Standard operating procedure for assignment of micro-, small- or medium-sized-enterprise status

EMA multi-stakeholder workshop on qualification of novel methodologies, Online, European Medicines Agency, Amsterdam, the Netherlands, 17 April 2023

Human medicines European public assessment report (EPAR): Dovprela (previously Pretomanid FGK), pretomanid, Date of authorisation: 31/07/2020, Revision: 11, Status: Authorised

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Referral: Havrix, hepatitis A virus (inactivated, adsorbed), associated names: Havrix and associated names Article 30 referrals European Commission final decision, 27/06/2024, 26/08/2024, 04/09/2024

Appendix 1: Acceptable intakes established for N-nitrosamines

Rapid alert notification of a quality defect / recall

Follow-up and non-urgent information for quality defects

Sponsor's report on the maintenance of the designation criteria at the time of marketing authorisation for a designated orphan-medicinal-product

Human medicines European public assessment report (EPAR): Fabrazyme, agalsidase beta, Date of authorisation: 03/08/2001, Revision: 37, Status: Authorised