Active substance
Galantamine
- SFDA 7
- US FDA 22
- Health Canada 15
- US price lines 6
- NHS prices 4
- Safety 5
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| REMINYL 4 MG - ML ORAL SOLUTION | 4 mg/ml | Oral solution · Oral use | 1 Bottle | SAR 137.80 | NCE · Prescription | JANSSEN PHARMACEUTICA N.V | Valid |
| REMINYL 12MG TABLET | 12 mg | Film-coated tablet · Oral use | 56 Blister | SAR 147.05 | NCE · Prescription | JANSSEN-CILAG | Withdrawn by MAH · Not Marketed |
| REMINYL 16 MG PROLONGED RELEASE CAPSULE | 16 mg | Modified-release capsule · Oral use | 28 Blister | SAR 340.55 | Generic · Prescription | JANSSEN-CILAG | Withdrawn by MAH · Not Marketed |
| REMINYL 24 MG PROLONGED RELEASE CAPSULE | 24 mg | Modified-release capsule · Oral use | 28 Blister | SAR 443.30 | Generic · Prescription | JANSSEN-CILAG | Withdrawn by MAH · Not Marketed |
| REMINYL 4MG TABLET | 4 mg | Film-coated tablet · Oral use | 14 Blister | SAR 29.00 | NCE · Prescription | JANSSEN-CILAG | Withdrawn by MAH · Not Marketed |
| REMINYL 8 MG PROLONGED RELEASE CAPSULE | 8 mg | Modified-release capsule · Oral use | 28 Blister | SAR 240.75 | Generic · Prescription | JANSSEN-CILAG | Withdrawn by MAH · Not Marketed |
| REMINYL 8MG TABLET | 8 mg | Film-coated tablet · Oral use | 56 Blister | SAR 91.40 | NCE · Prescription | JANSSEN-CILAG | Withdrawn by MAH · Not Marketed |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 |
|---|---|---|---|---|---|
| GALANTAMINE HYDROBROMIDE | EQ 4MG BASE; EQ 8MG BASE; EQ 12MG BASE | tablet · oral | BARR | Prescription | 28 Aug 2008 |
| GALANTAMINE HYDROBROMIDE | EQ 4MG BASE; EQ 8MG BASE; EQ 12MG BASE | tablet · oral | PHARMAZONE | Prescription | 11 Sep 2008 |
| GALANTAMINE HYDROBROMIDE | EQ 8MG BASE; EQ 16MG BASE; EQ 24MG BASE | capsule, extended release · oral | BARR | Prescription | 15 Sep 2008 |
| GALANTAMINE HYDROBROMIDE | EQ 8MG BASE; EQ 16MG BASE; EQ 24MG BASE | capsule, extended release · oral | WATSON LABS | Prescription | 15 Dec 2008 |
| GALANTAMINE HYDROBROMIDE | 4MG/ML | solution · oral | HIKMA PHARMS | Prescription | 30 Jan 2009 |
| GALANTAMINE HYDROBROMIDE | EQ 4MG BASE; EQ 8MG BASE; EQ 12MG BASE | tablet · oral | YABAO PHARM | Prescription | 6 Feb 2009 |
| GALANTAMINE HYDROBROMIDE | EQ 4MG BASE; EQ 8MG BASE; EQ 12MG BASE | tablet · oral | SANDOZ | Prescription | 22 Jun 2009 |
| GALANTAMINE HYDROBROMIDE | EQ 8MG BASE; EQ 16MG BASE; EQ 24MG BASE | capsule, extended release · oral | SUN PHARM | Prescription | 2 Feb 2011 |
| GALANTAMINE HYDROBROMIDE | EQ 4MG BASE; EQ 8MG BASE; EQ 12MG BASE | tablet · oral | ZYDUS PHARMS USA INC | Prescription | 17 Feb 2011 |
| GALANTAMINE HYDROBROMIDE | EQ 4MG BASE; EQ 8MG BASE; EQ 12MG BASE | tablet · oral | AUROBINDO PHARMA LTD | Prescription | 29 Mar 2011 |
| GALANTAMINE HYDROBROMIDE | EQ 8MG BASE; EQ 16MG BASE; EQ 24MG BASE | capsule, extended release · oral | AUROBINDO PHARMA | Prescription | 5 Aug 2016 |
| RAZADYNE | EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | JANSSEN PHARMS | Discontinued | 28 Feb 2001 |
| RAZADYNE | 4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | solution · oral | JANSSEN PHARMS | Discontinued | 22 Jun 2001 |
| RAZADYNE ER | EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | capsule, extended release · oral | JANSSEN PHARMS | Discontinued | 1 Apr 2005 |
| GALANTAMINE HYDROBROMIDE | EQ 4MG BASE; EQ 8MG BASE; EQ 12MG BASE | tablet · oral | PHARMOBEDIENT | Discontinued | 28 Aug 2008 |
| GALANTAMINE HYDROBROMIDE | EQ 4MG BASE; EQ 8MG BASE; EQ 12MG BASE | tablet · oral | HIKMA PHARMS | Discontinued | 11 Feb 2009 |
| GALANTAMINE HYDROBROMIDE | EQ 8MG BASE; EQ 16MG BASE; EQ 24MG BASE | capsule, extended release · oral | IMPAX LABS | Discontinued | 27 May 2009 |
