FIRMAGON

Medicinal product

(Invented) name

FIRMAGON

Active substance (s)

Degareliksas

Strength

80 mg

Pharmaceutical form

milteliai ir tirpiklis injekciniam tirpalui

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L02BX02, Degarelix

Marketing authorisation holder

Ferring Pharmaceuticals A/S, Danija

Date of authorisation

2009-02-17

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Powder and solvent for solution for injection	1 vnt.
Degareliksas	80 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
34045	36403	1036403	flakonas	milteliai, tirpiklio užpildytas švirkštas (4,2 ml), stūmoklio kotelis, jungiklis ir adata N1		Receptinis	EU/1/08/504/001	Netiekiama	-	-	No	-	-
44267	58059	1058059	flakonas	milteliai, tirpiklio užpildytas švirkštas (4,2 ml), stūmoklio kotelis, jungiklis ir adata N3 (sudėtinė pakuotė)		Receptinis	EU/1/08/504/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-02-17	Registruotas