Active substance
Donepezil
- SFDA 9
- US FDA 52
- Health Canada 37
- US price lines 5
- NHS prices 5
- Safety 8
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| ALZAMED 5MG F.C.TABLET | 5 mg | Film-coated tablet · Oral use | 14 Blister | SAR 47.45 | Generic · Prescription | World Medicine İlaç San. ve Tic. A.Ş. | Valid |
| ALZAMED 5MG F.C.TABLET | 5 mg | Film-coated tablet · Oral use | 28 Blister | SAR 89.60 | Generic · Prescription | World Medicine İlaç San. ve Tic. A.Ş. | Valid |
| Alzil | 5 mg | Orodispersible tablet · Oral use | 30 Blister | SAR 107.00 | Generic · Prescription | Al-Taqaddom pharmaceutical Industries | Valid |
| Alzil | 10 mg | Orodispersible tablet · Oral use | 30 Blister | SAR 197.45 | Generic · Prescription | Al-Taqaddom pharmaceutical Industries | Valid |
| DEMENTILE 10MG TABLET | 10 mg | Film-coated tablet · Oral use | 30 Blister | SAR 358.65 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| DEMENTILE 5MG TABLET | 5 mg | Film-coated tablet · Oral use | 30 Blister | SAR 211.60 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| Poliza | 5 mg | Dispersible tablet · Oral use | 30 Blister | SAR 120.45 | Generic · Prescription | MS Pharma Saudi (MSPS) | Valid |
| Poliza | 10 mg | Dispersible tablet · Oral use | 30 Blister | SAR 197.45 | Generic · Prescription | MS Pharma Saudi (MSPS) | Valid |
| DONECEPT 5MG TABLET | 5 mg | Film-coated tablet · Oral use | 28 Blister | SAR 197.50 | Generic · Prescription | ACTAVIS | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
ALZHEIMER / DEMENTIA
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| ARICEPT | 10MG; 5MG | tablet · oral | EISAI INC | Prescription | 25 Nov 1996 |
| ARICEPT | 23MG | tablet · oral | EISAI INC | Prescription | 23 Jul 2010 |
| DONEPEZIL HYDROCHLORIDE | 5MG; 10MG | tablet · oral | CIPLA LTD | Prescription | 31 May 2011 |
| DONEPEZIL HYDROCHLORIDE | 5MG; 10MG | tablet · oral | AUROBINDO | Prescription | 31 May 2011 |
| DONEPEZIL HYDROCHLORIDE | 5MG; 10MG | tablet · oral | CHARTWELL RX | Prescription | 31 May 2011 |
| DONEPEZIL HYDROCHLORIDE | 5MG; 10MG | tablet · oral | NOVITIUM PHARMA | Prescription | 31 May 2011 |
| DONEPEZIL HYDROCHLORIDE | 5MG; 10MG | tablet · oral | TORRENT PHARMS | Prescription | 31 May 2011 |
| DONEPEZIL HYDROCHLORIDE | 5MG; 10MG | tablet · oral | JUBILANT GENERICS | Prescription | 31 May 2011 |
| DONEPEZIL HYDROCHLORIDE | 5MG; 10MG | tablet · oral | PRINSTON INC | Prescription | 31 May 2011 |
| DONEPEZIL HYDROCHLORIDE | 5MG; 10MG | tablet · oral | DR REDDYS LABS LTD | Prescription | 31 May 2011 |
| DONEPEZIL HYDROCHLORIDE | 5MG; 10MG | tablet · oral | MACLEODS PHARMS LTD | Prescription | 17 Aug 2012 |
| DONEPEZIL HYDROCHLORIDE | 5MG; 10MG | tablet · oral | ZYDUS LIFESCIENCES | Prescription | 24 Oct 2012 |
| DONEPEZIL HYDROCHLORIDE | 5MG; 10MG | tablet, orally disintegrating · oral | MACLEODS PHARMS LTD | Prescription | 14 Dec 2012 |
| DONEPEZIL HYDROCHLORIDE | 5MG; 10MG | tablet · oral | ALEMBIC PHARMS LTD | Prescription | 25 Feb 2013 |
| DONEPEZIL HYDROCHLORIDE | 5MG; 10MG | tablet · oral | RISING | Prescription | 5 Jul 2013 |
| DONEPEZIL HYDROCHLORIDE | 23MG | tablet · oral | DR REDDYS | Prescription | 24 Jul 2013 |
| DONEPEZIL HYDROCHLORIDE | 23MG | tablet · oral | MACLEODS PHARMS | Prescription | 22 Jan 2014 |
| DONEPEZIL HYDROCHLORIDE | 23MG | tablet · oral | TWI PHARMS | Prescription | 29 Oct 2014 |
| DONEPEZIL HYDROCHLORIDE | 5MG; 10MG | tablet · oral | SCIEGEN PHARMS | Prescription | 29 Oct 2014 |
| DONEPEZIL HYDROCHLORIDE | 5MG; 10MG | tablet · oral | HETERO LABS LTD V | Prescription | 30 Jan 2015 |
| DONEPEZIL HYDROCHLORIDE | 23MG | tablet · oral | DEXCEL | Prescription | 19 Feb 2016 |
| DONEPEZIL HYDROCHLORIDE | 23MG | tablet · oral | ZYDUS PHARMS | Prescription | 31 Aug 2017 |
| DONEPEZIL HYDROCHLORIDE | 5MG; 10MG | tablet · oral | CADILA PHARMS LTD | Prescription | 19 Sep 2017 |
| DONEPEZIL HYDROCHLORIDE | 5MG; 10MG | tablet, orally disintegrating · oral | HISUN PHARM HANGZHOU | Prescription | 27 Jul 2018 |
