Fulvestrant STADA

Medicinal product

(Invented) name

Fulvestrant STADA

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

2022-05-16

Date of renewal

2024-01-19

Documents

4948_Fulvestrant STADA_perr2024-01-19.docx

4948_pakuotes lapelis_2024-01-19.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/5465/001/E/001

Marketing authorisation procedure

Kartotinė 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
108633	94738	1094738	užpildytas švirkštas	5 ml ir saugioji adata N1		Receptinis	LT/1/22/4948/001	Netiekiama	-	-	No	-	-
108634	94739	1094739	užpildytas švirkštas	5 ml ir saugioji adata N2		Receptinis	LT/1/22/4948/002	Tiekiama	-	-	No	-	-	Download
108994	95100	1095100	užpildytas švirkštas	5 ml ir saugioji adata N6		Receptinis	LT/1/22/4948/003	Netiekiama	-	-	No	-	-
111566	97679	1097679	užpildytas švirkštas	5 ml ir saugioji adata N4		Receptinis	LT/1/22/4948/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-01-19	Perregistruotas
2022-05-16	Registruotas