MYSIMBA

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

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 more 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 more about Bupropion

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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