Fulvestrant ALIUD

Medicinal product

(Invented) name

Fulvestrant ALIUD

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

STADA Arzneimittel AG, Vokietija

Date of authorisation

2024-10-09

Date of renewal

Documents

5608_Fulvestrant ALIUD corr2025-02-26.doc

5608_pakuotes lapelis_2024-10-09.doc

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/7856/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Užpildytame švirkšte (5 ml tirpalo) 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
115316	101423	1101423	užpildytas švirkštas	N1 + saugioji adata		Receptinis	LT/1/24/5608/001	Netiekiama	-	-	No	-	-
115317	101424	1101424	užpildytas švirkštas	N2 + saugioji adata		Receptinis	LT/1/24/5608/002	Netiekiama	-	2025-11-30	No	-	-	Download
115318	101425	1101425	užpildytas švirkštas	N4 + saugioji adata		Receptinis	LT/1/24/5608/003	Netiekiama	-	-	No	-	-
115319	101426	1101426	užpildytas švirkštas	N6 + saugioji adata		Receptinis	LT/1/24/5608/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-10-09	Registruotas