PMDA drug package insert
ベージニオ錠50mg
PMDA Prescription drug · 日本イーライリリー株式会社 · package insert Sep 14, 2026
Key facts
| Brand names | ベージニオ錠50mg, ベージニオ錠100mg, ベージニオ錠150mg |
|---|---|
| Nonproprietary names | アベマシクリブ |
| Companies | 製造販売元／日本イーライリリー株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗悪性腫瘍剤 CDK注2）4及び6阻害剤; 注2）CDK:Cyclin-Dependent Kinase（サイクリン依存性キナーゼ） |
| Therapeutic category codes | 874291 |
| YJ codes | 4291054F1026, 4291054F2022, 4291054F3029 |
| Approval numbers | 23000AMX00808, 23000AMX00809, 23000AMX00810 |
| Package insert edition | 第3版 |
| Package insert date | Sep 14, 2026 |
| PMDA document key | 530471_4291054F1026_1 |
| PMDA company code | 530471 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- 1–9 Safety communications
- Yes PMDA review report published
- Yes Risk management plan (RMP)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMDA approved drugs and package inserts (Japan)
Japan's PMDA publishes the package insert (添付文書) of every prescription drug, OTC drug and regenerative medical product, with brand and nonproprietary names, YJ codes and approval numbers. Names appear in Japanese as published.
Source: Pharmaceuticals and Medical Devices Agency (PMDA), Japan, package insert database · Source date: