Opinion/decision on a Paediatric investigation plan (PIP): Evusheld, tixagevimab,cilgavimab, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Infectious diseases, PIP number: P/0119/2023

Orphan designation: Sorafenib tosilate Treatment of papillary thyroid cancer, 13/11/2013 Expired

Orphan designation: Sorafenib tosilate Treatment of follicular thyroid cancer, 13/11/2013 Expired

Orphan designation: Chimeric anti-interleukin-6 monoclonal antibody (siltuximab) Treatment of Castleman's disease, 30/11/2007 Expired

Human medicines European public assessment report (EPAR): Lamivudine Teva, lamivudine, Date of authorisation: 23/10/2009, Revision: 14, Status: Authorised

Opinion/decision on a Paediatric investigation plan (PIP): Menveo, Meningococcal group A oligosaccharide conjugated to Corynebacterium diphteriae CRM197 protein (MenA-CRM) Meningococcal group C oligosaccharide conjugated to Corynebacterium diphteriae CRM197 protein (MenC-CRM) Meningococcal group W-135 oligosaccharide conjugated to Corynebacterium diphteriae CRM197 protein (MenW-CRM) Meningococcal group Y oligosaccharide conjugated to Corynebacterium diphteriae CRM197 protein (MenY-CRM), decision type: W: decision granting a waiver in all age groups for all conditions or indications, therape

EMEA-003370-PIP01-22

EMEA-003364-PIP02-22

EMEA-003339-PIP02-23