Beriate

Medicinal product

(Invented) name

Beriate

Active substance (s)

Žmogaus VIII koaguliacijos faktorius

Strength

250 TV

Pharmaceutical form

milteliai ir tirpiklis injekciniam ar infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

B02BD02, Coagulation factor VIII

Marketing authorisation holder

CSL Behring GmbH, Vokietija

Date of authorisation

2019-12-13

Date of renewal

2021-04-07

Documents

4490-4493 pakuotes lapelis_2021-04-07.docx

4490_4493 Beriate PZ 2024 01 13.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DE/H/0483/001/E/002

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Flakone yra	1 vnt.
Žmogaus VIII koaguliacijos faktorius	250 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
102941	89042	1089042	flakonas	milteliai, tirpiklio flakonas (2,5 ml), filtruojamasis perpylimo įtaisas, suleidimo rinkinys (vienkartinis švirkštas (5 ml), venos punkcijos rinkinys, 2 alkoholiu suvilgyti tamponai, nesterilus pleistras), N1		Receptinis	LT/1/19/4490/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-04-07	Perregistruotas
2019-12-13	Registruotas