Dacarbazine Faulding

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
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.

Key facts

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

dacarbazine

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.

Status
European Commission final decision
Opinion date
25/04/2002
EC decision date
21/08/2002

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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