Kigabeq

Medicinal product

(Invented) name

Kigabeq

Active substance (s)

Vigabatrinas

Strength

500 mg

Pharmaceutical form

tirpinamosios tabletės

Route (s) of administration

vartoti į skrandį, vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

Yes

ATC code (s)

N03AG04, Vigabatrin

Marketing authorisation holder

ORPHELIA Pharma SAS, Prancūzija

Date of authorisation

2018-09-20

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Soluble tablet	1 vnt.
Vigabatrinas	500 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
100132	86241	1086241	buteliukas	N50		Receptinis	EU/1/18/1302/002	Netiekiama	2024-12-10	2025-12-31	Yes	2025-01-01	2025-12-31

Stadijos

Data	Stadija
2018-09-20	Registruotas