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Overview
The marketing authorisation for Ablavar has been withdrawn at the request of the marketing authorisation holder.
Ablavar: EPAR - Summary for the public
English (EN) (288.17 KB - PDF)
български (BG) (381.04 KB - PDF)
español (ES) (287.87 KB - PDF)
čeština (CS) (406.77 KB - PDF)
dansk (DA) (349.76 KB - PDF)
Deutsch (DE) (352.48 KB - PDF)
eesti keel (ET) (345.06 KB - PDF)
ελληνικά (EL) (446.47 KB - PDF)
français (FR) (289.45 KB - PDF)
italiano (IT) (351.53 KB - PDF)
latviešu valoda (LV) (412.83 KB - PDF)
lietuvių kalba (LT) (373.05 KB - PDF)
magyar (HU) (401.9 KB - PDF)
Malti (MT) (408.15 KB - PDF)
Nederlands (NL) (348.38 KB - PDF)
polski (PL) (410.26 KB - PDF)
português (PT) (287.7 KB - PDF)
română (RO) (316.56 KB - PDF)
slovenčina (SK) (405.64 KB - PDF)
slovenščina (SL) (400.68 KB - PDF)
Suomi (FI) (76.15 KB - PDF)
svenska (SV) (347.91 KB - PDF)
Product information
Ablavar: EPAR - Product Information
English (EN) (464.64 KB - PDF)
български (BG) (1.15 MB - PDF)
español (ES) (462.49 KB - PDF)
čeština (CS) (874.72 KB - PDF)
dansk (DA) (453.47 KB - PDF)
Deutsch (DE) (789.25 KB - PDF)
eesti keel (ET) (449.07 KB - PDF)
ελληνικά (EL) (1.17 MB - PDF)
français (FR) (482.84 KB - PDF)
íslenska (IS) (471.69 KB - PDF)
italiano (IT) (460.53 KB - PDF)
latviešu valoda (LV) (911.1 KB - PDF)
lietuvių kalba (LT) (628.25 KB - PDF)
magyar (HU) (1.14 MB - PDF)
Malti (MT) (917.79 KB - PDF)
Nederlands (NL) (494.7 KB - PDF)
norsk (NO) (463.27 KB - PDF)
polski (PL) (907.33 KB - PDF)
português (PT) (465.71 KB - PDF)
română (RO) (624.14 KB - PDF)
slovenčina (SK) (869.9 KB - PDF)
slovenščina (SL) (805.95 KB - PDF)
Suomi (FI) (767.16 KB - PDF)
svenska (SV) (458.85 KB - PDF)
Latest procedure affecting product information: IB/0020
15/05/2011
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).
Ablavar : EPAR - All Authorised presentations
English (EN) (458.35 KB - PDF)
български (BG) (320.82 KB - PDF)
español (ES) (247.26 KB - PDF)
čeština (CS) (321.05 KB - PDF)
dansk (DA) (248.48 KB - PDF)
Deutsch (DE) (248.4 KB - PDF)
eesti keel (ET) (459.36 KB - PDF)
ελληνικά (EL) (324.22 KB - PDF)
français (FR) (244.96 KB - PDF)
íslenska (IS) (237.03 KB - PDF)
italiano (IT) (246.86 KB - PDF)
latviešu valoda (LV) (325.42 KB - PDF)
lietuvių kalba (LT) (525.32 KB - PDF)
magyar (HU) (498.89 KB - PDF)
Malti (MT) (322.85 KB - PDF)
Nederlands (NL) (246.7 KB - PDF)
norsk (NO) (248.87 KB - PDF)
polski (PL) (325.48 KB - PDF)
português (PT) (248.48 KB - PDF)
română (RO) (310.55 KB - PDF)
slovenčina (SK) (324.12 KB - PDF)
slovenščina (SL) (273.98 KB - PDF)
Suomi (FI) (247.29 KB - PDF)
svenska (SV) (248.56 KB - PDF)
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 mediaTherapeutic 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
- Revision
- 10
Assessment history
Ablavar : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (312.69 KB - PDF)
Vasovist-H-C-601-A-20-15: EPAR - Assessment Report - Variation
English (EN) (420.55 KB - PDF)
More information on Ablavar
Public statement on Ablavar: Withdrawal of the marketing authorisation in the European Union
English (EN) (53.34 KB - PDF)
Questions and answers on the review of gadolinium-containing contrast agents
English (EN) (48.93 KB - PDF)
български (BG) (242.44 KB - PDF)
español (ES) (113.18 KB - PDF)
čeština (CS) (192.16 KB - PDF)
dansk (DA) (49.95 KB - PDF)
Deutsch (DE) (50.93 KB - PDF)
eesti keel (ET) (49.65 KB - PDF)
ελληνικά (EL) (237.73 KB - PDF)
français (FR) (51.25 KB - PDF)
italiano (IT) (50.72 KB - PDF)
latviešu valoda (LV) (193.87 KB - PDF)
lietuvių kalba (LT) (191.27 KB - PDF)
magyar (HU) (96.49 KB - PDF)
Malti (MT) (220.89 KB - PDF)
Nederlands (NL) (50.88 KB - PDF)
polski (PL) (136.04 KB - PDF)
português (PT) (111.38 KB - PDF)
română (RO) (189.91 KB - PDF)
slovenčina (SK) (189.71 KB - PDF)
slovenščina (SL) (184.89 KB - PDF)
Suomi (FI) (48.64 KB - PDF)
svenska (SV) (49.62 KB - PDF)