Gadopiclenol (1) – Elucirem®
Contrast-enhanced magnetic resonance imaging, ≥ 2 years
Characteristics
| Start date | 01.04.2024 – Marketing authorisation: 07.12.2023 |
|---|---|
| Resolution | 19.09.2024 |
| INN | Gadopiclenol |
| Brand name | Elucirem® |
| Pharm. company | Guerbet GmbH |
| G-BA Procedure ID | D-1050 |
| ATC code | V08CA12 Paramagnetic contrast media (V08CA) |
| ICD-10 codes (AIS) | Z03.9 |
| Alpha-ID codes (AIS) | I66935Clarification of a disease |
| Therapeutic area | Other diseases Magnetic resonance imaging |
| Reason for procedure | Initial assessment |
| Therapeutic indication of the resolution |
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This medicinal product is a diagnostic agent. Elucirem is used in adults and children aged 2 years and older for contrast-enhanced magnetic resonance imaging (MRI) to better recognise and visualise pathologies with a disruption of the blood-brain barrier (BBB) and/or vascular abnormalities in the following areas: – Brain, spine and associated tissues of the central nervous system (CNS); – Liver, kidney, pancreas, breast, lung, prostate and musculoskeletal system. It should only be used when the diagnostic information is necessary and cannot be obtained without contrast-enhanced MRI. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults, adolescents and children from the age of 2 years for whom contrast-enhanced magnetic resonance imaging is indicated in order to better recognise and visualise pathologies with a disruption of the blood-brain barrier and/or vascular abnormalities in areas of the body | Gadobutrol or gadoteridol or gadoteric acid |
Studies and Results
|
No. of studies
(best subpopulation) |
2 (PICTURE, PROMISE) 0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. ACT) |
- Clinical trials
- The PICTURE and PROMIS studies were blinded, randomised, controlled crossover trials with similar study designs, in which gadopiclenol was compared with gadobutrol.
Adults, adolescents and children aged 2 years and over for whom contrast-enhanced magnetic resonance imaging is indicated to improve the detection and visualisation of pathologies involving a disruption of the blood-brain barrier and/or vascular abnormalities in specific areas of the body
- For adults, adolescents and children aged 2 years and over for whom contrast-enhanced magnetic resonance imaging is indicated to improve the detection and visualisation of pathologies involving a disruption of the blood-brain barrier and/or vascular anomalies in specific areas of the body, an additional benefit is not proven.
- Overall, therefore, the additional benefit of gadopiclenol compared with the appropriate comparator therapy is not proven.
- Overall assessment
- Overall, no data were presented that fulfil the necessary criteria for establishing additional benefit. On balance, therefore, additional benefit of gadopiclenol over the appropriate comparator therapy is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Gadopiclenol (2) | Elucirem® | Guerbet GmbH | Contrast-enhanced magnetic resonance imaging, 0 to < 2 years | n.d. | active procedure | |
| Gadopiclenol (1) | Elucirem® | Guerbet GmbH | Contrast-enhanced magnetic resonance imaging, ≥ 2 years | 2,900,000–3,300,000 | 100% additional benefit not proven |
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