Nivestim

Medicinal product

(Invented) name

Nivestim

Active substance (s)

Filgrastimas

Strength

12 mln. V/0,2 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	0.2 ml
Filgrastimas	12 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
41841	55603	1055603	užpildytas švirkštas	0,2 ml N1		Receptinis	EU/1/10/631/001	Netiekiama	-	-	No	-	-
41842	55604	1055604	užpildytas švirkštas	0,2 ml N5		Receptinis	EU/1/10/631/002	Netiekiama	-	-	No	-	-
41843	55605	1055605	užpildytas švirkštas	0,2 ml N10		Receptinis	EU/1/10/631/003	Netiekiama	-	-	No	-	-
66331	80856	1080856	užpildytas švirkštas	0,2 ml N8		Receptinis	EU/1/10/631/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2010-06-08	Registruotas