EMEA-003237-PIP02-22

Human medicines European public assessment report (EPAR): Hexyon, diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed), Date of authorisation: 17/04/2013, Date of refusal: 22/02/2013, Revision: 33, Status: Authorised

Human medicines European public assessment report (EPAR): Eltrombopag Viatris, eltrombopag, Date of authorisation: 12/12/2024, Status: Authorised

PSUSA/00010483/202406

Human medicines European public assessment report (EPAR): Tygacil, tigecycline, Date of authorisation: 24/04/2006, Revision: 35, Status: Authorised

Human medicines European public assessment report (EPAR): Pregabalin Viatris (previously Pregabalin Mylan), pregabalin, Date of authorisation: 24/06/2015, Revision: 22, Status: Authorised

Opinion/decision on a Paediatric investigation plan (PIP): Vimpat, lacosamide, decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP, therapeutic area: Nervous system disorders, PIP number: P/0470/2023

EMEA-000325-PIP01-08-M11

Opinion/decision on a Paediatric investigation plan (PIP): Saxenda, liraglutide, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Endocrine disorders, PIP number: P/0468/2023

Opinion/decision on a Paediatric investigation plan (PIP): Xydalba, dalbavancin hydrochloride, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0467/2023