Ketoprofene Ethypharm LP - referral

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.

Summary information on the opinion pursuant to Article 10 of Council Directive 75/319/EEC as amended, for Kà©toprofà¨ne Ethypharm LP International Non-Proprietary Name (INN): ketoprofen: Background information

Adopted Reference Number: CPMP/1988/00

Key facts

About this medicine

• Approved name:
  Ketoprofene Ethypharm LP
• International non-proprietary name (INN) or common name:
  ketoprofen

About this procedure

• Current status:
  European Commission final decision
• 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.

Key dates and outcomes

• CHMP opinion date:
  29/06/2000
• EC decision date:
  27/12/2000

All documents

Summary information on the opinion pursuant to Article 10 of Council Directive 75/319/EEC as amended, for Kà©toprofà¨ne Ethypharm LP International Non-Proprietary Name (INN): ketoprofen: Background information

Adopted Reference Number: CPMP/1988/00

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.