Mysimba

Medicinal product

(Invented) name

Mysimba

Active substance (s)

Naltreksono hidrochloridas/Bupropiono hidrochloridas

Strength

8 mg/90 mg

Pharmaceutical form

pailginto atpalaidavimo tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A08AA62, Bupropion and naltrexone

Marketing authorisation holder

Abacus Medicine A/S, Danija

Date of authorisation

2024-02-06

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

CR-Lygiagretus platinimas

Qualitative and quantitative composition

Prolonged-release tablets	1 vnt.
Naltreksono hidrochloridas	8 mg
Bupropiono hidrochloridas	90 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
112913	99031	1099031	lizdinė plokštelė	N112		Receptinis	EU/1/14/988/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-02-06	Registruotas