Degarelix Accord

Medicinal product

(Invented) name

Degarelix Accord

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

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2023-09-29

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

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
111754	97869	1097869	flakonas	milteliai, tirpiklio užpildytas švirkštas (4,2 ml), stūmoklio kotelis, flakono adapteris ir injekcinė adata N1		Receptinis	EU/1/23/1753/001	Netiekiama	-	-	No	-	-
111755	97870	1097870	flakonas	milteliai, tirpiklio užpildytas švirkštas (4,2 ml), stūmoklio kotelis, flakono adapteris ir injekcinė adata N3		Receptinis	EU/1/23/1753/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-09-29	Registruotas