Sodium valproate

Sold as Epilim cr, Epilim crushable, Valeptic, Sandoz sodium valproate cr, Cerepiv cr, Sodium valproate propan cr, Valeptic cr, Adco sodium valproate cr, Convulex cr, Convulex iv, Navalpro liquid, Sodium valproate cipla intravenous, Valdilim intravenous, Velpalex iv, Evalex iv, Navalzyd iv, *Navalzyd iv, Navilize ( ), Epilizine cr, Navalpro, Epilizine intravenous, Epilim liquid sugar-free, Epirol, Convulex, Epilim intravenous

S3Read from the PI-PIL document and verified

No structure available

This product's active ingredient could not be matched to a single known compound.

Loading Wikipedia summary

Registration

Applicants: 11
Registrations: 42
Schedule source: SAHPRA documentation

Applicants and registrations

Applicant	Brands	Dosages	Registrations	Schedule	Leaflets
Sanofi-aventis South Africa (Pty) Ltd	Epilim cr, Epilim crushable, Epilizine cr, Epilizine intravenous, Epilim liquid sugar-free, Epilim intravenous	100, 200, 300, 400, 500	270322, 270323, 270500, A390038, A390039, A390040, A400699, J0148, Y0043, Y0286	Not determined	None
Adcock ingram limited2 of 7 cancelled	Valeptic, Sodium valproate propan cr, Valeptic cr, Adco sodium valproate cr	syrup, 300, 500	430267, 440065, 440066, 440067, 440068, 440069, 440070	Not determined	PI PIL
Sandoz South Africa (Pty) LtdCancelled	Sandoz sodium valproate cr, Cerepiv cr	300, 500	430861, 430862, 430865, 430866	Not determined	None
Acino Pharma (Pty) Ltd	Convulex cr, Convulex iv, Convulex	300, 500, syrup	450938, 450947, 460046, W0390	Not determined	None
Pharmacare limited û woodmeadCertificate held by Pharmacare limited	Navalpro liquid, Navalpro	200 mg/5 ml, 400 mg/4 ml	460796, A400342	S3	PI PIL
Cipla Medpro (Pty) LtdCancelled	Sodium valproate cipla intravenous, Valdilim intravenous	Not stated	500858, 500859.858	Not determined	None
Pharma Dynamics (Pty) Ltd	Velpalex iv	1 g, 300 mg, 400 mg	530664, 530665, 530666	Not determined	None
Macleods Pharmaceuticals SA (Pty) Ltd	Evalex iv	1 g, 300 mg, 400 mg	530667, 530668.665, 530669	Not determined	None
Abex Pharmaceutica (Pty) Ltd	Navalzyd iv, *Navalzyd iv	1 g, 300 mg, 400 mg	530670.664, 530671.665, 530672.666	Not determined	None
Juno Pharma SA (Pty) Ltd	Navilize ( )	100 mg/ml 3 ml, 100 mg/ml 4 ml, 100 mg/ml 10 ml	550551, 550552, 550553	Not determined	None
Oethmaan Biosims (Pty) LtdCertificate held by Oethmaan biosims	Epirol	200mg	S0072	S3	PI

