Pharmaceuticals - Union Register

  

Union Register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Cyramza   
Auth. number : EU/1/14/957
Active substance : ramucirumab
Orphan market exclusivity for "Treatment of gastric cancer" (based on designation EU/3/12/1004) started on 23/12/2014
   10 years of market exclusivity
   This orphan market exclusivity has ended on 22/12/2015
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01X - Other antineoplastic agents
Chemical subgroup: L01XC - Monoclonal antibodies
Chemical substance: L01XC21 - ramucirumab
(See WHO ATC Index)
Indication: Cyramza in combination with paclitaxel is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum and fluoropyrimidine chemotherapy.

Cyramza monotherapy is indicated for the treatment of adult patients with advanced gastric cancer or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum or fluoropyrimidine chemotherapy, for whom treatment in combination with paclitaxel is not appropriate.

Cyramza, in combination with FOLFIRI (irinotecan, folinic acid, and 5 fluorouracil), is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin and a fluoropyrimidine.

Cyramza in combination with docetaxel is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with disease progression after platinum-based chemotherapy.
Marketing Authorisation Holder: Eli Lilly Nederland B.V.
Papendorpseweg 83, 3528 BJ Utrecht, 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 Union Register.

European Commission proceduresGoto top of the page
Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
23/12/2014 Centralised - Authorisation EMEA/H/C/2829 (2014)10240 of 19/12/2014
19/01/2015 Centralised - Variation EMEA/H/C/2829/IAIN/1
Updated with Decision(2016)455 of 25/01/2016
16/09/2015 Centralised - Variation EMEA/H/C/2829/IA/8
Updated with Decision(2016)455 of 25/01/2016
24/09/2015 Centralised - Variation EMEA/H/C/2829/II/2
Updated with Decision(2016)455 of 25/01/2016
17/12/2015 Centralised - Variation EMEA/H/C/2829/II/3
Updated with Decision(2016)455 of 25/01/2016
22/12/2015 Centralised - (orphan status)
27/01/2016 Centralised - 2-Monthly update EMEA/H/C/2829/II/4 (2016)455 of 25/01/2016
23/02/2016 Centralised - Variation EMEA/H/C/2829/IA/662
Updated with Decision(2017)1304 of 17/02/2017
21/02/2017 Centralised - Yearly update (2017)1304 of 17/02/2017
17/05/2017 Centralised - Notification EMEA/H/C/2829/N/18
Updated with Decision(2018)6246 of 20/09/2018
27/09/2017 Centralised - Variation EMEA/H/C/2829/IB/20
Updated with Decision(2018)6246 of 20/09/2018
12/02/2018 Centralised - Variation EMEA/H/C/2829/IA/898
Updated with Decision(2018)6246 of 20/09/2018
20/09/2018 Centralised - Variation EMEA/H/C/2829/II/24
24/09/2018 Centralised - Yearly update (2018)6246 of 20/09/2018
13/12/2018 Centralised - Variation EMEA/H/C/2829/II/23G