| GALANTAMINE HYDROBROMIDE | EQ 4MG BASE; EQ 8MG BASE; EQ 12MG BASE | tablet · oral | MYLAN | Discontinued | 29 May 2009 |
| GALANTAMINE HYDROBROMIDE | EQ 4MG BASE; EQ 8MG BASE; EQ 12MG BASE | tablet · oral | CHARTWELL RX | Discontinued | 9 Jul 2009 |
| GALANTAMINE HYDROBROMIDE | EQ 4MG BASE; EQ 8MG BASE; EQ 12MG BASE | tablet · oral | HERITAGE PHARMA | Discontinued | 15 Sep 2009 |
| GALANTAMINE HYDROBROMIDE | EQ 8MG BASE; EQ 16MG BASE; EQ 24MG BASE | capsule, extended release · oral | PHARMOBEDIENT | Discontinued | 24 Jan 2011 |
| GALANTAMINE HYDROBROMIDE | EQ 4MG BASE; EQ 8MG BASE; EQ 12MG BASE | tablet · oral | APOTEX INC | Discontinued | 27 Sep 2011 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| AURO-GALANTAMINE ER | 02425157 | 8 MG | CAPSULE (EXTENDED-RELEASE) · ORAL | AURO PHARMA INC |
| AURO-GALANTAMINE ER | 02425165 | 16 MG | CAPSULE (EXTENDED-RELEASE) · ORAL | AURO PHARMA INC |
| AURO-GALANTAMINE ER | 02425173 | 24 MG | CAPSULE (EXTENDED-RELEASE) · ORAL | AURO PHARMA INC |
| GALANTAMINE ER | 02316943 | 8 MG | CAPSULE (EXTENDED-RELEASE) · ORAL | ESSENTIAL PHARMA SWITZERLAND GMBH |
| GALANTAMINE ER | 02316951 | 16 MG | CAPSULE (EXTENDED-RELEASE) · ORAL | ESSENTIAL PHARMA SWITZERLAND GMBH |
| GALANTAMINE ER | 02316978 | 24 MG | CAPSULE (EXTENDED-RELEASE) · ORAL | ESSENTIAL PHARMA SWITZERLAND GMBH |
| GALANTAMINE ER | 02443015 | 8 MG | CAPSULE (EXTENDED-RELEASE) · ORAL | SANIS HEALTH INC |
| GALANTAMINE ER | 02443023 | 16 MG | CAPSULE (EXTENDED-RELEASE) · ORAL | SANIS HEALTH INC |
| GALANTAMINE ER | 02443031 | 24 MG | CAPSULE (EXTENDED-RELEASE) · ORAL | SANIS HEALTH INC |
| GALANTAMINE ER | 02562154 | 8 MG | CAPSULE (EXTENDED-RELEASE) · ORAL | SIVEM PHARMACEUTICALS ULC |
| GALANTAMINE ER | 02562162 | 16 MG | CAPSULE (EXTENDED-RELEASE) · ORAL | SIVEM PHARMACEUTICALS ULC |
| GALANTAMINE ER | 02562170 | 24 MG | CAPSULE (EXTENDED-RELEASE) · ORAL | SIVEM PHARMACEUTICALS ULC |
| MYLAN-GALANTAMINE ER | 02339439 | 8 MG | CAPSULE (EXTENDED-RELEASE) · ORAL | MYLAN PHARMACEUTICALS ULC |
| MYLAN-GALANTAMINE ER | 02339447 | 16 MG | CAPSULE (EXTENDED-RELEASE) · ORAL | MYLAN PHARMACEUTICALS ULC |
| MYLAN-GALANTAMINE ER | 02339455 | 24 MG | CAPSULE (EXTENDED-RELEASE) · ORAL | MYLAN PHARMACEUTICALS ULC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | GALANTAMINE ER 16 MG CAPSULE | $0.846 | per EA | 23 Sep 2026 |
| US NADAC | GALANTAMINE ER 24 MG CAPSULE | $0.90496 | per EA | 23 Sep 2026 |
| US NADAC | GALANTAMINE ER 8 MG CAPSULE | $0.80235 | per EA | 23 Sep 2026 |
| US NADAC | GALANTAMINE HBR 12 MG TABLET | $0.51261 | per EA | 23 Sep 2026 |
| US NADAC | GALANTAMINE HBR 4 MG TABLET | $0.29398 | per EA | 23 Sep 2026 |
| US NADAC | GALANTAMINE HBR 8 MG TABLET | $0.40165 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Galantamine 16mg modified-release capsules | £64.90 | 28 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Galantamine 20mg/5ml oral solution sugar free | £109.51 | 100 ml | 1 Oct 2026 |
| NHS Drug Tariff | Galantamine 24mg modified-release capsules | £79.80 | 28 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Galantamine 8mg modified-release capsules | £51.88 | 28 capsule | 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 12 Mar 2026 PRAC signal: Nightmares
Action for MAH: update of the product information: Yes - EMA PRAC 4 Sep 2025 PRAC signal: Nightmares
Action for MAH: update of the product information: No - US FDA 3 Aug 2021 RAZADYNE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations - US FDA 3 Aug 2021 RAZADYNE ER — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations - US FDA 14 Feb 2017 RAZADYNE — safety-related labeling change
Labeling sections changed: Adverse Reactions
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.