Fulvestrant Mylan

Medicinal product

(Invented) name

Fulvestrant Mylan

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

Mylan Pharmaceuticals Limited, Airija

Date of authorisation

2018-01-08

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection in pre-filled syringe	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
98863	84967	1084967	užpildytas švirkštas	5 ml ir saugi adata N1		Receptinis	EU/1/17/1253/001	Netiekiama	-	-	No	-	-
98864	84968	1084968	užpildytas švirkštas	5 ml ir saugi adata N2		Receptinis	EU/1/17/1253/002	Netiekiama	-	-	No	-	-
105012	91114	1091114	užpildytas švirkštas	5 ml ir saugi adata N4		Receptinis	EU/1/17/1253/003	Netiekiama	-	-	No	-	-
105013	91115	1091115	užpildytas švirkštas	5 ml ir saugi adata N6		Receptinis	EU/1/17/1253/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-01-08	Registruotas