Gabitril

Medicinal product

(Invented) name

Gabitril

Active substance (s)

Tiagabinas

Strength

5 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

Yes

ATC code (s)

N03AG06, Tiagabine

Marketing authorisation holder

Teva B.V., Nyderlandai

Date of authorisation

2001-10-08

Date of renewal

2011-04-29

Documents

2442_1_4 Gabitril tab PZ PL 181031.docx

2442_1_4 Pakuotės lapelis 181031.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Tiagabinas	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
1753	7436	1007436	tablečių talpyklė	N100		Receptinis	LT/1/01/2442/001	Netiekiama	-	-	No	-	-
17261	4263	1004263	tablečių talpyklė	N50		Receptinis	LT/1/01/2442/002	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2019-06-04	Išregistruotas
2011-04-29	Perregistruotas
2001-10-08	Registruotas