Active substance
Fluvoxamine
- SFDA 4
- US FDA 27
- Health Canada 6
- US price lines 5
- NHS prices 2
- WHO EML 1
- Safety 13
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| FAVERIN 100MG EC TABS | 100 mg | Film-coated tablet · Oral use | 30 Blister | SAR 82.85 | NCE · Prescription | ABBOTT HEALTHCARE PRODUCTS | Valid |
| FAVERIN 50MG EC TABS | 50 mg | Film-coated tablet · Oral use | 60 Blister | SAR 82.85 | NCE · Prescription | ABBOTT HEALTHCARE PRODUCTS | Valid |
| Favox | 150 mg | Prolonged-release capsule · Oral use | 30 Blister | SAR 86.90 | Generic · Prescription | Saudi Amarox | Valid |
| Favox | 15 mg | Extended-release capsule · Oral use | 60 Blister | SAR 173.30 | Generic · Prescription | Saudi Amarox | Valid |
Indications — CHI Daman Drug Formulary
ACUTE BIPOLAR I DEPRESSION; ANXIETY DISORDERS; ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD); DEPRESSION; HUNTINGTON'S DISEASE-TICS; MENOPAUSE; POLYCYTHEMIA VERA - PRURITUS
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| FLUVOXAMINE MALEATE | 25MG; 50MG; 100MG | tablet · oral | AIPING PHARM INC | Prescription | 29 Nov 2000 |
| FLUVOXAMINE MALEATE | 25MG; 50MG; 100MG | tablet · oral | APOTEX | Prescription | 7 May 2001 |
| LUVOX | 25MG; 50MG; 100MG | tablet · oral | ANI PHARMS | Prescription | 20 Dec 2007 |
| LUVOX | 25MG; 50MG; 100MG | tablet · oral | JAZZ | Prescription | 14 Apr 2008 |
| FLUVOXAMINE MALEATE | 100MG; 150MG | capsule, extended release · oral | PH HEALTH | Prescription | 13 Mar 2013 |
| FLUVOXAMINE MALEATE | 100MG; 150MG | capsule, extended release · oral | ACTAVIS ELIZABETH | Prescription | 23 Apr 2013 |
| FLUVOXAMINE MALEATE | 150MG; 100MG | capsule, extended release · oral | BIONPHARMA | Prescription | 11 May 2020 |
| FLUVOXAMINE MALEATE | 25MG; 50MG; 100MG | tablet · oral | BIONPHARMA | Prescription | 22 Jan 2024 |
| FLUVOXAMINE MALEATE | 100MG; 150MG | capsule, extended release · oral | AJANTA PHARMA LTD | Prescription | 17 Oct 2024 |
| FLUVOXAMINE MALEATE | 100MG; 150MG | capsule, extended release · oral | ANNORA PHARMA | Prescription | 30 Jul 2025 |
| FLUVOXAMINE MALEATE | 100MG; 150MG | capsule, extended release · oral | APPCO | Prescription | 30 Apr 2026 |
| FLUVOXAMINE MALEATE | 100MG; 150MG | capsule, extended release · oral | MICRO LABS | Prescription | 23 Jun 2026 |
| FLUVOXAMINE MALEATE | 100MG; 150MG | capsule, extended release · oral | ZYDUS PHARMS | Prescription | 21 Jul 2026 |
| LUVOX | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | SOLVAY | Discontinued | 5 Dec 1994 |
| FLUVOXAMINE MALEATE | 25MG; 50MG; 100MG | tablet · oral | QUAGEN | Discontinued | 29 Nov 2000 |
| FLUVOXAMINE MALEATE | 25MG; 50MG; 100MG | tablet · oral | ACTAVIS ELIZABETH | Discontinued | 28 Dec 2000 |
| FLUVOXAMINE MALEATE | 25MG; 50MG; 100MG | tablet · oral | UPSHER SMITH LABS | Discontinued | 5 Jan 2001 |
| FLUVOXAMINE MALEATE | 25MG; 50MG; 100MG | tablet · oral | SYNTHON PHARMS | Discontinued | 17 Jan 2001 |
| FLUVOXAMINE MALEATE | 25MG; 50MG; 100MG | tablet · oral | ANI PHARMS | Discontinued | 25 Jan 2001 |
| FLUVOXAMINE MALEATE | 25MG; 50MG; 100MG | tablet · oral | ANI PHARMS | Discontinued | 12 Mar 2001 |
| FLUVOXAMINE MALEATE | 25MG; 50MG; 100MG | tablet · oral | HERITAGE PHARMA | Discontinued | 18 Apr 2001 |
| FLUVOXAMINE MALEATE | 50MG; 100MG | tablet · oral | MYLAN | Discontinued | 15 Oct 2001 |
