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

UAB Niromed, Lietuva

Date of authorisation

2025-01-28

Date of renewal

Documents

2346_SUBUTEX 8 mg poliež tab_PZ_2025-01-28.docx

2346_SUBUTEX 8 mg poliež tab_PL_2025-01-28.docx

Stage

Registruotas

Controlled?

Yes

Controlled substance type

Narkotinis

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

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
116508	102608	1102608	lizdinė plokštelė	N7		Receptinis	LT/L/25/2346/001	Netiekiama	-	2025-12-31	Yes	2025-02-19	2025-12-31	Download
116509	102609	1102609	lizdinė plokštelė	N28		Receptinis	LT/L/25/2346/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-01-28	Registruotas