Atropine
Sold as Atropine unimed, Pharma-q atropine, Atropine lamar, Atropine o,5, Atropine, Minims atropine sulphate, Adco-atropine sulphate, Atropine sulphateinjection B.P., Atropine sulphate B.P., Atropine sulphate-fresenius, Isopto atropine, Spersatropine, Atropine eye, Atropine sulphate fresenius, Adco atropine, Sabax atropine
[(1S,5R)-8-Methyl-8-azabicyclo[3.2.1]octan-3-yl] 3-hydroxy-2-phenylpropanoate
Drag to rotate. Structure from PubChem CID 174174.
Background
Registration
- Applicants
- 11
- Registrations
- 23
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Unimed Healthcare (Pty) Ltd | Atropine unimed | 0,6 mg, 1 mg | 270461, 300165 | Not determined | None |
| Pharma-q Holdings (Pty) Ltd | Pharma-q atropine | 0,5 mg/1 ml, 1 mg/1 ml | 310206, 310207 | Not determined | None |
| Lamar International (Pty) Ltd | Atropine lamar | 0,5 mg/ml, 1 mg/ml | 600067, 600068 | Not determined | None |
| Elanco Animal Health (Pty) Ltd | Atropine o,5, Atropine | injection, 10 | 83/60, 83/61 | Not determined | None |
| Soflens (Pty) LtdCancelled | Minims atropine sulphate | 1 % | C0039 | Not determined | None |
| Adcock ingram limited3 of 4 cancelled | Adco-atropine sulphate, Atropine eye | 0,6 MG, 0,8 MG, 1,2 MG, 10 mg/ml | C0603, C0607, C0608, J0312 | S3 | PIPIL |
| The Premier Pharmaceutical Co LtdCancelled | Atropine sulphateinjection B.P., Atropine sulphate B.P., Spersatropine, Atropine | injection, 1 % | C0691, C0693, H1261, H1263 | Not determined | None |
| Fresenius Medical Care South Africa (Pty) Ltd | Atropine sulphate-fresenius | 1,0 mg/1,0 ml | C1005 | Not determined | None |
| Alcon Laboratories (SA) (Pty) Ltd | Isopto atropine | Not stated | H1135 | Not determined | None |
| Fresenius Kabi Manufacturing SA (Pty) Ltd | Atropine sulphate fresenius, Atropine sulphate-fresenius | 0,5 mg/1 ml, 0,6 mg/1 ml | J0400, L0342 | Not determined | None |
| Adcock Ingram Critical Care (Pty) Ltd | Adco atropine, Sabax atropine | 0,5 mg/ml, 1,0 mg/ml | V0064, V0065 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Atropine 1 MG unimed EACH 1,0 ml SOLUTION CONTAINS ATROPINE SULPHATE 1,0 mg | 1 mg | 27046127/5.4/0461 | Registered | Not determined | None |
| Atropine 0,6 MG unimed EACH 1 ml SOLUTION CONTAINS ATROPINE SULPHATE 0,60 mg | 0,6 mg | 30016530/5.4/0165 | Registered | Not determined | None |
| Pharma-q atropine injection 0,5 mg/1 ML EACH 1 ml SOLUTION CONTAINS ATROPINE SULPHATE 0,5 mg | 0,5 mg/1 mlInjection | 31020631/5.4/0206 | Registered | Not determined | None |
| Pharma-q atropine injection 1 mg/1 ML EACH 1 ml SOLUTION CONTAINS ATROPINE SULPHATE 1,0 mg | 1 mg/1 mlInjection | 31020731/5.4/0207 | Registered | Not determined | None |
| Atropine 0,5 mg/ml lamar EACH 1,0 ml SOLUTION CONTAINS: ATROPINE SULPHATE 0,5 mg | 0,5 mg/ml | 60006760/5.4/0067 | Registered | Not determined | None |
| Atropine 1 mg/ml lamar EACH 1,0 ml SOLUTION CONTAINS: ATROPINE SULPHATE 1,0 mg | 1 mg/ml | 60006860/5.4/0068 | Registered | Not determined | None |
| Atropine o,5 injection EACH 1 ml SOLUTION CONTAINS ATROPINE SULPHATE A 0,5 mg | Injection | 83/60 | Old Medicine | Not determined | None |
| Atropine 10 injection EACH 1 ml SOLUTION CONTAINS ATROPINE A 10 mg | 10Injection | 83/61 | Old Medicine | Not determined | None |
| Minims atropine sulphate 1 % EACH 100 ml CONTAINS ATROPINE SULPHATE 1 g | 1 % | C0039C/15.4/39 | Cancelled | Not determined | None |
