Emadine

RSS

emedastine

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

Overview

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 16/12/2022

Authorisation details

Product details
Name
Emadine
Agency product number
EMEA/H/C/000223
Active substance
emedastine difumarate
International non-proprietary name (INN) or common name
emedastine
Therapeutic area (MeSH)
Conjunctivitis, Allergic
Anatomical therapeutic chemical (ATC) code
S01GX06
Publication details
Marketing-authorisation holder
Immedica Pharma AB
Revision
26
Date of issue of marketing authorisation valid throughout the European Union
27/01/1999
Contact address

Solnavagen 3H
113 63 Stockholm
Sweden

Product information

12/12/2022 Emadine - EMEA/H/C/000223 - IAIN/0054/G

Other EU languages available icon 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

Symptomatic treatment of seasonal allergic conjunctivitis.

Assessment history

How useful was this page?

Add your rating