Olopatadine
Sold as Patanol, Aslopad, Olopatadine eye pharma-q, Olopagen once daily, Conalap, Allodrop, Olopagen, Olotivo, Olopatadine clicks, Oftapat, Olopatadine eye FDC, Olovis, Zylopat
2-[(11Z)-11-[3-(Dimethylamino)propylidene]-6H-benzo[c][1]benzoxepin-2-yl]acetic acid
Drag to rotate. Structure from PubChem CID 5281071.
Background
Registration
- Applicants
- 10
- Registrations
- 13
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Novartis South Africa (Pty) LtdCertificate held by Novartis SA (Pty) Ltd | Patanol | 1 mg/ml | 330189 | Not determined | PIPIL |
| Pharmacare limited û woodmead | Aslopad | Not stated | 470817 | Not determined | None |
| Pharma-q Holdings (Pty) Ltd | Olopatadine eye pharma-q | drops | 471125 | Not determined | None |
| Gen-eye (Pty) Ltd | Olopagen once daily, Olopagen | Not stated | 471224, 491078 | Not determined | None |
| Ranbaxy Pharmaceutical (Pty) Ltd | Conalap | Not stated | 481211 | Not determined | None |
| Ipharma (Pty) Ltd | Allodrop | 1 mg/ml | 490538 | Not determined | PIL |
| Activo Health (Pty) Ltd | Olotivo | Not stated | 491209 | Not determined | None |
| Unicorn Pharmaceuticals (Pty) Ltd | Olopatadine clicks | Not stated | 520893 | Not determined | None |
| Austell Pharmaceuticals (Pty) Ltd | Oftapat | 1,0 mg | 530401 | S2 | PIPIL |
| FDC SA (Pty) Ltd | Olopatadine eye FDC, Olovis, Zylopat | drops | 561049, 561050.1049, 561051.1049 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Patanol EACH 1,0 ml SOLUTION CONTAINS OLOPATADINE HYDROCHLORIDE EQUIVALENT TO OLOPATADINE 1,0 mg | 1 mg/mlEye drops. Solution | 33018933/15.4/0189Approved 11 November 2021 | Registered | Not determined | PIPIL |
| Aslopad Each 1,0 ml contains OLOPATADINE HYDROCHLORIDE 1,0 mg | Not listed | 47081747/15.4/0817 | Registered | Not determined | None |
| Olopatadine eye drops pharma-q Each 1 ml contains OLOPATADINE HYDROCHLORIDE EQUIVALENT TO OLOPATADINE 1,0 mg | Drops | 47112547/15.4/1125 | Registered | Not determined | None |
| Olopagen once daily Each 1,0 ml contains: Olopatadine hydrochloride equivalent to olopatadine 2,0 mg | Not listed | 47122447/15.4/1224 | Registrered | Not determined | None |
| Conalap Each 1,0 ml contains OLOPATADINE HYDROCHLORIDE EQUIVALENT TO OLOPATADINE 1,0 mg | Not listed | 48121148/15.4/1211 | Registered | Not determined | None |
| Allodrop Each 1 ml contains OLOPATADINE HYDROCHLORIDE EQUIVALENT TO OLOPATADINE 1,0 mg | 1 mg/mlEye drops, solution | 49053849/15.4/0538Approved 31 August 2022 | Registered | Not determined | PIL |
| Olopagen Each 1 ml contains OLOPATADINE HYDROCHLORIDE EQUIVALENT TO OLOPATADINE 1,0 mg | Not listed | 49107849/15.4/1078 | Registered | Not determined | None |
| Olotivo Each 1,0 ml contains 1,11 mg OLOPATADINE HYDROCHLORIDE EQUIVALENT TO OLOPATADINE 1,0 mg | Not listed | 49120949/15.4/1209 | Registered | Not determined | None |
| Olopatadine clicks Each 1 ml of solution contains OLOPATADINE HYDROCHLORIDE EQUIVALENT TO OLOPATADINE 1,0 mg | Not listed | 52089352/15.4/0893 | Registered | Not determined | None |
| Oftapat OLOPATADINE HYDROCHLORIDE | 1,0 mgEye drops solution | 53040153/15.4/0401Approved 25 October 2022 | Registered | S2 | PIPIL |
| Olopatadine eye drops FDC EACH 1,0 ml SOLUTION CONTAINS OLOPATADINE HYDROCHLORIDE EQUIVALENT TO OLOPATADINE 1,0 mg | Drops | 56104956/15.4/1049 | Registered | Not determined | None |
| Olovis EACH 1,0 mg SOLUTION CONTAINS OLOPATADINE HYDROCHLORIDE EQUIVALENT TO OLOPATADINE 1,0 mg | Not listed | 561050.104956/15.4/1050.1049 | Registered | Not determined | None |
| Zylopat EACH 1,0 mg SOLUTION CONTAINS OLOPATADINE HYDROCHLORIDE EQUIVALENT TO OLOPATADINE 1,0 mg | Not listed | 561051.104956/15.4/1051.1049 | Registered | Not determined | None |
Regulatory status
Where S2 sits on the scale
A pharmacist can sell it directly, without a prescription.
Schedule 2 medicines sit behind the pharmacy counter. A pharmacist can decide to sell one of these directly, using their own professional judgement, without a doctor's prescription. It can also be dispensed against a prescription like the higher tiers, in which case the usual repeat limits apply. A child under 12 may only be sold a Schedule 2 substance on a prescription, or on a written order that names the purpose and carries a signature the seller recognises. Even though it cannot be advertised to the public in the ordinary sense, 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 S2, read from the product's PI-PIL leaflet.
Who may supply: Only a pharmacist, pharmacist intern or supervised pharmacist's assistant may sell it without a prescription. It may otherwise be dispensed by a pharmacist 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); and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.
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.