Overview
On 21 July 2011, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Sumatriptan Galpharm, intended for the relief of migraine attacks in people who have been diagnosed with migraine. The company that applied for authorisation is Galpharm Healthcare Ltd. The applicant requested a re-examination of the negative opinion. After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 17 November 2011.
Questions and answers on the refusal of the marketing authorisation for Sumatriptan Galpharm 50 mg tablets - Outcome of re-examination
Product details
- Name of medicine
- Sumatriptan Galpharm
- Active substance
- sumatriptan succinate
- International non-proprietary name (INN) or common name
- sumatriptan
- Therapeutic area (MeSH)
- Migraine Disorders
Assessment history
Sumatriptan Galpharm : EPAR - Public assessment report