Fulvestrant Sandoz

Medicinal product

(Invented) name

Fulvestrant Sandoz

Active substance (s)

Fulvestrantas

Strength

250 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

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

Sandoz d.d., Slovėnija

Date of authorisation

2015-11-03

Date of renewal

2020-10-23

Documents

3828 Pakuotės lapelis 2022 01 10.docx

3828 Fulvestrant Sandoz inj svirkste PCS PL 2022 01 10.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

PT/H/1309/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Viename užpildytame švirkšte yra:	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
59702	73936	1073936	užpildytas švirkštas	5 ml ir injekcinė adata N1		Receptinis	LT/1/15/3828/001	Netiekiama	-	-	No	-	-
64135	78582	1078582	užpildytas švirkštas	5 ml ir injekcinė adata N2		Receptinis	LT/1/15/3828/002	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2020-10-23	Perregistruotas
2015-11-03	Registruotas