investigation plan (PIP): Uplizna, Inebilizumab, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Nervous system disorders, PIP number: P/0471/2023

Opinion/decision on a Paediatric investigation plan (PI...

Mar 7, 2025 0

Opinion/decision on a Paediatric investigation plan (PIP): Uplizna, Inebilizumab...

Human medicines European public assessment report (EPAR): Kimmtrak, tebentafusp, Date of authorisation: 01/04/2022, Revision: 4, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 7, 2025 0

Human medicines European public assessment report (EPAR): Kimmtrak, tebentafusp,...

Human medicines European public assessment report (EPAR): Brinavess, vernakalant hydrochloride, Date of authorisation: 01/09/2010, Revision: 18, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 7, 2025 0

Human medicines European public assessment report (EPAR): Brinavess, vernakalant...

EMEA-003498-PIP01-23

EMEA-003498-PIP01-23

Mar 7, 2025 0

EMEA-003498-PIP01-23

List of withdrawn medicinal products in accordance with...

Mar 7, 2025 0

List of withdrawn medicinal products in accordance with Art. 123(4) of the Direc...

Human medicines European public assessment report (EPAR): Recarbrio, imipenem,cilastatin,relebactam, Date of authorisation: 13/02/2020, Revision: 7, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 7, 2025 0

Human medicines European public assessment report (EPAR): Recarbrio, imipenem,ci...

Veterinary medicines European public assessment report (EPAR): Equilis Prequenza Te, vaccine against equine influenza and tetanus in horses, Status: Authorised

Veterinary medicines European public assessment report ...

Mar 7, 2025 0

Veterinary medicines European public assessment report (EPAR): Equilis Prequenza...

EMEA-003466-PIP01-23

EMEA-003466-PIP01-23

Mar 7, 2025 0

EMEA-003466-PIP01-23

Human medicines European public assessment report (EPAR): Supemtek Tetra (previously Supemtek), Quadrivalent influenza vaccine (recombinant, prepared in cell culture), Date of authorisation: 16/11/2020, Revision: 7, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 7, 2025 0

Human medicines European public assessment report (EPAR): Supemtek Tetra (previo...

Human medicines European public assessment report (EPAR): Truqap, capivasertib, Date of authorisation: 17/06/2024, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 7, 2025 0

Human medicines European public assessment report (EPAR): Truqap, capivasertib, ...

Veterinary medicines European public assessment report (EPAR): Equilis Prequenza, vaccine against equine influenza in horses, Status: Authorised

Veterinary medicines European public assessment report ...

Mar 7, 2025 0

Veterinary medicines European public assessment report (EPAR): Equilis Prequenza...

Veterinary medicines European public assessment report (EPAR): Equilis Te, Adjuvanted vaccine against tetanus, Status: Authorised

Veterinary medicines European public assessment report ...

Mar 7, 2025 0

Veterinary medicines European public assessment report (EPAR): Equilis Te, Adjuv...

COVID-19 medicines

COVID-19 medicines

Mar 7, 2025 0

COVID-19 medicines

Minutes of the CHMP meeting 11-14 November 2024

Mar 7, 2025 0

Minutes of the CHMP meeting 11-14 November 2024

List of withdrawn medicinal products in accordance with...

Mar 7, 2025 0

List of withdrawn medicinal products in accordance with Art. 123(4) of the Direc...

EMEA-003238-PIP02-22

EMEA-003238-PIP02-22

Mar 6, 2025 0

EMEA-003238-PIP02-22

EMEA-003237-PIP02-22

EMEA-003237-PIP02-22

Mar 6, 2025 0

EMEA-003237-PIP02-22

Human medicines European public assessment report (EPAR): Hexyon, diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed), Date of authorisation: 17/04/2013, Date of refusal: 22/02/2013, Revision: 33, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 6, 2025 0

Human medicines European public assessment report (EPAR): Hexyon, diphtheria, te...

Human medicines European public assessment report (EPAR): Rybelsus, semaglutide, Date of authorisation: 03/04/2020, Revision: 13, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 6, 2025 0

Human medicines European public assessment report (EPAR): Rybelsus, semaglutide,...

Human medicines European public assessment report (EPAR): Eltrombopag Viatris, eltrombopag, Date of authorisation: 12/12/2024, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 6, 2025 0

Human medicines European public assessment report (EPAR): Eltrombopag Viatris, e...

PSUSA/00010483/202406

PSUSA/00010483/202406

Mar 6, 2025 0

PSUSA/00010483/202406

Human medicines European public assessment report (EPAR): Tygacil, tigecycline, Date of authorisation: 24/04/2006, Revision: 35, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 6, 2025 0

Human medicines European public assessment report (EPAR): Tygacil, tigecycline, ...

Human medicines European public assessment report (EPAR): Pregabalin Viatris (previously Pregabalin Mylan), pregabalin, Date of authorisation: 24/06/2015, Revision: 22, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 6, 2025 0

Human medicines European public assessment report (EPAR): Pregabalin Viatris (pr...

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