Regulatory PathRegulatory requirements compared

Active substance

Sumatriptan

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
IMIGRAN50 mgTablet · Oral use6 BlisterSAR 100.85NCE · PrescriptionGLAXO SAUDI ARABIAValid
IMIGRAN50 mgTablet · Oral use2 BlisterSAR 38.30NCE · PrescriptionGLAXO SAUDI ARABIAValid
IMIGRAN100 mgTablet · Oral use6 BlisterSAR 150.05NCE · PrescriptionGLAXO SAUDI ARABIAValid
IMIGRAN100 mgTablet · Oral use2 BlisterSAR 57.00NCE · PrescriptionGLAXO SAUDI ARABIAValid
IMIGRAN 20 MG NASAL SPRAY20 mgNasal spray · Nasal use2 Nasal ApplicatorSAR 38.20NCE · PrescriptionGlaxo Saudi Arabia Ltd.Valid
IMIGRAN 6MG-0.5ML AMP12 mg/mlSolution · Subcutaneous use1 Pre-filled syringeSAR 125.50NCE · PrescriptionGlaxo Saudi Arabia LtdValid
ORATAB 100 mg100 mgFilm-coated tablet · Oral use6 BlisterSAR 128.60Generic · PrescriptionTabuk Pharmaceutical Manufacturing CompanyValid
ORATAB 100MG F.C. TABLETS100 mgFilm-coated tablet · Oral use2 BlisterSAR 49.85Generic · PrescriptionTabuk Pharmaceutical Manufacturing CompanyValid
SUMAREX 100 MG F.C.TABLET (2S)100 mgFilm-coated tablet · Oral use2 BlisterSAR 40.35Generic · PrescriptionJamjoom Pharmaceuticals Factory CompanyValid
SUMAREX 100 MG F.C.TABLET (6S)100 mgFilm-coated tablet · Oral use6 BlisterSAR 104.15Generic · PrescriptionJamjoom Pharmaceuticals Factory CompanyValid
SUMAREX 50 MG F.C.TABLET (2S)50 mgFilm-coated tablet · Oral use2 BlisterSAR 30.20Generic · PrescriptionJamjoom Pharmaceuticals Factory CompanyValid
SUMAREX 50 MG F.C.TABLET (6S)50 mgFilm-coated tablet · Oral use6 BlisterSAR 79.40Generic · PrescriptionJamjoom Pharmaceuticals Factory CompanyValid
IMIGRAN 10 MG NASAL SPRAY10 mgNasal spray · Nasal use2 Nasal ApplicatorSAR 29.85NCE · PrescriptionGLAXOSMITHKLINE (GSK)Withdrawn by MAH · Not Marketed
IMIGRAN 10 MG NASAL SPRAY10 mgNasal spray · Nasal use2 Nasal ApplicatorSAR 23.90NCE · PrescriptionGlaxo Saudi Arabia Ltd.Withdrawn by MAH · Not Marketed
IMIGRAN 20 MG NASAL SPRAY20 mgNasal spray · Nasal use2 Nasal ApplicatorSAR 47.75NCE · PrescriptionGLAXOSMITHKLINE (GSK)Withdrawn by MAH · Not Marketed
MIGRABAN 100MG FILM COATED TABLETS100 mgFilm-coated tablet · Oral use2 BlisterSAR 44.85Generic · PrescriptionRIYADH PHARMAWithdrawn by MAH · Not Marketed
MIGRABAN 100MG FILM COATED TABLETS100 mgFilm-coated tablet · Oral use6 BlisterSAR 115.75Generic · PrescriptionRIYADH PHARMAWithdrawn by MAH · Not Marketed
MIGRABAN 50MG FILM COATED TABLETS50 mgFilm-coated tablet · Oral use2 BlisterSAR 33.55Generic · PrescriptionRIYADH PHARMAWithdrawn by MAH · Not Marketed
MIGRABAN 50MG FILM COATED TABLETS50 mgFilm-coated tablet · Oral use6 BlisterSAR 88.25Generic · PrescriptionRIYADH PHARMAWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