| Adco-atropine sulphate injection 0,8 MG 1 ML ATROPINE SULPHATE A 0,8 MG | 0,8 MGInjection | C0603 | Cancelled | Not determined | None |
| Adco-atropine sulphate injection 0,6 MG 1 ML ATROPINE SULPHATE A 0,6 MG | 0,6 MGInjection | C0607 | Cancelled | Not determined | None |
| Adco-atropine sulphate injection 1,2 MG 1 ML ATROPINE SULPHATE A 1,2 MG | 1,2 MGInjection | C0608 | Cancelled | Not determined | None |
| Atropine sulphateinjection B.P. 1 ML ATROPINE SULPHATE A 0,4 MG | Not listed | C0691 | Cancelled | Not determined | None |
| Atropine sulphate injection B.P. 1 ML ATROPINE SULPHATE A 0,8 MG | Injection | C0693 | Cancelled | Not determined | None |
| Atropine sulphate-fresenius 1,0 mg/1,0 ML EACH 1,0 ml SOLUTION CONTAINS ATROPINE SULPHATE A 1,0 mg | 1,0 mg/1,0 ml | C1005 | Old Medicine | Not determined | None |
| Isopto atropine EACH 1 ml OPTHALMIC SOLUTION CONTAINS ATROPINE SULPHATE A 10 mg | Not listed | H1135 | Old Medicine | Not determined | None |
| Spersatropine 1 % EACH 1 ml CONTAINS ATROPINE A 10,0 mg | 1 % | H1261 | Cancelled | Not determined | None |
| Atropine 1 % EACH 100 g CONTAINS ATROPINE A 1,0 g | 1 % | H1263 | Cancelled | Not determined | None |
| Atropine eye drops EACH 1 ml CONTAINS :ATROPINE SULPHATE 10 mg | 10 mg/mlSterile eye drops | J0312J/15.4/312Approved 28 October 2022 | Registered | S3 | PIPIL |
| Atropine sulphate 0,6 mg/1 ML fresenius EACH 1 ml CONTAINS ATROPINE SULPHATE 0,6 mg | 0,6 mg/1 ml | J0400J/5.4/400 | Registered | Not determined | None |
| Atropine sulphate-fresenius 0,5 mg/1 ML EACH 1,0 ml AMPOULE CONTAINS ATROPINE SULPHATE 0,5 mg | 0,5 mg/1 ml | L0342L/5.4/342 | Registered | Not determined | None |
| Adco atropine 0,5 mg/ml EACH 1 ml SOLUTION CONTAINS ATROPINE SULPHATE 0,5 mg | 0,5 mg/ml | V0064V/5.4/64 | Registered | Not determined | None |
| Sabax atropine 1,0 mg/ml EACH 1 ml SOLUTION CONTAINS ATROPINE SULPHATE 1,0 mg | 1,0 mg/ml | V0065V/5.4/65 | Registered | Not determined | None |
Regulatory status
Where S3 sits on the scale
Needs a doctor's prescription, dispensed by a pharmacist.
Schedule 3 medicines can only be sold on a prescription from an authorised prescriber, such as a doctor or dentist. A pharmacist dispenses the medicine once they have the written prescription, or a verbal instruction from a prescriber they know. 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 S3, read from the product's PI-PIL leaflet.
The Consolidated Schedules list this ingredient up to S4; the leaflet's S3 applies to this product.
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 Atropine sulphate
S4: Atropine
- when intended for use in injections. (S2)
- except when intended for use in ophthalmic preparations. (S3)
Consolidated Schedules 06 July 2026, lines 5387 to 5391
S3: Atropine
- when intended for use in ophthalmic preparations; (S2)
- except when intended for use in injections. (S4)
Consolidated Schedules 06 July 2026, lines 3150 to 3154
S2: Atropine
- when intended for use in ophthalmic preparations; (S3)
- when intended for use in injections. (S4)
Consolidated Schedules 06 July 2026, lines 1631 to 1635
Pharmacological class: Others. (class 15.4)
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
Schedule Verification
Atropine eye drops, Adcock ingram limited is scheduled S3 in its official SAHPRA documents, read with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.