Pre-authorisation guidance under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6)

Marketing authorisation (veterinary medicines)

Veterinary medicines marketing authorisation application pre-submission interaction request form

Human medicines European public assessment report (EPAR): Prolia, denosumab, Date of authorisation: 26/05/2010, Revision: 35, Status: Authorised

Accessibility

Human medicines European public assessment report (EPAR): Herwenda, trastuzumab, Date of authorisation: 15/11/2023, Revision: 3, Status: Authorised

Human medicines European public assessment report (EPAR): Tagrisso, osimertinib, Date of authorisation: 01/02/2016, Revision: 25, Status: Authorised

Human medicines European public assessment report (EPAR): Arixtra, fondaparinux sodium, Date of authorisation: 20/03/2002, Revision: 40, Status: Authorised

Human medicines European public assessment report (EPAR): Alimta, pemetrexed, Date of authorisation: 20/09/2004, Revision: 30, Status: Authorised

Human medicines European public assessment report (EPAR): Parsabiv, etelcalcetide, Date of authorisation: 11/11/2016, Revision: 11, Status: Authorised