Active substance
Mirtazapine
- SFDA 14
- US FDA 27
- Health Canada 31
- US price lines 9
- NHS prices 7
- Safety 13
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| MIRTAZA 15 mg film-coated tablet | 15 mg | Film-coated tablet · Oral use | 30 Blister | SAR 38.05 | Generic · Prescription | APOTEX INC. (SIGNET SITE) | Valid |
| MIRTAZA 30 mg film-coated tablet | 30 mg | Film-coated tablet · Oral use | 30 Blister | SAR 64.50 | Generic · Prescription | APOTEX INC. (SIGNET SITE) | Valid |
| MIRZAGEN 15 mg film-coated tablet | 15 mg | Coated tablet · Oral use | 30 Blister | SAR 39.20 | Generic · Prescription | RIYADH PHARMA | Valid |
| MIRZAGEN 30 mg film-coated tablet | 30 mg | Coated tablet · Oral use | 30 Blister | SAR 78.40 | Generic · Prescription | RIYADH PHARMA | Valid |
| REMERON 30MG TAB | 30 mg | Film-coated tablet · Oral use | 30 Blister | SAR 74.50 | NCE · Prescription | ORGANON | Valid |
| Razapena | 15 mg | Film-coated tablet · Oral use | 30 Blister | SAR 39.20 | Generic · Prescription | SPIMACO | Valid |
| Razapena | 30 mg | Film-coated tablet · Oral use | 30 Blister | SAR 78.40 | Generic · Prescription | SPIMACO | Valid |
| TAZMERON 15MG F.C.TABLET | 15 mg | Film-coated tablet · Oral use | 30 Blister | SAR 39.20 | Generic · Prescription | Jamjoom Pharmaceuticals Factory Company | Valid |
| TAZMERON 30MG F.C.TABLET | 30 mg | Film-coated tablet · Oral use | 30 Blister | SAR 78.40 | Generic · Prescription | Jamjoom Pharmaceuticals Factory Company | Valid |
| TAZMERON 45MG F.C.TABLET | 45 mg | Film-coated tablet · Oral use | 30 Blister | SAR 117.60 | Generic · Prescription | Jamjoom Pharmaceuticals Factory Company | Valid |
| MIRTAZA 15 mg film-coated tablet | 15 mg | Film-coated tablet · Oral use | 30 Blister | SAR 38.05 | Generic · Prescription | APOTEX | Withdrawn by MAH · Not Marketed |
| MIRTAZA 30 mg film-coated tablet | 30 mg | Film-coated tablet · Oral use | 30 Blister | SAR 64.50 | Generic · Prescription | APOTEX | Withdrawn by MAH · Not Marketed |
| MIRZAGEN 45 mg film-coated tablet | 45 mg | Gastro-resistant coated tablet · Oral use | 30 Blister | SAR 170.30 | Generic · Prescription | RIYADH PHARMA | Withdrawn by MAH · Not Marketed |
| REMERON 30MG TAB | 30 mg | Film-coated tablet · Oral use | 30 Blister | SAR 153.75 | NCE · Prescription | ORGANON | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
ALZHEIMER / DEMENTIA; ANXIETY DISORDERS; AUTISM SPECTRUM DISORDER; DEPRESSION; DYSPEPSIA; INSOMNIA; MIGRAINE/ HEADACHE; POLYCYTHEMIA VERA - PRURITUS; POSTOPERATIVE NAUSEA AND VOMITING
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| REMERON | 15MG; 30MG | tablet · oral | ORGANON | Prescription | 14 Jun 1996 |
| REMERON SOLTAB | 15MG; 30MG; 45MG | tablet, orally disintegrating · oral | ORGANON USA ORGANON | Prescription | 12 Jan 2001 |
| MIRTAZAPINE | 15MG; 30MG; 45MG | tablet · oral | TEVA | Prescription | 24 Jan 2003 |
| MIRTAZAPINE | 15MG; 30MG; 45MG | tablet · oral | MYLAN | Prescription | 19 Jun 2003 |
| MIRTAZAPINE | 15MG; 30MG; 45MG | tablet · oral | CHARTWELL RX | Prescription | 19 Jun 2003 |
| MIRTAZAPINE | 15MG; 30MG; 45MG; 7.5MG | tablet · oral | SUN PHARM INDS INC | Prescription | 22 Apr 2004 |
