Nintedanib esylate
Sold as Vatrana, Nintedanib cipla
Methyl 2-hydroxy-3-[N-[4-[methyl-[2-(4-methylpiperazin-1-yl)acetyl]amino]phenyl]-C-phenylcarbonimidoyl]-1H-indole-6-carboxylate
Drag to rotate. Structure from PubChem CID 135423438.
Background
Registration
- Applicants
- 1
- Registrations
- 4
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Cipla Medpro (Pty) Ltd | Vatrana, Nintedanib cipla | 100 mg, 150 mg | 560702, 560703, 560704.702, 560705.703 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Vatrana 100 EACH CAPSULE CONTAINS NINTEDANIB ESYLATE 100,0 mg | 100 | 56070256/26/0702 | Registered | Not determined | None |
| Vatrana 150 EACH CAPSULE CONTAINS NINTEDANIB ESYLATE 150,0 mg | 150 | 56070356/26/0703 | Registered | Not determined | None |
| Nintedanib 100 MG cipla EACH CAPSULE CONTAINS NINTEDANIB ESYLATE 100,0 mg | 100 mg | 560704.70256/26/0704.702 | Registered | Not determined | None |
| Nintedanib 150 MG cipla EACH CAPSULE CONTAINS NINTEDANIB ESYLATE 150,0 mg | 150 mg | 560705.70356/26/0705.703 | Registered | Not determined | None |
Regulatory status
This product is still scheduled by law even when this site could not determine which tier it falls under. The label carries the S number in a square border; ask a pharmacist if you need to know its schedule.
This is an informational summary of the Medicines and Related Substances Act 101 of 1965 and its 2017 General Regulations. It is not medical advice and not legal advice. Always check the medicine's label, which carries the schedule number inside a square border, or ask a pharmacist if you are unsure.
SAHPRA documents
SAHPRA has not published a professional information or patient information leaflet for this product.