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Human medicines European public assessment report (EPAR): Nuvaxovid, COVID-19 Vaccine (recombinant, adjuvanted), Date of authorisation: 20/12/2021, Revision: 16, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 17, 2025 0

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

EMEA-002755-PIP01-19-M02

EMEA-002755-PIP01-19-M02

Feb 17, 2025 0

EMEA-002755-PIP01-19-M02

EMEA-002713-PIP02-21-M01

EMEA-002713-PIP02-21-M01

Feb 17, 2025 0

EMEA-002713-PIP02-21-M01

Human medicines European public assessment report (EPAR): Daptomycin Hospira, daptomycin, Date of authorisation: 22/03/2017, Revision: 14, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 17, 2025 0

Human medicines European public assessment report (EPAR): Daptomycin Hospira, da...

EMEA-003301-PIP01-22-M01

EMEA-003301-PIP01-22-M01

Feb 17, 2025 0

EMEA-003301-PIP01-22-M01

Human medicines European public assessment report (EPAR): Ulunar Breezhaler, indacaterol,glycopyrronium bromide, Date of authorisation: 23/04/2014, Revision: 15, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 17, 2025 0

Human medicines European public assessment report (EPAR): Ulunar Breezhaler, ind...

Minutes - HMA-EMA joint Big Data Steering Group telecon...

Feb 17, 2025 0

Minutes - HMA-EMA joint Big Data Steering Group teleconference - 11 December 2024

International Coalition of Medicines Regulatory Authorities (ICMRA)

International Coalition of Medicines Regulatory Authori...

Feb 17, 2025 0

International Coalition of Medicines Regulatory Authorities (ICMRA)

Contact details of national competent authorities for r...

Feb 17, 2025 0

Contact details of national competent authorities for requests of translation ex...

Big data

Feb 17, 2025 0

Big data

Fifth EMA/HMA Big Data Stakeholder Forum, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 28 November 2024, 09:30 (CET) to 28 November 2024, 17:30 (CET)

Fifth EMA/HMA Big Data Stakeholder Forum, Online, Europ...

Feb 17, 2025 0

Fifth EMA/HMA Big Data Stakeholder Forum, Online, European Medicines Agency, Ams...

Human medicines European public assessment report (EPAR): Mekinist, trametinib, Date of authorisation: 30/06/2014, Revision: 36, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 17, 2025 0

Human medicines European public assessment report (EPAR): Mekinist, trametinib, ...

Environmental management

Environmental management

Feb 17, 2025 0

Environmental management

EU Implementation Guide (IG) on veterinary medicines pr...

Feb 17, 2025 0

EU Implementation Guide (IG) on veterinary medicines product data in the Union P...

European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting, European Medicines Agency, Amsterdam, the Netherlands, from 1 April 2025 to 2 April 2025

European Medicines Agency (EMA) Patients' and Consumers...

Feb 17, 2025 0

European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare P...

Human medicines European public assessment report (EPAR): CellCept, mycophenolate mofetil, Date of authorisation: 14/02/1996, Revision: 40, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 17, 2025 0

Human medicines European public assessment report (EPAR): CellCept, mycophenolat...

EMEA-003472-PIP01-23

EMEA-003472-PIP01-23

Feb 17, 2025 0

EMEA-003472-PIP01-23

Human medicines European public assessment report (EPAR): Trydonis, beclometasone,formoterol,glycopyrronium bromide, Date of authorisation: 26/04/2018, Revision: 8, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 17, 2025 0

Human medicines European public assessment report (EPAR): Trydonis, beclometason...

EMEA-003471-PIP01-23

EMEA-003471-PIP01-23

Feb 17, 2025 0

EMEA-003471-PIP01-23

EMEA-003468-PIP01-23

EMEA-003468-PIP01-23

Feb 17, 2025 0

EMEA-003468-PIP01-23

Human medicines European public assessment report (EPAR): Trimbow, beclometasone,formoterol,glycopyrronium bromide, Date of authorisation: 17/07/2017, Revision: 9, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 17, 2025 0

Human medicines European public assessment report (EPAR): Trimbow, beclometasone...

Human medicines European public assessment report (EPAR): Evenity, romosozumab, Date of authorisation: 09/12/2019, Revision: 7, Status: Authorised

Human medicines European public assessment report (EPAR...

Feb 17, 2025 0

Human medicines European public assessment report (EPAR): Evenity, romosozumab, ...

EMEA-003404-PIP01-23

EMEA-003404-PIP01-23

Feb 17, 2025 0

EMEA-003404-PIP01-23

Opinion/decision on a Paediatric investigation plan (PIP): Enerzair Breezhaler, Indacaterol (acetate),Mometasone (furoate),Glycopyrronium bromide, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Pneumology-allergology, PIP number: P/0493/2023

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

Feb 15, 2025 0

Opinion/decision on a Paediatric investigation plan (PIP): Enerzair Breezhaler, ...

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