Enrylaze

Medicinal product

(Invented) name

Enrylaze

Active substance (s)

Krizantaspazė, rekombinantinė (Erwinia chrysanthemi L-asparaginazė)

Strength

10 mg/0,5 ml

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti į veną, leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

L01XX02, Asparaginase

Marketing authorisation holder

Jazz Pharmaceuticals Ireland Ltd., Airija

Date of authorisation

2023-09-15

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection or infusion	0.5 ml
Krizantaspazė, rekombinantinė (Erwinia chrysanthemi L-asparaginazė)	10 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
111684	97797	1097797	flakonas	0,5 ml N3		Receptinis	EU/1/23/1747/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-09-15	Registruotas