Loraxin

Current status:
European Commission final decision

Overview

On 21 June 2012, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Loraxin. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that it was not possible to show that the benefits of Loraxin outweigh its risks based on the data submitted by the company. The Committee therefore recommended that the marketing authorisation granted in Finland should not be recognised in other Member States of the EU. The marketing authorisation in Finland should also be suspended.

Key facts

Approved name
Loraxin
International non-proprietary name (INN) or common name
loratadine
Class
-
Reference number
EMEA/H/A-29/1325
Type
Article 29(4) referrals

This type of referral is triggered when there is a disagreement between Member States regarding a marketing authorisation application being evaluated in a mutual-recognition or decentralised procedure, on the grounds of a potential serious risk to public health.

Status
European Commission final decision
Opinion date
18/10/2012
EC decision date
20/12/2012

All documents

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

  • Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes havebeen recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be takenfor the marketing authorisation(s) such as safety measures or extra studies

How useful was this page?

Add your rating
Average
1 rating