Regulatory PathRegulatory requirements compared

Active substance

Lamotrigine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
LAMICTAL50 mgTablet · Oral use30 BlisterSAR 57.20NCE · PrescriptionGLAXO SAUDI ARABIAValid
LAMICTAL25 mgTablet · Oral use30 BlisterSAR 32.65NCE · PrescriptionGLAXO SAUDI ARABIAValid
LAMICTAL5 mgChewable tablet · Oral use28 BlisterSAR 11.10NCE · PrescriptionGLAXO SAUDI ARABIAValid
LAMICTAL25 mgChewable tablet · Oral use56 BlisterSAR 50.95NCE · PrescriptionGLAXO SAUDI ARABIAValid
LAMICTAL100 mgChewable tablet · Oral use56 BlisterSAR 169.50NCE · PrescriptionGLAXO SAUDI ARABIAValid
LAMIRA 100 mg TABLET100 mgTablet · Oral use30 BlisterSAR 74.15Generic · PrescriptionSPIMACO ADDWAEIHValid
LAMIRA 25 mg TABLET25 mgTablet · Oral use30 BlisterSAR 25.85Generic · PrescriptionSPIMACO ADDWAEIHValid
LAMIRA 50 mg TABLET50 mgTablet · Oral use30 BlisterSAR 41.00Generic · PrescriptionSPIMACO ADDWAEIHValid
LAMOTRIX 100MG TABLET100 mgTablet · Oral use30 BlisterSAR 74.15Generic · PrescriptionMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRYValid
LAMOTRIX 25MG TABLET25 mgTablet · Oral use30 BlisterSAR 25.85Generic · PrescriptionMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRYValid
LAMOTRIX 50MG TABLET50 mgTablet · Oral use30 BlisterSAR 41.00Generic · PrescriptionMEDOCHEMIE LTD PHARMACEUTICAL INDUSTRYValid
LOXOL 100MG TABLET100 mgTablet · Oral use30 BlisterSAR 82.40Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
LOXOL 200MG TABLET200 mgTablet · Oral use30 BlisterSAR 135.15Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
LOXOL 25MG TABLET25 mgTablet · Oral use30 BlisterSAR 28.75Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
LOXOL 50MG TABLET50 mgTablet · Oral use30 BlisterSAR 45.55Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
Lamictal100 mgTablet · Oral use30 BlisterSAR 91.30NCE · PrescriptionGLAXO SAUDI ARABIAValid
Lamotrine25 mgTablet · Oral use30 BlisterSAR 23.25Generic · PrescriptionApex PharmaValid
Lamotrine100 mgTablet · Oral use30 BlisterSAR 66.75Generic · PrescriptionApex PharmaValid
Lamotrine50 mgTablet · Oral use30 BlisterSAR 33.35Generic · PrescriptionApex PharmaValid
SEIZET 100 mg Chewable/Dispersible Tablet100 mgChewable/dispersible tablet · Oral use30 BlisterSAR 66.75Generic · PrescriptionMS Pharma Saudi (MSPS)Valid
SEIZET 25 mg Chewable/Dispersible Tablet25 mgChewable/dispersible tablet · Oral use30 BlisterSAR 23.25Generic · PrescriptionMS Pharma Saudi (MSPS)Valid
LAMICTAL25 mgChewable tablet · Oral use14 BlisterSAR 18.10NCE · PrescriptionGLAXO SAUDI ARABIAWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

ACUTE BIPOLAR I DEPRESSION; ANXIETY DISORDERS; BIPOLAR I DISORDER MAINTENANCE; JUVENILE MYOCLONIC SEIZURES; LENNOX GASTAUT SYNDROME AND TONIC OR ATONIC SEIZURES; NEUROPATHIC PAIN; PAIN MANAGEMENT IN CANCER PATIENTS; TRIGEMINAL NEURALGIA

