Girolan and its associated name Apralan

Current status:
European Commission final decision


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).

Key facts

Approved name
Girolan and its associated name Apralan
International non-proprietary name (INN) or common name

apramycin sulfate

Associated names
Reference number
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.

European Commission final decision
Opinion date
EC decision date

All documents

Document description

  • Opinion - contains the CVMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents may not always be available:

How useful was this page?

Add your rating