Diacomit

Medicinal product

(Invented) name

Diacomit

Active substance (s)

Stiripentolis

Strength

500 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	500 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
25322	27931	1027931	buteliukas	N30		Receptinis	EU/1/06/367/004	Netiekiama	-	-	No	-	-
25323	27932	1027932	buteliukas	N60		Receptinis	EU/1/06/367/005	Tiekiama	-	-	No	-	-
25324	27933	1027933	buteliukas	N90		Receptinis	EU/1/06/367/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2007-01-04	Registruotas