Artesunat (1) – Artesunate Amivas®
Severe malaria, from birth
Characteristics
| Start date | 01.11.2024 – Marketing authorisation: 22.01.2024 |
|---|---|
| Resolution | 17.04.2025 |
| INN | Artesunat |
| Brand name | Artesunate Amivas® |
| Pharm. company | Amivas Ireland Ltd |
| G-BA Procedure ID | D-1135 |
| ATC code | n.d. |
| ICD-10 codes (AIS) | B50.0Cerebral malaria NOS, B50.8Severe or complicated Plasmodium falciparum malaria NOS, B51.0Plasmodium vivax malaria with rupture of spleen, B51.8Plasmodium vivax malaria with other complications, B52.0Plasmodium malariae malaria with nephropathy, B52.8Plasmodium malariae malaria with other complications |
| Alpha-ID codes (AIS) | I76969Complication of malaria tropica, I96827Malaria vivax with complications n.c |
| ORPHAcodes (AIS) | 673Complication of malaria tropica, 673Malaria vivax with complications n.c |
| Therapeutic area | Infectious diseases Malaria Orphan |
| Reason for procedure | Initial assessment |
| Therapeutic indication of the resolution |
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Artesunate Amivas is used for the initial treatment of severe malaria in adults and children. The official guidelines on the appropriate use of antimalarials should be followed. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Children from birth and adults with severe malaria (for initial treatment) | – (Orphan drug) |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (no data submitted) |
|---|---|
|
Study design
(best subpopulation) |
no data submitted (Dossier: ) |
Children from birth and adults with severe malaria (for initial treatment)
- Artesunate for the initial treatment of severe malaria in adults and children has a marketing authorisation as a medicinal product for the treatment of an orphan disease in accordance with Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999.
- In accordance with Section 35a(1), sentence 11, first half-sentence, of Book V of the Social Code (SGB V), the additional medical benefit is therefore deemed proven by virtue of the marketing authorisation.
- The pharmaceutical manufacturer did not submit a benefit assessment dossier at the relevant time.
- Consequently, the necessary evidence for the benefit assessment pursuant to Section 35a of the German Social Code, Book V (SGB V) was not submitted to the G-BA.
- Pursuant to Section 5(8), second sentence, in conjunction with paragraph 7, first sentence, number 4 of the AM-NutzenV, this therefore results in a non-quantifiable additional benefit, as the required evidence is incomplete.
Courtesy translation only, please refer to the German original.
Associated procedures
| Artesunat (1) | Artesunate Amivas® | Amivas Ireland Ltd | Severe malaria, from birth | 87 | 100% non-quantifiable additional benefit Orphan |
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