Biograstim

Medicinal product

(Invented) name

Biograstim

Active substance (s)

Filgrastimas

Strength

48 MTV/0,8 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	0.8 ml
Filgrastimas	48 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
31419	33843	1033843	užpildytas švirkštas	0.8 ml N1		Receptinis	EU/1/08/450/005	Netiekiama	-	-	No	-	-
31420	33844	1033844	užpildytas švirkštas	0.8 ml N5		Receptinis	EU/1/08/450/006	Netiekiama	-	-	No	-	-
31421	33845	1033845	užpildytas švirkštas	0.8 ml N2x5		Receptinis	EU/1/08/450/007	Netiekiama	-	-	No	-	-
31422	33846	1033846	užpildytas švirkštas	0.8 ml N10		Receptinis	EU/1/08/450/008	Netiekiama	-	-	No	-	-
49769	63640	1063640	užpildytas švirkštas	0,8 ml N5 (su saugos prietaisu)		Receptinis	EU/1/08/450/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
	Išregistruotas
2008-09-15	Registruotas