Lorbrena
(16R)-19-Amino-13-fluoro-4,8,16-trimethyl-9-oxo-17-oxa-4,5,8,20-tetrazatetracyclo[16.3.1.02,6.010,15]docosa-1(22),2,5,10(15),11,13,18,20-octaene-3-carbonitrile
Drag to rotate; arrow keys step through the atoms. Structure from PubChem CID 71731823.
Registration
- Applicants
- 1
- Registrations
- 2
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Pfizer Laboratories (Pty) Ltd | Lorbrena | 25 mg, 100 mg | 570092, 570093 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Lorbrena 25 MG EACH TABLET CONTAINS LORLATINIB 25,0 mg | 25 mg | 57009257/20.3/0092 | Registered | Not determined | None |
| Lorbrena 100 MG EACH TABLET CONTAINS LORLATINIB 100,0 mg | 100 mg | 57009357/20.3/0093 | 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.
Background
SAHPRA documents
SAHPRA has not published a professional information or patient information leaflet for this product.