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Levocetirizine

Sold as Xyzal, Allerway, Cetizal, Glencet, Cetlovo, Levotriz, Texamer, Levizal, Levocetirizine sandoz, Leceticit, Xenogex, Levogex, Levocetirizine adco, Cetorin, Cetaway, Xyleve, Xitolec fc, Xevolcin fc, Xitolec, Zalerg, Rhitrin, Levocetirizine austell, Lergilez, Lezlerg, Xyleve odt, Cetaway odt, Machista, Cezit, Levoway, Allerway meltaway

S2Read from the PI-PIL document and verified
Loading the molecular structure
C21H25ClN2O3388.90 g/mol

2-[2-[4-[(R)-(4-Chlorophenyl)-phenylmethyl]piperazin-1-yl]ethoxy]acetic acid

Drag to rotate. Structure from PubChem CID 1549000.

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Registration

Applicants
17
Registrations
35
Schedule source
SAHPRA documentation

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Glaxosmithkline South Africa (Pty) LimitedXyzal5mg & 0,5 mg/mL, oral solution360425, 410032S2PIPIL
Dr Reddyæs Laboratories (Pty) LtdCertificate held by Dr. Reddy’s Laboratories (Pty) Ltd., Dr. Reddy’s Laboratories (Pty) LtdAllerway, Allerway meltaway5 mg430815, 550712Not determinedPIPIL
Ranbaxy Pharmaceutical (Pty) LtdCetizal5440017Not determinedNone
Activo Health (Pty) LtdGlencet5440843Not determinedNone
Pharmacare limited û woodmeadCetlovo, Levotriz5450069, 450070Not determinedNone
Pharma Dynamics (Pty) LtdTexamer0,5 mg/ml, 5 mg451064, 480212S1PIPIL
Trinity Pharma (Pty) LtdLevizal, Xyleve, Xyleve odt, Cetaway odt, Levoway5 mg, solution, 0,5 mg460234, 470884, 520342, 520343.342, 550309S2PIPIL
Sandoz South Africa (Pty) LtdCancelledLevocetirizine sandoz5 mg460235.234Not determinedNone
Adcock ingram limited3 of 4 cancelledLeceticit, Xenogex, Levogex, Levocetirizine adcoNot stated460298, 460299, 460300, 460301Not determinedNone
Hetero Drugs South Africa (Pty) LtdCertificate held by Hetero Drugs South Africa (Pty) Ltd.Cetorin2,5 MG/ 5 ML, 5 mg460329, 520935S1PIPIL
Unicorn Pharmaceuticals (Pty) LtdCertificate held by Abex Pharmaceuticals (Pty) LtdCetaway0.5mg/ml460389S2PIPIL
Abex Pharmaceutica (Pty) LtdXitolec fc, Xitolec, Cetawaysolution470950, 470952, 470953.0952Not determinedNone
Astral Pharma (Pty) LtdXevolcin fcNot stated470951Not determinedNone
Innovata pharmaceuticalsZalergNot stated480492Not determinedNone
Unichem SA (Pty) LtdRhitrin, Xyleve5480743, 480744Not determinedNone
Austell Pharmaceuticals (Pty) LtdLevocetirizine austell, Lergilez, Lezlerg2 mg, 5 mg481132, 481134, 481135S1PIPIL
Macleods Pharmaceuticals SA (Pty) LtdMachista, Cezit5 MG520397, 520398.397Not determinedNone

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Xyzal

EACH TABLET CONTAINS LEVOCETIRIZINE DIHYDROCHLORIDE 5,0 mg

5mg & 0,5 mg/mLOral solution and tablets36042536/5.7.1/0425Approved 30 November 2022RegisteredS2PIPIL
Xyzal oral solution

EACH 1,0 ml SOLUTION CONTAINS LEVOCETIRIZINE DIHYDROCHLORIDE 0,50 mg

Oral solution41003241/5.7.1/0032RegisteredNot determinedNone
Allerway 5

EACH TABLET CONTAINS LEVOCETIRIZINE DIHYDROCHLORIDE 5,0 mg

5 mgFilm-coated tablet43081543/5.7.1/0815Approved 17 July 2024RegisteredNot determinedPIPIL
Cetizal 5 tablets

