Dacarbazine Faulding - referral

Current status

European Commission final decision

Overview

Dacarbazine Faulding contains the active substance dacarbazine which is a cytotoxic agent, and is authorised in several EU Member States. It is indicated for the treatment of patients with metastatic malignant melanoma. Additional indications for dacarbazine as part of combination chemotherapy are:

• Hodgkin's disease
• Advanced adult soft tissue sarcomas (except mesothelioma, Kaposi sarcoma)

Member States which have previously authorised the above mentioned medicinal product under a national procedure are the United Kingdom, Portugal and Ireland (100 mg, 200 mg only). The applicant, Faulding Pharmaceuticals plc, sought to initiate a Mutual Recognition (MR) procedure with the UK as Reference Member State (RMS). Applications were submitted to 3 Concerned Member States, France, Spain and Ireland, between 12 – 13 July 2001, and the Mutual Recognition Procedure started on 1 August 2001.

No breakout session of the MRFG was held. However, several discussions on the SPC and quality aspects took place in October 2001, and as a consequence the applicant circulated revised SPCs to all concerned MS on 30 October 2001 (day 90 of the MRP). At this time quality objections from France remained unresolved.

On 6 November 2001, in view of the unresolved quality objections, France therefore issued a Notification of an official referral for Arbitration, (under Article 29 of Directive 2001/83, formerly Article 10, paragraph 2 of Directive 75/319/EEC of 20 May 1975 as amended) to the CPMP The referral procedure started on 16 November 2001, when a List of Questions was sent to the applicant by the CPMP. The grounds for this arbitration procedure were based entirely on pharmaceutical quality issues:

• the uncertain quality of the active substance and
• the uncertain quality of the finished product.

The CPMP having considered the Rapporteur and the Co-Rapporteur assessment reports, Scientific discussion within the Committee and comments from the Marketing Authorisation Holder, was of the opinion that the objections raised by France had been resolved by the written representations made by the applicant during the arbitration procedure and should not prevent the granting of a Marketing Authorisation.

The CPMP therefore adopted a positive opinion, on 25 April 2002, recommending the maintenance of this product on the market, subject to a number of conditions relating to minor quality issues. The CPMP considered that the benefit/risk ratio of dacarbazine remained unchanged by this procedure and continues to be favourable for the agreed indications. The CPMP also adopted the latest MRP day 90 SPCs as an Annex to the opinion.

The list of product names concerned is given in the Annex I. The scientific conclusions are provided in the Annex II, together with the Summaries of Product Characteristics in Annex III and the conditions of the marketing authorisations in Annex IV.

The final opinion was converted into a Decision by the European Commission on 21 August 2002.

Summary information on a referral opinion following an arbitration pursuant to Article 29 of Directive 2001/83/EC (formerly Article 10, paragraph 2 of Directive 75/319/EEC of 20 May 1975 as amended) for Dacarbazine Fauld...

Adopted Reference Number: CPMP/2020/02

Key facts

About this medicine

• Approved name:
  Dacarbazine Faulding
• International non-proprietary name (INN) or common name:
  dacarbazine

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  CPMP/2020/02
• 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.

Key dates and outcomes

• CHMP opinion date:
  25/04/2002
• EC decision date:
  21/08/2002

All documents

Summary information on a referral opinion following an arbitration pursuant to Article 29 of Directive 2001/83/EC (formerly Article 10, paragraph 2 of Directive 75/319/EEC of 20 May 1975 as amended) for Dacarbazine Fauld...

Adopted Reference Number: CPMP/2020/02

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.