Okrido

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

Overview

On 27 June 2013, 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 Okrido. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Okrido outweigh its risks, and the marketing authorisation granted in the United Kingdom can be recognised in other Member States of the European Union (EU).

Key facts

Approved name
Okrido
International non-proprietary name (INN) or common name
prednisolone sodium phosphate
Class
-
Reference number
EMEA/H/A-29/1368
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
27/06/2013
EC decision date
05/09/2013

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:

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