Opatanol

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olopatadine

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

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.

This EPAR was last updated on 24/08/2022

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
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

23/08/2022 Opatanol - EMEA/H/C/000407 - IB/0046

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Select ‘available languages’ to access the language you need.

 

Product information documents contain:

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.

Assessment history

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