Gadovist 1 mmol/ml inj. sol. i.v. pre-filled syr.

Country: Belgium

Language: English

Source: AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

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Active ingredient:

Gadobutrol 4,5354 g

Available from:

Bayer SA-NV

ATC code:

V08CA09

INN (International Name):

Gadobutrol

Dosage:

1,0 mmol/ml

Pharmaceutical form:

Solution for injection

Composition:

Gadobutrol 604.72 mg/ml

Administration route:

Intravenous use

Therapeutic area:

Gadobutrol

Product summary:

CTI code: 221094-02 - Pack size: 5 x 15 ml - Commercialisation status: NO - Delivery mode: Medical prescription; CTI code: 221094-01 - Pack size: 15 ml - Commercialisation status: YES - FMD code: 04057601000942 - CNK code: 2041283 - Delivery mode: Medical prescription; CTI code: 480266-02 - Pack size: 5 x 15 ml - Commercialisation status: NO - Delivery mode: Medical prescription; CTI code: 480266-01 - Pack size: 15 ml - Commercialisation status: NO - Delivery mode: Medical prescription

Authorization status:

Commercialised: Yes

Authorization date:

2001-02-12

Documents in other languages

Patient Information leaflet Patient Information leaflet German 18-10-2022
Patient Information leaflet Patient Information leaflet French 18-10-2022
DHPC DHPC French 14-12-2022
Patient Information leaflet Patient Information leaflet Dutch 18-10-2022
DHPC DHPC Dutch 14-12-2022