Baclofen Sintetica

Medicinal product

(Invented) name

Baclofen Sintetica

Active substance (s)

Baklofenas

Strength

0,5 mg/ml

Pharmaceutical form

infuzinis tirpalas

Route (s) of administration

leisti į povoratinklinę ertmę

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

M03BX01, Baclofen

Marketing authorisation holder

Sintetica GmbH, Vokietija

Date of authorisation

2018-01-24

Date of renewal

2021-03-05

Documents

4180 Pakuotės lapelis 0,5mg_ml 2022 12 21.docx

4180 Baclofen Sintetica 0,5mg_ml II PL 2022 12 21.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

BE/H/0152/002/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Baklofenas	0,5 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
98758	84862	1084862	ampulė	20 ml N1		Receptinis	LT/1/18/4180/003	Netiekiama	-	-	No	-	-
106363	92464	1092464	ampulė	(20 ml) sterilioje lizdinėje plokštelėje, N1		Receptinis	LT/1/18/4180/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-03-28	Išregistruotas
2021-03-05	Perregistruotas
2018-01-24	Registruotas