Sumatriptan Galpharm

Refused

This medicine has been refused authorisation

sumatriptan

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

AdoptedReference Number: EMA/CHMP/896315/2011

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

Application details

• EMA product number:
  EMEA/H/C/002140
• 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.

• Marketing authorisation applicant:
  Galpharm Healthcare Ltd.
• Opinion adopted:
  17/11/2011
• Refusal of marketing authorisation:
  09/02/2012

Assessment history

Sumatriptan Galpharm : EPAR - Public assessment report

AdoptedReference Number: EMA/40740/2012