ACTIVE SUBSTANCE / INN

PERTUZUMAB

Brand name(s): Perjeta, PERJETA, Poherdy

FDA LISTED

EMA LISTED

PRESCRIPTION

AUTHORISED

OPINION

Breast Neoplasms

BLA125409

ACTIVE SUBSTANCE

Pertuzumab

REGULATORS

FDA · EMA

SPONSORS / MAH

GENENTECH, Roche Registration GmbH , Organon N.V.

TOTAL APPLICATIONS

3

FDA APPLICATIONS (DRUGS@FDA)

BRAND NAME	APPLICATION	SPONSOR	STATUS
PERJETA	BLA125409	GENENTECH	Prescription

EMA AUTHORISATIONS

PRODUCT NAME	HOLDER	STATUS	DATE	INDICATION
Poherdy	Organon N.V.	Opinion		Breast Neoplasms
Perjeta	Roche Registration GmbH	Authorised	04/03/2013	Breast Neoplasms