Guerbet: CHMP positive opinion
Approved by the FDA in September 2022, Elucirem™ is produced in France and in the USA.
- Approved by the FDA in September 2022, Elucirem™ is produced in France and in the USA.
- Villepinte, France, 12 october 2023: The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion concerning the granting of a marketing authorisation for Elucirem™ (Gadopiclenol) in the European Union (EU) for use in adults and children aged 2 years and over for MRI with contrast enhancement.
- The positive opinion from the CHMP is essentially based on data from two phase III clinical trials completed in March 2021.
- "This positive opinion from the CHMP,
at the end of 2023, will bring European patients and health professionals