Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: IBRANCE   
Auth. number : EU/1/16/1147
Active substance : palbociclib
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01X - Other antineoplastic agents
Chemical subgroup: L01XE - Protein kinase inhibitors
Chemical substance: L01XE33 - palbociclib
(See WHO ATC Index)
Indication: For the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer:
- in combination with an aromatase inhibitor;
- in combination with fulvestrant in women who have received prior endocrine therapy.
In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.
Marketing Authorisation Holder: Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
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
11/11/2016 Centralised - Authorisation EMEA/H/C/3853 (2016)7291 of 9/11/2016
28/11/2016 Centralised - Notification EMEA/H/C/3853/N/1
Updated with Decision(2018)548 of 24/01/2018
28/03/2017 Centralised - Variation EMEA/H/C/3853/IB/4
Updated with Decision(2018)548 of 24/01/2018
14/12/2017 Centralised - Variation EMEA/H/C/3853/II/6
Updated with Decision(2018)548 of 24/01/2018
26/01/2018 Centralised - 2-Monthly update EMEA/H/C/3853/II/7 (2018)548 of 24/01/2018
6/02/2018 Centralised - Variation EMEA/H/C/3853/IB/10/G
Updated with Decision(2018)5224 of 30/07/2018
1/08/2018 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/3853/T/14 (2018)5224 of 30/07/2018