Fluoxetin NM - referral

Current status

European Commission final decision

Overview

On 20 December 1996 Generics (UK) Ltd submitted an application for Mutual Recognition of the Marketing Authorisation granted by the Danish Competent Authorities for Fluoxetin NM, capsules 20 mg. The Mutual Recognition procedure started on 30 January 1997. The Reference Member State was Denmark and the Concerned Member State was Germany. Finland and Sweden had previously granted Marketing Authorisations under national procedures. The Concerned Member State, Germany not being able to agree with the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State referred the reasons for disagreement to the EMEA on 30 April 1997.

The major reasons concerned bioequivalence and possible therapeutic inefficacy related to the switch from the brand leader.

The Reference Member State sent its report to the EMEA on 12 May 1997. The matter was referred to the CPMP on 14 May 1997. Written explanations and further supplementary information were provided by the Marketing Authorisation Holder on 29 August 1997 and 11 December 1997, respectively.

The CPMP adopted a positive Opinion on 17 December 1997 recommending the granting of the Marketing Authorisation for Fluoxetin NM with amendments to the SPC of the Reference Member State.

A copy of the final opinion for Fluoxetin NM is provided on the Internet, together with Annexes A and B and Annex I, which contains the amended SPC.

The final Opinion was converted into a Decision by the European Commission on 9 June 1998.

Opinion following an Article 10 referral for Fluoxetin NM International Non-Proprietary Name (INN): Fluoxetine: Background information

Adopted Reference Number: CPMP/1154/98

Key facts

About this medicine

• Approved name:
  Fluoxetin NM
• International non-proprietary name (INN) or common name:
  fluoxetine

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  CPMP/1154/98
• 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:
  18/12/1997
• EC decision date:
  09/06/1998

All documents

Opinion of the Committee for proprietary medicinal products pursuant to Article 10 of Council Directive 75/319/EEC as amended, for Fluoxetin NM

Adopted Reference Number: EMEA/H/A/200

Opinion following an Article 10 referral for Fluoxetin NM International Non-Proprietary Name (INN): Fluoxetine: Background information

Adopted Reference Number: CPMP/1154/98

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.