Convulex

Medicinal product

(Invented) name

Convulex

Active substance (s)

Natrio valproatas

Strength

300 mg/ml

Pharmaceutical form

geriamasis tirpalas

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

Yes

ATC code (s)

N03AG01, Valproic acid

Marketing authorisation holder

G.L. Pharma GmbH, Austrija

Date of authorisation

1999-02-03

Date of renewal

2014-07-23

Documents

Paciento kortele.pdf

0115 Pakuotės lapelis geriam tirp 2025 02 26.docx

Paciento vadovas vyrams.pdf

valproate DHPC_J0043-PASS_LT_2024.02.01.pdf

Paciento vadovas moterims.pdf

Valproatu vartojimo sutikimo forma.pdf

0115 Convulex geriam tirp RPP 2025 02 26.docx

Vadovas sveikatos prieziuros specialistams.pdf

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

1 ml tirpalo yra	1 ml
Natrio valproatas	300 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
11254	2538	1002538	buteliukas	100 ml ir geriamasis švirkštas (3 ml) N1		Receptinis	LT/1/99/0115/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2014-07-23	Perregistruotas
1999-02-03	Registruotas