NovoSeven

Medicinal product

(Invented) name

NovoSeven

Active substance (s)

Žmogaus VIIa (rDNR) koaguliacijos faktorius

Strength

2 mg (100 KTV)

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)

B02BD08, Coagulation factor VIIa

Marketing authorisation holder

Novo Nordisk A/S, Danija

Date of authorisation

1996-02-23

Date of renewal

Documents

Tiesioginis pranesimas sveikatos prieziuros specialsitui-NovoSeven tiekimo sutrikimas_2024_09.pdf

LT_N7_DHPC_Deviation_VVKT_pasirašytas.pdf

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Powder and solvent for solution for injection	1 vnt.
Žmogaus VIIa (rDNR) koaguliacijos faktorius	2 mg (100 KTV)

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
57474	71590	1071590	flakonas	2 mg (100 KTV), švirkštas ir flakono adapteris N1		Receptinis	EU/1/96/006/009	Netiekiama	2025-08-01	2025-12-31	Yes	2025-07-18	2025-12-31

Stadijos

Data	Stadija
1996-02-23	Registruotas