Fulvestrant Teva

Medicinal product

(Invented) name

Fulvestrant Teva

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

Teva B.V., Nyderlandai

Date of authorisation

2016-04-06

Date of renewal

2021-02-10

Documents

3898 Pakuotės lapelis 2025 07 12.docx

3898 Fulvestrant Teva RPP 2025 07 12.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/4234/001/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
60976	75285	1075285	užpildytas švirkštas	5 ml ir saugioji adata N1		Receptinis	LT/1/16/3898/001	Netiekiama	-	-	No	-	-
65442	79946	1079946	užpildytas švirkštas	5 ml ir saugioji adata N2		Receptinis	LT/1/16/3898/002	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-02-10	Perregistruotas
2016-04-06	Registruotas