Submission dates

The timing and planning of the submission of applications and the timetable for assessment of applications is important for applicants and marketing-authorisation holders (MAHs). It is also important for the European Medicines Agency (EMA), and for the members and experts working on its Committees for Medicinal Products for Human Use (CHMP)...

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HumanRegulatory and procedural guidance
PRAC recommendations on safety signals

Each month, the European Medicines Agency publishes an overview listing all safety signals discussed during the latest Pharmacovigilance Risk Assessment Committee (PRAC) meeting and the recommendations given for each of them. The overview includes PRAC recommendations for centrally and nationally authorised medicines.

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HumanRegulatory and procedural guidancePharmacovigilance
Opening procedures at EMA to non-EU authorities (OPEN) initiative

The European Medicines Agency (EMA) collaborates with medicine regulators outside the European Union (EU) in the scientific evaluation of certain medicines, within a framework called OPEN (opening procedures at EMA to non-EU authorities).

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EMEA-002052-PIP02-23 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neurology
PIP number: P/0205/2023
Route(s) of administration: Oral use
Pharmaceutical form(s):
Tablet
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Fifth EMA/HMA Big Data Stakeholder Forum
Online
European Medicines Agency, Amsterdam, the Netherlands
Live broadcast
Start date: 28 November 2024, 09:00 (CET)
End date: 28 November 2024, 17:00 (CET)
EventHumanMedicines
Obgemsa
vibegron
Urinary Bladder, Overactive
Urinary Incontinence
Date of authorisation:
Last updated:
MedicineHumanAuthorised