| FLUVOXAMINE MALEATE | 25MG; 50MG; 100MG | tablet · oral | SUN PHARM INDUSTRIES | Discontinued | 29 Apr 2002 |
| FLUVOXAMINE MALEATE | 25MG; 50MG; 100MG | tablet · oral | TEVA | Discontinued | 10 Sep 2002 |
| FLUVOXAMINE MALEATE | 25MG; 50MG; 100MG | tablet · oral | CHARTWELL RX | Discontinued | 23 Feb 2006 |
2 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| APO-FLUVOXAMINE | 02231329 | 50 MG | TABLET · ORAL | APOTEX INC |
| APO-FLUVOXAMINE | 02231330 | 100 MG | TABLET · ORAL | APOTEX INC |
| LUVOX | 01919342 | 50 MG | TABLET · ORAL | BGP PHARMA ULC |
| LUVOX | 01919369 | 100 MG | TABLET · ORAL | BGP PHARMA ULC |
| TEVA-FLUVOXAMINE | 02255529 | 50 MG | TABLET · ORAL | TEVA CANADA LIMITED |
| TEVA-FLUVOXAMINE | 02255537 | 100 MG | TABLET · ORAL | TEVA CANADA LIMITED |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | FLUVOXAMINE ER 100 MG CAPSULE | $4.07757 | per EA | 7 Oct 2026 |
| US NADAC | FLUVOXAMINE ER 150 MG CAPSULE | $3.97362 | per EA | 7 Oct 2026 |
| US NADAC | FLUVOXAMINE MALEATE 100 MG TAB | $0.24481 | per EA | 23 Sep 2026 |
| US NADAC | FLUVOXAMINE MALEATE 25 MG TAB | $0.15136 | per EA | 23 Sep 2026 |
| US NADAC | FLUVOXAMINE MALEATE 50 MG TAB | $0.19537 | per EA | 30 Sep 2026 |
| NHS Drug Tariff | Fluvoxamine 100mg tablets | £17.10 | 30 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Fluvoxamine 50mg tablets | £17.10 | 60 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.
WHO WHO Model List of Essential Medicines (2025)
- 24.3. Medicines for anxiety disorders · core (EML); complementary (EMLc)
Therapeutic equivalent to fluoxetine for Generalised anxiety disorder
Safety signals and safety-related labeling changes
- US FDA 18 Aug 2023 LUVOX — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - EMA PRAC 29 Sep 2022 PRAC signal: Pulmonary hypertension
Action for MAH: update of the product information: No - EMA PRAC 10 Mar 2022 PRAC signal: Pulmonary hypertension
Action for MAH: update of the product information: No - EMA PRAC 1 Oct 2020 PRAC signal: Postpartum haemorrhage
Action for MAH: update of the product information: Yes - EMA PRAC 11 Jun 2020 PRAC signal: Postpartum haemorrhage
Action for MAH: update of the product information: No - EMA PRAC 12 Mar 2020 PRAC signal: Postpartum haemorrhage
Action for MAH: update of the product information: No - EMA PRAC 16 May 2019 PRAC signal: Persistent sexual dysfunction after drug withdrawal
Action for MAH: update of the product information: Yes - EMA PRAC 31 Oct 2018 PRAC signal: Persistent sexual dysfunction after drug withdrawal
Action for MAH: update of the product information: No - EMA PRAC 6 Sep 2018 PRAC signal: Persistent sexual dysfunction after drug withdrawal
Action for MAH: update of the product information: No - US FDA 4 Jan 2017 LUVOX CR — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Patient Counseling Information / Patient Information / Medication Guide - EMA PRAC 2 Sep 2016 PRAC signal: Risk of autism spectrum disorders (ASD) after maternal use of SSRI/SNRI
Action for MAH: update of the product information: No - EMA PRAC 13 May 2016 PRAC signal: Risk of autism spectrum disorders (ASD) after maternal use of SSRI/SNRI
Action for MAH: update of the product information: No - EMA PRAC 6 Nov 2015 PRAC signal: New malformative risks in newborn and risk of autism spectrum disorders (ASD) after maternal use of SSRI/SNRI
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.