Adjusol trimethoprim sulfa liquide and its associated names - referral

Current status

European Commission final decision

Overview

On 10 December 2020, the European Medicines Agency (the Agency) completed a review of Adjusol trimethoprim sulfa liquide 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 product in the European Union (EU).

What is Adjusol trimethoprim sulfa liquide and its associated names?

Adjusol is a veterinary medicine available as a solution for use in drinking water or milk containing sulfadiazine and trimethoprim as active substances. Sulfadiazine and trimethoprim are antimicrobials which, when used separately, work by preventing bacteria from growing, but do not kill them. They are often used together because when their effects are added, the combination can kill bacteria. This veterinary medicine is used to treat infections caused by bacteria in calves, lambs, pigs, rabbits and chickens.

Adjusol is marketed in France, Greece, Luxembourg, and Portugal.

Why was Adjusol reviewed?

Adjusol is authorised in the EU via national procedures. This has led to inconsistency 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 Adjusol is marketed.

On 8 July 2019, the European Commission referred the matter to the CVMP in order to harmonise the product information for Adjusol 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 Adjusol should be harmonised across the EU.

The amended product information is available on the 'All documents' tab.  

The European Commission issued a decision on 25 February 2021.

Adjusol trimethoprim sulfa liquide Article-34 referral - Questions and answers on Adjusol trimethoprim sulfa liquide and its associated names

Reference Number: EMA/822260/2021

Key facts

About this medicine

• Approved name:
  Adjusol trimethoprim sulfa liquide and its associated names

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/V/A/134
• Type:
  Article 34 referrals (prior to January 2022)

  This type of referral is 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:
  10/12/2020
• EC decision date:
  25/02/2021

All documents

European Commission final decision

Adjusol trimethoprim sulfa liquide Article-34 referral - Annex I, II, III

Adjusol trimethoprim sulfa liquide Article-34 referral - Questions and answers on Adjusol trimethoprim sulfa liquide and its associated names

Reference Number: EMA/822260/2021

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)