SUBUTEX

Medicinal product

(Invented) name

SUBUTEX

Active substance (s)

Buprenorfino hidrochloridas

Strength

8 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)

N07BC01, Buprenorphine

Marketing authorisation holder

Indivior Europe Limited , Airija

Date of authorisation

2005-11-16

Date of renewal

2008-07-31

Documents

0345 SUBUTEX RPP 2025 05 26.docx

0345 Pakuotės lapelis 2025 05 26.docx

Stage

Perregistruotas

Controlled?

Yes

Controlled substance type

Narkotinis

Legal basis

8(3)

Procedure number

FR/H/0147/003

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Buprenorfino hidrochloridas	8 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
18080	21806	1021806	lizdinė plokštelė	N7		Receptinis	LT/1/05/0345/005	Netiekiama	-	-	No	-	-	Download
18081	21807	1021807	lizdinė plokštelė	N28		Receptinis	LT/1/05/0345/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2008-07-31	Perregistruotas
2005-11-16	Registruotas