Motilium - referral
Current status
Referral
Human
Domperidone is a peripheral dopamine D2-receptor antagonist with gastrokinetic and anti-emetic properties. It is used in the treatment of symptoms of nausea and vomiting of variable origin. It exerts its actions via inhibition of dopamine receptors in the human gut, and in the chemoreceptor trigger zone (CTZ), which lies outside the blood-brain barrier in the area postrema. The active substance is available as domperidone and as domperidone maleate.
From the registrations in Member States, different Summaries of Product Characteristics have been issued, based on national, divergent decisions. On 31 October 2000, France presented to the EMEA a referral under Article 30 of Directive 2001/83/EC1.
The referral procedure started on 31 May 2001 in order to harmonise the Summaries of Product Characteristics (SPC) within the Member States and Norway and Iceland. The CPMP having considered the Rapporteur and the Co-Rapporteur assessment reports, scientific discussion within the Committee and comments from the Marketing Authorisation Holders, was of the opinion that the benefit/risk ratio of domperidone is considered to be favourable for the agreed indications. The CPMP issued a positive opinion, on 27 June 2002, recommending the harmonisation of the SPC for Motilium and associated names. The grounds for referral are appended to this report.
An overall summary of the scientific evaluation is provided together with the amended summary of product characteristics.
A Decision was issued by the European Commission on 17 October 2002.
1 Corresponding to Article 11 of Directive 75/319/EEC, for referrals presented before 18 December 2001
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.
Description of documents published
Please note that some of the listed documents apply only to certain procedures.
Note that older documents may have different titles.