FABHALTA

Medicinal product

(Invented) name

FABHALTA

Active substance (s)

Iptakopanas

Strength

200 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AJ08, iptacopan

Marketing authorisation holder

Novartis Europharm Ltd., Airija

Date of authorisation

2024-05-17

Date of renewal

Documents

Fabhalta paciento kortele.pdf

Fabhalta mokomoji medziaga sveikatos prieziuros specialistams.pdf

Fabhalta mokomoji medziaga pacientui_globejams.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

Kapsulėje yra:	1 vnt.
Iptakopanas	200 mg

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
113756	99873	1099873	lizdinė plokštelė	N28		Receptinis	EU/1/24/1802/001	Netiekiama	-	-	No	-	-
113757	99874	1099874	lizdinė plokštelė	N56		Receptinis	EU/1/24/1802/002	Netiekiama	-	-	No	-	-
113758	99875	1099875	lizdinė plokštelė	N168 (3×56)		Receptinis	EU/1/24/1802/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-05-17	Registruotas