Lincocin and its associated names - referral

Current status

European Commission final decision

Overview

On 13 July 2017, the European Medicines Agency (the Agency) completed a review of Lincocin. The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that there is a need to harmonise the product information [summary of product characteristics (SPC), labelling and package leaflet] for Lincocin in the European Union (EU).

What is Lincocin?

Lincocin is a veterinary medicinal product available as powder for oral solution and contains 400 mg lincomycin per gram of product. Lincomycin is a lincosamide antibiotic which is produced by Streptomyces lincolnensis. Lincocin is indicated for the treatment and metaphylaxis of enzootic pneumonia caused by Mycoplasma hyopneumoniae in pigs and treatment and metaphylaxis of necrotic enteritis caused by Clostridium perfringens in chickens.

Lincocin (and associated names, such as Lincocine poudre soluble and Albiotic Pulver 400 mg/g) is marketed in Belgium, Denmark, France, Germany, Hungary, Ireland, Poland and United Kingdom.

Why was Lincocin reviewed?

Lincocin is authorised in the EU via national procedures. The European Commission noted that there are divergences across Member States in the way the veterinary medicinal product can be used, as seen in the differences in the product information in the countries where Lincocin is marketed.

On 5 July 2016, the European Commission referred the matter to the CVMP in order to harmonise the product information for Lincocin (and associated names) in the EU.

What are the conclusions of the CVMP?

Based on the evaluation of the currently-available data, the CVMP concluded that the product information for Lincocin and its associated names should be harmonised across the EU. Consequently, the CVMP recommended that variations to the terms of the marketing authorisations for the aforementioned product are required in order to amend the product information accordingly.

The amended product information is available on the 'All documents' tab.

The European Commission issued a decision on 5 October 2017.

Lincocin Article-34 referral - Questions and answers on Lincocin and its associated names

Summary:

Outcome of a procedure under Article 34 of Directive 2001/82/EC (EMEA/V/A/123)

Key facts

About this medicine

• Approved name:
  Lincocin and its associated names
• International non-proprietary name (INN) or common name:
  lincomycin

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/V/A/123
• 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.

Key dates and outcomes

• Opinion date:
  13/07/2017
• EC decision date:
  05/10/2017

All documents

European Commission final decision

Lincocin Article-34 referral - Annex I, II, III

Lincocin Article-34 referral - Questions and answers on Lincocin and its associated names

Summary:

Outcome of a procedure under Article 34 of Directive 2001/82/EC (EMEA/V/A/123)

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)