ELIGARD

Medicinal product

(Invented) name

ELIGARD

Active substance (s)

Leuprorelino acetatas

Strength

7,5 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)

L02AE02, Leuprorelin

Marketing authorisation holder

Recordati Industria Chimica e Farmaceutica S.p.A., Italija

Date of authorisation

2005-12-09

Date of renewal

2011-09-28

Documents

0277 ELIGARD 7,5mg PCS PL 2024 10 06.docx

Eligard paruosimo ir vartojimo instrukcija.pdf

0277 PAKUOTĖS LAPELIS 7,5mg 2024 10 06.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DE/H/0508/001/MR

Marketing authorisation procedure

Savitarpio pripažinimo procedūra

Qualitative and quantitative composition

Viename švirkšte yra	1 vnt.
Leuprorelino acetatas	7,5 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
12615	4419	1004419	užpildytas švirkštas	milteliai, užpildytas švirkštas tirpiklio, injekcinė adata ir jungtis N1		Receptinis	LT/1/05/0277/001	Netiekiama	2025-01-29	2025-12-31	Yes	2025-08-01	2025-12-31	Download
12616	16980	1016980	užpildytas švirkštas	milteliai, užpildytas švirkštas tirpiklio, injekcinė adata ir jungtis N3		Receptinis	LT/1/05/0277/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-09-28	Perregistruotas
2005-12-09	Registruotas