Loratadine Sandoz 10

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
European Commission final decision

Overview

The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Loratadine Sandoz 10. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Loratadine Sandoz 10 do not outweigh its risks, and the marketing authorisation granted in the Netherlands cannot be recognised in other Member States of the EU. The marketing authorisation in the Netherlands should also be suspended.
The review was carried out under an 'Article 29' referral1.

The European Commission issued a decision on 6 August 2009.

1 Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health

Key facts

Approved name
Loratadine Sandoz 10
International non-proprietary name (INN) or common name
loratadine 10 mg tablets
Reference number
EMEA/H/A-29/1060
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
29/05/2009
EC decision date
06/08/2009

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

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