Active substance
Clobazam
- SFDA 2
- US FDA 35
- Health Canada 2
- US price lines 9
- NHS prices 4
- Safety 6
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| TAPCLOB 10MG/5ML ORAL SUSPENSION | 2 mg/ml | Suspension · Oral use | 1 Bottle | SAR 447.20 | NCE · Prescription | MARTINDALE PHARMACEUTICALS LTD TRADING AS MARTINDALE PHARMA | Valid |
| TAPCLOB 5MG/5ML ORAL SUSPENSION | 1 mg/ml | Suspension · Oral use | 1 Bottle | SAR 420.70 | NCE · Prescription | MARTINDALE PHARMACEUTICALS LTD TRADING AS MARTINDALE PHARMA | Valid |
Indications — CHI Daman Drug Formulary
ABSENCE SEIZURES AND IDIOPATHIC GENERALIZED EPILEPSY; ACUTE MANIA; ANXIETY DISORDERS; DRAVET SYNDROME; HUNTINGTON'S DISEASE-TICS; JUVENILE MYOCLONIC SEIZURES; SCHIZOPHRENIA; VERTIGO - MOTION SICKNESS
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| ONFI | 10MG; 20MG | tablet · oral | LUNDBECK PHARMS LLC | Prescription | 21 Oct 2011 |
| ONFI | 2.5MG/ML | suspension · oral | LUNDBECK PHARMS LLC | Prescription | 14 Dec 2012 |
| CLOBAZAM | 2.5MG/ML | suspension · oral | BIONPHARMA | Prescription | 22 Oct 2018 |
| CLOBAZAM | 10MG; 20MG | tablet · oral | BIONPHARMA | Prescription | 22 Oct 2018 |
| CLOBAZAM | 10MG; 20MG | tablet · oral | UPSHER SMITH LABS | Prescription | 22 Oct 2018 |
| CLOBAZAM | 10MG; 20MG | tablet · oral | AMNEAL PHARMS CO | Prescription | 22 Oct 2018 |
| CLOBAZAM | 10MG; 20MG | tablet · oral | HETERO LABS LTD III | Prescription | 22 Oct 2018 |
| CLOBAZAM | 10MG; 20MG | tablet · oral | PIRAMAL | Prescription | 22 Oct 2018 |
| CLOBAZAM | 2.5MG/ML | suspension · oral | AMNEAL | Prescription | 22 Oct 2018 |
| CLOBAZAM | 10MG; 20MG | tablet · oral | ZYDUS PHARMS | Prescription | 22 Oct 2018 |
| SYMPAZAN | 5MG; 10MG; 20MG | film · oral | COSETTE | Prescription | 1 Nov 2018 |
| CLOBAZAM | 10MG; 20MG | tablet · oral | LUPIN | Prescription | 14 Dec 2018 |
| CLOBAZAM | 10MG; 20MG | tablet · oral | MICRO LABS | Prescription | 30 Jan 2019 |
| CLOBAZAM | 2.5MG/ML | suspension · oral | TARO | Prescription | 15 Apr 2019 |
| CLOBAZAM | 10MG; 20MG; 5MG | tablet · oral | ALKEM LABS LTD | Prescription | 6 Sep 2019 |
| CLOBAZAM | 2.5MG/ML | suspension · oral | HETERO LABS LTD III | Prescription | 24 Feb 2020 |
| CLOBAZAM | 2.5MG/ML | suspension · oral | CHARTWELL MOLECULAR | Prescription | 24 Apr 2020 |
| CLOBAZAM | 2.5MG/ML | suspension · oral | ALKEM LABS LTD | Prescription | 6 May 2021 |
| CLOBAZAM | 10MG; 20MG | tablet · oral | MSN | Prescription | 11 May 2021 |
| CLOBAZAM | 2.5MG/ML | suspension · oral | AUROBINDO PHARMA LTD | Prescription | 24 Mar 2022 |
| ONFI | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | LUNDBECK PHARMS LLC | Discontinued | 21 Oct 2011 |
| CLOBAZAM | 10MG; 20MG | tablet · oral | HIKMA PHARMS | Discontinued | 22 Oct 2018 |
| CLOBAZAM | 10MG; 20MG; 5MG | tablet · oral | NOVITIUM PHARMA | Discontinued | 22 Oct 2018 |
| CLOBAZAM | 10MG; 20MG | tablet · oral | TARO | Discontinued | 22 Oct 2018 |
| CLOBAZAM | 2.5MG/ML | suspension · oral | HIKMA PHARMS | Discontinued | 22 Oct 2018 |
10 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| APO-CLOBAZAM | 02244638 | 10 MG | TABLET · ORAL | APOTEX INC |
| TEVA-CLOBAZAM | 02238334 | 10 MG | TABLET · ORAL | TEVA CANADA LIMITED |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | CLOBAZAM 10 MG TABLET | $0.24265 | per EA | 23 Sep 2026 |
| US NADAC | CLOBAZAM 2.5 MG/ML SUSPENSION | $0.17304 | per ML | 23 Sep 2026 |
| US NADAC | CLOBAZAM 20 MG TABLET | $0.43208 | per EA | 23 Sep 2026 |
| US NADAC | ONFI 10 MG TABLET | $29.91293 | per EA | 23 Sep 2026 |
| US NADAC | ONFI 2.5 MG/ML SUSPENSION | $12.47305 | per ML | 23 Sep 2026 |
| US NADAC | ONFI 20 MG TABLET | $59.81597 | per EA | 23 Sep 2026 |
| US NADAC | SYMPAZAN 10 MG FILM | $32.75766 | per EA | 1 Apr 2026 |
| US NADAC | SYMPAZAN 20 MG FILM | $65.42818 | per EA | 1 Apr 2026 |
| US NADAC | SYMPAZAN 5 MG FILM | $16.40306 | per EA | 1 Apr 2026 |
| NHS Drug Tariff | Clobazam 10mg tablets | £5.49 | 30 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Clobazam 10mg/5ml oral suspension sugar free | £21.44 | 150 ml | 1 Oct 2026 |
| NHS Drug Tariff | Clobazam 20mg tablets | £9.75 | 30 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Clobazam 5mg/5ml oral suspension sugar free | £27.14 | 150 ml | 1 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
- EMA PRAC 7 May 2026 PRAC signal: Miscarriage associated with in utero exposure to benzodiazepines (including fixed-dose combinations)
Action for MAH: update of the product information: No - EMA PRAC 16 May 2024 PRAC signal: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Action for MAH: update of the product information: No - US FDA 12 Mar 2024 ONFI — 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 12 Mar 2024 ONFI — 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 12 Mar 2024 SYMPAZAN — 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 - EMA PRAC 11 Jan 2024 PRAC signal: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Action for MAH: update of the product information: No
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.