Tobramycin VVB and associated names

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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.

What is Tobramycin VVB?

Tobramycin VVB is an antibiotic for treating long-term lung infection caused by the bacteria Pseudomonas aeruginosa in patients aged 6 years and older who have cystic fibrosis. Cystic fibrosis is an inherited disease in which there is an accumulation of thick mucus in the lungs that allows bacteria to grow more easily and cause infections. P. aeruginosa is a frequent cause of infections in cystic fibrosis patients.

Tobramycin VVB is to be available as a nebuliser solution (300 mg/5 ml) to be inhaled. The active substance in Tobramycin VVB, tobramycin, belongs to the group of antibiotics known as ‘aminoglycosides’. It works by disrupting the production of proteins that P. aeruginosa needs to build its cell walls, resulting in damage to the bacteria which eventually kills them.

Tobramycin VVB is a ‘hybrid medicine’ that has been developed to be comparable to a ‘reference medicine’ containing tobramycin called Tobi (300 mg/5 ml nebuliser solution).

Why was Tobramycin VVB reviewed?

UAB VVB submitted Tobramycin VVB to the Lithuanian medicines regulatory agency for a decentralised procedure. This is a procedure where one Member State (the ‘reference Member State’, in this instance Lithuania) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States’, in this instance Bulgaria, Estonia, Hungary, Latvia, Poland and Romania).

However, the Member States were not able to reach an agreement and the Lithuanian medicines regulatory agency referred the matter to the CHMP for arbitration on 14 October 2015.

The reason for the referral was a disagreement over whether Tobramycin VVB is clinically superior to Tobi Podhaler, another medicine containing tobramycin. Demonstration of clinical superiority is required because Tobi Podhaler is an orphan medicine and was granted market exclusivity in the EU at the time of its market authorisation in July 2011. This means that during the period of market exclusivity similar products, such as Tobramycin VVB, cannot be placed on the market; there are, however, exceptions such as where clinically superiority over Tobi Podhaler can be shown.

What are the conclusions of the CHMP?

Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that Tobramycin VVB is clinically superior to Tobi Podhaler because a substantial proportion of patients are intolerant to Tobi Podhaler but can be treated with Tobramycin VVB. The CHMP therefore recommended that Tobramycin VVB be granted marketing authorisation in Lithuania as well as in the other concerned Member States.

The European Commission issued a decision on this opinion on 04 April 2016.

Name Language First published Last updated
Questions and answers on Tobramycin VVB and associated names (tobramycin, 300 mg/5 ml nebuliser solution) BG = bălgarski 2016-05-04  
Questions and answers on Tobramycin VVB and associated names (tobramycin, 300 mg/5 ml nebuliser solution) ES = español 2016-05-04  
Questions and answers on Tobramycin VVB and associated names (tobramycin, 300 mg/5 ml nebuliser solution) CS = čeština 2016-05-04  
Questions and answers on Tobramycin VVB and associated names (tobramycin, 300 mg/5 ml nebuliser solution) DA = dansk 2016-05-04  
Questions and answers on Tobramycin VVB and associated names (tobramycin, 300 mg/5 ml nebuliser solution) DE = Deutsch 2016-05-04  
Questions and answers on Tobramycin VVB and associated names (tobramycin, 300 mg/5 ml nebuliser solution) ET = eesti keel 2016-05-04  
Questions and answers on Tobramycin VVB and associated names (tobramycin, 300 mg/5 ml nebuliser solution) EL = elliniká 2016-05-04  
Questions and answers on Tobramycin VVB and associated names (tobramycin, 300 mg/5 ml nebuliser solution) EN = English 2016-05-04  
Questions and answers on Tobramycin VVB and associated names (tobramycin, 300 mg/5 ml nebuliser solution) FR = français 2016-05-04  
Questions and answers on Tobramycin VVB and associated names (tobramycin, 300 mg/5 ml nebuliser solution) IT = italiano 2016-05-04  
Questions and answers on Tobramycin VVB and associated names (tobramycin, 300 mg/5 ml nebuliser solution) LV = latviešu valoda 2016-05-04  
Questions and answers on Tobramycin VVB and associated names (tobramycin, 300 mg/5 ml nebuliser solution) LT = lietuvių kalba 2016-05-04  
Questions and answers on Tobramycin VVB and associated names (tobramycin, 300 mg/5 ml nebuliser solution) HU = magyar 2016-05-04  
Questions and answers on Tobramycin VVB and associated names (tobramycin, 300 mg/5 ml nebuliser solution) MT = Malti 2016-05-04  
Questions and answers on Tobramycin VVB and associated names (tobramycin, 300 mg/5 ml nebuliser solution) NL = Nederlands 2016-05-04  
Questions and answers on Tobramycin VVB and associated names (tobramycin, 300 mg/5 ml nebuliser solution) PL = polski 2016-05-04  
Questions and answers on Tobramycin VVB and associated names (tobramycin, 300 mg/5 ml nebuliser solution) PT = português 2016-05-04  
Questions and answers on Tobramycin VVB and associated names (tobramycin, 300 mg/5 ml nebuliser solution) RO = română 2016-05-04  
Questions and answers on Tobramycin VVB and associated names (tobramycin, 300 mg/5 ml nebuliser solution) SK = slovenčina 2016-05-04  
Questions and answers on Tobramycin VVB and associated names (tobramycin, 300 mg/5 ml nebuliser solution) SL = slovenščina 2016-05-04  
Questions and answers on Tobramycin VVB and associated names (tobramycin, 300 mg/5 ml nebuliser solution) FI = suomi 2016-05-04  
Questions and answers on Tobramycin VVB and associated names (tobramycin, 300 mg/5 ml nebuliser solution) SV = svenska 2016-05-04  
Questions and answers on Tobramycin VVB and associated names (tobramycin, 300 mg/5 ml nebuliser solution) HR = Hrvatski 2016-05-04  

