Fulvestrant Orion

Medicinal product

(Invented) name

Fulvestrant Orion

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

Orion Corporation, Suomija

Date of authorisation

2026-06-04

Date of renewal

Documents

6045_Fulvestrant Orion.docx

6045_pakuotes lapelis_2026-06-04.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

PT/H/2922/001/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
121121	107229	1107229	užpildytas švirkštas	N1		Receptinis	LT/1/26/6045/001	Netiekiama	-	-	No	-	-
121122	107230	1107230	užpildytas švirkštas	N2		Receptinis	LT/1/26/6045/002	Netiekiama	-	-	No	-	-
121123	107231	1107231	užpildytas švirkštas	N4		Receptinis	LT/1/26/6045/003	Netiekiama	-	-	No	-	-
121124	107232	1107232	užpildytas švirkštas	N6		Receptinis	LT/1/26/6045/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-06-04	Registruotas