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Irish Medicines Database · HPRA register

Dotarem 279.32 mg/ml solution for injection

Authorisation PA0686/003/002 · Guerbet

← All medicines

Dotarem 279.32 mg/ml solution for injection

Licence PA0686/003/002 · Marketed

Licence holder: Guerbet (all products →)
Active substance: Gadoteric acid
Dosage form: Solution for injection
Route of administration: Intravenous use
ATC codes: V08CA, V08CA02
First authorised: 10/06/1996
Prescription status: Product subject to Restricted Prescription (C)
Supply: Supply through pharmacies only
Legal basis: Full application (Article 8(3) of Directive No 2001/83/EC)

Data: Health Products Regulatory Authority (HPRA) open dataset, licensed CC BY 4.0, published 04 Jul 2026. This listing is regulatory information, not medical advice — consult the package leaflet, SPC, or a healthcare professional. For the authoritative record see the HPRA register.