Suboxone

Medicinal product

(Invented) name

Suboxone

Active substance (s)

Buprenorfinas/Naloksonas

Strength

12 mg/3 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	12 mg
Naloksonas	3 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
104708	90809	1090809	paketėlis	N7×1		Receptinis	EU/1/06/359/016	Netiekiama	-	-	No	-	-
104709	90810	1090810	paketėlis	N14×1		Receptinis	EU/1/06/359/017	Netiekiama	-	-	No	-	-
104710	90811	1090811	paketėlis	N28×1		Receptinis	EU/1/06/359/018	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2006-09-26	Registruotas