Mirtazapine

Overview

Mirtazapine is a tetracyclic piperazino-azepine antidepressant agent that was initially approved for the treatment of major depressive disorder (MDD) in the Netherlands in 1994. This drug was first manufactured by Organon Inc., and received FDA approval in 1997 for the treatment of major depressive disorder. The effects of this drug may be observed as early as 1 week after beginning therapy. In addition to its beneficial effects in depression, mirtazapine has been reported to be efficacious in the off-label management of various other conditions. It may improve the symptoms of neurological disorders, reverse weight loss caused by medical conditions, improve sleep, and prevent nausea and vomiting after surgery.

Indication

This drug is indicated for the treatment of major depressive disorder and its associated symptoms. Mirtazapine has been used off-label for a variety of conditions including panic disorder, generalized anxiety disorder, dysthymia, tension headaches, hot flushes, post-traumatic stress disorder (PTSD), sleep disorders, substance abuse disorders, and sexual disorders, among others.

Associated Conditions

Cancer Pain
Depression
Fibromyalgia
Generalized Anxiety Disorder
Hot Flashes
Insomnia
Major Depressive Disorder (MDD)
Obsessive Compulsive Disorder (OCD)
Panic Disorder
Persistent Depressive Disorder (Dysthymia)
Post Operative Nausea and Vomiting (PONV)
Poststroke depression
Sleep disorders and disturbances
Substance Abuse Disorders
Tension Headache

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Novel Pilot Study to Treat Symptoms of IBS with Diarrhea Using Combination Therapy of a Low-FODMAP Diet and a Neuromodulator	2024/11/12	NCT06684470	Early Phase 1	Recruiting	Mayo Clinic
Prophylactic Mirtazapine and Different Doses of Intrathecal Morphine in Preventing Nausea and Vomiting After Cesarean Section	2024/11/08	NCT06681805	Not Applicable	Completed	Kafrelsheikh University
Evaluating the Effect of Mirtazapine on Anxiety in Parkinson's Disease Patients	2024/07/31	NCT06530290	Phase 2	Recruiting	Leila Dargahi. PharmD PhD
Mirtazapine for Acute and Chronic Post Mastectomy Pain	2024/07/12	NCT06499090	Early Phase 1	Active, not recruiting	Assiut University
Mirtazapine for the Treatment of Methamphetamine Use in Opioid Use Disorder Patients Receiving Medication Assisted Treatment	2024/03/21	NCT06323837	Phase 2	Recruiting	Washington State University
Trial of Mirtazapine for Depression in IBD	2024/03/13	NCT06309472	Phase 2	Recruiting	King's College London
Elucidating Mechanisms That Underlie the Symptomatology of Functional Dyspepsia Using Novel Techniques and Its Therapeutic Validation Using Neuromodulators	2024/01/19	NCT06213948	Phase 1	Recruiting	Universiti Sains Malaysia
Efficacy of Mirtazapine in Major Depressive Disorder With Insomnia	2023/08/07	NCT05978219	Phase 4	Completed	National Institute of Mental Health, Dhaka
Endeavor to Stop Nausea/Vomiting Associated With Pregnancy (E-SNAP)	2022/07/11	NCT05452174	Phase 1	Withdrawn	Northwestern University
Mirtazapine Versus Megestrol Acetate in Treatment of Anorexia-cachexia in Advanced Cancer Patients.	2022/05/18	NCT05380479	Phase 2	UNKNOWN	Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Mirtazapine	State of Florida DOH Central Pharmacy	53808-0482	ORAL	15 mg in 1 1	8/6/2010
Mirtazapine	Proficient Rx LP	63187-206	ORAL	15 mg in 1 1	10/1/2022
Mirtazapine	Aphena Pharma Solutions - Tennessee, LLC	71610-717	ORAL	15 mg in 1 1	6/29/2023
Mirtazapine	Sun Pharmaceutical Industries, Inc.	57664-510	ORAL	7.5 mg in 1 1	11/30/2021
Mirtazapine	Bryant Ranch Prepack	71335-1332	ORAL	45 mg in 1 1	2/1/2024
Mirtazapine	Sun Pharmaceutical Industries, Inc.	57664-500	ORAL	30 mg in 1 1	11/30/2021
REMERON	Physicians Total Care, Inc.	54868-4848	ORAL	15 mg in 1 1	2/17/2012
Mirtazapine	Contract Pharmacy Services-PA	67046-319	ORAL	30 mg in 1 1	6/25/2020
Mirtazapine	Prasco Laboratories	66993-607	ORAL	15 mg in 1 1	2/1/2023
Mirtazapine	REMEDYREPACK INC.	70518-2819	ORAL	7.5 mg in 1 1	3/6/2024

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
Mirtazapine Sandoz Orodispersible Tablets 15mg	Sandoz Private Limited	SIN13643P	TABLET, ORALLY DISINTEGRATING	15.0mg	5/4/2009
REMERON SOLTAB 30 mg	Anesta LLC	SIN12527P	TABLET	30 mg	3/25/2004
APO-MIRTAZAPINE TABLET 30MG	Apotex Inc. (Etobicoke Site)	SIN14012P	TABLET, FILM COATED	30 mg	9/9/2011
Mirtazapine Sandoz Orodispersible Tablets 30mg	Sandoz Private Limited	SIN13644P	TABLET, ORALLY DISINTEGRATING	30.0mg	5/4/2009
REMERON SOLTAB 15 mg	Anesta LLC	SIN12526P	TABLET	15 mg	3/25/2004

