CRED NPM

05/11/2024

Switch strategy

Self-diagnosis? Safe use without supervision of a doctor?

Hurdles to overcome:

• Mode of action of triptans: risk in cardiovascular diseases

• Risk of medicine induced headache (tension headache) with prolonged use

• Underlaying problems could not be detected in OTC use

• Self-diagnosis: Confusion with other forms of headache

The Organisation for Professionals in Regulatory Affairs

5

Switch strategy

Product profile for sucessful switch:

Strength: 2.5 mg

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Pack size: 2 tablets

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• Indication: For patients with diagnosed migraine

• Patient population: Limited to adults from 18 to 65 years

• Warnings & Contraindications: Hypertension,…

Development of specific OTC labelling

The Organisation for Professionals in Regulatory Affairs

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