Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: AstraZeneca AB, SE-151 85 Södertälje, Sweden
Koselugo 10 mg hard capsules.
Koselugo 25 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule. Koselugo 10 mg hard capsules: White to off-white, opaque, size 4 (approximately 14 mm x 5 mm), hard capsule, which has a centre band and is marked with “SEL 10” in black ink. Koselugo 25 mg hard capsules: Blue, opaque, size 4 (approximately 14 mm x 5 mm), hard capsule, which has a centre band and is marked with “SEL 25” in black ink. |
Koselugo 10 mg hard capsules: Each hard capsule contains 10 mg of selumetinib (as hydrogen sulfate).
Koselugo 25 mg hard capsules: Each hard capsule contains 25 mg of selumetinib (as hydrogen sulfate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Selumetinib |
Selumetinib is a selective inhibitor of mitogen activated protein kinase kinases 1 and 2 (MEK ½). Selumetinib blocks MEK activity and the RAF-MEK-ERK pathway. Therefore, MEK inhibition can block the proliferation and survival of tumour cells in which the RAF-MEK-ERK pathway is activated. |
| List of Excipients |
|---|
|
Capsule content: Vitamin E polyethylene glycol succinate (D α-tocopheryl polyethylene glycol succinate). Capsule shell: Koselugo 10 mg hard capsules: Hypromellose (E464) Koselugo 25 mg hard capsules: Hypromellose (E464) Printing ink: Koselugo 10 mg hard capsules: Shellac glaze, standard (E904) Koselugo 25 mg hard capsules: Iron oxide red (E172) |
Koselugo 10 mg hard capsules: High-density polyethylene (HDPE) plastic bottle with white child-resistant polypropylene closure.
Koselugo 25 mg hard capsules: High-density polyethylene (HDPE) plastic bottle with blue child-resistant polypropylene closure.
Each bottle contains 60 hard capsules and a silica gel desiccant. Each carton contains one bottle.
AstraZeneca AB, SE-151 85 Södertälje, Sweden
EU/1/21/1552/001 10 mg hard capsules
EU/1/21/1552/002 25 mg hard capsules
| Drug | Countries | |
|---|---|---|
| KOSELUGO | Brazil, Estonia, Finland, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Poland, Romania, United States |
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