Dossier assessment
Fidaxomicin - Benefit assessment according to § 35a Social Code Book V (dossier assessment)
Report documents
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Extract of dossier assessment
Fidaxomicin - Benefit assessment according to § 35a Social Code Book V (dossier assessment)
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Dossier assessment
Fidaxomicin - Benefit assessment according to § 35a Social Code Book V (dossier assessment)
Press releases
Fidaxomicin: Data subsequently submitted by manufacturer prove added benefit
Now proof of minor added benefit in severe cases or recurrences of Clostridium difficile infections
Fidaxomicin in Clostridium difficile infection: added benefit not proven
Drug manufacturer did not submit studies on mild cases, and processed data in an unusable way for severe cases and recurrences
Project details
- Project no.
- A13-05
- Commission
- Commission awarded on 15.01.2013 by the Federal Joint Committee (GBA).
- Report type
- Dossier assessment
- Status
- Commission completed
- Department/Division
- Drug Assessment
- Topic
- Digestion, metabolism and hormones, Immune system and infections
- Note
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After completion of the assessment by IQWiG the Federal Joint Committee (G-BA) 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 G-BA website.
Connected Projects
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Dossier assessment
Fidaxomicin (Clostridioides difficile infection) - Benefit assessment according to §35a Social Code Book V
Status: Commission completed