Each tablet contains LEVOCETIRIZINE DIHYDROCHLORIDE 5,0 mg

5Tablets44001744/5.7.1/0017RegisteredNot determinedNone
Glencet 5

EACH TABLET CONTAINS LEVOCETIRIZINE DIHYDROCHLORIDE 5,0 mg

544084344/5.7.1/0843RegisteredNot determinedNone
Cetlovo

EACH TABLET CONTAINS LEVOCETIRIZINE DIHYDROCHLORIDE 5,0 mg

Not listed45006945/5.7.1/0069RegisteredNot determinedNone
Levotriz 5

EACH TABLET CONTAINS LEVOCETIRIZINE DIHYDROCHLORIDE 5,0 mg

545007045/5.7.1/0070RegisteredNot determinedNone
Texamer

EACH TABLET CONTAINS LEVOCETIRIZINE DIHYDROCHLORIDE 5,0 mg

5 mgFilm-coated tablets.45106445/5.7.1/1064Approved 4 March 2025RegisteredS1PIPIL
Levizal 5 MG

EACH TABLET CONTAINS LEVOCETIRIZINE DIHYDROCHLORIDE 5,0 mg

5 mg46023446/5.7.1/0234RegisteredNot determinedNone
Levocetirizine sandoz 5 MG

EACH TABLET CONTAINS LEVOCETIRIZINE DIHYDROCHLORIDE 5,0 mg

5 mg460235.23446/5.7.1/0235.234CancelledNot determinedNone
Leceticit

EACH TABLET CONTAINS LEVOCETIRIZINE DIHYDROCHLORIDE 5,0 mg

Not listed46029846/5.7.1/0298CancelledNot determinedNone
Xenogex

EACH TABLET CONTAINS LEVOCETIRIZINE DIHYDROCHLORIDE 5,0 mg

Not listed46029946/5.7.1/0299CancelledNot determinedNone
Levogex

EACH TABLET CONTAINS LEVOCETIRIZINE DIHYDROCHLORIDE 5,0 mg

Not listed46030046/5.7.1/0300RegisteredNot determinedNone
Levocetirizine adco

EACH TABLET CONTAINS LEVOCETIRIZINE DIHYDROCHLORIDE 5,0 mg

Not listed46030146/5.7.1/0301CancelledNot determinedNone
Cetorin 5

EACH TABLET CONTAINS LEVOCETIRIZINE DIHYDROCHLORIDE 5,0 mg

5 mgFilm-coated tablets.46032946/5.7.1/0329Approved 5 May 2026RegisteredS1PIPIL
Cetaway

EACH TABLET CONTAINS : LEVOCETIRIZINE DIHYDROCHLORIDE 5,0 mg

0.5mg/mlOral solution46038946/5.7.1//0389Approved 23 August 2022RegisteredS2PIPIL
Xyleve solution

Each 1,0 ml contains LEVOCETIRIZINE DIHYDROCHLORIDE 0,5 mg

Solution47088447/5.7.1/0884RegisteredNot determinedNone
Xitolec fc

Each Tablet Contains: Levocetirizine Dihydrochloride 5,0mg

Not listed47095047/5.7.1/0950RegisteredNot determinedNone
Xevolcin fc

Each Tablet Contains: Levocetirizine Dihydrochloride 5,0mg

Not listed47095147/5.7.1/0951RegisteredNot determinedNone
Xitolec solution

Each 1,0 ml solution contains :LEVOCETIRIZINE DIHYDROCHLORIDE 0,5 mg

Solution47095247/5.7.1/0952RegisteredNot determinedNone
Cetaway solution

EACH 1,0 ML SOLUTION CONTAINS: LEVOCETIRIZINE DIHYDROCHLORIDE 0,5 mg

Solution470953.095247/5.7.1/0953.952RegisteredNot determinedNone
Texamer syrup

Each 1,0 ml solution contains LEVOCETIRIZINE DIHYDROCHLORIDE 0,5 mg

0,5 mg/mlOral solution48021248/5.7.1/0212Approved 3 September 2024RegisteredS1PIPIL
Zalerg

