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Dossier assessment

Gadopiclenol (contrast-enhanced magnetic resonance imaging, 0 to < 2 years) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A26-13
Last updated

Report documents

  1. Extract of dossier assessment

    Gadopiclenol (contrast-enhanced magnetic resonance imaging, 0 to < 2 years) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 151 kB, DE, not accessible
    Download file : Extract of dossier assessment (PDF document, 151 kB, DE, not accessible)

  2. Dossier assessment

    Gadopiclenol (contrast-enhanced magnetic resonance imaging, 0 to < 2 years) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 464 kB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A26-13
    Download file : Dossier assessment (PDF document, 464 kB, DE, not accessible)

Drug assessment at a glance

  1. Drug assessment at a glance

    Gadopiclenol (contrast-enhanced magnetic resonance imaging, 0 to < 2 years) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 197 kB, EN, not accessible
    Download file : Drug assessment at a glance (PDF document, 197 kB, EN, not accessible)

Dossier assessment

Indication:

Children from birth to < 2 years of age for contrast-enhanced MRI to improve detection and visualization of pathologies with disruption of the blood-brain-barrier and/or abnormal vascularity of:

  • the brain, spine and associated tissues of the CNS
  • the liver, kidney, pancreas, breast, lung, prostate and musculoskeletal system

It should be used only when diagnostic information is essential and not available with unenhanced MRI.

Result of dossier assessment:

Added benefit not proven

Project details

Project no.
A26-13
Commission
Commission awarded on 19.02.2026 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Diagnostics
Note

After completion of the assessment by IQWiG the Federal Joint Committee (GBA) conducts a commenting procedure. This may provide supplementary information and as a result lead to a modified benefit assessment. Further information and the decision on the early benefit assessment can be found on the relevant page of the GBA website.

DOI

https://doi.org/10.60584/A26-13

Connected Projects

  1. Dossier assessment

    Gadopiclenol (contrast-enhanced magnetic resonance imaging) – Benefit assessment according to §35a Social Code Book V

    Project no.
    A24-37
    Last updated

    Status: Commission completed

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