Guerbet announces marketing authorisation approval of Elucirem™ (Gadopiclenol) in the European Union
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星期一, 十二月 11, 2023
Syringe, Safety, Regulatory affairs, European Medicines Agency, Aulnay-sous-Bois, European Commission, Ageing, GBCA, Gadolinium, Civil service commission, Medicine, European, FDA, CHMP, BBB, Marketing, Committee, Pathology, Marans, Charente-Maritime, Person, Medical imaging, Seine-Saint-Denis, MRI, Radiology
The marketing authorisation (MA) for Elucirem™ (Gadopiclenol) was granted to Guerbet by the European Commission based on the positive opinion of the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) dated 12 October 2023.
Key Points:
- The marketing authorisation (MA) for Elucirem™ (Gadopiclenol) was granted to Guerbet by the European Commission based on the positive opinion of the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) dated 12 October 2023.
- It will be marketed by Guerbet in the European Union in the following forms: vials and prefilled syringes.
- "After its approval by the FDA for the American market, the European marketing authorisation for Elucirem™ reinforces our strategic perspective: combining medical innovation and environmental commitment.
- This authorisation is ground-breaking for Medical Imaging in Europe," concludes David Hale, Guerbet CEO.