AfricaRegulatory
African Pharmaceutical Regulatory Intelligence
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Zopiclone in South Africa
17 products registered with SAHPRA — 16 active
| Brand / Product | Reg. No. | Holder | Status | Expires |
|---|---|---|---|---|
| ZOPICLONE 7,5 INNOVATA | 57/2.2/0124 | Innovata Pharmaceuticals | active | 22 Oct 2029 |
| PROPAN ZOPICLONE | 33/2.2/0451 | Adcock Ingram Limited | suspended | 26 Sept 2025 |
| ADCO ZOPIMED | 33/2.2/0450 | Adcock Ingram Limited | active | 1 Jan 1900 |
| SEDASTELL 7,5 mg | 43/2.2/0065 | Austell Pharmaceuticals (Pty) Ltd | active | 1 Jan 1900 |
| ALCHERA | 33/2.2/0029 | Pharmacare Limited û Woodmead | active | 1 Jan 1900 |
| Z-DORM HS | 36/2.2/0447 | Oethmaan Biosims (Pty) Ltd | active | 1 Jan 1900 |
| BIO ZOPICLONE 7,5 | 42/2.2/0537 | Biotech Laboratories (Pty) Ltd | active | 1 Jan 1900 |
| ZOPICLONE 7,5 MG UNICORN | A39/2.2/0021 | Austell Pharmaceuticals (Pty) Ltd | active | 1 Jan 1900 |
| AUSTOVANE 3,75 mg | 43/2.2/0066 | Austell Pharmaceuticals (Pty) Ltd | active | 1 Jan 1900 |
| AUSTOVANE 7,5 mg | 43/2.2/0067 | Austell Pharmaceuticals (Pty) Ltd | active | 1 Jan 1900 |
| ZOPISLEEP | 37/2.2/0375 | iPharma (Pty) Ltd | active | 1 Jan 1900 |
| Z-DORM | 34/2.2/0421 | Kiara Health (Pty) Ltd | active | 1 Jan 1900 |
| SANDOZ ZOPICLONE 7,5 | 32/2.2/0487 | Sandoz South Africa (Pty) Ltd | active | 1 Jan 1900 |
| ZOPICLONE 7,5 mg AUSTELL | A39/2.2/0022 | Austell Pharmaceuticals (Pty) Ltd | active | 1 Jan 1900 |
| ZOPIGEN | 36/2.2/0426 | Viatris South Africa (Pty) Ltd | active | 1 Jan 1900 |
| SEDASTELL 3,75 mg | 43/2.2/0064 | Austell Pharmaceuticals (Pty) Ltd | active | 1 Jan 1900 |
| ZOPIVANE | 35/2.2/0021 | Cipla Medpro (Pty) Ltd | active | 1 Jan 1900 |
Zopiclone — SAHPRA Registration Details
SAHPRA (South Africa) has 17 registered products containing Zopiclone, of which 16 are currently active. Data is sourced directly from the official SAHPRA drug register and refreshed daily.
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