Girolan and its associated name Apralan - referral

Current status

European Commission final decision

Overview

Questions and answers on Girolan and its associated name Apralan

Outcome of a procedure under Article 34 of Directive 2001/82/EC (EMEA/V/A/122)

On 15 February 2018, the European Medicines Agency (the Agency) completed a review of Girolan and its associated name, Apralan. 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 Girolan and its associated name Apralan?

Girolan is a veterinary medicinal product available as a powder for use in drinking water/milk containing apramycin sulfate as the active substance. Apramycin is a broad-spectrum aminocyclitol antibiotic produced by a strain of Streptomyces tenebrarius. Girolan is indicated for the treatment of bacterial enteritis caused by Escherichia coli in pigs; treatment of bacterial enteritis caused by Escherichia coli and clinical outbreaks due to Salmonella enterica subsp. enterica serovar Dublin (Salmonella Dublin) in pre-ruminant calves; treatment of colibacillosis caused by Escherichia coli in chickens and treatment and metaphylaxis of bacterial enteritis caused by Escherichia coli in rabbits.

Girolan (and its associated name Apralan) is marketed in Denmark, France, Germany, Ireland, Italy, The Netherlands, Portugal, Spain and the United Kingdom.

Why was Girolan and its associated name Apralan reviewed?

Girolan is authorised in the EU via national procedures. Spain noted that there are divergences across Member States in the way the veterinary medicinal product can be used, as seen in the differences in the product information in the countries where Girolan (and its associated name Apralan) is marketed.

On 24 June 2016, Spain referred the matter to the CVMP in order to harmonise the product information for Girolan (and its associated name Apralan) in the EU.

What are the conclusions of the CVMP?

Based on the evaluation of the currently-available data, the CVMP concluded by majority that the product information for Girolan and its associated name Apralan should be harmonised across the EU.

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

The European Commission issued a decision on 8 May 2018.

Girolan Article-34 referral - Questions and answers on Girolan and its associated name Apralan

Key facts

About this medicine

• Approved name:
  Girolan and its associated name Apralan
• International non-proprietary name (INN) or common name:
  apramycin sulfate
• Associated names:
  Apralan

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA-V-A-122
• 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.

All documents

European Commission final decision

Girolan Article-34 referral - Annex I, II, III

Girolan Article-34 referral - Divergent position 1

Girolan Article-34 referral - Divergent position 2

Girolan Article-34 referral - Questions and answers on Girolan and its associated name Apralan

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)