Oncaspar

Medicinal product

(Invented) name

Oncaspar

Active substance (s)

Pegaspargazė

Strength

750 V/ml

Pharmaceutical form

milteliai injekciniam ar infuziniam tirpalui

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

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Powder for 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
98595	84699	1084699	flakonas	N1		Receptinis	EU/1/15/1070/002	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-01-14	Registruotas