ReFacto AF

Medicinal product

(Invented) name

ReFacto AF

Active substance (s)

Žmogaus VIII (rDNR) koaguliacijos faktorius

Strength

1000 TV

Pharmaceutical form

milteliai ir tirpiklis injekciniam tirpalui užpildytame švirkšte

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

B02BD02, Coagulation factor VIII

Marketing authorisation holder

Pfizer Europe MA EEIG, Belgija

Date of authorisation

1999-04-13

Date of renewal

Documents

Stage

Registruotas

Controlled?

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 in pre-filled syringe	1 vnt.
Žmogaus VIII (rDNR) koaguliacijos faktorius	1000 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
46874	60685	1060685	užpildytas švirkštas	N1 (4 ml tirpiklio, užpildytas švirkštas, stūmoklio strypelis, sterilus infuzinis rinkinys, 2 alkoholiu suvilgyti tamponai, pleistras, marlė ir sterilus nuorinimo dangtelis)		Receptinis	EU/1/99/103/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
1999-04-13	Registruotas