Human C1-esterase inhibitor CSL Behring

Medicinal product

(Invented) name

Human C1-esterase inhibitor CSL Behring

Active substance (s)

Žmogaus C1-esterazės inhibitorius

Strength

1500 TV

Pharmaceutical form

milteliai ir tirpiklis injekciniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

B06AC01, c1-inhibitor, plasma derived

Marketing authorisation holder

CSL Behring GmbH, Vokietija

Date of authorisation

2021-07-23

Date of renewal

2021-11-24

Documents

4784 pakuotes lapelis-2021-11-24.docx

4783_4784 Human C1_esterase inhibitor CSL Behring PZ 2024 01 13.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DE/H/0481/002/E/003

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Flakone yra:	1 vnt.
Žmogaus C1-esterazės inhibitorius	1500 TV

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
106889	92992	1092992	flakonas	milteliai, tirpiklio flakonas (3 ml), filtruojamasis perpylimo įtaisas, 20/20, suleidimo rinkinys (švirkštas (5 ml), venos punkcijos rinkinys, 2 alkoholiu suvilgyti tamponai ir pleistras) N1		Receptinis	LT/1/21/4784/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-11-24	Perregistruotas
2021-07-23	Registruotas