- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Remeron and associated names, 15, 30 and 45 mg tablets, 15, 30 and 45 mg orodispersible tablets, 15 mg/ml oral solution, is a noradrenergic and specific serotonergic antidepressant indicated for the treatment of episodes of major depression.
On 11 October 2007, N.V. Organon presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet, including quality aspects of the medicinal product Remeron and associated names.
The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) including quality aspects of Remeron and associated names approved across EU Member States, with respect to treatment of major depressive episodes.
The procedure started on 15 November 2007. The Marketing Authorisation Holder provided supplementary information on 19 March 2008
During its June 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package Leaflet including the quality aspects was acceptable and that they should be amended.
The CHMP gave a positive opinion on 26 June 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet including quality aspects for Remeron and associated names.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended SPC, Labelling and Package Leaflet in Annex III.
A Decision was issued by the European Commission on 15 September 2008.
|International non-proprietary name (INN) or common name||
Article 30 referrals
This type of referral is triggered when Member States have adopted different decisions over the years for some medicines (e.g. different indications, contraindications or posology) and there is a need to harmonise across the EU.
European Commission final decision
|EC decision date||
Opinion following an Article 30 referral for Remeron and associated names International Non-Proprietary Name (INN): mirtazapine: Background information (PDF/30.6 KB)Adopted
First published: 16/09/2008
Last updated: 16/09/2008
Remeron - Article 30 referral - Annex I, II, III (PDF/463.32 KB)Adopted
First published: 13/10/2008
Last updated: 13/10/2008
- 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 takenfor the marketing authorisation(s) such as safety measures or extra studies