Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, The Netherlands
Retsevmo 40 mg hard capsules.
Retsevmo 80 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsules. Retsevmo 40 mg hard capsules: Grey opaque capsule, 6 × 18 mm (size 2), imprinted with “Lilly”, “3977” and “40 mg” in black ink. Retsevmo 80 mg hard capsules: Blue opaque capsule, 8 × 22 mm (size 0), imprinted with “Lilly”, “2980” and “80 mg” in black ink. |
Retsevmo 40 mg hard capsules: Each hard capsule contains 40 mg selpercatinib.
Retsevmo 80 mg hard capsules: Each hard capsule contains 80 mg selpercatinib.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Selpercatinib |
Selpercatinib is an inhibitor of the rearranged during transfection (RET) receptor tyrosine kinase. Selpercatinib inhibited wild-type RET and multiple mutated RET isoforms as well as VEGFR1 and VEGFR3 with IC50 values ranging from 0.92 nM to 67.8 nM. In in vitro and in vivo tumor models, selpercatinib demonstrated anti-tumor activity in cells harboring constitutive activation of RET protein resulting from gene fusions and mutations, including CCDC6-RET, KIF5B-RET, RET V804M, and RET M918T. |
| List of Excipients |
|---|
|
Capsule content: Cellulose, microcrystalline Capsule shell: Retsevmo 40 mg hard capsules: Gelatin Retsevmo 80 mg hard capsules: Gelatin Capsules black ink composition: Shellac |
Each pack contains 1 HDPE bottle with a plastic screw cap.
Retsevmo 40 mg hard capsules: Retsevmo 40 mg hard capsules is supplied as a 60 count HDPE bottle.
Retsevmo 80 mg hard capsules: Retsevmo 80 mg hard capsules is supplied as 60 count HDPE bottle or 120 count HDPE bottle.
Retsevmo 40 mg hard capsules: Supplied as PCTFE/PVC blisters sealed with an aluminium foil in a blister card, in packs of 14, 42, 56 or 168 hard capsules.
Retsevmo 80 mg hard capsules: Supplied as PCTFE/PVC blisters sealed with an aluminium foil in a blister card, in packs of 14, 28, 56 or 112 hard capsules.
Not all pack sizes may be marketed.
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ Utrecht, The Netherlands
EU/1/20/1527/001
EU/1/20/1527/002
EU/1/20/1527/003
EU/1/20/1527/004
EU/1/20/1527/005
EU/1/20/1527/006
EU/1/20/1527/007
EU/1/20/1527/008
EU/1/20/1527/009
EU/1/20/1527/010
EU/1/20/1527/011
Date of first authorisation: 11 February 2021
Date of latest renewal: 09 December 2022
| Drug | Countries | |
|---|---|---|
| RETSEVMO | Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Poland, Romania, United Kingdom |
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