Ketoprofene Ethypharm LP

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

Overview

In July 1999 Laboratoires Ethypharm SA submitted applications for Mutual Recognition of the Marketing Authorisation granted by the Competent Authority in France, acting as Reference Member State, for Kétoprofène Ethypharm LP 100 mg and 200 mg prolonged-release capsules, referring to essential similarity to two already authorised medicinal products in the EU.

Kétoprofène Ethypharm LP is a hard capsule filled with prolonged-release microgranules containing either 100 mg or 200 mg of the active substance ketoprofen, which is a non-steroidal anti-inflammatory drug (NSAID) marketed within the European Union for about 25 years under different tradenames. Kétoprofène Ethypharm LP prolonged-release capsules are indicated in adults and adolescents over 15 years for symptomatic treatment of chronic inflammatory rheumatisms, such as rheumatoid arthritis and ankylosing spondylitis and osteoarthritis. Kétoprofène Ethypharm LP prolonged-release capsules are to be administered once a day.

The Mutual Recognition procedure started on 01 September 1999. The Concerned Member States were Austria, Belgium, Denmark, Finland, Germany Greece, Ireland, Italy, Luxembourg, Netherlands, Sweden and the United Kingdom. In the course of the Mutual Recognition procedure the Concerned Member State, Sweden considered that the authorisation of Kétoprofène Ethypharm LP may present a risk to public health and referred the matter to the CPMP on 30 November 1999 under article 10 of Directive 75/319/EEC as amended.

The public health risk raised by Sweden, and to be addressed by the applicant, was to document the safe use of ketoprofen in patients with severe heart failure. In addition, further issues to be addressed were justification of:

  • maintenance of the last trimester of pregnancy as a contra-indication
  • the reference product used in the bioequivalence study.
  • the change of the method of manufacture of the test-product

The CPMP adopted accordingly a list of questions on 16 December 1999.

The Marketing Authorisation Holder provided written responses on 23 March 2000.

The CPMP having considered the written responses received from the Applicant, the Rapporteur/Co- Rapporteur's assessment reports and the comments from CPMP members was of the opinion that the public health risk issue raised by Sweden should not prevent the granting of a marketing authorisation provided that adequate amendments to the Summaries of Product Characteristics (SPC) are made, as stated in the following overall summary of the scientific evaluation and the amended SPC attached (200mg strength as a relevant example).

The CPMP adopted a positive opinion on 29 June 2000 recommending the granting of the Marketing Authorisation for Kétoprofène Ethypharm LP 100 mg and 200 mg prolonged-release hard capsules with amendments to the Summaries of Product Characteristics (SPC) of the Reference Member State.

On the basis of the Opinion adopted by the CPMP the European Commission issued a Decision on 27 December 2000.

Key facts

Approved name
Ketoprofene Ethypharm LP
International non-proprietary name (INN) or common name
ketoprofen
Reference number
CPMP/1988/00
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
29/06/2000
EC decision date
27/12/2000

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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