Suboxone

Medicinal product

(Invented) name

Suboxone

Active substance (s)

Buprenorfinas/Naloksonas

Strength

4 mg/1 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	4 mg
Naloksonas	1 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
104702	90803	1090803	paketėlis	N7x1		Receptinis	EU/1/06/359/010	Netiekiama	-	-	No	-	-
104703	90804	1090804	paketėlis	N14x1		Receptinis	EU/1/06/359/011	Netiekiama	-	-	No	-	-
104704	90805	1090805	paketėlis	N28x1		Receptinis	EU/1/06/359/012	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2006-09-26	Registruotas