Linco-Spectin 100 and associated names

Current status:
European Commission final decision

Overview

Linco-Spectin 100 is a powder for oral solution containing 33.3 g lincomycin (as lincomycin hydrochloride) and 66.7 g spectinomycin (as spectinomycin sulphate) per 150 g pack. Lincomycin is a lincosamide antibiotic, closely related to macrolide and streptogramin B antimicrobials. Spectinomycin is classified as an aminocyclitol antibiotic, close to aminoglycosides.

Due to divergent national decisions taken by Member States with respect to target species, indications, posology and withdrawal periods concerning the authorisations of Linco-Spectin 100 and its associated names, on 28 September 2012 Belgium referred the issue to the CVMP under Article 34(1) of Directive 2001/82/EC, in order to resolve divergences in the nationally authorised product information across the European Union.

The referral procedure started on 10 October 2012. The Committee appointed B. Urbain as rapporteur and C. Muñoz Madero as co-rapporteur.

Written explanations were provided by the marketing authorisation holders on 10 September 2013 and 10 February 2014.

Based on the evaluation of the currently available data, the CVMP considered that the benefit-risk profile of of Linco-Spectin 100 and its associated names remains positive, subject to variation of the marketing authorisations in accordance with the recommended product information. The Committee adopted a positive opinion by consensus on 10 April 2014.

The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended summary of product characteristics, labelling and package leaflet in Annex III.

The final opinion was converted into a Decision by the European Commission on 11 July 2014.

Key facts

Approved name
Linco-Spectin 100 and associated names
International non-proprietary name (INN) or common name
lincomycin and spectinomycin
Reference number
EMEA/V/A/088
Type
Article 34

Divergent decision referral: initiated in order to obtain harmonisation within the EU of the conditions of authorisation for products already authorised by Member States.

Status
European Commission final decision
Opinion date
10/04/2014
EC decision date
11/07/2014

All documents

Document description

  • Opinion - contains the CVMP 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 may not always be available:

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