MIGRAINE/ HEADACHE; NAUSEA AND VOMITING IN CYCLIC VOMITING SYNDROME; POLYCYTHEMIA VERA - MIGRAINES

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

ProductStrengthForm · routeApplicantStatusFirst approved
IMITREX STATDOSE (AUTOINJECTOR)EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML); EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)solution · subcutaneousGLAXOSMITHKLINEPrescription28 Dec 1992
IMITREXEQ 100MG BASE; EQ 25MG BASE; EQ 50MG BASEtablet · oralGLAXOSMITHKLINEPrescription1 Jun 1995
IMITREX5MG/SPRAY; 20MG/SPRAYspray · nasalGLAXOSMITHKLINEPrescription26 Aug 1997
SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)solution · subcutaneousWOCKHARDT BIO AGPrescription6 Feb 2009
SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)solution · subcutaneousHIKMA PHARMSPrescription6 Feb 2009
SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)solution · subcutaneousFRESENIUS KABI USAPrescription2 Mar 2009
SUMATRIPTAN SUCCINATEEQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASEtablet · oralDR REDDYS LABS INCPrescription10 Aug 2009
SUMATRIPTAN SUCCINATEEQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASEtablet · oralWATSON LABSPrescription10 Aug 2009
SUMATRIPTAN SUCCINATEEQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASEtablet · oralMYLANPrescription10 Aug 2009
SUMATRIPTAN SUCCINATEEQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASEtablet · oralORBION PHARMSPrescription10 Aug 2009
SUMATRIPTAN SUCCINATEEQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASEtablet · oralAUROBINDO PHARMAPrescription10 Aug 2009
SUMATRIPTAN SUCCINATE (AUTOINJECTOR)EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)solution · subcutaneousONESOURCE SPECIALTYPrescription10 Jun 2010
SUMATRIPTAN SUCCINATE (AUTOINJECTOR)EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)solution · subcutaneousSUN PHARMPrescription21 Jun 2011
SUMATRIPTAN SUCCINATEEQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASEtablet · oralZHEJIANGPrescription19 Jun 2012
SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)solution · subcutaneousEUGIA PHARMAPrescription23 Apr 2013
SUMATRIPTAN SUCCINATEEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)solution · subcutaneousHIKMAPrescription16 Sep 2013
SUMATRIPTAN SUCCINATE (AUTOINJECTOR)EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)solution · subcutaneousDR REDDYSPrescription29 Jan 2014
ONZETRA XSAILEQ 11MG BASEpowder · nasalAZURITYPrescription27 Jan 2016
ZEMBRACE SYMTOUCH (AUTOINJECTOR)EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)solution · subcutaneousTONIX MEDSPrescription28 Jan 2016
SUMATRIPTAN5MG/SPRAY; 20MG/SPRAYspray · nasalLANNETT CO INCPrescription19 Feb 2016
TOSYMRA10MG/SPRAYspray · nasalTONIX MEDSPrescription25 Jan 2019
SUMATRIPTAN20MG/SPRAY; 5MG/SPRAYspray · nasalPADAGIS ISRAELPrescription21 Sep 2020
SUMATRIPTAN5MG/SPRAYspray · nasalPERRIGO UK FINCOPrescription21 Sep 2020
SUMATRIPTAN20MG/SPRAYspray · nasalREGCON HOLDINGSPrescription17 Feb 2021
SUMATRIPTAN20MG/SPRAYspray · nasalCIPLAPrescription22 Feb 2021

30 more — full table

EMA European Union — centrally authorised medicines

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-SUMATRIPTAN0226838850 MGTABLET · ORALAPOTEX INC
APO-SUMATRIPTAN02268396100 MGTABLET · ORALAPOTEX INC
IMITREX022121886 MG / 0.5 MLSOLUTION · SUBCUTANEOUSGLAXOSMITHKLINE INC
IMITREX022304185 MG / ACTSPRAY · NASALGLAXOSMITHKLINE INC
IMITREX0223042020 MG / ACTSPRAY · NASALGLAXOSMITHKLINE INC
IMITREX DF - TAB 100MG02212161100 MGTABLET · ORALGLAXOSMITHKLINE INC
JAMP SUMATRIPTAN0254534925 MGTABLET · ORALJAMP PHARMA CORPORATION
JAMP SUMATRIPTAN0254535750 MGTABLET · ORALJAMP PHARMA CORPORATION
JAMP SUMATRIPTAN02545365100 MGTABLET · ORALJAMP PHARMA CORPORATION
JAMP SUMATRIPTAN DF0254529225 MGTABLET · ORALJAMP PHARMA CORPORATION
JAMP SUMATRIPTAN DF0254530650 MGTABLET · ORALJAMP PHARMA CORPORATION
JAMP SUMATRIPTAN DF02545314100 MGTABLET · ORALJAMP PHARMA CORPORATION
MYLAN-SUMATRIPTAN0226890625 MGTABLET · ORALMYLAN PHARMACEUTICALS ULC
MYLAN-SUMATRIPTAN0226891450 MGTABLET · ORALMYLAN PHARMACEUTICALS ULC
MYLAN-SUMATRIPTAN02268922100 MGTABLET · ORALMYLAN PHARMACEUTICALS ULC
PMS-SUMATRIPTAN0225642825 MGTABLET · ORALPHARMASCIENCE INC
PMS-SUMATRIPTAN0225643650 MGTABLET · ORALPHARMASCIENCE INC
PMS-SUMATRIPTAN02256444100 MGTABLET · ORALPHARMASCIENCE INC
PRO-SUMATRIPTAN0232465250 MGTABLET · ORALPRO DOC LIMITEE
PRO-SUMATRIPTAN02324660100 MGTABLET · ORALPRO DOC LIMITEE
SUMATRIPTAN0228652150 MGTABLET · ORALSANIS HEALTH INC
SUMATRIPTAN02286548100 MGTABLET · ORALSANIS HEALTH INC
SUMATRIPTAN0254603550 MGTABLET · ORALSIVEM PHARMACEUTICALS ULC
SUMATRIPTAN02546043100 MGTABLET · ORALSIVEM PHARMACEUTICALS ULC
SUMATRIPTAN DF0238557050 MGTABLET · ORALSIVEM PHARMACEUTICALS ULC

