Vibativ

RSS

Withdrawn

This medicine's authorisation has been withdrawn

telavancin
MedicineHumanWithdrawn

Spanish is available via eTranslation, the European Commission's machine translation service.

Translate to Spanish | Important information about machine translation

  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

The marketing authorisation for Vibativ has been withdrawn at the request of the marketing authorisation holder.

български (BG) (634.53 KB - PDF)

Ver

español (ES) (549.37 KB - PDF)

Ver

čeština (CS) (617.26 KB - PDF)

Ver

dansk (DA) (547.17 KB - PDF)

Ver

Deutsch (DE) (552 KB - PDF)

Ver

eesti (ET) (546.46 KB - PDF)

Ver

ελληνικά (EL) (639.48 KB - PDF)

Ver

français (FR) (550.8 KB - PDF)

Ver

hrvatski (HR) (1.06 MB - PDF)

Ver

italiano (IT) (548.98 KB - PDF)

Ver

latviešu (LV) (616.63 KB - PDF)

Ver

lietuvių (LT) (577.48 KB - PDF)

Ver

magyar (HU) (610.46 KB - PDF)

Ver

Malti (MT) (620.67 KB - PDF)

Ver

Nederlands (NL) (547.6 KB - PDF)

Ver

polski (PL) (615.07 KB - PDF)

Ver

português (PT) (549.16 KB - PDF)

Ver

română (RO) (576.09 KB - PDF)

Ver

slovenčina (SK) (617.05 KB - PDF)

Ver

slovenščina (SL) (568.91 KB - PDF)

Ver

suomi (FI) (547.15 KB - PDF)

Ver

svenska (SV) (548.33 KB - PDF)

Ver

Product information

български (BG) (1.66 MB - PDF)

Ver

español (ES) (972.49 KB - PDF)

Ver

čeština (CS) (1.37 MB - PDF)

Ver

dansk (DA) (998.7 KB - PDF)

Ver

Deutsch (DE) (1012.89 KB - PDF)

Ver

eesti (ET) (990.29 KB - PDF)

Ver

ελληνικά (EL) (1.7 MB - PDF)

Ver

français (FR) (1.03 MB - PDF)

Ver

hrvatski (HR) (1014.8 KB - PDF)

Ver

italiano (IT) (1.03 MB - PDF)

Ver

latviešu (LV) (1.41 MB - PDF)

Ver

lietuvių (LT) (1023.66 KB - PDF)

Ver

magyar (HU) (1.37 MB - PDF)

Ver

Malti (MT) (1.44 MB - PDF)

Ver

Nederlands (NL) (1016.54 KB - PDF)

Ver

polski (PL) (1.45 MB - PDF)

Ver

português (PT) (1004.82 KB - PDF)

Ver

română (RO) (1.06 MB - PDF)

Ver

slovenčina (SK) (1.39 MB - PDF)

Ver

slovenščina (SL) (1.39 MB - PDF)

Ver

suomi (FI) (983.01 KB - PDF)

Ver

svenska (SV) (1002.26 KB - PDF)

Ver

Íslenska (IS) (985.54 KB - PDF)

Ver

norsk (NO) (343.48 KB - PDF)

Ver
Latest procedure affecting product information:IAIN/0031
08/09/2017
icon globe

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).

български (BG) (529.08 KB - PDF)

Ver

español (ES) (485.69 KB - PDF)

Ver

čeština (CS) (529.3 KB - PDF)

Ver

dansk (DA) (485.73 KB - PDF)

Ver

Deutsch (DE) (484.5 KB - PDF)

Ver

eesti (ET) (485.88 KB - PDF)

Ver

ελληνικά (EL) (528.76 KB - PDF)

Ver

français (FR) (484.57 KB - PDF)

Ver

hrvatski (HR) (492.6 KB - PDF)

Ver

italiano (IT) (503.04 KB - PDF)

Ver

latviešu (LV) (526.53 KB - PDF)

Ver

lietuvių (LT) (502.59 KB - PDF)

Ver

magyar (HU) (508.09 KB - PDF)

Ver

Malti (MT) (522.89 KB - PDF)

Ver

Nederlands (NL) (485.68 KB - PDF)

Ver

polski (PL) (523.08 KB - PDF)

Ver

português (PT) (485.04 KB - PDF)

Ver

română (RO) (509.16 KB - PDF)

Ver

slovenčina (SK) (540.33 KB - PDF)

Ver

slovenščina (SL) (507.44 KB - PDF)

Ver

suomi (FI) (488.95 KB - PDF)

Ver

svenska (SV) (485.59 KB - PDF)

Ver

Íslenska (IS) (484.25 KB - PDF)

Ver

norsk (NO) (469.96 KB - PDF)

Ver

български (BG) (700.28 KB - PDF)

Ver

español (ES) (613.31 KB - PDF)

Ver

čeština (CS) (1.19 MB - PDF)

Ver

dansk (DA) (614.54 KB - PDF)

Ver

Deutsch (DE) (617.65 KB - PDF)

Ver

eesti (ET) (617.52 KB - PDF)

Ver

ελληνικά (EL) (697.34 KB - PDF)

Ver

français (FR) (618.22 KB - PDF)

Ver

italiano (IT) (619.69 KB - PDF)

Ver

latviešu (LV) (660.48 KB - PDF)

Ver

lietuvių (LT) (634.24 KB - PDF)

Ver

magyar (HU) (647.41 KB - PDF)

Ver

Malti (MT) (768.5 KB - PDF)

Ver

Nederlands (NL) (613.46 KB - PDF)

Ver

polski (PL) (699.38 KB - PDF)

Ver

português (PT) (625.07 KB - PDF)

Ver

română (RO) (643.04 KB - PDF)

Ver

slovenčina (SK) (679.65 KB - PDF)

Ver

slovenščina (SL) (744.22 KB - PDF)

Ver

suomi (FI) (606.41 KB - PDF)

Ver

svenska (SV) (612 KB - PDF)

Ver

Product details

Name of medicine
Vibativ
Active substance
telavancin
International non-proprietary name (INN) or common name
telavancin
Therapeutic area (MeSH)
  • Pneumonia, Bacterial
  • Cross Infection
Anatomical therapeutic chemical (ATC) code
J01XA03

Pharmacotherapeutic group

Antibacterials for systemic use

Therapeutic indication

Vibativ is indicated for the treatment of adults with nosocomial pneumonia including ventilator-associated pneumonia, known or suspected to be caused by methicillin-resistant Staphylococcus aureus (MRSA).

Vibativ should be used only in situations where it is known or suspected that other alternatives are not suitable.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Authorisation details

EMA product number
EMEA/H/C/001240
Marketing authorisation holder
Theravance Biopharma Ireland Umited

Connaught House 1
Burlington Road
Fourth Floor
D04 C5Y6
Dublin 4
Ireland

Marketing authorisation issued
02/09/2011
Revision
10

Assessment history

This page was last updated on

Share this page