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
LAMICTAL100MG; 150MG; 200MG; 25MGtablet · oralGLAXOSMITHKLINE LLCPrescription27 Dec 1994
LAMICTAL CD5MG; 25MG; 2MGtablet, for suspension · oralGLAXOSMITHKLINE LLCPrescription24 Aug 1998
LAMOTRIGINE5MG; 25MGtablet, for suspension · oralDR REDDYS LABS LTDPrescription22 Jan 2009
LAMOTRIGINE2MG; 5MG; 25MGtablet, for suspension · oralWATSON LABSPrescription22 Jan 2009
LAMOTRIGINE2MGtablet, chewable · oralZYDUS PHARMS USA INCPrescription22 Jan 2009
LAMOTRIGINE5MG; 25MGtablet, for suspension · oralZYDUS PHARMS USA INCPrescription22 Jan 2009
LAMOTRIGINE2MGtablet · oralCHARTWELL RXPrescription22 Jan 2009
LAMOTRIGINE25MG; 100MG; 150MG; 200MGtablet · oralDR REDDYS LABS LTDPrescription27 Jan 2009
LAMOTRIGINE25MG; 50MG; 100MG; 150MG; 200MG; 250MGtablet · oralZYDUS PHARMS USAPrescription27 Jan 2009
LAMOTRIGINE25MG; 100MG; 150MG; 200MGtablet · oralTARO PHARM INDSPrescription27 Jan 2009
LAMOTRIGINE25MG; 100MG; 150MG; 200MGtablet · oralRUBICON RESEARCHPrescription27 Jan 2009
LAMOTRIGINE25MG; 100MG; 150MG; 200MGtablet · oralTORRENT PHARMSPrescription27 Jan 2009
LAMOTRIGINE25MG; 100MG; 150MG; 200MGtablet · oralAUROBINDO PHARMAPrescription27 Jan 2009
LAMOTRIGINE25MG; 100MG; 150MG; 200MGtablet · oralJUBILANT CADISTAPrescription27 Jan 2009
LAMOTRIGINE5MG; 25MGtablet, for suspension · oralGLENMARK PHARMS LTDPrescription19 Feb 2009
LAMICTAL ODT25MG; 50MG; 100MG; 200MGtablet, orally disintegrating · oralGLAXOSMITHKLINE LLCPrescription8 May 2009
LAMICTAL XR25MG; 50MG; 100MG; 200MG; 300MG; 250MGtablet, extended release · oralGLAXOSMITHKLINE LLCPrescription29 May 2009
LAMOTRIGINE5MGtablet · oralAUROBINDO PHARMAPrescription4 Nov 2009
LAMOTRIGINE5MG; 25MGtablet, for suspension · oralAUROBINDO PHARMAPrescription4 Nov 2009
LAMICTAL XR25MG; 50MG; 100MG; 200MGtablet, extended release · oralSMITHKLINE BEECHAMPrescription29 Jan 2010
LAMOTRIGINE25MG; 100MG; 150MG; 200MGtablet · oralALEMBIC PHARMS LTDPrescription13 Jan 2011
LAMOTRIGINE25MG; 100MG; 150MG; 200MGtablet · oralUNICHEM LABS LTDPrescription6 Oct 2011
LAMOTRIGINE25MG; 100MG; 150MG; 200MGtablet · oralGLENMARK PHARMS LTDPrescription4 May 2012
LAMOTRIGINE25MG; 50MG; 100MG; 200MG; 250MG; 300MGtablet, extended release · oralPH HEALTHPrescription26 Dec 2012
LAMOTRIGINE25MG; 50MG; 100MG; 200MG; 300MGtablet, extended release · oralSCIEGEN PHARMSPrescription4 Jan 2013