7 more — full table

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACIMITREX 100 MG TABLET$72.39673per EA23 Sep 2026
US NADACIMITREX 4 MG/0.5 ML PEN INJECT$463.07333per ML23 Sep 2026
US NADACIMITREX 6 MG/0.5 ML CARTRIDGES$436.79714per ML23 Sep 2026
US NADACIMITREX 6 MG/0.5 ML PEN INJECT$460.05429per ML23 Sep 2026
US NADACSUMATRIPTAN 20 MG NASAL SPRAY$16.5061per EA23 Sep 2026
US NADACSUMATRIPTAN 5 MG NASAL SPRAY$17.03859per EA23 Sep 2026
US NADACSUMATRIPTAN 6 MG/0.5 ML AUTOINJ$61.41234per ML23 Sep 2026
US NADACSUMATRIPTAN 6 MG/0.5 ML VIAL$15.0per ML2 Sep 2026
US NADACSUMATRIPTAN 6 MG/0.5 ML VIAL$14.93447per ML23 Sep 2026
US NADACSUMATRIPTAN SUCC 100 MG TABLET$0.43878per EA23 Sep 2026
US NADACSUMATRIPTAN SUCC 25 MG TABLET$0.23942per EA23 Sep 2026
US NADACSUMATRIPTAN SUCC 50 MG TABLET$0.30222per EA30 Sep 2026
NHS Drug TariffSumatriptan 100mg tablets£2.106 tablet1 Oct 2026
NHS Drug TariffSumatriptan 10mg/0.1ml nasal spray unit dose£14.162 unit dose1 Oct 2026
NHS Drug TariffSumatriptan 20mg/0.1ml nasal spray unit dose£42.476 unit dose1 Oct 2026
NHS Drug TariffSumatriptan 3mg/0.5ml solution for injection pre-filled disposable devices£39.502 pre-filled disposable injection1 Oct 2026
NHS Drug TariffSumatriptan 50mg tablets£4.246 tablet1 Oct 2026
NHS Drug TariffSumatriptan 6mg/0.5ml solution for injection pre-filled disposable devices£43.562 pre-filled disposable injection1 Oct 2026
NHS Drug TariffSumatriptan 6mg/0.5ml solution for injection pre-filled syringes with device£50.962 pre-filled disposable injection1 Oct 2026
NHS Drug TariffSumatriptan 6mg/0.5ml solution for injection syringe refill£48.492 pre-filled disposable injection1 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)

  • 5.1.5.3. Medicines for cluster headache · core
    Trigeminal autonomic cephalalgias
    Parenteral > General injections > SC: 6 mg per 0.5 mL in pre-filled pen; 6 mg per 0.5 mL in pre-filled syringe
  • 5.1.5.1. Medicines for acute migraine attacks · core
    Migraine
    Oral > Solid > tablet: 50 mg

Safety signals and safety-related labeling changes

  • US FDA 9 Dec 2025 IMITREX — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 9 Dec 2025 IMITREX — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 9 Dec 2025 IMITREX STATDOSE — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 9 Dec 2025 IMITREX — safety-related labeling change
    Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 21 Nov 2024 TREXIMET — safety-related labeling change
    Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 2 Jul 2020 SUMAVEL DOSEPRO — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 10 Jun 2019 ZEMBRACE SYMTOUCH — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for sumatriptan →

Combinations containing Sumatriptan

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.