Tobramycin VVB and associated names

Current status:
European Commission final decision

Overview

On 28 January 2015, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Tobramycin VVB. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Tobramycin VVB can be granted marketing authorisation in Lithuania and in the following Member States of the EU: Bulgaria, Estonia, Hungary, Latvia, Poland and Romania.

Key facts

Approved name
Tobramycin VVB and associated names
International non-proprietary name (INN) or common name
tobramycin
Reference number
EMEA/H/A-29/1428
Type
Article 29(4) referrals

This type of referral is triggered when there is a disagreement between Member States regarding a marketing authorisation application being evaluated in a mutual-recognition or decentralised procedure, on the grounds of a potential serious risk to public health.

Status
European Commission final decision
Opinion date
28/01/2015
EC decision date
04/04/2016

All documents

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP 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 are sometimes available:

News

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