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


Tacrolimus is a macrolide immunosuppressant belonging to the pharmacological class of the calcineurin inhibitors.

Different Summaries of Product Characteristics (SPC) had been authorised, based on national, divergent decisions from the authorisations in the EU Member States. On 23 march 2005, Fujisawa GmbH on behalf of all the Marketing Authorisation Holders (see Annex 1 of Opinion) presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the national SPCs of the medicinal product Prograf and associated names.

The referral procedure started on 29 April 2005. The CHMP having considered the Rapporteur and the Co-Rapporteur assessment reports, the scientific discussion within the Committee and the comments from the Marketing Authorisation Holders (MAH), was of the opinion that the benefit/risk ratio of Prograf and associated names is considered to be positive in the following indications:

  • Prophylaxis of transplant rejection in liver, kidney or heart allograft recipients.
  • Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products.

The CHMP gave a positive opinion on 26 January 2006 recommending the harmonisation of the SPC for Prograf and associated names.

The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended SPC in Annex III.

A Decision was issued by the European Commission on 10/04/06.

Key facts

Approved name
International non-proprietary name (INN) or common name
Reference number
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.

European Commission final decision
Opinion date
EC decision date

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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