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.
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
|
Generic |
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
-
List item
Sumatriptan Galpharm : EPAR - Public assessment report (PDF/351.11 KB)
Adopted
First published: 16/02/2012
Last updated: 16/02/2012
EMA/40740/2012 -
List item
Questions and answers on the recommendation for the refusal of a marketing authorisation application for Sumitriptan Galpharm 50 mg tablets (PDF/61.2 KB)
Adopted
First published: 22/07/2011
Last updated: 22/07/2011
EMA/CHMP/423166/2011