Grimodin

Medicinal product

(Invented) name

Grimodin

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

Egis Pharmaceuticals PLC, Vengrija

Date of authorisation

2009-05-19

Date of renewal

2012-08-02

Documents

1582_1_4,9_11,14_23 Grimodin kaps PCS PL 170831.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

PT/H/0210/001/MR

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
30948	33399	1033399	lizdinė plokštelė	N20		Receptinis	LT/1/09/1582/001	Netiekiama	-	-	No	-	-
35614	37947	1037947	lizdinė plokštelė	N60		Receptinis	LT/1/09/1582/002	Netiekiama	-	-	No	-	-
39013	52696	1052696	lizdinė plokštelė	N50		Receptinis	LT/1/09/1582/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-04-19	Išregistruotas
2012-08-02	Perregistruotas
2009-05-19	Registruotas