Opinion/decision on a Paediatric investigation plan (PIP): Stelara,Ustekinumab, decision type: , therapeutic area: , PIP number: P/0401/2022

Opinion/decision on a Paediatric investigation plan (PIP): Cannabidiol,delta-9-tetrahydrocannabinol, decision type: , therapeutic area: , PIP number: P/0373/2022

Opinion/decision on a Paediatric investigation plan (PIP): Rekambys,rilpivirine, decision type: , therapeutic area: , PIP number: P/0397/2022

EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 7: Submission of other post-authorisation data

Human medicines European public assessment report (EPAR): Mepsevii, vestronidase alfa, Mucopolysaccharidosis VII, Date of authorisation: 23/08/2018, Revision: 7, Status: Authorised

Human medicines European public assessment report (EPAR): Docetaxel Accord, docetaxel, Head and Neck Neoplasms;Carcinoma, Non-Small-Cell Lung;Adenocarcinoma;Prostatic Neoplasms;Breast Neoplasms, Date of authorisation: 22/05/2012, Revision: 17, Status: Authorised

Human medicines European public assessment report (EPAR): Deferasirox Accord, deferasirox, Iron Overload;beta-Thalassemia, Date of authorisation: 09/01/2020, Revision: 5, Status: Authorised

Guidance on paediatric submissions

Human medicines European public assessment report (EPAR): Benepali, etanercept, Arthritis, Psoriatic;Arthritis, Rheumatoid;Psoriasis, Date of authorisation: 13/01/2016, Revision: 21, Status: Authorised

Spikevax: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5