Voydeya

Medicinal product

(Invented) name

Voydeya

Active substance (s)

Danikopanas+Danikopanas

Strength

50 mg + 100 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AJ09, danicopan

Marketing authorisation holder

Alexion Europe SAS, Prancūzija

Date of authorisation

2024-04-19

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

Tabletėje (50 mg) yra:	1 vnt.
Danikopanas	50 mg
Tabletėje (100 mg) yra:	1 vnt.
Danikopanas	100 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
113656	99775	1099775	buteliukas	N180 (1×90×50 mg + 1×90×100 mg)		Receptinis	EU/1/24/1792/001	Netiekiama	-	-	No	-	-
113657	99776	1099776	lizdinė plokštelė	N168 (84×50 mg + 84×100 mg)		Receptinis	EU/1/24/1792/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-04-19	Registruotas