Diacomit

Medicinal product

(Invented) name

Diacomit

Active substance (s)

Stiripentolis

Strength

250 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

Yes

ATC code (s)

N03AX17, Stiripentol

Marketing authorisation holder

Biocodex, Prancūzija

Date of authorisation

2007-01-04

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Capsule, hard	1 vnt.
Stiripentolis	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
25319	27928	1027928	buteliukas	N30		Receptinis	EU/1/06/367/001	Netiekiama	-	-	No	-	-
25320	27929	1027929	buteliukas	N60		Receptinis	EU/1/06/367/002	Tiekiama	-	-	No	-	-
25321	27930	1027930	buteliukas	N90		Receptinis	EU/1/06/367/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-01-04	Registruotas