Sumatriptan Galpharm

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sumatriptan

Refused
This medicine was refused authorisation for use in the European Union.

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.

This EPAR was last updated on 16/02/2012

Application details

Product details
Name
Sumatriptan Galpharm
Active substance
sumatriptan succinate
International non-proprietary name (INN) or common name
sumatriptan
Therapeutic area (MeSH)
Migraine Disorders
GenericGeneric

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Application details
Marketing-authorisation applicant
Galpharm Healthcare Ltd.
Date of opinion
17/11/2011
Date of refusal of marketing authorisation
09/02/2012

Assessment history

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