Mizollen - referral

Current status

European Commission final decision

Overview

In January 1996 Lorex Synthelabo UK, submitted applications for Mutual Recognition of the Marketing Authorisation granted by the UK Competent Authorities for Mizollen, modified release tablets 10 mg. The Mutual Recognition procedure started on 13 February 1996. The Reference Member State was the UK and the Concerned Member States were Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain and Sweden. The Concerned Member State, Sweden 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 13 May 1996.

The reasons concerned the potential for mizolastine to prolong the QT interval and the potential implications for the benefit risk profile and for the SPC for the medicinal product.

The Reference Member State sent its report to the EMEA on 15 May 1996.The matter was referred to the CPMP on 22 May 1996. Written and an oral explanations were provided by the Marketing Authorisation Holder on 15 October and 17 December 1996, respectively.

The CPMP adopted a positive opinion on 18 December 1996 recommending the granting of the Marketing Authorisation for Mizollen with amendments to the SPC of the Reference Member State.

A copy of the final opinion for Mizollen is provided on the Internet, together with Annex I and Annex II, which contains the amended SPC. Annex III provides an overall summary of the CPMP scientific evaluation.

The final Opinion was converted into a Decision by the European Commission on 1 April 1997.

Opinion following an Article 10 referral for Mizollen International Non-Proprietary Name (INN): Mizalostine: Background information

Adopted Reference Number: CPMP/1500/98 - EN

Key facts

About this medicine

• Approved name:
  Mizollen
• International non-proprietary name (INN) or common name:
  mizalostine

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  CPMP/1500/98
• 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:
  19/12/1996
• EC decision date:
  01/04/1997

All documents

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

Adopted Reference Number: CPMP/1034/96-EN

Opinion following an Article 10 referral for Mizollen International Non-Proprietary Name (INN): Mizalostine: Background information

Adopted Reference Number: CPMP/1500/98 - EN

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.