Ruconest

Medicinal product

(Invented) name

Ruconest

Active substance (s)

Konestatas alfa

Strength

2100 V

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)

B06AC04, Conestat alfa

Marketing authorisation holder

Pharming Group N.V., Nyderlandai

Date of authorisation

2010-10-28

Date of renewal

Documents

Ruconest paciento kortele.pdf

Ruconest paciento dienorastis.pdf

Ruconest mokomoji medziaga pacientams.pdf

Ruconest mokomoji medziaga sveikatos prieziuros specialistams.pdf

Ruconest mokomoji medziaga sveikatos prieziuros specialistams imunologiniai verinimai.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.
Konestatas alfa	2100 V

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
67911	82471	1082471	flakonas	milteliai, tirpiklio flakonas (20 ml), 2 flakonų adapteriai, švirkštas, infuzijos sistema ir adata, 2 alkoholiu suvilgyti tamponai, sterili neaustinė servetėlė, pleistras N1		Receptinis	EU/1/10/641/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2010-10-28	Registruotas