Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Izba   
Auth. number : EU/1/13/905
Active substance : travoprost
ATC: Anatomical main group: S - Sensory organs
Therapeutic subgroup: S01 - Ophthalmologicals
Pharmacological subgroup: S01E - Antiglaucoma preparations and miotics
Chemical subgroup: S01EE - Prostaglandin analogues
Chemical substance: S01EE04 - Travoprost
(See WHO ATC Index)
Indication: Decrease of elevated intraocular pressure in adult patients with ocular hypertension or open-angle glaucoma.
Decrease of elevated intraocular pressure in paediatric patients aged 3 years to < 18 years with ocular hypertension or paediatric glaucoma.
Marketing Authorisation Holder: Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
24/02/2014 Centralised - Authorisation EMEA/H/C/2738 (2014)1262 of 20/02/2014
24/04/2017 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2738/T/7 (2017) 2774 of 20/04/2017
27/06/2017 Centralised - 2-Monthly update EMEA/H/C/2738/II/5 (2017)4468 of 23/06/2017