Vantobra
Withdrawn
This medicine's authorisation has been withdrawn
tobramycin
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 18 February 2019, the European Commission withdrew the marketing authorisation for Vantobra (tobramycin) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, PARI Pharma GmbH, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Vantobra was granted marketing authorisation in the EU on 18 March 2015 for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis. The marketing authorisation was initially valid for a 5-year period. Vantobra is an identical product to Tobramycin PARI, which is authorised in the EU for the same condition.
The European Public Assessment Report (EPAR) for Vantobra is updated to reflect the fact that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:
N/0010
21/09/2017
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Vantobra
- Active substance
- Tobramycin
- International non-proprietary name (INN) or common name
- tobramycin
- Therapeutic area (MeSH)
- Cystic Fibrosis
- Respiratory Tract Infections
- Anatomical therapeutic chemical (ATC) code
- J01GB01
Pharmacotherapeutic group
- Antibacterials for systemic use
- Aminoglycoside antibacterials
Therapeutic indication
Vantobra is indicated for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis (CF).
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
News on Vantobra
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