Linco-Spectin 100 and associated names - referral

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.

Opinion following an Article 34 referral for Linco-Spectin 100 and associated names: Background information

Key facts

About this medicine

• Approved name:
  Linco-Spectin 100 and associated names
• International non-proprietary name (INN) or common name:
  • lincomycin
  • spectinomycin

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/V/A/088
• Type:
  Article 34 referrals (prior to January 2022)

  This type of referral is initiated in order to obtain harmonisation within the EU of the conditions of authorisation for products already authorised by Member States.

Key dates and outcomes

• Opinion date:
  10/04/2014
• EC decision date:
  11/07/2014

All documents

European Commission final decision

Linco-Spectin 100 and associated names: Annex I, II, III

Opinion following an Article 34 referral for Linco-Spectin 100 and associated names: Background information

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
• 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. veterinary healthcare professionals, farmers, academia) (if applicable)
• Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
• Scientific conclusions – scientific conclusions of CVMP
• Divergent positions – divergent positions of the CVMP members (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)