Faslodex

Medicinal product

(Invented) name

Faslodex

Active substance (s)

Fulvestrantas

Strength

250 mg

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L02BA03, Fulvestrant

Marketing authorisation holder

AstraZeneca AB, Švedija

Date of authorisation

2004-03-10

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	5 ml
Fulvestrantas	250 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
25805	28397	1028397	užpildytas švirkštas	5 ml ir saugi adata N1		Receptinis	EU/1/03/269/001	Netiekiama	-	-	No	-	-
45823	59625	1059625	užpildytas švirkštas	5 ml ir saugi adata N2		Receptinis	EU/1/03/269/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2004-03-10	Registruotas