Neupogen

Medicinal product

(Invented) name

Neupogen

Active substance (s)

Filgrastimas

Strength

480 µg (0,96 mg/ml)

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

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

Amgen Europe B.V., Nyderlandai

Date of authorisation

2005-12-21

Date of renewal

2018-05-29

Documents

0371_3_4 Pakuotės lapelis 190529.docx

0371_3_4 Neupogen 480 RPP 190529.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

NL/H/4571/003

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Švirkšte yra	0.5 ml
Filgrastimas	480 µg (0,96 mg/ml)

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
15667	4418	1004418	užpildytas švirkštas	0,5 ml N1		Receptinis	LT/1/05/0371/003	Netiekiama	-	-	No	-	-	Download
15668	19798	1019798	užpildytas švirkštas	0,5 ml N5		Receptinis	LT/1/05/0371/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-12-27	Išregistruotas
2018-05-29	Perregistruotas
2005-12-21	Registruotas