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Omniscan 0.5 mmol / ml Solution for Injection, glass vial / bottles

Licence status
Suspended: 13/05/2021
Active substances
Gadodiamide
Dosage Form
Solution for injection
Licence number
PA0735/008/006
Licence holder
GE Healthcare AS

Licence information

ATC code
V08CA Paramagnetic contrast media, V08CA03 gadodiamide
Route of supply
Product subject to prescription which may not be renewed (A)
Place of sale
Supply through pharmacies only
Conditions of Licence
Parametric Release for Sterility approved on 12th July 2007 in accordance with CPMP/QWP/3015/00, Note for Guidance on Parametric Release and Annex 17 to the EU guide on Good Manufacturing Practice provided the following conditions apply: 1. The approval i
Marketing availability
Marketed
Advertising conditions
Advertising to healthcare professionals only
Licence issued
29/06/2007

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