Each tablet contains LEVOCETIRIZINE DIHYDROCHLORIDE 5,0 mg

Not listed48049248/5.7.1/0492RegisteredNot determinedNone
Rhitrin 5

Each tablet contains LEVOCETIRIZINE DIHYDROCHLORIDE 5,0 mg

548074348/5.7.1/0743RegisteredNot determinedNone
Xyleve 5

Each tablet contains LEVOCETIRIZINE DIHYDROCHLORIDE 5,0 mg

548074448/5.7.1/0744RegisteredNot determinedNone
Levocetirizine 5 MG austell

Each tablet contains LEVOCETIRIZINE DIHYDROCHLORIDE 5,0 mg

5 mgFilm-coated tablets48113248/5.7.1/1132Approved 29 September 2023RegisteredS1PIPIL
Lergilez 5 MG

Each tablet contains LEVOCETIRIZINE DIHYDROCHLORIDE 5,0 mg

5 mgFilm-coated tablets48113448/5.7.1/1134Approved 29 September 2023RegisteredS1PIPIL
Lezlerg 5 MG

Each tablet contains LEVOCETIRIZINE DIHYDROCHLORIDE 5,0 mg

2 mgFilm-coated tablets48113548/5.7.1/1135Approved 29 September 2023RegisteredS1PIPIL
Xyleve odt

Each tablet contains LEVOCETIRIZINE DIHYDROCHLORIDE 5,0 mg

Not listed52034252/5.7.1/0342RegisteredNot determinedNone
Cetaway odt

Each tablet contains LEVOCETIRIZINE DIHYDROCHLORIDE 5,0 mg

Not listed520343.34252/5.7.1/0343.342RegisteredNot determinedNone
Machista 5 MG

Each tablet contains LEVOCETIRIZINE DIHYDROCHLORIDE 5,0 mg

5 MG52039752/5.7.1/0397RegisteredNot determinedNone
Cezit 5 MG

Each tablet contains LEVOCETIRIZINE DIHYDROCHLORIDE 5,0 mg

5 MG520398.39752/5.7.1/0398.397RegisteredNot determinedNone
Cetorin oral solution 2,5 mg/ 5 ML

Each 5 ml contains LEVOCETIRIZINE DIHYDROCHLORIDE 2,5 mg

2,5 MG/ 5 MLOral solution52093552/5.7.1/0935RegisteredNot determinedNone
Levoway 0,5 mg/ml

LEVOCETIRIZINE DIHYDROCHLORIDE

0,5 mgOral solution55030955/5.7.1/0309Approved 14 February 2023RegisteredS2PIPIL
Allerway meltaway 5

EACH TABLET CONTAINS LEVOCETIRIZINE DIHYDROCHLORIDE 0,5 mg

5 mgTablet55071255/5.7.1/0712Approved 23 May 2023RegisteredNot determinedPIPIL

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.

The Consolidated Schedules list this ingredient up to S1; the leaflet's S2 applies to this product.

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.

Consolidated Schedules listings for Levocetirizine dihydrochloride

  • S1: Levocetirizine

    Consolidated Schedules 06 July 2026, line 775

Pharmacological class: Antihistaminics. (class 5.7.1)

3 of 9 approved products with this ingredient carry S2 on their leaflet.

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 verified from official documents

Schedule Verification

Xyzal, Glaxosmithkline South Africa (Pty) Limited is scheduled S2 in its official SAHPRA documents, read with 90% confidence.

Professional information (PI)For healthcare professionalsXyzal, Glaxosmithkline South Africa (Pty) LimitedPatient information leaflet (PIL)For patients and carersXyzal, Glaxosmithkline South Africa (Pty) Limited

These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.

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