Grastofil

Medicinal product

(Invented) name

Grastofil

Active substance (s)

Filgrastimas

Strength

48 mln. V/0,5 ml

Pharmaceutical form

injekcinis ar infuzinis 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

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2013-10-18

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(4)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection or infusion in pre-filled syringe	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
57637	71756	1071756	užpildytas švirkštas	0,5 ml N1		Receptinis	EU/1/13/877/003	Netiekiama	-	-	No	-	-
57638	71757	1071757	užpildytas švirkštas	0,5 ml N5		Receptinis	EU/1/13/877/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-01-13	Išregistruotas
2013-10-18	Registruotas