Opatanol
olopatadine
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Opatanol. 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 Opatanol.
Authorisation details
Product details | |
---|---|
Name |
Opatanol
|
Agency product number |
EMEA/H/C/000407
|
Active substance |
olopatadine hydrochloride
|
International non-proprietary name (INN) or common name |
olopatadine
|
Therapeutic area (MeSH) |
Conjunctivitis, Allergic
|
Anatomical therapeutic chemical (ATC) code |
S01GX09
|
Publication details | |
---|---|
Marketing-authorisation holder |
Novartis Europharm Limited
|
Revision |
23
|
Date of issue of marketing authorisation valid throughout the European Union |
16/05/2002
|
Contact address |
Vista Building |
Product information
23/08/2022 Opatanol - EMEA/H/C/000407 - IB/0046
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Ophthalmologicals
Therapeutic indication
Treatment of ocular signs and symptoms of seasonal allergic conjunctivitis.