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Pharmaceuticals - Union Register
Union Register of medicinal products for human use |
AUTHORISED |
Product information |
Invented name: | Cyramza
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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 procedures |
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 | ||||