Shortage of Abraxane (paclitaxel)
Shortage of Abraxane (paclitaxel)
Shortage of Abraxane (paclitaxel)
Multi-annual artificial intelligence workplan 2023-2028 - HMA / EMA joint Big Data Steering Group
ADHD medicines (atomoxetine, methylphenidate, lisdexamfetamine) supply shortage
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
Annex to Letter of Intent (pre-submission request form)
Assessment of SmPC section 5.1: A Guide for Assessors of Centralised Applications - Scientific guideline
Risk management plans (RMP) in post-authorisation phase: questions and answers