Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Perjeta   
Auth. number : EU/1/13/813
INN : pertuzumab
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Cytostatics
Pharmacological subgroup: L01X - Other cytostatics
Chemical subgroup: L01XC - Monoclonal antibodies
Chemical substance: L01XC13 - Pertuzumab
(See WHO ATC Index)
Indication: Perjeta is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.
Marketing Authorisation Holder: Roche Registration Limited
6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
06/03/2013 Centralised - Authorisation EMEA/H/C/2547 (2013)1324 of 04/03/2013
17/06/2013 Centralised - Variation EMEA/H/C/2547/IB/3
Updated with Decision(2014)4588 of 30/06/2014
13/09/2013 Centralised - Variation EMEA/H/C/2547/IB/5
Updated with Decision(2014)4588 of 30/06/2014
25/04/2014 Centralised - Variation EMEA/H/C/2547/II/7
Updated with Decision(2014)4588 of 30/06/2014
02/07/2014 Centralised - Variation (2014)4588 of 30/06/2014
24/07/2014 Centralised - Variation EMEA/H/C/2547/II/9