Biograstim

Medicinal product

(Invented) name

Biograstim

Active substance (s)

Filgrastimas

Strength

30 MTV/0,5 ml

Pharmaceutical form

injekcinis ar infuzinis tirpalas

Route (s) of administration

leisti į veną, leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L03AA02, Filgrastim

Marketing authorisation holder

AbZ-Pharma GmbH, Vokietija

Date of authorisation

2008-09-15

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection or infusion-	0.5 ml
Filgrastimas	30 mln. TV

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
31415	33839	1033839	užpildytas švirkštas	0.5 ml N1		Receptinis	EU/1/08/450/001	Netiekiama	-	-	No	-	-
31416	33840	1033840	užpildytas švirkštas	0.5 ml N5		Receptinis	EU/1/08/450/002	Netiekiama	-	-	No	-	-
31417	33841	1033841	užpildytas švirkštas	0.5 ml N2x5		Receptinis	EU/1/08/450/003	Netiekiama	-	-	No	-	-
31418	33842	1033842	užpildytas švirkštas	0.5 ml N10		Receptinis	EU/1/08/450/004	Netiekiama	-	-	No	-	-
49768	63639	1063639	užpildytas švirkštas	0,5 ml N5 (su saugos prietaisu)		Receptinis	EU/1/08/450/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
	Išregistruotas
2008-09-15	Registruotas