Porcilis M Hyo

Current status:
European Commission final decision


Porcilis M Hyo is an immunological veterinary medicinal product containing Mycoplasma hyopneumoniae. The product is indicated for finishing pigs from 1 week of age. Pigs should be vaccinated twice with a 3 week interval.

The marketing authorisation holder Intervet International B.V. submitted an application for a Type II variation subject to Mutual Recognition Procedure for Porcilis M Hyo concerning simultaneous administration with Porcilis PRRS. The application was submitted in the framework of Article 6 of Commission Regulation (EC) No 1084/2003, where the Reference Member State was France2 and the Concerned Member States were Austria, Belgium, Cyprus, Czech Republic, Germany, Denmark, Estonia, Greece, Spain, Finland, Hungary, Ireland, Italy, Malta, Luxembourg, Lithuania, Latvia, the Netherlands, Norway, Poland, Portugal, Sweden, Slovenia, Slovakia and the United Kingdom. The Mutual Recognition procedure (FR/V/0158/001/II/002) started on 30 January 2009.

On 2 October 2009 the United Kingdom on behalf of France, referred the matter to the Agency under Article 39 of Directive 2001/82/EC as amended by reference to Article 6(12) of Regulation (EC) No 1084/2003 due to concerns raised by Spain relating to the quality, safety and efficacy of the simultaneous administration of Porcilis M Hyo with Porcilis PRRS.

The referral procedure started on 14 October 2009. The Committee appointed Dr C. Rubio Montejano as rapporteur and Dr A.M. Brady as co-rapporteur. During the procedure Dr C. Muñoz Madero replaced Dr C. Rubio Montejano as rapporteur. Written explanations were provided by the marketing authorisation holder on 15 January 2010 and supplementary information was submitted on 20 April 2010.

Based on the rapporteurs' assessment of the currently available data, the CVMP adopted, on 19 May 2010, an opinion recommending that the variation application applied for the veterinary medicinal product Porcilis M Hyo satisfies the criteria for approval.

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 and package leaflet in the Annex III.

The final opinion was converted into a Decision by the European Commission on 16 August 2010.

Key facts

Approved name
Porcilis M Hyo
International non-proprietary name (INN) or common name

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11

Reference number
Articles 39 and 40

Follow-up referral.

European Commission final decision
Opinion date
EC decision date

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:

  • Changes to the summary of product characteristics, labeling or package leaflet ('annex III') - available when changes have been recommended by the Committee
  • Conditions of the marketing authorisation (Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies

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