MYSIMBA

This brand name is authorized in Austria, Cyprus, Estonia, Spain, Finland, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom

Active ingredients

The drug MYSIMBA contains a combination of these active pharmaceutical ingredients (APIs):

1 Naltrexone UNII Z6375YW9SF - NALTREXONE HYDROCHLORIDE

Naltrexone is an orally used, long acting specific opioid antagonist. Naltrexone binds competitively to receptors which are located in the central and peripheral nervous system and hence blocks the access for exogenously administered opioids. Read about Naltrexone

2 Bupropion UNII ZG7E5POY8O - BUPROPION HYDROCHLORIDE

Bupropion is a selective inhibitor of the neuronal re-uptake of catecholamines (noradrenaline and dopamine) with minimal effect on the re-uptake of indolamines (serotonin) and does not inhibit either monoamine oxidase. The mechanism by which bupropion enhances the ability of patients to abstain from smoking is unknown. However, it is presumed that this action is mediated by noradrenergic and/or dopaminergic mechanisms. Read about Bupropion

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
MYSIMBA Prolonged-release tablet	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
A08AA62		A Alimentary tract and metabolism → A08 Antiobesity preparations, excl. diet products → A08A Antiobesity preparations, excl. diet products → A08AA Centrally acting antiobesity products
Discover more medicines within A08AA62

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: EE	Ravimiamet	Identifier(s): 1683132, 1761476
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 114988001
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 190131
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 345554
Country: IT	Agenzia del Farmaco	Identifier(s): 044014013, 044014025
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1076048, 1084582
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 199222
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100342358
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W63034001