CRED NPM

05/11/2024

Switch criteria

Abuse or misuse

• No abuse (no psychotropic effect)

• Very unlikely that Naratriptan will be misused in other indications due to specific mode of action

Abuse or misuse

Pack size restriction → prevents prolonged use (tension heachache) Risk Minimization

The Organisation for Professionals in Regulatory Affairs

11

Switch criteria

New substance

Several years market experience in general population available

No specific risk minimization required, but AEs were closely monitored after OTC status was obtained Risk Minimization

New substance

The Organisation for Professionals in Regulatory Affairs

12

6