Topiramat Orion

Medicinal product

(Invented) name

Topiramat Orion

Active substance (s)

Topiramatas

Strength

100 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

Orion Corporation, Suomija

Date of authorisation

2008-10-29

Date of renewal

2014-11-25

Documents

Topiramat Orion paciento kortele.pdf

Topiramatas mokomoji medziaga pacientams.pdf

Topiramatas mokomoji medziaga sveikatos prieziuros specialistams.pdf

1322 Topiramat Orion PCS PL 2024 05 08.docx

1322 Pakuotės lapelis 2024 05 08.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

FI/H/0800/003/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Topiramatas	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
32623	5328	1005328	buteliukas	N60		Receptinis	LT/1/08/1322/005	Tiekiama	-	-	No	-	-	Download
32624	35008	1035008	buteliukas	N100		Receptinis	LT/1/08/1322/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2014-11-25	Perregistruotas
2008-10-29	Registruotas