DEPAKINE Chronosphere

Medicinal product

(Invented) name

DEPAKINE Chronosphere

Active substance (s)

Natrio valproatas

Strength

250 mg

Pharmaceutical form

modifikuoto atpalaidavimo granulės

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

Sanofi Winthrop Industrie, Prancūzija

Date of authorisation

2007-12-20

Date of renewal

2013-05-07

Documents

valproate DHPC_J0043-PASS_LT_2024.02.01.pdf

0952 Pakuotės lapelis 2024 12 02.docx

0952 DEPAKINE Chronosphere PCS PL 2024 12 02.docx

Valproatu vartojimo sutikimo forma.pdf

Paciento vadovas vyrams.pdf

Vadovas sveikatos prieziuros specialistams.pdf

Paciento kortele.pdf

Paciento vadovas moterims.pdf

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Paketėlyje yra	1 vnt.
Natrio valproatas	250 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
17780	21567	1021567	paketėlis	N30		Receptinis	LT/1/94/0952/005	Tiekiama	-	-	No	-	-	Download
17781	21568	1021568	paketėlis	N50		Receptinis	LT/1/94/0952/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-05-07	Perregistruotas
2007-12-20	Registruotas