Ivermectin (1) – Soolantra®
Inflammatory lesions of rosacea
Characteristics
| Start date | 01.06.2015 |
|---|---|
| Resolution | 27.11.2015 repealed |
| INN | Ivermectin |
| Brand name | Soolantra® |
| Pharm. company | Galderma Laboratorium GmbH |
| G-BA Procedure ID | D-170 |
| ATC code | D11AX22 Other dermatologicals (D11AX) |
| ICD-10 codes (AIS) | L71.8Other rosacea, L71.9Rosacea, unspecified |
| Alpha-ID codes (AIS) | I15225Rosacea, I6364Rosacea papulosa |
| DDD | 10 mg T |
| Therapeutic area | Skin diseases Rosacea |
| Reason for procedure | Initial assessment – New data exclusivity (known INN) |
| Specialty | Patent/data protection expired |
| Therapeutic indication of the resolution |
|---|
|
Ivermectin (Soolantra) is used in adult patients for the topical treatment of inflammatory lesions of (papulopustular) rosacea. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Erwachsene Patienten mit entzündlichen Läsionen der (papulopustulösen) Rosazea | Azelaic acid or doxycycline (oral) or metronidazole (topical) |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (no data submitted) |
|---|---|
|
Study design
(best subpopulation) |
no data submitted (Dossier: ) |
adult patients for the topical treatment of inflammatory lesions associated with (papulopustular) rosacea
- No dossier had been submitted by the pharmaceutical manufacturer at the relevant time.
- Pursuant to Section 35a(1), fifth sentence, of SGB V, this means that no assessment has been carried out as to whether the active ingredient ivermectin has any additional benefit, no additional benefit or a minor additional benefit compared with the appropriate comparator therapy, and that the additional benefit of ivermectin in relation to the appropriate comparator therapy is deemed not proven.
- As the required proof has not been submitted, the additional benefit in relation to the appropriate comparator therapy is deemed not proven (Section 35a(1), fifth sentence, of Book V of the Social Code).
- Appropriate comparator therapy
- The appropriate comparator therapy for the topical treatment of (papulopustular) rosacea is: azelaic acid or doxycycline (oral) or metronidazole (topical).
Courtesy translation only, please refer to the German original.
Associated procedures
| Ivermectin (1) | Soolantra® | Galderma Laboratorium GmbH | Inflammatory lesions of rosacea |
0
309,000–703,000 |
100% additional benefit not proven repealed |
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