Register of Medicinal Products

MYSIMBA

Product class:	Authorized package
Medicinal product class:	For human use
Package code:	1683132
Name of medicinal product:	MYSIMBA
Active substances:	Bupropion+Naltrexone Estonian, English, Latin
ATC code:	A08AA62
Dosage form:	prolonged-release tablet
Route of administration:	oral use
Strengh:	90mg+8mg
Amount in package:	112TK
Legal status for supply*:	Subject to medicinal prescription
Class of active substance:
Additional information:
Indication:	Mysimba is indicated, as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (>=18 years) with an initial Body Mass Index (BMI) of - >= 30 kg/m2 (obese), or - >= 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of one or more weight-related co-morbidities (e.g., type 2 diabetes, dyslipidaemia, or controlled hypertension) Treatment with Mysimba should be discontinued after 16 weeks if patients have not lost at least 5% of their initial body weight (see Section 5.1).
Safety features:	Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL):	EST
Labelling:
Last imported to Estonia:	October 26, 2023
:	This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Patients and healthcare professionals are asked to report any suspected adverse reactions to State Agency of Medicines.State Agency of Medicines

Marketing authorization holder:	Orexigen Therapeutics Ireland Limited
Marketing authorization number:	EU/1/14/988
Marketing authorization issued on:	March 26, 2015
Marketing authorization expires on:	Unlimited
Marketing authorization procedure type:	Centralised

Reference price:
Under reference price:
Reference price of daily dose:

Entry/Changing date: January 24, 2020

Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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