GORDIUS

Medicinal product

(Invented) name

GORDIUS

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

Gedeon Richter Plc, Vengrija

Date of authorisation

2004-02-10

Date of renewal

2014-06-06

Documents

3575 GORDIUS PCS PL 2025 06 12.docx

3575 Pakuotės lapelis 2025 06 12.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė 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
7739	4171	1004171	lizdinė plokštelė	N50		Receptinis	LT/1/04/3575/003	Tiekiama	-	-	No	-	-	Download
7740	12655	1012655	lizdinė plokštelė	N100		Receptinis	LT/1/04/3575/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-06-06	Perregistruotas
2004-02-10	Registruotas