Convulex

Medicinal product

(Invented) name

Convulex

Active substance (s)

Natrio valproatas

Strength

100 mg/ml

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti į veną

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

2007-09-18

Date of renewal

2015-04-13

Documents

Vadovas sveikatos prieziuros specialistams.pdf

Paciento kortele.pdf

Paciento vadovas moterims.pdf

Paciento vadovas vyrams.pdf

valproate DHPC_J0043-PASS_LT_2024.02.01.pdf

Valproatu vartojimo sutikimo forma.pdf

0115 Convulex inj_inf RPP 2025 02 26.docx

0115 Pakuotės lapelis inj_inf 2025 02 26.docx

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	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
17355	4993	1004993	ampulė	5 ml N5		Receptinis	LT/1/99/0115/006	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2015-04-13	Perregistruotas
2007-09-18	Registruotas