NovoSeven

Medicinal product

(Invented) name

NovoSeven

Active substance (s)

Žmogaus VIIa (rDNR) koaguliacijos faktorius

Strength

1 mg (50 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

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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	1 mg (50 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
57473	71589	1071589	flakonas	1 mg (50 KTV), švirkštas ir flakono adapteris N1		Receptinis	EU/1/96/006/008	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
1996-02-23	Registruotas