EMA health threats plan - Annex 1: Acceleration of regulatory procedures during public health emergencies

EMA health threats plan

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Human medicines European public assessment report (EPAR): Tecentriq, atezolizumab, Date of authorisation: 20/09/2017, Revision: 35, Status: Authorised

Human medicines European public assessment report (EPAR): Ozawade, pitolisant, Date of authorisation: 01/09/2021, Revision: 6, Status: Authorised

Dates of 2025 Scientific Advice Working Party - Human (SAWP-H) meetings and submission deadlines for scientific advice, protocol assistance, qualification of novel methodologies and HTACG/EMA parallel Joint Scientific Consultation (JSC) requests

Dates of 2026 Scientific Advice Working Party - Human (SAWP-H) meetings and submission deadlines for scientific advice, protocol assistance, qualification of novel methodologies and HTACG/EMA parallel Joint Scientific Consultation (JSC) requests

Human medicines European public assessment report (EPAR): Ristfor, sitagliptin,metformin hydrochloride, Date of authorisation: 15/03/2010, Revision: 31, Status: Authorised

EMEA-001489-PIP02-19

EMEA-001489-PIP01-13-M02