Regulatory PathRegulatory requirements compared

Active substance

Pyridostigmine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
MESTINON 60MG TABLET60 mgTablet · Oral use20 BottleSAR 22.25NCE · PrescriptionMEDA Pharmaceuticals Switzerland GmbHValid
Indications — CHI Daman Drug Formulary

HYPOTENSION; MYASTHENIA GRAVIS

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

ProductStrengthForm · routeApplicantStatusFirst approved
MESTINON60MGtablet · oralBAUSCHPrescription6 Apr 1955
MESTINON5MG/MLinjectable · injectionBAUSCHPrescription2 Oct 1955
MESTINON180MGtablet, extended release · oralBAUSCHPrescription12 Jan 1959
MESTINON60MG/5MLsyrup · oralBAUSCHPrescription25 Jan 1965
REGONOL5MG/MLinjectable · injectionSANDOZPrescription14 Aug 1973
PYRIDOSTIGMINE BROMIDE60MG; 30MGtablet · oralIMPAX LABSPrescription24 Apr 2003
PYRIDOSTIGMINE BROMIDE60MGtablet · oralANI PHARMSPrescription8 Oct 2003
PYRIDOSTIGMINE BROMIDE60MGtablet · oralZYDUS PHARMSPrescription22 Jun 2015
PYRIDOSTIGMINE BROMIDE180MGtablet, extended release · oralALVOGENPrescription26 Jun 2015
PYRIDOSTIGMINE BROMIDE180MGtablet, extended release · oralRISINGPrescription15 Aug 2017
PYRIDOSTIGMINE BROMIDE60MG; 30MGtablet · oralMLVPrescription20 Jul 2018
PYRIDOSTIGMINE BROMIDE60MG/5MLsyrup · oralNOVITIUM PHARMAPrescription8 Mar 2019
PYRIDOSTIGMINE BROMIDE60MG/5MLsyrup · oralRISINGPrescription9 Jan 2020
PYRIDOSTIGMINE BROMIDE60MG/5MLsyrup · oralAMNEALPrescription10 Jan 2020
PYRIDOSTIGMINE BROMIDE60MG/5MLsyrup · oralMILLA PHARMSPrescription19 Apr 2022
PYRIDOSTIGMINE BROMIDE60MG/5MLsyrup · oralMSNPrescription21 Sep 2023
PYRIDOSTIGMINE BROMIDE30MGtablet · oralSOLVAYDiscontinued27 Nov 1990
PYRIDOSTIGMINE BROMIDE60MGtablet · oralIMPAX LABS INCDiscontinued26 Dec 2002
PYRIDOSTIGMINE BROMIDE30MGtablet · oralUS ARMYDiscontinued5 Feb 2003
PYRIDOSTIGMINE BROMIDE30MGtablet · oralANI PHARMSDiscontinued8 Oct 2003
PYRIDOSTIGMINE BROMIDE180MGtablet, extended release · oralIMPAX LABS INCDiscontinued15 Sep 2015
PYRIDOSTIGMINE BROMIDE105MGtablet, extended release · oralAMNEALDiscontinued4 Oct 2024

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
JAMP PYRIDOSTIGMINE BROMIDE0250836260 MGTABLET · ORALJAMP PHARMA CORPORATION
MESTINON0086996160 MGTABLET · ORALBAUSCH HEALTH, CANADA INC.
MESTINON-SR00869953180 MGTABLET (EXTENDED-RELEASE) · ORALBAUSCH HEALTH, CANADA INC.
RIVA-PYRIDOSTIGMINE0249564360 MGTABLET · ORALLABORATOIRE RIVA INC.

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACPYRIDOSTIGMINE 60 MG/5 ML SOLN$0.56484per ML23 Sep 2026
US NADACPYRIDOSTIGMINE BR 30 MG TABLET$6.94704per EA23 Sep 2026
US NADACPYRIDOSTIGMINE BR 60 MG TABLET$0.24872per EA23 Sep 2026
US NADACPYRIDOSTIGMINE ER 180 MG TAB$3.99632per EA23 Sep 2026
NHS Drug TariffPyridostigmine bromide 12mg/1ml oral solution sugar free£90.00150 ml1 Oct 2026
NHS Drug TariffPyridostigmine bromide 60mg tablets£14.24200 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)

  • 5.2.2. Medicines for myasthenia gravis · complementary
    Myasthenia gravis
    Parenteral > General injections > IV: 5 mg per mL in ampoule or vial (pyridostigmine bromide) | Oral > Solid > tablet: 60 mg scored (pyridostigmine bromide)
  • 20. Muscle relaxants (peripherally-acting) and cholinesterase inhibitors · complementary
    Myasthenia gravis
    Parenteral > General injections > IV: 5 mg per mL in ampoule or vial (pyridostigmine bromide) | Oral > Solid > tablet: 60 mg scored (pyridostigmine bromide)

Safety signals and safety-related labeling changes

All safety entries for pyridostigmine →

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.