| MIRTAZAPINE | 7.5MG; 15MG; 30MG; 45MG | tablet · oral | AUROBINDO | Prescription | 22 Oct 2004 |
| MIRTAZAPINE | 15MG; 30MG; 45MG | tablet, orally disintegrating · oral | AUROBINDO PHARMA | Prescription | 8 Dec 2005 |
| MIRTAZAPINE | 15MG; 30MG; 45MG | tablet · oral | APOTEX | Prescription | 22 Aug 2007 |
| MIRTAZAPINE | 15MG; 30MG; 45MG | tablet, orally disintegrating · oral | SQUARE PHARMS PLC | Prescription | 1 Jun 2017 |
| MIRTAZAPINE | 7.5MG; 15MG; 30MG; 45MG | tablet · oral | PRASCO | Prescription | 18 Jan 2023 |
| MIRTAZAPINE | 7.5MG; 15MG; 30MG; 45MG | tablet · oral | ANNORA PHARMA | Prescription | 2 Oct 2025 |
| MIRTAZAPINE | 7.5MG; 15MG; 30MG; 45MG | tablet · oral | NOVITIUM PHARMA | Prescription | 2 Feb 2026 |
| MIRTAZAPINE | 7.5MG; 15MG; 30MG; 45MG | tablet · oral | MICRO LABS | Prescription | 19 May 2026 |
| REMERON | 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | ORGANON | Discontinued | 14 Jun 1996 |
| MIRTAZAPINE | 15MG; 30MG; 45MG | tablet · oral | PHARMAZONE | Discontinued | 19 Jun 2003 |
| MIRTAZAPINE | 15MG; 30MG; 45MG | tablet · oral | UPSHER SMITH LABS | Discontinued | 19 Jun 2003 |
| MIRTAZAPINE | 15MG; 30MG; 45MG | tablet · oral | ROXANE | Discontinued | 19 Jun 2003 |
| MIRTAZAPINE | 15MG; 30MG; 45MG | tablet · oral | WATSON LABS | Discontinued | 19 Jun 2003 |
| MIRTAZAPINE | 15MG; 30MG; 45MG | tablet · oral | ACTAVIS ELIZABETH | Discontinued | 20 Jun 2003 |
| MIRTAZAPINE | 15MG; 30MG; 45MG | tablet · oral | ACTAVIS LABS FL INC | Discontinued | 20 Jun 2003 |
| MIRTAZAPINE | 15MG; 30MG; 45MG | tablet · oral | ACTAVIS ELIZABETH | Discontinued | 25 Jun 2003 |
| MIRTAZAPINE | 15MG; 30MG; 45MG | tablet, orally disintegrating · oral | ACTAVIS LABS FL INC | Discontinued | 17 Dec 2003 |
| MIRTAZAPINE | 15MG; 30MG; 45MG | tablet · oral | IVAX SUB TEVA PHARMS | Discontinued | 22 Dec 2003 |
| MIRTAZAPINE | 15MG; 30MG; 45MG | tablet, orally disintegrating · oral | IMPAX LABS INC | Discontinued | 28 Jun 2005 |
2 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| APO-MIRTAZAPINE | 02286610 | 15 MG | TABLET · ORAL | APOTEX INC |
| APO-MIRTAZAPINE | 02286629 | 30 MG | TABLET · ORAL | APOTEX INC |
| APO-MIRTAZAPINE | 02286637 | 45 MG | TABLET · ORAL | APOTEX INC |
| AURO-MIRTAZAPINE | 02411695 | 15 MG | TABLET · ORAL | AURO PHARMA INC |
| AURO-MIRTAZAPINE | 02411709 | 30 MG | TABLET · ORAL | AURO PHARMA INC |
| AURO-MIRTAZAPINE | 02411717 | 45 MG | TABLET · ORAL | AURO PHARMA INC |
| AURO-MIRTAZAPINE OD | 02299801 | 15 MG | TABLET (ORALLY-DISINTEGRATING) · ORAL | AURO PHARMA INC |
| AURO-MIRTAZAPINE OD | 02299828 | 30 MG | TABLET (ORALLY-DISINTEGRATING) · ORAL | AURO PHARMA INC |
| AURO-MIRTAZAPINE OD | 02299836 | 45 MG | TABLET (ORALLY-DISINTEGRATING) · ORAL | AURO PHARMA INC |
| MIRTAZAPINE | 02370689 | 30 MG | TABLET · ORAL | SANIS HEALTH INC |
| MIRTAZAPINE | 02496666 | 15 MG | TABLET · ORAL | SIVEM PHARMACEUTICALS ULC |
| MIRTAZAPINE | 02496674 | 30 MG | TABLET · ORAL | SIVEM PHARMACEUTICALS ULC |
| MIRTAZAPINE | 02496682 | 45 MG | TABLET · ORAL | SIVEM PHARMACEUTICALS ULC |
| MIRTAZAPINE | 02532689 | 15 MG | TABLET · ORAL | SANIS HEALTH INC |
