Kovaltry

Medicinal product

(Invented) name

Kovaltry

Active substance (s)

Žmogaus VIII (rDNR) koaguliacijos faktorius

Strength

3000 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)

B02BD02, Coagulation factor VIII

Marketing authorisation holder

Bayer AG, Vokietija

Date of authorisation

2016-02-18

Date of renewal

Documents

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 VIII (rDNR) koaguliacijos faktorius	3000 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
65195	79695	1079695	flakonas	milteliai, užpildytas švirkštas (5 ml), flakono adapteris ir venepunkcijos rinkinys N1		Receptinis	EU/1/15/1076/010	Netiekiama	-	-	No	-	-
103189	89290	1089290	flakonas	N30 (milteliai, užpildytas švirkštas (5 ml) + flakono adapteris + 1 venepunkcijos rinkinys) (daugiadozė)		Receptinis	EU/1/15/1076/024	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-02-18	Registruotas