Vantobra

RSS
Withdrawn

This medicine's authorisation has been withdrawn

tobramycin
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

The marketing authorisation for Vantobra has been withdrawn at the request of the marketing authorisation holder.

Vantobra : EPAR - Summary for the public

Reference Number: EMA/169512/2015

English (EN) (543.33 KB - PDF)

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български (BG) (626.87 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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español (ES) (542.06 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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čeština (CS) (606.64 KB - PDF)

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dansk (DA) (542.61 KB - PDF)

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Deutsch (DE) (544.04 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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eesti keel (ET) (544.87 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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ελληνικά (EL) (630.6 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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français (FR) (543.28 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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hrvatski (HR) (564.42 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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italiano (IT) (544.71 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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latviešu valoda (LV) (604.24 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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lietuvių kalba (LT) (566.91 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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magyar (HU) (602.93 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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Malti (MT) (609.65 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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Nederlands (NL) (547.25 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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polski (PL) (607.26 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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português (PT) (547.78 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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română (RO) (566.62 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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slovenčina (SK) (605.91 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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slovenščina (SL) (598.41 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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Suomi (FI) (540.13 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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svenska (SV) (541.79 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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Vantobra : EPAR - Risk-management-plan summary

Reference Number: EMA/169513/2015

English (EN) (578.05 KB - PDF)

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Product information

Vantobra : EPAR - Product Information

English (EN) (773.19 KB - PDF)

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Latest procedure affecting product information: N/0010
21/09/2017
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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).

Vantobra : EPAR - All Authorised presentations

English (EN) (474.54 KB - PDF)

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български (BG) (515.54 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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español (ES) (474.28 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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čeština (CS) (504.15 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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dansk (DA) (476.85 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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Deutsch (DE) (476.66 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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eesti keel (ET) (488.49 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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ελληνικά (EL) (510.86 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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français (FR) (474.01 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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hrvatski (HR) (479.67 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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íslenska (IS) (473.89 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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italiano (IT) (476.77 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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latviešu valoda (LV) (505.07 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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lietuvių kalba (LT) (489.11 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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magyar (HU) (495.44 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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Malti (MT) (505.29 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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Nederlands (NL) (473.49 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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norsk (NO) (473.56 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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polski (PL) (502.07 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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português (PT) (473.98 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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română (RO) (489.95 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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slovenčina (SK) (504.65 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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slovenščina (SL) (499 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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Suomi (FI) (476.15 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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svenska (SV) (473.59 KB - PDF)

First published: 19/03/2015Last updated: 29/03/2019
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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.

Authorisation details

EMA product number
EMEA/H/C/002633
Marketing authorisation holder
Pari Pharma GmbH

Moosstrasse 3
82319 Starnberg
Germany

Marketing authorisation issued
18/03/2015
Revision
3

Assessment history

Vantobra : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (560.49 KB - PDF)

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Vantobra : EPAR - Public assessment report

AdoptedReference Number: EMA/86872/2015

English (EN) (2.81 MB - PDF)

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CHMP summary of positive opinion for Vantobra

AdoptedReference Number: EMA/CHMP/780275/2014

English (EN) (554.55 KB - PDF)

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More information on Vantobra

This product is no longer an orphan medicine. It was originally designated an orphan medicine on 27 February 2009. Vantobra was withdrawn from the Community register of orphan medicinal products in June 2014 upon request of the marketing authorisation holder at the time of the granting of a marketing authorisation.

Public statement on Vantobra: Withdrawal of the marketing authorisation in the European Union

Reference Number: EMA/154324/2019

English (EN) (65.96 KB - PDF)

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