Girolan and its associated name Apralan

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).

Key facts

Approved name
Girolan and its associated name Apralan
International non-proprietary name (INN) or common name
apramycin sulfate
Associated names
Apralan
Reference number
EMEA-V-A-122
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.

Status
European Commission final decision
Opinion date
15/02/2018
EC decision date
08/05/2018

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:

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