Ablavar (previously Vasovist)

RSS
Withdrawn

This medicine's authorisation has been withdrawn

gadofosveset trisodium
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 3 October 2005 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Vasovist (gadofosveset) for contrast-enhanced magnetic resonance angiography (CE-MRA) for visualisation of abdominal or limb vessels in adults only, with suspected or known vascular disease. The name of the medicinal product was changed to Ablavar on 10 January 2011. The marketing authorisation holder (MAH) responsible for Ablavar was TMC Pharma Services Ltd. 

The European Commission was notified by a letter dated 13 September 2011 of the MAH’s decision to voluntarily withdraw the marketing authorisation as of the Commission Decision date for Ablavar for commercial reasons. Ablavar was not marketed in any European country. On 18 October 2011 the European Commission issued a decision to withdraw the marketing authorisation for Ablavar. 

Pursuant to this decision the European Public Assessment Report for Ablavar is updated to reflect that the marketing authorisation is no longer valid.

български (BG) (381.04 KB - PDF)

View

español (ES) (287.87 KB - PDF)

View

čeština (CS) (406.77 KB - PDF)

View

dansk (DA) (349.76 KB - PDF)

View

Deutsch (DE) (352.48 KB - PDF)

View

eesti keel (ET) (345.06 KB - PDF)

View

ελληνικά (EL) (446.47 KB - PDF)

View

français (FR) (289.45 KB - PDF)

View

italiano (IT) (351.53 KB - PDF)

View

latviešu valoda (LV) (412.83 KB - PDF)

View

lietuvių kalba (LT) (373.05 KB - PDF)

View

magyar (HU) (401.9 KB - PDF)

View

Malti (MT) (408.15 KB - PDF)

View

Nederlands (NL) (348.38 KB - PDF)

View

polski (PL) (410.26 KB - PDF)

View

português (PT) (287.7 KB - PDF)

View

română (RO) (316.56 KB - PDF)

View

slovenčina (SK) (405.64 KB - PDF)

View

slovenščina (SL) (400.68 KB - PDF)

View

Suomi (FI) (76.15 KB - PDF)

View

svenska (SV) (347.91 KB - PDF)

View

Product information

български (BG) (1.15 MB - PDF)

View

español (ES) (462.49 KB - PDF)

View

čeština (CS) (874.72 KB - PDF)

View

dansk (DA) (453.47 KB - PDF)

View

Deutsch (DE) (789.25 KB - PDF)

View

eesti keel (ET) (449.07 KB - PDF)

View

ελληνικά (EL) (1.17 MB - PDF)

View

français (FR) (482.84 KB - PDF)

View

íslenska (IS) (471.69 KB - PDF)

View

italiano (IT) (460.53 KB - PDF)

View

latviešu valoda (LV) (911.1 KB - PDF)

View

lietuvių kalba (LT) (628.25 KB - PDF)

View

magyar (HU) (1.14 MB - PDF)

View

Malti (MT) (917.79 KB - PDF)

View

Nederlands (NL) (494.7 KB - PDF)

View

norsk (NO) (463.27 KB - PDF)

View

polski (PL) (907.33 KB - PDF)

View

português (PT) (465.71 KB - PDF)

View

română (RO) (624.14 KB - PDF)

View

slovenčina (SK) (869.9 KB - PDF)

View

slovenščina (SL) (805.95 KB - PDF)

View

Suomi (FI) (767.16 KB - PDF)

View

svenska (SV) (458.85 KB - PDF)

View
Latest procedure affecting product information: IB/0020
15/05/2011
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) (320.82 KB - PDF)

View

español (ES) (247.26 KB - PDF)

View

čeština (CS) (321.05 KB - PDF)

View

dansk (DA) (248.48 KB - PDF)

View

Deutsch (DE) (248.4 KB - PDF)

View

eesti keel (ET) (459.36 KB - PDF)

View

ελληνικά (EL) (324.22 KB - PDF)

View

français (FR) (244.96 KB - PDF)

View

íslenska (IS) (237.03 KB - PDF)

View

italiano (IT) (246.86 KB - PDF)

View

latviešu valoda (LV) (325.42 KB - PDF)

View

lietuvių kalba (LT) (525.32 KB - PDF)

View

magyar (HU) (498.89 KB - PDF)

View

Malti (MT) (322.85 KB - PDF)

View

Nederlands (NL) (246.7 KB - PDF)

View

norsk (NO) (248.87 KB - PDF)

View

polski (PL) (325.48 KB - PDF)

View

português (PT) (248.48 KB - PDF)

View

română (RO) (310.55 KB - PDF)

View

slovenčina (SK) (324.12 KB - PDF)

View

slovenščina (SL) (273.98 KB - PDF)

View

Suomi (FI) (247.29 KB - PDF)

View

svenska (SV) (248.56 KB - PDF)

View

Product details

Name of medicine
Ablavar (previously Vasovist)
Active substance
gadofosveset trisodium
International non-proprietary name (INN) or common name
gadofosveset trisodium
Therapeutic area (MeSH)
Magnetic Resonance Angiography
Anatomical therapeutic chemical (ATC) code
V08CA

Pharmacotherapeutic group

Contrast media

Therapeutic indication

This medicinal product is for diagnostic use only.

Ablavar is indicated for contrast-enhanced magnetic resonance angiography (CE-MRA) for visualisation of abdominal or limb vessels in adults only, with suspected or known vascular disease.

Authorisation details

EMA product number
EMEA/H/C/000601
Marketing authorisation holder
TMC Pharma Services Ltd.

Finchampstead
Berkshire RG40 4LJ
United Kingdom

Marketing authorisation issued
03/10/2005
Withdrawal of marketing authorisation
18/10/2011
Revision
10

Assessment history

This page was last updated on

Share this page