Terfenadine - referral

Current status

European Commission final decision

Overview

Article 12 of Council Directive 75/319/EEC as amended was invoked for reasons of community interest by France on 10 February 1997, requesting that the CPMP “give an opinion on whether there is an unfavourable benefit/risk ratio for terfenadine in relation to its arrhythmogenic potential and to its serious cardiac adverse effects. The opinion should take into account the global safety profile of terfenadine in comparison with existing alternative non sedative anti-histaminic drugs available for the same indications in the European Union.“

On 19 November 1997, the CPMP adopted five Opinions recommending that:

• the Marketing Authorisations for all terfenadine 120 mg tablet and all terfenadinepseudoephedrine tablet formulations should be withdrawn (CPMP/1000-1/97),
• the Marketing Authorisations for all terfenadine 30 mg tablet, 60 mg tablet and 6 mg/ml oral suspension formulations should be varied and the Summary of Product Characteristics (SPC) amended.

One Marketing Authorisation Holder for terfenadine 60 mg tablet formulation appealed against the Opinion. The appeal related to the wording of the section 4.5 (“Interaction with other medicinal products and other forms of interaction”) of the amended SPC.

On 25 February 1998, the CPMP, having considered the grounds for appeal submitted on 21 January 1998, adopted three final Opinions (CPMP/255-7/98) for terfenadine 30 mg tablet, 60 mg tablet and 6 mg/ml oral suspension formulations revising the SPC annexed to its Opinions dated 19 November 1997.

Copies of the final Opinions for all formulations of terfenadine containing medicinal products are available on the Internet together with the scientific conclusions and grounds for restriction in Annex B and the amended SPC for terfenadine 30 mg tablet, 60 mg tablet and 6 mg/ml oral suspension formulations in Annex I. Translations of such Opinions are available on the Internet in French, German and Spanish.

On the basis of the final Opinions the European Commission adopted Decisions on 22 September 1998 which were addressed to the concerned Member States for compliance within 30 days.

Opinions following an Article 12 referral for Terfenadine International Non-Proprietary Name (INN): Terfenadine: Background information

Adopted Reference Number: EMEA/34168/98

Key facts

About this medicine

• Approved name:
  Terfenadine
• International non-proprietary name (INN) or common name:
  terfenadine

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  CPMP/34168/98
• Type:
  Article 31 referrals

  This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

Key dates and outcomes

• CHMP opinion date:
  20/11/1997
• EC decision date:
  22/09/1998

All documents

Opinion of the Committee for proprietary medicinal products pursuant to Article 12 of Council Directive 75/319/EEC as amended for Terfenadine 120mg and Annexes A and B

Adopted Reference Number: CPMP/1000/97-EN

Opinion of the Committee for proprietary medicinal products pursuant to Article 12 of Council Directive 75/319/EEC as amended for Terfenadine and Pseudoephedrine hydrochloride and Annexes A and B

Adopted Reference Number: CPMP/1001/97-EN

Opinion of the Committee for proprietary medicinal products pursuant to Article 12 of Council Directive 75/319/EEC as amended for Terfenadine 60mg and Annexes A and B

Adopted Reference Number: CPMP/255/98-EN

Final opinion of the Committee for proprietary medicinal products pursuant to Article 12 of Council Directive 75/319/EEC as amended for Terfenadine 30mg and Annexes A, B and I

Adopted Reference Number: CPMP/256/98-EN

Final opinion of the Committee for proprietary medicinal products pursuant to Article 12 of Council Directive 75/319/EEC as amended for Terfenadine 6mg/ml and Annexes A, B and I

Adopted Reference Number: CPMP/257/98-EN

Opinions following an Article 12 referral for Terfenadine International Non-Proprietary Name (INN): Terfenadine: Background information

Adopted Reference Number: EMEA/34168/98

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.