Jaypirca

Medicinal product

(Invented) name

Jaypirca

Active substance (s)

Pirtobrutinibas

Strength

50 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)

L01EL05, pirtobrutinib

Marketing authorisation holder

Eli Lilly Nederland B.V., Nyderlandai

Date of authorisation

2023-10-30

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

Film-coated tablet	1 vnt.
Pirtobrutinibas	50 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
111922	98037	1098037	lizdinė plokštelė	N28		Receptinis	EU/1/23/1738/001	Netiekiama	-	-	No	-	-
111923	98038	1098038	dalomoji lizdinė plokštelė	N30		Receptinis	EU/1/23/1738/002	Netiekiama	-	-	No	-	-
111924	98039	1098039	lizdinė plokštelė	N84		Receptinis	EU/1/23/1738/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-10-30	Registruotas