Bupropion hydrochloride

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
European Commission final decision


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support in nicotine-dependent patients” should be maintained or changed in the terms of marketing authorisation or withdrawn, based on the reported serious suspected adverse reactions associated with these products, in particular reports on depression, suicidal ideation, suicide,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.

Key facts

Approved name
Bupropion hydrochloride
International non-proprietary name (INN) or common name
Reference number
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.

European Commission final decision
Opinion date
EC decision date

All documents

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

  • Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes havebeen recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies

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