Orphan designation: Selumetinib Treatment of amyotrophic lateral sclerosis, 13/12/2023 Positive

Human medicines European public assessment report (EPAR): Ambirix, hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed), Date of authorisation: 30/08/2002, Revision: 18, Status: Authorised

pseudoephedrine

Committee for Herbal Medicinal Products (HMPC): 20-22 November 2023, European Medicines Agency, Amsterdam, the Netherlands, 20 November 2023

Saxenda (liraglutide) supply shortage

Methodology European Specialised Expert Community

Human medicines European public assessment report (EPAR): Twinrix Adult, hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed), Date of authorisation: 19/09/1996, Revision: 24, Status: Authorised

Human medicines European public assessment report (EPAR): Twinrix Paediatric, hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed), Date of authorisation: 10/02/1997, Revision: 24, Status: Authorised

Human medicines European public assessment report (EPAR): Strensiq, asfotase alfa, Date of authorisation: 28/08/2015, Revision: 17, Status: Authorised

Cibinqo-H-C-005452-P46-005 : EPAR - Assessment Report - Variation