Human medicines European public assessment report (EPAR): Vpriv, velaglucerase alfa, Gaucher Disease, Date of authorisation: 26/08/2010, Revision: 20, Status: Authorised

Orphan designation: Adeno-associated virus serotype HSC 15 expressing human iduronate 2-sulfatase (Bevufenogene nofeparvovec), Treatment of mucopolysaccharidosis type II (Hunter Syndrome), 16/03/2022, Withdrawn

Orphan designation: Adeno-associated virus serotype HSC15 expressing human phenylalanine hydroxylase, Treatment of phenylalanine hydroxylase deficiency, 14/12/2018, Withdrawn

Orphan designation: Human telomerase reverse transcriptase peptide (611-626) (tertomotide), Treatment of pancreatic cancer, 25/07/2006, Withdrawn

Document file name in title field

Withdrawn application: Lumevoq, lenadogene nolparvovec, Date of withdrawal: 20/04/2023, Initial authorisation

Guidance to applicants/marketing authorisation holders on oral explanations at European Medicines Agency

Human medicines European public assessment report (EPAR): Plerixafor Accord, plerixafor, Multiple Myeloma;Hematopoietic Stem Cell Transplantation, Date of authorisation: 16/12/2022, Revision: 1, Status: Authorised

Human medicines European public assessment report (EPAR): Fluenz Tetra, influenza vaccine (live attenuated, nasal), Influenza, Human, Date of authorisation: 04/12/2013, Revision: 24, Status: Authorised

Human medicines European public assessment report (EPAR): Camzyos, mavacamten, Cardiomyopathy, Hypertrophic, Date of authorisation: 26/06/2023, Revision: 1, Status: Authorised