Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Caprelsa   
Auth. number : EU/1/11/749
Active substance : vandetanib
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: L01XE12 - Vandetanib
(See WHO ATC Index)
Indication: Caprelsa is indicated for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease.
For patients in whom Rearranged during Transfection (RET) mutation is not known or is negative, a possible lower benefit should be taken into account before individual treatment decision
Marketing Authorisation Holder: Genzyme Europe B.V.
Gooimeer 10, NL-1411 DD Naarden, Nederland
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
21/02/2012 Centralised - Authorisation EMEA/H/C/2315 (2012)1174 of 17/02/2012
21/02/2012 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/2315 (2012)1173 of 17/02/2012
20/02/2013 Centralised - Annual renewal EMEA/H/C/2315/R/2 (2013)1019 of 18/02/2013
18/12/2013 Centralised - Variation EMEA/H/C/2315/II/4/G
Updated with Decision(2015)238 of 15/01/2015
27/12/2013 Centralised - Annual renewal EMEA/H/C/2315/R/5 (2013)9845 of 20/12/2013
23/10/2014 Centralised - Variation EMEA/H/C/2315/II/11
Updated with Decision(2015)238 of 15/01/2015
19/01/2015 Centralised - Annual renewal EMEA/H/C/2315/R/9 (2015)238 of 15/01/2015
18/12/2015 Centralised - Annual renewal EMEA/H/C/2315/R/15 (2015)9655 of 16/12/2015
18/01/2016 PSUSA - Modification EMEA/H/C/PSUSA/9327/201504 (2016)239 of 14/01/2016
26/04/2016 Centralised - Variation EMEA/H/C/2315/IB/19
Updated with Decision(2016)5835 of 08/09/2016
12/09/2016 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2315/T/22 (2016)5835 of 08/09/2016