Gabagamma

Medicinal product

(Invented) name

Gabagamma

Active substance (s)

Gabapentinas

Strength

100 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

Yes

ATC code (s)

N02BF01, Gabapentin

Marketing authorisation holder

Wörwag Pharma GmbH & Co. KG, Vokietija

Date of authorisation

2008-01-25

Date of renewal

2009-11-04

Documents

0991 Pakuotės lapelis 2023 02 15, KR_0169.docx

0991 Gabagamma PCS PL 2023 02 15, KR_0169.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/3998/001

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
Gabapentinas	100 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
23377	4875	1004875	lizdinė plokštelė	N20		Receptinis	LT/1/08/0991/001	Netiekiama	-	-	No	-	-	Download
23378	26082	1026082	lizdinė plokštelė	N50		Receptinis	LT/1/08/0991/002	Tiekiama	-	-	No	-	-
23379	26083	1026083	lizdinė plokštelė	N100		Receptinis	LT/1/08/0991/003	Netiekiama	-	-	No	-	-
23299	26021	1026021	buteliukas	N100		Receptinis	LT/1/08/0991/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-11-04	Perregistruotas
2008-01-25	Registruotas