AfricaRegulatory
African Pharmaceutical Regulatory Intelligence
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Dexmedetomidine Hydrochloride in South Africa
9 products registered with SAHPRA — 9 active
| Brand / Product | Reg. No. | Holder | Status | Expires |
|---|---|---|---|---|
| DEXITHERA 100 µg/ml 10 ml | 56/2.9/0941 | Abbott Laboratories S.A. (Pty) Ltd | active | 26 Nov 2029 |
| DEXITHERA 100 µg/ml 2 ml | 56/2.9/0939 | Abbott Laboratories S.A. (Pty) Ltd | active | 26 Nov 2029 |
| DEXITHERA 100 µg/ml 4 ml | 56/2.9/0940 | Abbott Laboratories S.A. (Pty) Ltd | active | 26 Nov 2029 |
| TOMEXA 1000 µg/10 ml | 56/2.2/0235 | Pharmacorp (Pty) Ltd | active | 11 Jun 2029 |
| TOMEXA 200 µg/2 ml | 56/2.2/0233 | Pharmacorp (Pty) Ltd | active | 11 Jun 2029 |
| TOMEXA 400 µg/4 ml | 560/2.2/0234 | Pharmacorp (Pty) Ltd | active | 11 Jun 2029 |
| SEDMEDEX 100 μg/ml | 54/2.9/0696 | Juno Pharma SA (Pty) Ltd | active | 21 Feb 2028 |
| SESODEX | 55/2.9/0841 | Austell Pharmaceuticals (Pty) Ltd | active | 7 Feb 2028 |
| EUSEDEX | 56/2.9/0850 | Pfizer Laboratories (Pty) Ltd | active | 11 Oct 2027 |
Dexmedetomidine Hydrochloride — SAHPRA Registration Details
SAHPRA (South Africa) has 9 registered products containing Dexmedetomidine Hydrochloride, of which 9 are currently active. Data is sourced directly from the official SAHPRA drug register and refreshed daily.
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