Opinion/decision on a Paediatric investigation plan (PIP): Otezla,apremilast, decision type: , therapeutic area: , PIP number: P/0353/2022

Human medicines European public assessment report (EPAR): Pandemic Influenza Vaccine H5N1 Baxter AG, pandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture), Influenza, Human;Immunization;Disease Outbreaks, Date of authorisation: 16/10/2009, Revision: 8, Status: Withdrawn

Opinion/decision on a Paediatric investigation plan (PIP): Bosulif,Bosutinib, decision type: , therapeutic area: , PIP number: P/0368/2021

Orphan designation: 2-[6-(6,7-Dimethoxyquinolin-3-yl)pyridin-3-yl]-N-[3-(1,1,1-trifluoro-2-methylpropan-2-yl)-1,2-oxazol-5-yl]acetamide (zeteletinib), Treatment of medullary thyroid carcinoma, 19/02/2021, Positive

Orphan designation: Entinostat, Treatment of Hodgkin's lymphoma, 10/06/2010, Positive

Orphan designation: Mixture of seven synthetic fragments consisting of p21 RAS peptides, Treatment of pancreatic cancer, 05/08/2011, Positive

Opinion/decision on a Paediatric investigation plan (PIP): Tybost,cobicistat, decision type: , therapeutic area: , PIP number: P/0360/2022

Opinion/decision on a Paediatric investigation plan (PIP): Lenvima,Lenvatinib, decision type: , therapeutic area: , PIP number: P/0280/2022

Opinion/decision on a Paediatric investigation plan (PIP): Rxulti,brexpiprazole, decision type: , therapeutic area: , PIP number: P/0294/2022

Opinion/decision on a Paediatric investigation plan (PIP): Cometriq,cabozantinib, decision type: , therapeutic area: , PIP number: P/0357/2022