Suboxone

Medicinal product

(Invented) name

Suboxone

Active substance (s)

Buprenorfinas/Naloksonas

Strength

16 mg/4 mg

Pharmaceutical form

poliežuvinės tabletės

Route (s) of administration

vartoti po liežuviu

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N07BC51, Buprenorphine, combinations

Marketing authorisation holder

Indivior Europe Limited , Airija

Date of authorisation

2006-09-26

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

Yes

Controlled substance type

Narkotinis

Legal basis

10b

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Sublingual tablet	1 vnt.
Buprenorfinas	16 mg
Naloksonas	4 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
64774	79263	1079263	lizdinė plokštelė	N7		Receptinis	EU/1/06/359/005	Netiekiama	-	-	No	-	-
64775	79264	1079264	lizdinė plokštelė	N28		Receptinis	EU/1/06/359/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2006-09-26	Registruotas