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

Orexigen Therapeutics Ireland Limited, Airija

Date of authorisation

2015-03-26

Date of renewal

Documents

Mysimba laiškas gydytojams.pdf

Mysimba paciento kortele.pdf

Mysimba kontrolinis sarasas gydytojui.pdf

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Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10b

Procedure number

Marketing authorisation procedure

Centrinė registracija

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
61706	76048	1076048	lizdinė plokštelė	N112		Receptinis	EU/1/14/988/001	Tiekiama	-	-	No	-	-
98479	84582	1084582	lizdinė plokštelė	N28		Receptinis	EU/1/14/988/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-03-26	Registruotas