Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Orexigen Therapeutics Ireland Limited, 2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland
Mysimba 8 mg/90 mg prolonged-release tablets.
| Pharmaceutical Form |
|---|
|
Prolonged-release tablet. Blue, biconvex, round tablet of 12-12.2 mm diameter debossed with “NB-890” on one side. |
Each tablet contains 8 mg naltrexone hydrochloride, equivalent to 7.2 mg of naltrexone, and 90 mg bupropion hydrochloride, equivalent to 78 mg of bupropion.
Excipient with known effect: Each prolonged-release tablet contains 73.2 mg of lactose (see section 4.4).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Bupropion |
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. |
|
| Bupropion and Naltrexone |
The exact neurochemical appetite suppressant effects of naltrexone/bupropion are not fully understood. Naltrexone is a mu-opioid antagonist and bupropion, a weak inhibitor of neuronal dopamine and norepinephrine reuptake. These components affect two principal areas of the brain, specifically the arcuate nucleus of the hypothalamus and the mesolimbic dopaminergic reward system. |
|
| Naltrexone |
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. |
| List of Excipients |
|---|
|
Tablet core: Cysteine hydrochloride Film-coating: Polyvinyl alcohol |
PVC/PCTFE/PVC/Aluminium blisters.
Pack sizes: 28, 112 tablets.
Not all pack sizes may be marketed.
Orexigen Therapeutics Ireland Limited, 2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland
EU/1/14/988/001-002
Date of first authorisation: 26 March 2015
Date of latest renewal: 17 January 2020
| Drug | Countries | |
|---|---|---|
| MYSIMBA | Austria, Cyprus, Estonia, Spain, Finland, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
