Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Bosulif   
Auth. number : EU/1/13/818
Active substance : Bosutinib
Orphan market exclusivity for "Treatment of chronic myeloid leukaemia" (based on designation EU/3/10/762) started on 2/04/2013
   10 years of market exclusivity
   This orphan market exclusivity has ended on 15/03/2018
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: L01XE14 - bosutinib
(See WHO ATC Index)
Indication: Bosulif is indicated for the treatment of adult patients with:
• newly diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML).
• CP, accelerated phase (AP), and blast phase (BP) Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.
Marketing Authorisation Holder: Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, 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
2/04/2013 Centralised - Authorisation EMEA/H/C/2373 (2013)1968 of 27/03/2013
24/02/2014 Centralised - Annual renewal EMEA/H/C/2373/R/2 (2014)1263 of 20/02/2014
22/05/2014 Centralised - Variation EMEA/H/C/2373/IB/6
Updated with Decision(2014)4368 of 23/06/2014
25/06/2014 Centralised - 2-Monthly update EMEA/H/C/2373/II/1 (2014)4368 of 23/06/2014
23/10/2014 Centralised - Variation EMEA/H/C/2373/II/8
Updated with Decision(2015)1431 of 26/02/2015
23/12/2014 Centralised - Variation EMEA/H/C/2373/IB/13
Updated with Decision(2015)8390 of 23/11/2015
2/03/2015 Centralised - Annual renewal EMEA/H/C/2373/R/10 (2015)1431 of 26/02/2015
24/06/2015 Centralised - Notification EMEA/H/C/2373/N/15
Updated with Decision(2015)8390 of 23/11/2015
23/07/2015 Centralised - Variation EMEA/H/C/2373/II/14
Updated with Decision(2015)8390 of 23/11/2015
22/10/2015 Centralised - Variation EMEA/H/C/2373/II/18
Updated with Decision(2016)71 of 07/01/2016
25/11/2015 PSUSA - Modification EMEA/H/C/2373/PSUSA/10073/201503 (2015)8390 of 23/11/2015
11/01/2016 Centralised - Annual renewal EMEA/H/C/2373/R/19 (2016)71 of 7/01/2016
11/05/2016 Centralised - Variation EMEA/H/C/2373/IAIN/21
Updated with Decision(2016)8536 of 08/12/2016
12/12/2016 PSUSA - Modification EMEA/H/C/2373/PSUSA/10073/201603 (2016)8536 of 8/12/2016
28/03/2017 Centralised - Annual renewal EMEA/H/C/2373/R/23 (2017)2124 of 24/03/2017
12/02/2018 Centralised - Annual renewal EMEA/H/C/2373/R/27 (2018)908 of 8/02/2018
15/03/2018 Centralised - Variation EMEA/H/C/2373/II/28
Updated with Decision(2018)3269 of 22/05/2018
15/03/2018 Centralised - (orphan status)
25/04/2018 Centralised - 2-Monthly update EMEA/H/C/2373/II/25/G (2018)2583 of 23/04/2018
24/05/2018 Centralised - Variation EMEA/H/C/2373/X/26 (2018)3269 of 22/05/2018