Compagel - referral

Current status

European Commission final decision

Overview

Compagel Gel for Horses contains heparin sodium, levomenthol and hydroxyethyl salicylates. The gel is applied on the skin and its indications are:

• Haematoma, tendinitis, tendovaginitis, bursitis, capped hock, saddle sore, sprain, torsion, contusion, bruising, inflammation of the joint capsule (synovitis), muscle rupture, after nerve block anaesthesia, after paravenous injection.
• To accelerate the absorption of infiltrates (e.g. postoperative swelling, penile paralysis).
• To treat inflammations of superficial veins (e.g. phlebitis, thrombophlebitis, infusion thrombophlebitis).

Compagel Gel for Horses is a generic product.

In June 2007 a mutual recognition procedure started with Germany as Reference Member State and 5 Concerned Member States.

France and Sweden could not agree to the granting of a marketing authorisation as they considered there were potential serious risks to animal health. The matter was referred to the Co-ordination Group for Mutual Recognition and Decentralised Procedures CMD(v) and subsequently to the CVMP.

France and Sweden considered that due to the absence of efficacy documentation it cannot be assumed that the product is efficacious and that this as such presents a potential serious risk to animal health.

The CVMP started the referral procedure during its meeting of 15-17 January 2008. The Marketing Authorisation Holder was requested to provide a copy of the dossier and, in view of the concerns raised by France and Sweden, to indicate and to substantiate where necessary any differences between Compagel Gel for Horses and the reference product that could justify different conclusions on the safety or efficacy for the two products.

In response to the questions, the applicant submitted the dossier and argued on the basis of a comparison of the compositions that there are no differences between Compagel Gel for Horses and the reference product that could justify different conclusions on the safety and efficacy.

Having considered the referral notification and responses of the applicant, the CVMP concluded that all concerned member states in the mutual recognition procedure agreed that Compagel Gel for Horses is essentially similar to Tensolvet 50000. No differences between the two products have been identified that would justify different conclusions on the safety and efficacy. Under these conditions the applicant is exempted from submitting further preclinical or clinical data on efficacy of the proposed product and can claim the same indications for use as for the reference product. Therefore, the absence of efficacy documentation does not present a potential serious risk to animal health.

The objections from France and Sweden should not prevent the granting of a marketing authorisation.

The CVMP Opinion was adopted on 13 February 2008 and the subsequent Commission Decision on 2 April 2008.

Opinion following an Article 33(4) referral for Compagel gel for horses: Background information

Adopted Reference Number: EMEA/459391/2008

Key facts

About this medicine

• Approved name:
  Compagel
• International non-proprietary name (INN) or common name:
  • heparin sodium
  • levomenthol
  • hydroxyethyl salicylate

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  CVMP/459391/08
• Type:
  Article 33 referrals (prior to January 2022)

  This type of referral is initiated because of disagreement between Member States within the framework of the mutual-recognition or decentralised procedure.

Key dates and outcomes

• Opinion date:
  13/02/2008
• EC decision date:
  02/04/2008

All documents

Compagel azuril - Article 33 Referral - Annex I, II, III

Adopted

Opinion following an Article 33(4) referral for Compagel gel for horses: Background information

Adopted Reference Number: EMEA/459391/2008

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)