Potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines: PRAC recommends precautionary measures

Q&A: Good clinical practice (GCP)

Policy on the determination of the condition(s) for a paediatric investigation plan (PIP) / waiver (scope of the PIP / waiver)

Human medicines European public assessment report (EPAR): Flebogamma DIF (previously Flebogammadif), human normal immunoglobulin, Date of authorisation: 23/07/2007, Revision: 19, Status: Authorised

Human medicines European public assessment report (EPAR): Lokelma, sodium zirconium cyclosilicate, Date of authorisation: 22/03/2018, Revision: 10, Status: Authorised

Opinions and letters of support on the qualification of novel methodologies for medicine development

Human medicines highlights - January 2024

EMEA-003339-PIP01-22

EMEA-003084-PIP03-22

EMEA-003380-PIP01-22