fibryga

Medicinal product

(Invented) name

fibryga

Active substance (s)

Žmogaus fibrinogenas

Strength

1 g

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)

B02BB01, Fibrinogen, human

Marketing authorisation holder

Octapharma (IP) SPRL, Belgija

Date of authorisation

2020-07-30

Date of renewal

2021-12-15

Documents

4597 Pakuotės lapelis 2025 03 25.docx

4597 fibryga RPP 2025 03 25.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

DE/H/4900/001/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Buteliuke yra	1 vnt.
Žmogaus fibrinogenas	1 g

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
104785	90886	1090886	buteliukas	milteliai, tirpiklio buteliukas (50 ml), nextaro perkėlimo įtaisas, N1		Receptinis	LT/1/20/4597/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-12-15	Perregistruotas
2020-07-30	Registruotas