Support for industry on clinical data publication

Clinical data publication

Sampling and testing

Coordination of pharmacovigilance inspections

Human medicines European public assessment report (EPAR): Opsumit, macitentan, Hypertension, Pulmonary, Date of authorisation: 20/12/2013, Revision: 23, Status: Authorised

Praziquantel (fin fish): European public MRL assessment report (EPMAR) - CVMP

COMP: Agendas, minutes and meeting reports

Human medicines European public assessment report (EPAR): Zutectra, human hepatitis B immunoglobulin, Immunization, Passive;Hepatitis B;Liver Transplantation, Date of authorisation: 30/11/2009, Revision: 16, Status: Authorised

Marketing authorisation

Human medicines European public assessment report (EPAR): Idacio, adalimumab, Arthritis, Rheumatoid;Arthritis, Psoriatic;Psoriasis;Spondylitis, Ankylosing;Uveitis;Hidradenitis Suppurativa;Colitis, Ulcerative;Crohn Disease;Arthritis, Juvenile Rheumatoid, Date of authorisation: 02/04/2019, Revision: 11, Status: Authorised