Nivestim

Medicinal product

(Invented) name

Nivestim

Active substance (s)

Filgrastimas

Strength

30 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	30 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
41844	55606	1055606	užpildytas švirkštas	0,5 ml N1		Receptinis	EU/1/10/631/004	Netiekiama	-	-	No	-	-
41845	55607	1055607	užpildytas švirkštas	0,5 ml N5		Receptinis	EU/1/10/631/005	Tiekiama	-	2025-12-31	No	-	-
41846	55608	1055608	užpildytas švirkštas	0,5 ml N10		Receptinis	EU/1/10/631/006	Netiekiama	-	-	No	-	-
66332	80857	1080857	užpildytas švirkštas	0,5 ml N8		Receptinis	EU/1/10/631/011	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2010-06-08	Registruotas