Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Perjeta   
Auth. number : EU/1/13/813
Active substance : 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: Metastatic Breast Cancer
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.

Neoadjuvant Treatment of Breast Cancer
Perjeta is indicated for use in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence
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 - Yearly update (2014)4588 of 30/06/2014
24/07/2014 Centralised - Variation EMEA/H/C/2547/II/9
Updated with Decision(2015)4850 of 08/07/2015
26/03/2015 Centralised - Variation EMEA/H/C/2547/II/12
Updated with Decision(2015)4850 of 08/07/2015
10/07/2015 Centralised - Yearly update (2015)4850 of 08/07/2015
30/07/2015 Centralised - 2-Monthly update EMEA/H/C/2547/II/10 (2015)5467 of 28/07/2015
22/09/2015 PSUSA - Modification EMEA/H/C/PSUSA/10125/201412 (2015)6549 of 18/09/2015
22/10/2015 Centralised - Variation EMEA/H/C/2547/IB/18
25/02/2016 Centralised - Variation EMEA/H/C/2547/II/21/G
04/05/2016 Centralised - Notification EMEA/H/C/2547/N/24