Neulasta

Medicinal product

(Invented) name

Neulasta

Active substance (s)

Pegfilgrastimas

Strength

6 mg

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L03AA13, Pegfilgrastim

Marketing authorisation holder

Amgen Europe B.V., Nyderlandai

Date of authorisation

2002-08-22

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection	0.6 ml
Pegfilgrastimas	6 mg

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
26907	29471	1029471	užpildytas švirkštas	0,6 ml N1		Receptinis	EU/1/02/227/001	Netiekiama	-	-	No	-	-
26908	29472	1029472	užpildytas švirkštas	0,6 ml N1 (ne lizdinėje plokštelėje)		Receptinis	EU/1/02/227/002	Netiekiama	-	-	No	-	-
42786	56554	1056554	užpildytas švirkštas	0,6 ml N1 (su adatos apsauga)		Receptinis	EU/1/02/227/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2002-08-22	Registruotas