Talzenna

Medicinal product

(Invented) name

Talzenna

Active substance (s)

Talazoparibas

Strength

0,25 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)

L01XK04, talazoparib

Marketing authorisation holder

Pfizer Europe MA EEIG, Belgija

Date of authorisation

2019-06-20

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.
Talazoparibas	0,25 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
102019	88121	1088121	buteliukas	N30		Receptinis	EU/1/19/1377/001	Netiekiama	-	-	No	-	-
102020	88122	1088122	dalomoji lizdinė plokštelė	N30x1		Receptinis	EU/1/19/1377/002	Netiekiama	-	-	No	-	-
102021	88123	1088123	dalomoji lizdinė plokštelė	N60x1		Receptinis	EU/1/19/1377/003	Netiekiama	-	-	No	-	-
102022	88124	1088124	dalomoji lizdinė plokštelė	N90x1		Receptinis	EU/1/19/1377/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-06-20	Registruotas