Ganfort

RSS

bimatoprost / timolol

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Ganfort. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Ganfort.

This EPAR was last updated on 06/02/2019

Authorisation details

Product details
Name
Ganfort
Agency product number
EMEA/H/C/000668
Active substance
  • bimatoprost
  • timolol
International non-proprietary name (INN) or common name
bimatoprost / timolol
Therapeutic area (MeSH)
  • Glaucoma, Open-Angle
  • Ocular Hypertension
Anatomical therapeutic chemical (ATC) code
S01ED51
Publication details
Marketing-authorisation holder
Allergan Pharmaceuticals Ireland
Revision
16
Date of issue of marketing authorisation valid throughout the European Union
19/05/2006
Contact address
Castlebar Road
Westport, Co Mayo
Ireland

Product information

18/10/2018 Ganfort - EMEA/H/C/000668 - IB/0030

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Ophthalmologicals

Therapeutic indication

Reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues.

Assessment history

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