Oncaspar

Medicinal product

(Invented) name

Oncaspar

Active substance (s)

Pegaspargazė

Strength

750 V/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)

Yes

ATC code (s)

L01XX24, Pegaspargase

Marketing authorisation holder

Les Laboratoires Servier, Prancūzija

Date of authorisation

2016-01-14

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection/infusion	1 ml
Pegaspargazė	750 V

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
65005	79500	1079500	flakonas	5 ml N1		Receptinis	EU/1/15/1070/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-06-02	Išregistruotas
2016-01-14	Registruotas