| ARICEPT | 5MG/5ML | solution · oral | EISAI INC | Discontinued | 18 Oct 2004 |
27 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| ACH-DONEPEZIL | 02402645 | 5 MG | TABLET · ORAL | ACCORD HEALTHCARE INC |
| ACH-DONEPEZIL | 02402653 | 10 MG | TABLET · ORAL | ACCORD HEALTHCARE INC |
| AG-DONEPEZIL | 02432684 | 5 MG | TABLET · ORAL | ANGITA PHARMA INC. |
| AG-DONEPEZIL | 02432692 | 10 MG | TABLET · ORAL | ANGITA PHARMA INC. |
| APO-DONEPEZIL | 02362260 | 5 MG | TABLET · ORAL | APOTEX INC |
| APO-DONEPEZIL | 02362279 | 10 MG | TABLET · ORAL | APOTEX INC |
| ARICEPT | 02232043 | 5 MG | TABLET · ORAL | PFIZER CANADA ULC |
| ARICEPT | 02232044 | 10 MG | TABLET · ORAL | PFIZER CANADA ULC |
| AURO-DONEPEZIL | 02400561 | 5 MG | TABLET · ORAL | AURO PHARMA INC |
| AURO-DONEPEZIL | 02400588 | 10 MG | TABLET · ORAL | AURO PHARMA INC |
| BIO-DONEPEZIL | 02412853 | 5 MG | TABLET · ORAL | BIOMED PHARMA |
| BIO-DONEPEZIL | 02412861 | 10 MG | TABLET · ORAL | BIOMED PHARMA |
| DONEPEZIL | 02420597 | 5 MG | TABLET · ORAL | SIVEM PHARMACEUTICALS ULC |
| DONEPEZIL | 02420600 | 10 MG | TABLET · ORAL | SIVEM PHARMACEUTICALS ULC |
| DONEPEZIL | 02426846 | 5 MG | TABLET · ORAL | SANIS HEALTH INC |
| DONEPEZIL | 02426854 | 10 MG | TABLET · ORAL | SANIS HEALTH INC |
| DONEPEZIL | 02475278 | 5 MG | TABLET · ORAL | LABORATOIRE RIVA INC. |
| JAMP-DONEPEZIL TABLETS | 02416948 | 5 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| JAMP-DONEPEZIL TABLETS | 02416956 | 10 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| M-DONEPEZIL | 02467453 | 5 MG | TABLET · ORAL | MANTRA PHARMA INC |
| M-DONEPEZIL | 02467461 | 10 MG | TABLET · ORAL | MANTRA PHARMA INC |
| MAR-DONEPEZIL | 02402092 | 5 MG | TABLET · ORAL | MARCAN PHARMACEUTICALS INC |
| MAR-DONEPEZIL | 02402106 | 10 MG | TABLET · ORAL | MARCAN PHARMACEUTICALS INC |
| MINT-DONEPEZIL | 02408600 | 5 MG | TABLET · ORAL | MINT PHARMACEUTICALS INC |
| MINT-DONEPEZIL | 02408619 | 10 MG | TABLET · ORAL | MINT PHARMACEUTICALS INC |
12 more — full table
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | DONEPEZIL HCL 10 MG TABLET | $0.04843 | per EA | 23 Sep 2026 |
| US NADAC | DONEPEZIL HCL 23 MG TABLET | $0.73542 | per EA | 23 Sep 2026 |
| US NADAC | DONEPEZIL HCL 5 MG TABLET | $0.04395 | per EA | 23 Sep 2026 |
| US NADAC | DONEPEZIL HCL ODT 10 MG TABLET | $0.29119 | per EA | 23 Sep 2026 |
| US NADAC | DONEPEZIL HCL ODT 5 MG TABLET | $0.28066 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Donepezil 10mg orodispersible tablets sugar free | £40.35 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Donepezil 10mg tablets | £0.96 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Donepezil 1mg/ml oral solution sugar free | £123.02 | 150 ml | 1 Oct 2026 |
| NHS Drug Tariff | Donepezil 5mg orodispersible tablets sugar free | £21.02 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Donepezil 5mg tablets | £0.77 | 28 tablet | 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 8 Jul 2021 PRAC signal: Cardiac conduction disorders including QT prolongation and torsades de pointes
Action for MAH: update of the product information: Yes - EMA PRAC 11 Mar 2021 PRAC signal: Cardiac conduction disorders including QT prolongation and torsades de pointes
Action for MAH: update of the product information: No - US FDA 18 Dec 2018 ARICEPT — safety-related labeling change
Labeling sections changed: Use in Specific Populations - US FDA 18 Dec 2018 ARICEPT — safety-related labeling change
Labeling sections changed: Use in Specific Populations - US FDA 18 Dec 2018 ARICEPT ODT — safety-related labeling change
Labeling sections changed: Use in Specific Populations - US FDA 18 Jul 2016 NAMZARIC — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations - EMA PRAC 9 Jul 2015 PRAC signal: Rhabdomyolysis
Action for MAH: update of the product information: Yes - EMA PRAC 12 Mar 2015 PRAC signal: Rhabdomyolysis
Action for MAH: update of the product information: No
Combinations containing Donepezil
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.