Variants

Product	Strength and form	Registration	Status	Schedule	Leaflets
Epilim cr 200 EACH TABLET CONTAINS :SODIUM VALPROATE 200 mg	200	27032227/2.5/0322	Registered	Not determined	None
Epilim cr 500 EACH TABLET CONTAINS :SODIUM VALPROATE 500,0 mg	500	27032327/2.5/0323	Registered	Not determined	None
Epilim 100 crushable EACH TABLET CONTAINS :SODIUM VALPROATE 100 mg	100	27050027/2.5/0500	Registered	Not determined	None
Valeptic syrup EACH 5,0 ml SYRUP CONTAINS SODIUM VALPROATE 200,0 mg	Syrup	43026743/2.5/0267	Registered	Not determined	None
Sandoz sodium valproate 300 cr EACH TABLET CONTAINS SODIUM VALPROATE 300,0 mg	300	43086143/2.5/0861	Cancelled	Not determined	None
Sandoz sodium valproate 500 cr EACH TABLET CONTAINS SODIUM VALPROATE 500,0 mg	500	43086243/2.5/0862	Cancelled	Not determined	None
Cerepiv 300 cr EACH TABLET CONTAINS SODIUM VALPROATE 300,0 mg	300	43086543/2.5/0865	Cancelled	Not determined	None
Cerepiv 500 cr EACH TABLET CONTAINS SODIUM VALPROATE 500,0 mg	500	43086643/2.5/0866	Cancelled	Not determined	None
Sodium valproate propan 300 cr EACH TABLET CONTAINS SODIUM VALPROATE 300,0 mg	300	44006544/2.5/0065	Cancelled	Not determined	None
Sodium valproate propan 500 cr EACH TABLET CONTAINS SODIUM VALPROATE 500,0 mg	500	44006644/2.5/0066	Cancelled	Not determined	None
Valeptic cr 300 EACH TABLET CONTAINS SODIUM VALPROATE 300,0 mg	300Prolonged release, film coated tablets	44006744/2.5/0067Approved 23 May 2025	Registered	Not determined	PI PIL
Valeptic cr 500 EACH TABLET CONTAINS SODIUM VALPROATE 500,0 mg	500Prolonged release, film coated tablets	44006844/2.5/0068Approved 23 May 2025	Registered	Not determined	PI PIL
Adco sodium valproate 300 cr EACH TABLET CONTAINS SODIUM VALPROATE 300,0 mg	300	44006944/2.5/0069	Registered	Not determined	None
Adco sodium valproate 500 cr EACH TABLET CONTAINS SODIUM VALPROATE 500,0 mg	500	44007044/2.5/0070	Registered	Not determined	None
Convulex cr 300 EACH TABLET CONTAINS SODIUM VALPROATE 300,0 mg	300	45093845/2.5/0938	Registered	Not determined	None
Convulex cr 500 EACH TABLET CONTAINS SODIUM VALPROATE 500,0 mg	500	45094745/2.5/0947	Registered	Not determined	None
Convulex iv EACH 1,0 ml CONTAINS : SODIUM VALPROATE 100,0 mg	Not listed	46004646/2.5/0046	Registered	Not determined	None
Navalpro liquid Each 5,0 mlcontains SODIUM VALPROATE 200,0 mg	200 mg/5 mlLiquid.	46079646/2.5/0796Approved 26 July 2022	Registered	S3	PI PIL
Sodium valproate cipla intravenous EACH 20 mL VIAL CONTAINS: SODIUM VALPROATE 400,0 mg	Not listed	50085850/2.5/0858	Cancelled	Not determined	None
Valdilim intravenous EACH 20 mL VIAL CONTAINS: SODIUM VALPROATE 400,0 mg	Not listed	500859.85850/2.5/0859.858	Cancelled	Not determined	None
Velpalex 300 MG iv EACH 3,0 ml SOLUTION: SODIUM VALPROATE 300,0 mg	300 mg	53066453/2.5/0664	Registered	Not determined	None
Velpalex 400 MG iv EACH 4,0 ml SOLUTION CONTAINS :SODIUM VALPROATE 400,0 mg	400 mg	53066553/2.5/0665	Registered	Not determined	None
Velpalex 1 g iv EACH 10,0 ml SOLUTION CONTAINS :SODIUM VALPROATE 1,0 g	1 g	53066653/2.5/0666	Registered	Not determined	None
