Ronaxan and its associated names - referral

Current status

European Commission final decision

Overview

On 17 June 2021, the European Medicines Agency (the Agency) completed a review of Ronaxan and its associated names. 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 the aforementioned medicines in the European Union (EU).

What is Ronaxan and its associated names?

Ronaxan is a veterinary medicine available as 20 mg, 100 mg and 250 mg tablets containing doxycycline hyclate as active substance. Doxycycline is an antibiotic used to treat infections caused by bacteria in dogs and cats.
Ronaxan and its associated names is marketed in Belgium, Croatia, Czech Republic, Denmark, France, Germany, Greece, Ireland, Italy, Lithuania, Luxembourg, Malta, Norway, Portugal, Romania, Slovak Republic, Spain, Sweden, the Netherlands, United Kingdom (Northern Ireland)¹.

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 1. For the United Kingdom, as from 1 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.

Why was Ronaxan reviewed?

Ronaxan is authorised in the EU via national procedures. This has led to divergences across Member States in the way the veterinary medicine can be used, as seen in the differences in the product information in the countries where Ronaxan is marketed.

On 12 August 2019, the German veterinary medicines authority referred the matter to the CVMP in order to harmonise the product information for Ronaxan in the EU.

What are the conclusions of the CVMP?

Based on the evaluation of the currently available data, the CVMP concluded by consensus that the product information for Ronaxan 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 medicines are required in order to amend the product information accordingly.

The amended product information is available on the Agency’s website, under the 'All documents' tab. 

The European Commission issued a decision on 30 August 2021.

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

Key facts

About this medicine

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

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/V/A/135
• 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.

• Authorisation model:
  Nationally authorised product(s)

Key dates and outcomes

• Opinion date:
  17/06/2021
• EC decision date:
  30/08/2021

All documents

European Commission final decision

Ronaxan and its associated names Article-34 referral - Annex I, II, III

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

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)