Epidyolex

Medicinal product

(Invented) name

Epidyolex

Active substance (s)

Kanabidiolis

Strength

100 mg/ml

Pharmaceutical form

geriamasis tirpalas

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N03AX24, cannabidiol

Marketing authorisation holder

Jazz Pharmaceuticals Ireland Ltd., Airija

Date of authorisation

2019-09-19

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

Oral solution	1 ml
Kanabidiolis	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
102398	88498	1088498	buteliukas	100 ml N1 ir 2 geriamieji švirkštai (1 ml; 5 ml), 2 buteliuko adapteriai		Receptinis	EU/1/19/1389/001	Tiekiama	-	-	No	-	-
110326	96437	1096437	buteliukas	100 ml N3 ir 2 geriamieji švirkštai (1 ml, 5 ml), 3 buteliuko adapteriai		Receptinis	EU/1/19/1389/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-09-19	Registruotas