Prograf - referral

Current status

European Commission final decision

Overview

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.

Summary information on referral opinion pursuant to Article 30 of Council Directive 2001/83/EC for Prograf and associated names (see Annex I) International Non-Proprietary Name (INN): Tacrolimus: Background information

Adopted Reference Number: EMEA/85997/2006

Key facts

About this medicine

• Approved name:
  Prograf
• International non-proprietary name (INN) or common name:
  tacrolimus

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  CHMP/85997/06
• 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.

Key dates and outcomes

• CHMP opinion date:
  26/01/2006
• EC decision date:
  10/04/2006

All documents

Prograf - Article 30 referral - Annex I, II, III

Adopted

Summary information on referral opinion pursuant to Article 30 of Council Directive 2001/83/EC for Prograf and associated names (see Annex I) International Non-Proprietary Name (INN): Tacrolimus: Background information

Adopted Reference Number: EMEA/85997/2006

Description of documents published

Please note that some of the listed documents apply only to certain procedures.

• Overview - lay-language summary of the stage of the procedure
• Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
• Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
• List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
• Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
• List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
• List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
• Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
• Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
• Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
• Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
• Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
• Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
• Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
• Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

Note that older documents may have different titles.