Nivestim

Medicinal product

(Invented) name

Nivestim

Active substance (s)

Filgrastimas

Strength

48 mln. V/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

Pfizer Europe MA EEIG, Belgija

Date of authorisation

2010-06-08

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(4)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection/infusion	0.5 ml
Filgrastimas	48 mln. 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
41847	55609	1055609	užpildytas švirkštas	0,5 ml N1		Receptinis	EU/1/10/631/007	Netiekiama	-	-	No	-	-
41848	55610	1055610	užpildytas švirkštas	0,5 ml N5		Receptinis	EU/1/10/631/008	Tiekiama	-	2025-12-31	No	-	-
41849	55611	1055611	užpildytas švirkštas	0,5 ml N10		Receptinis	EU/1/10/631/009	Netiekiama	-	-	No	-	-
66333	80858	1080858	užpildytas švirkštas	0,5 ml N8		Receptinis	EU/1/10/631/012	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2010-06-08	Registruotas