Moclobemide

Overview

A reversible monoamine oxidase inhibitor (MAOI) selective for isoform A (RIMA) used to treat major depressive disorder. Most meta-analyses and most studies indicate that in the acute management of depression, moclobemide is more efficacious than placebo medication and similarly efficacious as tricyclic antidepressants (TCA) or selective serotonin reuptake inhibitors (SSRIs). Due to negligible anticholinergic and antihistaminic actions, moclobemide has been better tolerated than tri- or heterocyclic antidepressants .

Indication

For the treatment of major depressive disorder and bipolar disorder .

Associated Conditions

Major Depressive Disorder (MDD)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Establishment of Cessation Therapy by Clinical Trials for Subjects With Betel-quid Dependence and Oral Pre-cancer	2017/01/05	NCT03010761	Phase 2	Terminated	China Medical University Hospital
Pharmacovigilance in Gerontopsychiatric Patients	2015/03/02	NCT02374567	Phase 3	Terminated	Hannover Medical School
Evaluation of Moclobemide, a Reversible MAO-A Inhibitor, as an Adjunct to Nicotine Replacement Therapy in Female Smokers	2013/08/21	NCT01926626	Phase 2	Completed	Jed E. Rose

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

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
MOCLOBEMIDE HEXAL TABLET 150mg	Salutas Pharma GmbH	SIN13093P	TABLET	150mg	4/21/2005

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
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
CLOBEMIX moclobemide 150 mg film-coated tablet blister pack	184084	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	4/19/2012
MOCLOBEMIDE-ARX moclobemide 150 mg film-coated tablet blister pack	333640	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	5/4/2020
MOCLOBIN moclobemide 300 mg film-coated tablet blister pack	184081	Strides Pharma Science Pty Ltd	Medicine	A	4/19/2012
MOCLOBEMIDE SANDOZ moclobemide 300mg tablet blister pack	76935	Sandoz Pty Ltd	Medicine	A	12/7/2000
MOCLOBEMIDE-ARX moclobemide 300 mg film-coated tablet blister pack	333641	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	5/4/2020
AURORIX moclobemide 300mg tablet blister pack	51626	Viatris Pty Ltd	Medicine	A	3/15/1995
MOCLOBEMIDE-WGR moclobemide 300 mg film-coated tablet blister pack	333639	GM Pharma International Pty Ltd	Medicine	A	5/4/2020
AURORIX 150mg tablet blister pack	9987	Viatris Pty Ltd	Medicine	A	8/2/1991
CLOBEMIX moclobemide 300 mg film-coated tablet blister pack	184085	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	4/19/2012
APO-MOCLOBEMIDE moclobemide 300mg tablet blister pack	73835	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	8/17/2000

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
RIVA-MOCLOBEMIDE 150MG TABLETS	laboratoire riva inc.	02240736	Tablet - Oral	150 MG / TAB	8/30/1999
MOCLOBEMIDE	aa pharma inc	02232150	Tablet - Oral	150 MG	9/18/1997
MANERIX	bausch health, canada inc.	00899356	Tablet - Oral	150 MG	12/31/1992
RATIO-MOCLOBEMIDE - TAB 300MG	ratiopharm inc division of teva canada limited	02218429	Tablet - Oral	300 MG	7/12/1999
MOCLOBEMIDE-100	PRO DOC LIMITEE	02236928	Tablet - Oral	100 MG / TAB	6/2/1998
MANERIX TAB 100MG	Hoffmann-La Roche Limited	00899348	Tablet - Oral	100 MG / TAB	12/31/1992
PMS-MOCLOBEMIDE	Pharmascience Inc	02243218	Tablet - Oral	150 MG	1/8/2001
NU-MOCLOBEMIDE	nu-pharm inc	02237112	Tablet - Oral	150 MG	7/28/1998
MOCLOBEMIDE	aa pharma inc	02240456	Tablet - Oral	300 MG	7/14/1999
TEVA-MOCLOBEMIDE	teva canada limited	02239746	Tablet - Oral	100 MG	5/20/1999

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
MANERIX 300 COMPRIMIDOS RECUBIERTOS CON PELICULA	Viatris Healthcare Limited	60824	COMPRIMIDO RECUBIERTO	Medicamento Sujeto A Prescripción Médica	Commercialized
MANERIX 150 COMPRIMIDOS RECUBIERTOS CON PELICULA.	Viatris Healthcare Limited	59169	COMPRIMIDO RECUBIERTO	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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