Regulatory PathRegulatory requirements compared

Active substance

Clonazepam

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
RIVOTRIL 2.5MG-ML ORAL SOLUTION2.5 mg/mlOral drops, solution · Oral use1 BottleSAR 12.10NCE · PrescriptionROCHEValid
RIVOTRIL TAB 0.5MG0.5 mgTablet · Oral use50 BlisterSAR 15.30NCE · PrescriptionROCHEValid
RIVOTRIL TAB 2 MG2 mgTablet · Oral use30 BottleSAR 19.20NCE · PrescriptionROCHEValid
RIVOTRIL AMP 1MG+SOLV 1ML1 mgInjection · Intravenous use25 AmpouleSAR 91.05NCE · PrescriptionROCHEWithdrawn by MAH · Not Marketed
RIVOTRIL TAB 2 MG2 mgTablet · Oral use100 BlisterSAR 41.85NCE · PrescriptionROCHEWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

ABSENCE SEIZURES AND IDIOPATHIC GENERALIZED EPILEPSY; ACUTE MANIA; ANXIETY DISORDERS; BIPOLAR II DISORDER; HUNTINGTON'S DISEASE-TICS; JUVENILE MYOCLONIC SEIZURES; SCHIZOPHRENIA; SPASTICITY; VERTIGO - MENIERE'S DISEASE; VERTIGO - MOTION SICKNESS

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

ProductStrengthForm · routeApplicantStatusFirst approved
KLONOPIN0.5MG; 1MG; 2MGtablet · oralCHEPLAPHARMPrescription4 Jun 1975
CLONAZEPAM0.5MG; 1MG; 2MGtablet · oralTEVAPrescription10 Sep 1996
CLONAZEPAM0.5MG; 1MG; 2MGtablet · oralACTAVIS ELIZABETHPrescription31 Oct 1996
CLONAZEPAM0.5MG; 1MG; 2MGtablet · oralSANDOZPrescription29 Aug 1997
CLONAZEPAM0.5MG; 1MG; 2MGtablet · oralCHARTWELL RXPrescription30 Sep 1997
CLONAZEPAM0.5MG; 1MG; 2MGtablet · oralAUROBINDO PHARMA USAPrescription5 Oct 1998
CLONAZEPAM0.5MG; 1MG; 2MG; 0.25MGtablet · oralRUBICON RESEARCHPrescription6 Oct 2000
CLONAZEPAM0.5MG; 1MG; 2MGtablet · oralACCORD HLTHCAREPrescription2 May 2005
CLONAZEPAM0.125MG; 0.25MG; 0.5MG; 1MG; 2MGtablet, orally disintegrating · oralPH HEALTHPrescription3 Aug 2005
CLONAZEPAM0.125MG; 0.25MG; 0.5MG; 1MG; 2MGtablet, orally disintegrating · oralBARRPrescription10 Aug 2005
CLONAZEPAM0.5MG; 1MG; 2MGtablet · oralPRINSTON INCPrescription28 Jun 2006
CLONAZEPAM0.125MG; 0.25MG; 0.5MG; 1MG; 2MGtablet, orally disintegrating · oralALEMBICPrescription28 Jun 2019
CLONAZEPAM0.125MG; 0.25MG; 0.5MG; 1MG; 2MGtablet, orally disintegrating · oralRUBICON RESEARCHPrescription21 May 2026
KLONOPIN0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralCHEPLAPHARMDiscontinued4 Jun 1975
CLONAZEPAM0.5MG; 1MG; 2MGtablet · oralQUAGENDiscontinued30 Oct 1997
KLONOPIN RAPIDLY DISINTEGRATING0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet, orally disintegrating · oralROCHEDiscontinued23 Dec 1997
CLONAZEPAM0.5MG; 1MG; 2MGtablet · oralWATSON LABSDiscontinued30 Dec 1997
CLONAZEPAM0.5MG; 1MG; 2MGtablet · oralTEVADiscontinued4 Aug 1998
CLONAZEPAM0.5MG; 1MG; 2MGtablet · oralSUN PHARM INDS INCDiscontinued27 Apr 2001
CLONAZEPAM0.125MG; 0.25MG; 0.5MG; 1MG; 2MGtablet, orally disintegrating · oralSUN PHARM INDS INCDiscontinued27 Aug 2014

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-CLONAZEPAM021778890.5 MGTABLET · ORALAPOTEX INC
APO-CLONAZEPAM021778972 MGTABLET · ORALAPOTEX INC
PMS-CLONAZEPAM020487281 MGTABLET · ORALPHARMASCIENCE INC
PMS-CLONAZEPAM020487362 MGTABLET · ORALPHARMASCIENCE INC
PMS-CLONAZEPAM021796600.25 MGTABLET · ORALPHARMASCIENCE INC
PMS-CLONAZEPAM-R022078180.5 MGTABLET · ORALPHARMASCIENCE INC
RIVOTRIL003828250.5 MGTABLET · ORALCHEPLAPHARM ARZNEIMITTEL GMBH
RIVOTRIL003828412 MGTABLET · ORALCHEPLAPHARM ARZNEIMITTEL GMBH

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACCLONAZEPAM 0.125 MG DIS TAB$0.51985per EA23 Sep 2026
US NADACCLONAZEPAM 0.125 MG ODT$0.51985per EA23 Sep 2026
US NADACCLONAZEPAM 0.25 MG ODT$0.43849per EA23 Sep 2026
US NADACCLONAZEPAM 0.5 MG DIS TABLET$0.52314per EA23 Sep 2026
US NADACCLONAZEPAM 0.5 MG ODT$0.52314per EA23 Sep 2026
US NADACCLONAZEPAM 0.5 MG TABLET$0.01961per EA23 Sep 2026
US NADACCLONAZEPAM 1 MG DIS TABLET$0.56689per EA23 Sep 2026
US NADACCLONAZEPAM 1 MG ODT$0.56689per EA23 Sep 2026
US NADACCLONAZEPAM 1 MG TABLET$0.02438per EA23 Sep 2026
US NADACCLONAZEPAM 2 MG ODT$0.87917per EA23 Sep 2026
US NADACCLONAZEPAM 2 MG TABLET$0.04017per EA23 Sep 2026
US NADACKLONOPIN 0.5 MG TABLET$2.67886per EA23 Sep 2026
NHS Drug TariffClonazepam 1mg tablets£41.95100 tablet1 Oct 2026
NHS Drug TariffClonazepam 2mg tablets£2.04100 tablet1 Oct 2026
NHS Drug TariffClonazepam 2mg/5ml oral solution sugar free£43.07150 ml1 Oct 2026
NHS Drug TariffClonazepam 500microgram tablets£1.69100 tablet1 Oct 2026
NHS Drug TariffClonazepam 500micrograms/5ml oral solution sugar free£31.72150 ml1 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.

Safety signals and safety-related labeling changes

All safety entries for clonazepam →

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.