- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
Bupropion is a selective inhibitor of the neuronal re-uptake of catecholamines (noradrenaline and dopamine) with minimal effect on the re-uptake of indolamines (serotonin). Its mode of action in smoking cessation is not entirely understood.
In the European Union, bupropion containing medicinal products were authorised as an “aid to smoking-cessation in combination with motivational support in nicotine-dependent patients” through a Mutual Recognition Procedure (MRP) with the Netherlands as Reference Member State (RMS). Since licensing, concerns were raised in relation to the reports of suspected adverse drug reactions (ADRs) received associated with the use of bupropion containing medicinal products, particularly those of seizure and fatalities.
On 19 February 2002, Germany triggered a referral to the EMEA under Article 36 of Directive 2001/83/EC.
Germany requested the CPMP to give an opinion on whether the marketing authorisations of bupropion containing products indicated as “aid to smoking cessation in combination with motivational support in nicotine-dependent patients” should be maintained or changed in the terms of marketing authorisation or withdrawn, based on the reported serious suspected adverse reactions associated with these products, in particular reports on depression, suicidal ideation, suicide, seizures, undesirable cardiovascular effects, and angioedema, which raise potential public health concerns. The referral procedure started on 22 February 2002. Written explanation was provided by the Marketing Authorisation Holders (MAHs) on 21 May 2002.
Based on re-evaluation of the currently available data, the majority of CPMP considered that the benefit/risk balance of bupropion containing medicinal products remains favourable for the current indication and adopted an opinion on 25 July 2002 recommending the maintenance of the Marketing Authorisations with amendments to the Summary of Product Characteristics as set out in Annex III. The CPMP recommended also that bupropion should be used in accordance with smoking cessation guidelines.
The Member States competent authorities will continue to keep the product under regular review, including follow-up measures, which have been submitted in the upcoming Periodic Safety Update Report.
The list of product names concerned is given in the Annex I. A summary of the scientific conclusions is provided in the Annex II together with the amended Summary of Product Characteristics in the Annex III.
The final opinion was converted into a Decision by the European Commission on 25 October 2002.
Opinion following an Article 36 referral for Bupropion hydrochloride International Non-Proprietary Name (INN): Bupropion: Background information and Annexes I, II (English) and Annex III (All languages) (PDF/252.88 KB)Adopted
First published: 29/11/2002
Last updated: 29/11/2002
About this medicine
|International non-proprietary name (INN) or common name||
About this procedure
European Commission final decision
Article 36 referrals (prior to July 2012)
This type of referral applied for a marketing authorisation that were granted via the mutual-recognition or decentralised procedure. It was triggered when a Member State considered that action (variation, suspension or withdrawal) was needed on the grounds of the need to protect public health. This referral has been replaced by Articles 107i and 31.
Key dates and outcomes
|CHMP opinion date||
|EC decision date||
Opinion following an Article 36 referral for Bupropion hydrochloride International Non-Proprietary Name (INN): Bupropion: Background information and Annexes I, II (English) and Annex III (All languages) (PDF/252.88 KB)
First published: 29/11/2002
Last updated: 29/11/2002
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.