Spectrila

Medicinal product

(Invented) name

Spectrila

Active substance (s)

Asparaginazė

Strength

10000 V

Pharmaceutical form

milteliai infuzinio tirpalo koncentratui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

L01XX02, Asparaginase

Marketing authorisation holder

medac Gesellschaft für klinische Spezialpräparate mbH, Vokietija

Date of authorisation

2016-01-14

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

Powder for concentrate for solution for infusion	1 vnt.
Asparaginazė	10000 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
64779	79268	1079268	flakonas	N1		Receptinis	EU/1/15/1072/001	Netiekiama	-	-	No	-	-
64780	79269	1079269	flakonas	N5		Receptinis	EU/1/15/1072/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-01-14	Registruotas