| MYLAN-MIRTAZAPINE | 02256096 | 15 MG | TABLET · ORAL | MYLAN PHARMACEUTICALS ULC |
| MYLAN-MIRTAZAPINE | 02256118 | 30 MG | TABLET · ORAL | MYLAN PHARMACEUTICALS ULC |
| MYLAN-MIRTAZAPINE | 02256126 | 45 MG | TABLET · ORAL | MYLAN PHARMACEUTICALS ULC |
| NRA-MIRTAZAPINE | 02534924 | 15 MG | TABLET · ORAL | NORA PHARMA INC |
| NRA-MIRTAZAPINE | 02534932 | 30 MG | TABLET · ORAL | NORA PHARMA INC |
| NRA-MIRTAZAPINE | 02534940 | 45 MG | TABLET · ORAL | NORA PHARMA INC |
| PRO-MIRTAZAPINE | 02312778 | 15 MG | TABLET · ORAL | PRO DOC LIMITEE |
| PRO-MIRTAZAPINE | 02312786 | 30 MG | TABLET · ORAL | PRO DOC LIMITEE |
| REMERON | 02243910 | 30 MG | TABLET · ORAL | ORGANON CANADA INC. |
| REMERON RD | 02248542 | 15 MG | TABLET (ORALLY-DISINTEGRATING) · ORAL | ORGANON CANADA INC. |
| REMERON RD | 02248543 | 30 MG | TABLET (ORALLY-DISINTEGRATING) · ORAL | ORGANON CANADA INC. |
6 more — full table
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | MIRTAZAPINE 15 MG ODT | $0.31386 | per EA | 23 Sep 2026 |
| US NADAC | MIRTAZAPINE 15 MG TABLET | $0.06299 | per EA | 23 Sep 2026 |
| US NADAC | MIRTAZAPINE 30 MG ODT | $0.42285 | per EA | 23 Sep 2026 |
| US NADAC | MIRTAZAPINE 30 MG TABLET | $0.08852 | per EA | 23 Sep 2026 |
| US NADAC | MIRTAZAPINE 45 MG ODT | $0.40814 | per EA | 23 Sep 2026 |
| US NADAC | MIRTAZAPINE 45 MG TABLET | $0.11084 | per EA | 23 Sep 2026 |
| US NADAC | MIRTAZAPINE 7.5 MG TABLET | $0.34857 | per EA | 23 Sep 2026 |
| US NADAC | REMERON 15 MG TABLET | $6.36287 | per EA | 23 Sep 2026 |
| US NADAC | REMERON 30 MG TABLET | $6.67309 | per EA | 1 Jan 2026 |
| NHS Drug Tariff | Mirtazapine 15mg orodispersible tablets | £1.91 | 30 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Mirtazapine 15mg tablets | £1.12 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Mirtazapine 15mg/ml oral solution sugar free | £148.39 | 66 ml | 1 Oct 2026 |
| NHS Drug Tariff | Mirtazapine 30mg orodispersible tablets | £2.06 | 30 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Mirtazapine 30mg tablets | £1.18 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Mirtazapine 45mg orodispersible tablets | £2.11 | 30 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Mirtazapine 45mg tablets | £1.49 | 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 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 14 May 2020 PRAC signal: Amnesia
Action for MAH: update of the product information: Yes - EMA PRAC 14 May 2020 PRAC signal: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Action for MAH: update of the product information: Yes - US FDA 29 Apr 2020 REMERON — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 29 Apr 2020 REMERON SOLTAB — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - EMA PRAC 12 Mar 2020 PRAC signal: Postpartum haemorrhage
Action for MAH: update of the product information: No - EMA PRAC 16 Jan 2020 PRAC signal: Amnesia
Action for MAH: update of the product information: No - 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 - EMA PRAC 11 Apr 2013 PRAC signal: Pancreatitis
Action for MAH: update of the product information: Yes - EMA PRAC 3 Oct 2012 PRAC signal: Pancreatitis
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.