Catophos 100 mg/ml+0.05 mg/ml solution for injection for horses, cattle, dogs and cats and associated names - referral

Current status

European Commission final decision

Overview

On 15 February 2023, the European Medicines Agency (the Agency) completed an arbitration procedure following a disagreement amongst Member States of the European Union (EU) regarding the authorisation of the medicine Catophos 100 mg/ml+0.05 mg/ml solution for injection for horses, cattle, dogs and cats and associated names (thereafter called Catophos). The Agency’s Committee for Veterinary Medicinal Products (CVMP) concluded that the benefits of Catophos outweigh its risks, and that the marketing authorisation can be granted in Czechia and in the following Member States of the EU: Austria, Belgium, Denmark, Estonia, Finland, France, Germany, Hungary, Ireland, Italy, Latvia, Lithuania, the Netherlands, Norway, Poland, Portugal, Slovakia, Spain, Sweden and the United Kingdom (Northern Ireland).

What is Catophos?

Catophos is a veterinary medicine available as solution for injection and contains 100 mg of butafosfan per ml and 0.05 mg of cyanocobalamin (vitamin B12) per ml as active substances. Catophos is used in horses, cattle, dogs and cats as supportive treatment for metabolic or reproductive disorders when supplementation of phosphorus and vitamin B12 is needed. In case of metabolic disorders occurring around the time of giving birth, or in case of tetany (muscle spasm and twitching caused by deficiency of salts) or paresis (milk fever), this medicine should be administered in addition to magnesium and calcium, respectively. It may be used also to support muscle function in the presence of deficiencies of phosphorus and/or vitamin B12.

This veterinary medicine can be administered intravenously in cattle and horses and intravenously, intramuscularly and subcutaneously in dogs and cats.

Catophos was developed as a ‘hybrid medicine’ which means that it is similar to a ‘reference medicine’ that is already authorised in the EU, containing the same active substances. However, the therapeutic indication and routes of administration for Catophos are different compared to the reference medicine called Catosal. In addition, Catophos contains a different excipient (ingredient of a medicine other than the active substance).

Why was Catophos reviewed?

CP-Pharma Handelsgesellschaft mbH submitted the marketing authorisation application for Catophos to the Czech veterinary medicines authority via a decentralised procedure. This is a procedure where one Member State (the ‘reference Member State’, in this instance Czechia) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country, as well as in the other Member States (the ‘concerned Member States’, see list above) where the company has applied for a marketing authorisation.

However, the Member States were not able to reach an agreement on the outcome of the assessment and consequently the Czech veterinary medicines agency referred the matter to the CVMP for arbitration on 25 August 2022.

The grounds for the referral were concerns raised by the German veterinary medicines authority that, in their view, the data submitted in support of the intramuscular and subcutaneous routes of administration in dogs and cats did not confirm that Catophos is bioequivalent to the reference medicine Catosal. Germany therefore considered that the authorisation of Catophos may present a potential serious risk to animal health.

What are the conclusions of the CVMP?

Based on evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that bioequivalence to the reference medicine has been shown. The Committee concluded that the difference in excipient between Catophos and the reference medicine Catosal would not result in a clinically relevant effect on the amount of active substance that is released into the bloodstream after intramuscular and subcutaneous administration in dogs and cats. 

The CVMP concluded that the benefits of Catophos outweigh its risks and recommended that the marketing authorisation be granted in all Member States concerned.

The European Commission issued a decision on 3 April 2023.

Questions and answers on Catophos 100 mg/ml+0.05 mg/ml solution for injection for horses, cattle, dogs and cats and associated names (butafosfan, cyanocobalamin)

Reference Number: EMA/144348/2023

Key facts

About this medicine

• Approved name:
  Catophos 100 mg/ml+0.05 mg/ml solution for injection for horses, cattle, dogs and cats and associated names
• International non-proprietary name (INN) or common name:
  • butafosfan
  • cyanocobalamin

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/V/A/147
• 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.

• Authorisation model:
  Nationally authorised product(s)

Key dates and outcomes

• Opinion date:
  15/02/2023
• EC decision date:
  03/04/2023

All documents

European Commission final decision

Catophos Article 33(4) referral - Annex I, II, III

Questions and answers on Catophos 100 mg/ml+0.05 mg/ml solution for injection for horses, cattle, dogs and cats and associated names (butafosfan, cyanocobalamin)

Reference Number: EMA/144348/2023

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)