Shortage of Metalyse (tenecteplase)

Human medicines European public assessment report (EPAR): Vanflyta, quizartinib, Date of authorisation: 06/11/2023, Revision: 2, Status: Authorised

Human medicines European public assessment report (EPAR): Pioglitazone Accord, pioglitazone, Date of authorisation: 21/03/2012, Revision: 9, Status: Authorised

Human medicines European public assessment report (EPAR): Vitrakvi, larotrectinib, Date of authorisation: 19/09/2019, Revision: 12, Status: Authorised

ICH guideline E11A on pediatric extrapolation Step 5

Seventh European Medicines Agency - Medicines for Europe annual bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, from 29 May 2024, 14:00 (CEST) to 29 May 2024, 16:00 (CEST)

Human medicines European public assessment report (EPAR): Bexsero, meningococcal group B Vaccine (rDNA, component, adsorbed), Date of authorisation: 13/01/2013, Revision: 35, Status: Authorised

Questions and answers relating to Grant Procedure no. EMA/GRANT/2024/02/IA - Medicines regulatory systems strengthening in Sub-Saharan Africa

Request to the CVMP for classification of a veterinary medicinal product as intended for a limited market according to Article 4(29) and for eligibility for authorisation according to Article 23 (Applications for limited markets)

Orphan designation: sargramostim Treatment of hereditary orotic aciduria, 28/06/2024 Positive