42 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
AG-LAMOTRIGINE0254371025 MGTABLET · ORALANGITA PHARMA INC.
AG-LAMOTRIGINE02543729100 MGTABLET · ORALANGITA PHARMA INC.
AG-LAMOTRIGINE02543737150 MGTABLET · ORALANGITA PHARMA INC.
APO-LAMOTRIGINE0224520825 MGTABLET · ORALAPOTEX INC
APO-LAMOTRIGINE02245209100 MGTABLET · ORALAPOTEX INC
APO-LAMOTRIGINE02245210150 MGTABLET · ORALAPOTEX INC
AURO-LAMOTRIGINE0238135425 MGTABLET · ORALAURO PHARMA INC
AURO-LAMOTRIGINE02381362100 MGTABLET · ORALAURO PHARMA INC
AURO-LAMOTRIGINE02381370150 MGTABLET · ORALAURO PHARMA INC
JAMP LAMOTRIGINE0254273025 MGTABLET · ORALJAMP PHARMA CORPORATION
JAMP LAMOTRIGINE02542749100 MGTABLET · ORALJAMP PHARMA CORPORATION
JAMP LAMOTRIGINE02542757150 MGTABLET · ORALJAMP PHARMA CORPORATION
LAMICTAL0214208225 MGTABLET · ORALGLAXOSMITHKLINE INC
LAMICTAL02142104100 MGTABLET · ORALGLAXOSMITHKLINE INC
LAMICTAL02142112150 MGTABLET · ORALGLAXOSMITHKLINE INC
LAMICTAL022401155 MGTABLET · ORALGLAXOSMITHKLINE INC
LAMICTAL022438032 MGTABLET · ORALGLAXOSMITHKLINE INC
LAMOTRIGINE0234301025 MGTABLET · ORALSANIS HEALTH INC
LAMOTRIGINE02343029100 MGTABLET · ORALSANIS HEALTH INC
LAMOTRIGINE02343037150 MGTABLET · ORALSANIS HEALTH INC
LAMOTRIGINE0242820225 MGTABLET · ORALSIVEM PHARMACEUTICALS ULC
LAMOTRIGINE02428210100 MGTABLET · ORALSIVEM PHARMACEUTICALS ULC
LAMOTRIGINE02428229150 MGTABLET · ORALSIVEM PHARMACEUTICALS ULC
LAMOTRIGINE-10002302985100 MGTABLET · ORALPRO DOC LIMITEE
LAMOTRIGINE-15002302993150 MGTABLET · ORALPRO DOC LIMITEE

4 more — full table

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACLAMICTAL 100 MG TABLET$10.91795per EA23 Sep 2026
US NADACLAMICTAL 150 MG TABLET$11.4684per EA23 Sep 2026
US NADACLAMICTAL 200 MG TABLET$12.05122per EA23 Sep 2026
US NADACLAMICTAL 25 MG DISPER TABLET$11.18289per EA23 Sep 2026
US NADACLAMICTAL 25 MG TABLET$10.29501per EA23 Sep 2026
US NADACLAMICTAL ODT 100 MG TABLET$14.63582per EA23 Sep 2026
US NADACLAMICTAL ODT 200 MG TABLET$17.48893per EA23 Sep 2026
US NADACLAMICTAL ODT 25 MG TABLET$12.81313per EA23 Sep 2026
US NADACLAMICTAL ODT 50 MG TABLET$13.65287per EA20 May 2026
US NADACLAMICTAL XR 100 MG TABLET$30.40041per EA23 Sep 2026
US NADACLAMICTAL XR 200 MG TABLET$32.33073per EA23 Sep 2026
US NADACLAMICTAL XR 25 MG TABLET$14.2042per EA23 Sep 2026
NHS Drug TariffLamotrigine 100mg dispersible tablets sugar free£15.1956 tablet1 Oct 2026
NHS Drug TariffLamotrigine 100mg tablets£2.5556 tablet1 Oct 2026
NHS Drug TariffLamotrigine 200mg tablets£3.0656 tablet1 Oct 2026
NHS Drug TariffLamotrigine 25mg dispersible tablets sugar free£18.1156 tablet1 Oct 2026
NHS Drug TariffLamotrigine 25mg tablets£1.9756 tablet1 Oct 2026
NHS Drug TariffLamotrigine 2mg dispersible tablets sugar free£18.8130 tablet1 Oct 2026
NHS Drug TariffLamotrigine 50mg tablets£2.3856 tablet1 Oct 2026
NHS Drug TariffLamotrigine 5mg dispersible tablets sugar free£13.1828 tablet1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

  • 5.1.1. Antiseizure medicines · core
    Epilepsy or seizures
    Oral > Solid: 25 mg tablet; 50 mg tablet; 100 mg tablet; 200 mg tablet; 2 mg tablet (chewable, dispersible); 5 mg tablet (chewable, dispersible); 25 mg tablet (chewable, dispersible); 50 mg tablet (chewable, dispersible); 100 mg tablet (chewable, dispersible); 200 mg tablet (chewable, dispersible)

Safety signals and safety-related labeling changes

All safety entries for lamotrigine →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.