Key facts

Approved nameTobramycin VVB and associated names
International non-proprietary name (INN) or common name

tobramycin

Associated names
Class
Reference numberEMEA/H/A-29/1428
TypeArticle 29(4) referrals

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

StatusEuropean Commission final decision
Opinion date28/01/2015

All documents

Name Language First published Last updated
Tobramycin VVB and associated names Article-29(4) referral - CHMP assessment report (English only) 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex I BG = bălgarski 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex I ES = español 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex I CS = čeština 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex I DA = dansk 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex I DE = Deutsch 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex I ET = eesti keel 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex I EL = elliniká 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex I EN = English 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex I FR = français 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex I IT = italiano 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex I LV = latviešu valoda 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex I LT = lietuvių kalba 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex I HU = magyar 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex I MT = Malti 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex I NL = Nederlands 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex I PL = polski 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex I PT = português 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex I RO = română 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex I SK = slovenčina 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex I SL = slovenščina 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex I FI = suomi 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex I SV = svenska 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex I HR = Hrvatski 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex II BG = bălgarski 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex II ES = español 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex II CS = čeština 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex II DA = dansk 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex II DE = Deutsch 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex II ET = eesti keel 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex II EL = elliniká 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex II EN = English 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex II FR = français 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex II IT = italiano 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex II LV = latviešu valoda 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex II LT = lietuvių kalba 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex II HU = magyar 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex II MT = Malti 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex II NL = Nederlands 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex II PL = polski 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex II PT = português 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex II RO = română 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex II SK = slovenčina 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex II SL = slovenščina 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex II FI = suomi 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex II SV = svenska 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex II HR = Hrvatski 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex III BG = bălgarski 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex III ES = español 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex III CS = čeština 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex III DA = dansk 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex III DE = Deutsch 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex III ET = eesti keel 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex III EL = elliniká 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex III EN = English 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex III FR = français 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex III IT = italiano 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex III LV = latviešu valoda 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex III LT = lietuvių kalba 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex III HU = magyar 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex III MT = Malti 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex III NL = Nederlands 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex III PL = polski 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex III PT = português 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex III RO = română 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex III SK = slovenčina 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex III SL = slovenščina 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex III FI = suomi 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex III SV = svenska 2016-05-04  
Tobramycin VVB and associated names Article-29(4) referral - Annex III HR = Hrvatski 2016-05-04  
Questions and answers on Tobramycin VVB and associated names (tobramycin, 300 mg/5 ml nebuliser solution) (English only) 2016-01-29  
Tobramycin VVB and associated names Article-29(4) referral - Annex III (English only) 2016-01-29  

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:

  • Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes have been recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies

Current status:
European Commission final decision

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