Eravacyclin (2) – Xerava®
Complicated intra-abdominal infections (cIAI), aged ≥ 12 to < 18 years, weighing ≥ 50 kg
Characteristics
| Start date | 01.02.2026 – Marketing authorisation: 24.12.2025 |
|---|---|
| Resolution | 16.07.2026 |
| INN | Eravacyclin |
| Brand name | Xerava® |
| Pharm. company | Paion Pharma GmbH |
| G-BA Procedure ID | D-1298 |
| ATC code | J01AA13 Tetracyclines (J01AA) |
| Therapeutic area | Infectious diseases |
| Reason for procedure | New therapeutic indication |
Studies and Results
Young people aged 12 to <18 years with a body weight of ≥ 50 kg and complicated intra-abdominal infections (cIAI)
- For the medicinal product Xerava, containing the active ingredient eravacycline, an exemption from the obligation to submit evidence in accordance with Section 35a(1), third sentence, points 2 and 3 of Book V of the Social Code (SGB V) was granted by resolution of 21 April 2022, as it is a reserve antibiotic within the meaning of Section 35a(1c), first sentence, of SGB V.
- Where the Federal Joint Committee (G-BA) has decided to grant an exemption for a reserve antibiotic pursuant to Section 35a(1c), first sentence, of SGB V, the additional benefit is deemed proven.
- The extent of the additional benefit and its therapeutic significance are not to be assessed by the Federal Joint Committee (G-BA).
- Overall assessment
- The additional benefit of eravacycline is deemed proven for adolescents aged 12 years and over with a body weight of ≥ 50 kg suffering from complicated intra-abdominal infections (cIAI).
Courtesy translation only, please refer to the German original.
Associated procedures
| Eravacyclin (2) | Xerava® | Paion Pharma GmbH | Complicated intra-abdominal infections (cIAI), aged ≥ 12 to < 18 years, weighing ≥ 50 kg | 175–440 | 100% additional benefit considered proven | |
| Eravacyclin (1) | Xerava® | PAION Deutschland GmbH | Reserve antibiotics: Complicated intra-abdominal infections (cIAI) | 2,600–6,600 | 100% additional benefit considered proven |
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