CRED NPM

05/11/2024

EU Switch Criteria

Direct or Indirect danger

New substance

Abuse or misuse

Injectable

The Organisation for Professionals in Regulatory Affairs

7

Switch criteria

Direct danger

• Well-established safety profile & low risk of serious adverse reactions based on post-marketing data • Minimal risk of incorrect use → use in non-migraine headaches, use in patients at risk of cardiovascular disease, prolonged use

Direct or Indirect danger

Labelling (Contraindications & Warnings) Pack size limitation Migraine questionnaire for pharmacists Risk Minimization

The Organisation for Professionals in Regulatory Affairs

8

4