PERJETA

This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Spain, Tunisia, Turkey, UK.

Active ingredients

The drug PERJETA contains one active pharmaceutical ingredient (API):

1
UNII K16AIQ8CTM - PERTUZUMAB
 

Pertuzumab is a recombinant humanised monoclonal antibody that specifically targets the extracellular dimerization domain (subdomain II) of the human epidermal growth factor receptor 2 protein (HER2). Pertuzumab inhibits ligand-initiated intracellular signalling through two major signal pathways, mitogen-activated protein (MAP) kinase and phosphoinositide 3-kinase (PI3K). Inhibition of these signalling pathways can result in cell growth arrest and apoptosis, respectively.

 
Read more about Pertuzumab

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 PERJETA Concentrate for solution for infusion MPI, EU: SmPC European Medicines Agency (EU)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group Classification
L01FD02 Pertuzumab L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01F Monoclonal antibodies and antibody drug conjugates → L01FD HER2 (Human Epidermal Growth Factor Receptor 2) inhibitors
Discover more medicines within L01FD02

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
AU Pharmaceutical Benefits Scheme 10267J, 10308M, 10333W, 10334X
BR Câmara de Regulação do Mercado de Medicamentos 529213110025202
CA Health Products and Food Branch 02405016
EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria H3120113
EE Ravimiamet 1609512
ES Centro de información online de medicamentos de la AEMPS 113813001, 113813001IP
FI Lääkealan turvallisuus- ja kehittämiskeskus 574423
FR Base de données publique des médicaments 60912227
GB Medicines & Healthcare Products Regulatory Agency 221354, 368194
HK Department of Health Drug Office 62758
IL מִשְׂרַד הַבְּרִיאוּת 7116
IT Agenzia del Farmaco 042682017, 050953013
JP 医薬品医療機器総合機構 4291424A1020
LT Valstybinė vaistų kontrolės tarnyba 1069701
NL Z-Index G-Standaard, PRK 105422
NZ Medicines and Medical Devices Safety Authority 15722
PL Rejestru Produktów Leczniczych 100299600
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W64394001
SG Health Sciences Authority 14501P
TN Direction de la Pharmacie et du Médicament 6993211H
TR İlaç ve Tıbbi Cihaz Kurumu 8699505762791
US FDA, National Drug Code 50242-145

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