Suboxone

Medicinal product

(Invented) name

Suboxone

Active substance (s)

Buprenorfinas/Naloksonas

Strength

8 mg/2 mg

Pharmaceutical form

poliežuvinė plėvelė

Route (s) of administration

vartoti už žando, 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 film	1 vnt.
Buprenorfinas	8 mg
Naloksonas	2 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
104705	90806	1090806	paketėlis	N7x1		Receptinis	EU/1/06/359/013	Netiekiama	-	-	No	-	-
104706	90807	1090807	paketėlis	N14x1		Receptinis	EU/1/06/359/014	Netiekiama	-	-	No	-	-
104707	90808	1090808	paketėlis	N28x1		Receptinis	EU/1/06/359/015	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2006-09-26	Registruotas