Sandimmun and associated names

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
Opinion provided by Committee for Medicinal Products for Human Use

Overview

On 27 June 2013, the European Medicines Agency completed a review of Sandimmun and Sandimmun Neoral. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Sandimmun and Sandimmun Neoral in the European Union (EU).

Key facts

Approved name
Sandimmun and associated names
International non-proprietary name (INN) or common name
ciclosporin
Reference number
EMEA/H/A-30/1300, EMEA/H/A-30/1320
Type
Article 30 referrals

This type of referral is triggered when Member States have adopted different decisions over the years for some medicines (e.g. different indications, contraindications or posology) and there is a need to harmonise across the EU.

Status
Opinion provided by Committee for Medicinal Products for Human Use
Opinion date
27/06/2013
EC decision date
31/10/2013

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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