Topamax

Medicinal product

(Invented) name

Topamax

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

UAB Johnson & Johnson, Lietuva

Date of authorisation

1998-06-02

Date of renewal

2012-04-02

Documents

Topamax paciento kortele.pdf

0093 Pakuotės lapelis 2024 03 18.docx

Topiramatas mokomoji medziaga pacientams.pdf

Topiramatas mokomoji medziaga sveikatos prieziuros specialistams.pdf

0093 Topamax PCS PL 2024 03 18.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

SE/H/0110/003

Marketing authorisation procedure

Savitarpio pripažinimo 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
7500	3184	1003184	lizdinė plokštelė	N60		Receptinis	LT/1/98/0093/003	Tiekiama	-	-	No	-	-	Download
58540	72707	1072707	lizdinė plokštelė	N200 (100x2)		Receptinis	LT/1/98/0093/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2012-04-02	Perregistruotas
1998-06-02	Registruotas