Lisdexamfetamine dimesilate
Sold as Vyvanse, Vyfocis, Dystralex, Vysera
(2S)-2,6-Diamino-N-[(2S)-1-phenylpropan-2-yl]hexanamide
Drag to rotate. Structure from PubChem CID 11597698.
Background
Registration
- Applicants
- 3
- Registrations
- 12
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Takeda (Pty) Ltd | Vyvanse, Vysera | 30 mg, 50 mg, 70 mg | 480407, 480408, 480409, 600799, 600800, 600801 | Not determined | None |
| Cipla Medpro (Pty) Ltd | Vyfocis | 30, 50, 70 | 561238, 561240, 561242 | Not determined | None |
| Teva Pharmaceuticals (Pty) Ltd | Dystralex | 30, 50, 70 | 570448, 570449, 570450 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Vyvanse 30 LISDEXAMFETAMINE DIMESILATE 30,0 mg | 30 | 48040748/1.6/0407 | Registered | Not determined | None |
| Vyvanse 50 LISDEXAMFETAMINE DIMESILATE 50,0 mg | 50 | 48040848/1.6/0408 | Registered | Not determined | None |
| Vyvanse 70 LISDEXAMFETAMINE DIMESILATE 70,0 mg | 70 | 48040948/1.6/0409 | Registered | Not determined | None |
| Vyfocis 30 EACH CAPSULE CONTAINS: LISDEXAMFETAMINE DIMESILATE 30,0 mg | 30 | 56123856/1.6/1238 | Registered | Not determined | None |
| Vyfocis 50 EACH CAPSULE CONTAINS: LISDEXAMFETAMINE DIMESILATE 50,0 mg | 50 | 56124056/1.6/1240 | Registered | Not determined | None |
| Vyfocis 70 EACH CAPSULE CONTAINS: LISDEXAMFETAMINE DIMESILATE 70,0 mg | 70 | 56124256/1.6/1242 | Registered | Not determined | None |
| Dystralex 30 EACH CAPSULE CONTAINS: LISDEXAMFETAMINE DIMESILATE 30,0 mg | 30 | 57044857/1.6/0448 | Registered | Not determined | None |
| Dystralex 50 EACH CAPSULE CONTAINS: LISDEXAMFETAMINE DIMESILATE 50,0 mg | 50 | 57044957/1.6/0449 | Registered | Not determined | None |
| Dystralex 70 EACH CAPSULE CONTAINS: LISDEXAMFETAMINE DIMESILATE 70,0 mg | 70 | 57045057/1.6/0450 | Registered | Not determined | None |
| Vysera 30 MG EACH CAPSULE CONTAINS: LISDEXAMFETAMINE DIMESILATE 30,0 mg | 30 mg | 60079960/1.6/0799 | Registered | Not determined | None |
| Vysera 50 MG EACH CAPSULE CONTAINS: LISDEXAMFETAMINE DIMESILATE 50,0 mg | 50 mg | 60080060/1.6/0800 | Registered | Not determined | None |
| Vysera 70 MG EACH CAPSULE CONTAINS: LISDEXAMFETAMINE DIMESILATE 70,0 mg | 70 mg | 60080160/1.6/0801 | 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.
Listings for this ingredient that could not be applied to this product
S7: Lisdexamfetamine
- except in medicines registered in terms of the Act and intended for the treatment of Attention-Deficit Hyperactivity Disorder. (S6)
Consolidated Schedules 06 July 2026, lines 10751 to 10752
S6: Lisdexamfetamine
- in medicines registered in terms of the Act and intended for the treatment of Attention-Deficit Hyperactivity Disorder. (S7)
Consolidated Schedules 06 July 2026, lines 10289 to 10290
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.