Rydapt

Medicinal product

(Invented) name

Rydapt

Active substance (s)

Midostaurinas

Strength

25 mg

Pharmaceutical form

minkštosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01EX10, midostaurin

Marketing authorisation holder

Novartis Europharm Ltd., Airija

Date of authorisation

2017-09-18

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

Capsule, soft	1 vnt.
Midostaurinas	25 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
97852	83947	1083947	lizdinė plokštelė	N112 (4x28)		Receptinis	EU/1/17/1218/001	Netiekiama	-	-	No	-	-
98833	84937	1084937	lizdinė plokštelė	N56 (2x28)		Receptinis	EU/1/17/1218/002	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-09-18	Registruotas