Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Takeda Pharma A/S, Dybendal Alle 10, 2630, Taastrup, Denmark
NINLARO 2.3 mg hard capsules.
NINLARO 3 mg hard capsules.
NINLARO 4 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule. NINLARO 2.3 mg hard capsules: Light pink, size 4 gelatin hard capsule, marked “Takeda” on the cap and “2.3 mg” on the body with black ink. NINLARO 3 mg hard capsules: Light grey, size 4 gelatin hard capsule, marked “Takeda” on the cap and “3 mg” on the body with black ink. NINLARO 4 mg hard capsules: Light orange, size 3 gelatin hard capsule, marked “Takeda” on the cap and “4 mg” on the body with black ink. |
NINLARO 2.3 mg hard capsules: Each capsule contains 2.3 mg of ixazomib (as 3.3 mg of ixazomib citrate).
NINLARO 3 mg hard capsules: Each capsule contains 3 mg of ixazomib (as 4.3 mg of ixazomib citrate).
NINLARO 4 mg hard capsules: Each capsule contains 4 mg of ixazomib (as 5.7 mg of ixazomib citrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ixazomib |
Ixazomib is an oral, highly selective and reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome. Ixazomib induced apoptosis of several tumour cell types in vitro. In vivo, ixazomib demonstrated antitumour activity in various tumour xenograft models, including models of multiple myeloma. |
| List of Excipients |
|---|
NINLARO 2.3 mg hard capsulesCapsule contents: Microcrystalline cellulose Capsule shell: Gelatin Printing ink: Shellac NINLARO 3 mg hard capsulesCapsule contents: Microcrystalline cellulose Capsule shell: Gelatin Printing ink: Shellac NINLARO 4 mg hard capsulesCapsule contents: Microcrystalline cellulose Capsule shell: Gelatin Printing ink: Shellac |
PVC-Aluminium/Aluminium blister sealed inside a wallet pack containing one capsule.
Three single blister wallet packs are packaged in one carton.
Takeda Pharma A/S, Dybendal Alle 10, 2630, Taastrup, Denmark
EU/1/16/1094/001
EU/1/16/1094/002
EU/1/16/1094/003
Date of first authorisation: 21 November 2016
Date of Last Renewal: 16 September 2019
| Drug | Countries | |
|---|---|---|
| NINLARO | Austria, Brazil, Canada, Cyprus, Estonia, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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