Copiktra

Medicinal product

(Invented) name

Copiktra

Active substance (s)

Duvelisibas

Strength

15 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)

L01EM04, duvelisib

Marketing authorisation holder

Secura Bio Limited, Airija

Date of authorisation

2021-05-19

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

Capsule, hard	1 vnt.
Duvelisibas	15 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
106566	92668	1092668	lizdinė plokštelė	N56 (2×28)		Receptinis	EU/1/21/1542/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-05-19	Registruotas