Gabagamma

Medicinal product

(Invented) name

Gabagamma

Active substance (s)

Gabapentinas

Strength

400 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 Gabagamma PCS PL 2023 02 15, KR_0169.docx

0991 Pakuotės lapelis 2023 02 15, KR_0169.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/3998/003

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
Gabapentinas	400 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
23301	4876	1004876	lizdinė plokštelė	N50		Receptinis	LT/1/08/0991/008	Tiekiama	-	-	No	-	-	Download
23382	26085	1026085	lizdinė plokštelė	N100		Receptinis	LT/1/08/0991/009	Netiekiama	-	-	No	-	-
23302	26023	1026023	buteliukas	N100		Receptinis	LT/1/08/0991/010	Netiekiama	-	-	No	-	-

Stadijos

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