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Pharmaceuticals - Community Register
Community register of medicinal products for human use |
AUTHORISED |
Product information |
| Invented name: | Lenvima
|
| Auth. number : | EU/1/15/1002 |
| Active substance : | lenvatinib |
| Orphan market exclusivity for "Treatment of follicular thyroid cancer" (based on designation EU/3/13/1119) started on 01/06/2015 10 years of market exclusivity This orphan market exclusivity will expire on 01/06/2025 Orphan market exclusivity for "Treatment of papillary thyroid cancer" (based on designation EU/3/13/1121) started on 01/06/2015 10 years of market exclusivity This orphan market exclusivity will expire on 01/06/2025 | |
| 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: L01XE29 - Lenvatinib (See WHO ATC Index) |
| Indication: | LENVIMA is indicated for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI). |
| Marketing Authorisation Holder: | Eisai Europe Limited
European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom |
EPAR and active package presentations
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Package presentations | |
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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 procedures |
| Close date procedure | Procedure type | EMEA number | Decision | summary publ | decision docs | annex |
| 01/06/2015 | Centralised - Authorisation | EMEA/H/C/3727 | (2015)3725 of 28/05/2015 | |||
| 15/09/2016 | Centralised - Variation | EMEA/H/C/3727/II/04 | ||||
| 23/03/2017 | Centralised - Variation | EMEA/H/C/3727/WS/1123 | ||||
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