Suanovil 20 / Captalin associated names and generic products thereof - referral

Current status

European Commission final decision

Overview

Spiramycin is a macrolide antibiotic exerting bacteriostatic action against Mycoplasma, Gram-negative and Gram-positive bacteria which cause infections in cattle and pigs.

The veterinary medicinal products Suanovil 20 solution for injection and its generic product Spirovet are solutions for injection which contain 20 g spiramycin per 100 ml, corresponding to 600 000 IU spiramycin per ml.

Captalin solution for injection contains 31.25 g spiramycin per 100 ml, corresponding to 1 000 000 IU spiramycin per ml.

On 12 September 2012, Gemany presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding Suanovil 20 and associated names, Captalin and associated names and generic products thereof. The CVMP was requested to give its opinion on the indications, dosing regimens and withdrawal periods in cattle and pigs, in order to ensure efficacious treatment and lower the risk of development of antimicrobial resistance to spiramycin taking into account the available data and also to harmonise the withdrawal periods in cattle and pigs for the concerned products.

The referral started on 13 September 2012. The Committee appointed C. Ibrahim as rapporteur and B. Urbain as co-rapporteur. Written explanations were provided by the applicants and marketing authorisation holders on 10 December 2012, 14 October 2013, 1 April 2014 and 10 June 2014. Oral explanations were given on 9 September 2014.

Based on the evaluation of the currently available data, the CVMP considered that the overall benefit-risk profile for these products remains positive subject to amendments in the product information. Therefore, on 9 September 2014 the Committeeadopted by majority a positive opinion, recommending variations to the terms of the marketing authorisations for Suanovil 20 and associated names, Captalin and associated names and generic products thereof.

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

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

Opinion following an Article-35 referral for Suanovil 20 and associated names, Captalin and associated names and generic products thereof

Reference Number: EMA/745255/2014Summary:

EMEA/V/A/086

Key facts

About this medicine

• Approved name:
  Suanovil 20 / Captalin associated names and generic products thereof
• International non-proprietary name (INN) or common name:
  spiramycin

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/V/A/086
• Type:
  Article 35

  Community interest referral: initiated in cases involving the interests of the Community or concerns relating to the protection of human or animal health or the environment.

Key dates and outcomes

• Opinion date:
  09/09/2014
• EC decision date:
  11/12/2014

All documents

European Commission final decision

Suanovil 20 / Captalin Article-35 referral - Annex I,II,III

Suanovil 20 / Captalin Article-35 referral - Divergent position on a CVMP opinion on an Article 35 of Directive 2001/82/EC

Opinion following an Article-35 referral for Suanovil 20 and associated names, Captalin and associated names and generic products thereof

Reference Number: EMA/745255/2014Summary:

EMEA/V/A/086

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)