Aerinaze

RSS

desloratadine / pseudoephedrine

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

Overview

This is a summary of the European public assessment report (EPAR) for Aerinaze. 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 Aerinaze.

This EPAR was last updated on 18/07/2018

Authorisation details

Product details
Name
Aerinaze
Agency product number
EMEA/H/C/000772
Active substance
  • desloratadine
  • pseudophedrine sulphate
International non-proprietary name (INN) or common name
desloratadine / pseudoephedrine
Therapeutic area (MeSH)
Rhinitis, Allergic, Seasonal
Anatomical therapeutic chemical (ATC) code
R01BA52
Publication details
Marketing-authorisation holder
Merck Sharp Dohme B.V. 
Revision
16
Date of issue of marketing authorisation valid throughout the European Union
30/07/2007
Contact address
Merck Sharp Dohme B.V.
Waarderweg 39
2031 BN Harlem
The Netherlands

Product information

15/06/2018 Aerinaze - EMEA/H/C/000772 - T/0037

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

NASAL PREPARATIONS

Therapeutic indication

Symptomatic treatment of seasonal allergic rhinitis when accompanied by nasal congestion.

Assessment history

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