Cilastatin, imipenem
Sold as Bacqure, Cilapen, Imipenem and cilastatin adco, Sepencil, Imipenem/cilastatin fresenius, Actapen, Imcil, Cilnem, Tienam
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
Background
Registration
- Applicants
- 8
- Registrations
- 10
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Ranbaxy Pharmaceutical (Pty) LtdCertificate held by Ranbaxy Pharmaceuticals (Pty) Ltd1 of 2 cancelled | Bacqure, Cilapen | 500 mg | 420636, 420637 | S4 | PIPIL |
| Adcock Ingram Critical Care (Pty) Ltd | Imipenem and cilastatin adco | 500 mg/20 ml | 440796 | Not determined | None |
| Pharma Dynamics (Pty) Ltd | Sepencil | 500 mg | 440814 | Not determined | None |
| Fresenius Kabi South Africa (Pty) LtdCancelled | Imipenem/cilastatin fresenius | 250 mg/250 mg | 471149 | Not determined | None |
| Teva Pharmaceuticals (Pty) LtdCancelled | Actapen | 250, 500 | 490342, 490343 | Not determined | None |
| Austell Pharmaceuticals (Pty) Ltd | Imcil | 500 | 500653 | S4 | None |
| Astral Pharma (Pty) LtdCertificate held by Abex Pharmaceutica (Pty) Ltd | Cilnem | 500 mg | 540204.203 | S4 | PIPIL |
| Msd (Pty) Ltd | Tienam | 500 | S0175 | S4 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Bacqure 500 EACH VIAL CONTAINS CILASTATIN SODIUM EQUIVALENT TO CILASTATIN 500,0 mg IMIPENEM 500,0 mg | 500 mg.Powder for injection | 42063642/20.1.1/0636Approved 1 June 2021 | Cancelled | S4 | PIPIL |
| Cilapen 500 EACH VIAL CONTAINS CILASTATIN SODIUM EQUIVALENT TO CILASTATIN 500,0 mgIMIPENEM 500,0 mg | 500 mg.Powder for injection | 42063742/20.1.1/0637Approved 13 January 2025 | Registered | S4 | PIPIL |
| Imipenem and cilastatin adco 500 mg/20 ML EACH VIAL CONTAINS: IMIPENEM MONOHYDRATE EQUIVALENT TO ANHYDROUS IMIPENEM 500,0 mg CILASTATIN SODIUM EQUIVALENT TO CILASTATIN 500,0 mg | 500 mg/20 ml | 44079644/20.1.1/0796 | Registered | Not determined | None |
| Sepencil 500 MG EACH VIAL CONTAINS: IMIPENEM MONOHYDRATE EQUIVALENT TO IMIPENEM 500,0 mg ,CILASTATIN SODIUM EQUIVALENT TO CILASTATIN 500,0 mgNone | 500 mg | 44081444/20.1.1/0814 | Registered | Not determined | None |
| Imipenem/cilastatin 250 mg/250 MG fresenius EACH VIAL CONTAINS: IMIPENEM MONOHYDRATE EQUIVALENT TO IMIPENEM 250,0 mg CILASTATIN SODIUM EQUIVALENT TO CILASTATIN 250,0 mg | 250 mg/250 mg | 47114947/20.1.1/1149 | Cancelled | Not determined | None |
| Actapen 250 Each Vial contains: Imipenem Monohydrate equivalent to Imipenem 250 mg ; Cilastatin equivalent to Cilastatin 250 mg | 250 | 49034249/20.1.1/0342 | Cancelled | Not determined | None |
| Actapen 500 Each Vial contains: Imipenem Monohydrate equivalent to Imipenem 500 mg ; Cilastatin equivalent to Cilastatin 500 mg | 500 | 49034349/20.1.1/0343 | Cancelled | Not determined | None |
| Imcil 500 EACH VIAL CONTAINS :CILASTATIN SODIUM EQUIVALENT TO CILASTATIN 500,0 mg, IMIPENEM 500,0 mg | 500 | 50065350/20.1.1/0653 | Registered | S4 | None |
| Cilnem Each vial contains: Imipenem Monohydrate Equivalent to imipenem 500 mg; Cilastatin Sodium equivalent to cilastatin 500 mg | 500 mgSterile powder for solution for infusion | 540204.20354/20.1.1/0204.203Approved 24 May 2022 | Registered | S4 | PIPIL |
| Tienam 500 EACH VIAL CONTAINS CILASTATIN SODIUM EQUIVALENT TO CILASTATIN 500 mg IMIPENEM 500 mg | 500 | S0175S/20.1.1/175 | Registered | S4 | None |
Regulatory status
Where S4 sits on the scale
Prescription-only medicine.
Schedule 4 covers most ordinary prescription medicines. You need a prescription from an authorised prescriber, such as a doctor or dentist, and a pharmacist dispenses it. Its price, name, pack size and strength can still be told to the public, as long as nothing links it to what it treats.
Schedule S4, matched to the Consolidated Schedules by ingredient, confidence medium.
Who may supply: A pharmacist dispensing against a written or verbal prescription from an authorised prescriber; a veterinarian, who may also prescribe, compound or dispense it directly; a medical practitioner or dentist, who may prescribe it and may compound or dispense it directly only if licensed under section 22C(1)(a); manufacturers and wholesalers may supply people who may lawfully possess it; and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.
Consolidated Schedules listings for Cilastatin sodium equivalent to cilastatin, imipenem
S4: Cilastatin
Consolidated Schedules 06 July 2026, line 5807
S4: Imipenem
Consolidated Schedules 06 July 2026, line 6738
Pharmacological class: Broad and medium spectrum antibiotics. (class 20.1.1)
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
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.