Topiramate ELVIM [Topiramate Portfarma]

Medicinal product

(Invented) name

Topiramate ELVIM [Topiramate Portfarma]

Active substance (s)

Topiramatas

Strength

200 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

Yes

ATC code (s)

N03AX11, Topiramate

Marketing authorisation holder

Elvim Ltd., Latvija

Date of authorisation

2010-10-12

Date of renewal

2012-02-14

Documents

2190_1_12 Topiramate ELVIM 160907 taisyta.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DK/H/0930/004/E/002

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Topiramatas	200 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
38771	52453	1052453	lizdinė plokštelė	N28		Receptinis	LT/1/10/2190/010	Netiekiama	-	-	No	-	-
43379	57150	1057150	lizdinė plokštelė	N60		Receptinis	LT/1/10/2190/011	Netiekiama	-	-	No	-	-	Download
38770	52452	1052452	daugiadozė talpyklė	N60		Receptinis	LT/1/10/2190/012	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-01-04	Išregistruotas
2012-02-14	Perregistruotas
2010-10-12	Registruotas