Dossier assessment

Letermovir (CMV prophylaxis after stem cell transplantation, < 18 years) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A25-67
Last updated

Report documents

  1. Extract of dossier assessment

    Letermovir (CMV prophylaxis after stem cell transplantation, < 18 years) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 301 kB, EN, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-67_en
  2. Dossier assessment

    Letermovir (CMV prophylaxis after stem cell transplantation, < 18 years) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 589 kB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A25-67

Dossier assessment

Indication:

Prophylaxis of cytomegalovirus reactivation and disease in paediatric patients with a body weight of at least 5 kg who are cytomegalovirus-seropositive recipients of an allogeneic haematopoietic stem cell transplant

Result of dossier assessment:

Added benefit not proven

Additional information

Federal Joint Committee (G-BA)

2025-11-06 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A25-67
Commission
Commission awarded on 15.05.2025 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Immune system and infections
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/A25-67_en

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  3. Addendum

    Letermovir (CMV prophylaxis after stem cell transplantation, < 18 years) – Addendum to Project A25-67

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    Status: Commission completed

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