Evalex 300 MG iv EACH 3,0 ml SOLUTION CONTAINS SODIUM VALPROATE 300,0 mg	300 mg	53066753/2.5/0667.664	Registered	Not determined	None
Evalex 400 MG iv EACH 4,0 ml SOLUTION CONTAINS SODIUM VALPROATE 400,0 mg	400 mg	530668.66553/2.5/0668.665	Registered	Not determined	None
Evalex 1 g iv EACH 10,0 ml SOLUTION CONTAINS SODIUM VALPROATE 1,0 g	1 g	53066953/2.5/0669.666	Registered	Not determined	None
Navalzyd 300 MG iv EACH 3,0 ml SOLUTION CONTAINS :SODIUM VALPROATE 300,0 mg	300 mg	530670.66453/2.5/0670.664	Registered	Not determined	None
Navalzyd 400 MG iv EACH 4,0 ml SOLUTION CONTAINS :SODIUM VALPROATE 400,0 mg	400 mg	530671.66553/2.5/0671.665	Registered	Not determined	None
*Navalzyd 1 g iv EACH 10,0 ml SOLUTION CONTAINS: SODIUM VALPROATE 1,0 g	1 g	530672.66653/2.5/0672.666	Registered	Not determined	None
Navilize 100 mg/ml (3 ml) EACH 1,0 ml SOLUTION CONTAINS SODIUM VALPROATE 100,0 mg	100 mg/ml 3 ml	55055155/2.5/0551	Registered	Not determined	None
Navilize 100 mg/ml (4 ml) EACH 1,0 ml SOLUTION CONTAINS SODIUM VALPROATE 100,0 mg	100 mg/ml 4 ml	55055255/2.5/0552	Registered	Not determined	None
Navilize 100 mg/ml (10 ml) EACH 1,0 ml SOLUTION CONTAINS SODIUM VALPROATE 100,0 mg	100 mg/ml 10 ml	55055355/2.5/0553	Registered	Not determined	None
Epilizine cr 200 EACH TABLET CONTAINS SODIUM VALPROATE 200,0 mg	200	A390038A39/2.5/0038	Registered	Not determined	None
Epilizine cr 300 EACH TABLET CONTAINS SODIUM VALPROATE 300,0 mg	300	A390039A39/2.5/0039	Registered	Not determined	None
Epilizine cr 500 EACH TABLET CONTAINS SODIUM VALPROATE 500,0 mg	500	A390040A39/2.5/0040	Registered	Not determined	None
Navalpro 400 mg/4 ML EACH VIAL CONTAINS SODIUM VALPROATE 400,0 mg	400 mg/4 mlPowder and solvent for injectable solution	A400342A40/2.5/0342Approved 3 August 2021	Registered	S3	PI PIL
Epilizine intravenous 400 EACH VIAL CONTAINS SODIUM VALPROATE 400,0 mg	400	A400699A40/2.5/0699	Registered	Not determined	None
Epilim liquid sugar-free EACH 5 ml SYRUP CONTAINS:SODIUM VALPROATE 200 mg	Not listed	J0148J/2.5/148	Registered	Not determined	None
Epirol EACH CAPSULE CONTAINS SODIUM VALPROATE 200 mg	200mgTablet	S0072S/2.5/72Approved 1 August 2017	Registered	S3	PI
Convulex syrup EACH 5 ml SYRUP CONTAINS SODIUM VALPROATE 250 mg	Syrup	W0390W/2.5/390	Registered	Not determined	None
Epilim intravenous EACH VIAL CONTAINS :SODIUM VALPROATE 400,0 mg	Not listed	Y0043Y/2.5/43	Registered	Not determined	None
Epilim cr 300 EACH TABLET CONTAINS :SODIUM VALPROATE 300 mg	300	Y0286Y/2.5/286	Registered	Not determined	None

Regulatory status

Where S3 sits on the scale

S0S1S2S3S4S5S6S7S8

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.

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.

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

Professional information (PI)For healthcare professionalsValeptic cr 300, Adcock ingram limited Patient information leaflet (PIL)For patients and carersValeptic cr 300, Adcock ingram limited

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

Research articles

Loading PubMed articles

Background