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
REMERON SOLTAB ORODISPERSIBLE TAB 15MG	N/A	Organon Hong Kong Limited	N/A	N/A	7/8/2004

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
Mirtazapine tablet 30 mg bottle	202228	Alphapharm Pty Ltd	Medicine	A	10/25/2012
MIRTAZAPINE-RJIC ODT mirtazapine 45 mg orally disintegrating tablet blister pack	421098	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	1/17/2024
APO-MIRTAZAPINE mirtazapine 30 mg tablet bottle	127677	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	8/14/2007
BLOOMS THE CHEMIST MIRTAZAPINE mirtazapine 15mg tablets blister pack	394004	Sandoz Pty Ltd	Medicine	A	12/23/2022
MIRTAZAPINE-DWRN ODT mirtazapine 45 mg orally disintegrating tablet blister pack	421151	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	1/17/2024
MIRTAZAPINE-WGR mirtazapine 45 mg tablets blister pack	420952	GM Pharma International Pty Ltd	Medicine	A	2/16/2024
Mirtazapine Tablets 15mg Bulk	117777	Alphapharm Pty Ltd	Medicine	A	3/31/2005
Mirtazapine tablet 15 mg bottle	202282	Alphapharm Pty Ltd	Medicine	A	10/25/2012
MIRTAZAPINE SANDOZ mirtazapine 15mg tablets bottle	117165	Sandoz Pty Ltd	Medicine	A	6/19/2006
MIRTANZA ODT mirtazapine 15 mg orally disintegrating tablet blister pack	183404	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	1/25/2012

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
SANDOZ MIRTAZAPINE FC	Sandoz Canada, Inc.	02267292	Tablet - Oral	30 MG	5/9/2005
TEVA-MIRTAZAPINE OD	teva canada limited	02279894	Tablet (Orally Disintegrating) - Oral	15 MG	8/30/2006
TEVA-MIRTAZAPINE	teva canada limited	02259354	Tablet - Oral	30 MG	10/22/2005
SANDOZ MIRTAZAPINE	Sandoz Canada, Inc.	02250608	Tablet - Oral	30 MG	3/31/2004
REMERON RD	organon canada inc.	02248544	Tablet (Orally Disintegrating) - Oral	45 MG	12/22/2003
PMS-MIRTAZAPINE	Pharmascience Inc	02248762	Tablet - Oral	30 MG	1/14/2004
GD-MIRTAZAPINE OD	genmed a division of pfizer canada ulc	02352826	Tablet (Orally Disintegrating) - Oral	15 MG	4/26/2012
DOM-MIRTAZAPINE	dominion pharmacal	02252287	Tablet - Oral	30 MG	5/27/2004
MYLAN-MIRTAZAPINE	Mylan Pharmaceuticals ULC	02256118	Tablet - Oral	30 MG	8/17/2004
MIRTAZAPINE	sivem pharmaceuticals ulc	02496674	Tablet - Oral	30 MG	10/22/2020

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
MIRTAZAPINA VIATRIS PHARMACEUTICALS 30 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG	Viatris Limited	66342	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
REXER 30 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Organon Salud S.L.	61017	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
MIRTAZAPINA FLAS BLUEFISH 45 mg COMPRIMIDOS BUCODISPERSABLES EFG	Bluefish Pharmaceuticals Ab (Publ)	71808	COMPRIMIDO BUCODISPERSABLE	Medicamento Sujeto A Prescripción Médica	Commercialized
MIRTAZAPINA FLAS STADA 15 mg COMPRIMIDOS BUCODISPERSABLES EFG	Laboratorio Stada S.L.	69008	COMPRIMIDO BUCODISPERSABLE	Medicamento Sujeto A Prescripción Médica	Commercialized
MIRTAZAPINA CINFA 30 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Laboratorios Cinfa S.A.	67068	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
MIRTAZAPINA FLAS CINFA 30 mg COMPRIMIDOS BUCODISPERSABLES EFG	Laboratorios Cinfa S.A.	69853	COMPRIMIDO BUCODISPERSABLE	Medicamento Sujeto A Prescripción Médica	Not Commercialized
MIRTAZAPINA SANDOZ 15 MG COMPRIMIDOS BUCODISPERSABLES EFG	Sandoz Farmaceutica S.A.	69490	COMPRIMIDO BUCODISPERSABLE	Medicamento Sujeto A Prescripción Médica	Commercialized
MIRTAZAPINA ETHYPHARM 45 mg COMPRIMIDOS BUCODISPERSABLES EFG	Ethypharm	68987	COMPRIMIDO BUCODISPERSABLE	Medicamento Sujeto A Prescripción Médica	Not Commercialized
MIRTAZAPINA FLAS BLUEFISH 15 mg COMPRIMIDOS BUCODISPERSABLES EFG	Bluefish Pharmaceuticals Ab (Publ)	71806	COMPRIMIDO BUCODISPERSABLE	Medicamento Sujeto A Prescripción Médica	Commercialized
MIRTAZAPINA TECNIGEN 30 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Tecnimede España Industria Farmaceutica S.A.	69873	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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