PMDA drug package insert
リバーロキサバンOD錠10mg「バイエル」
PMDA Prescription drug · バイエル ライフサイエンス株式会社 · package insert Aug 19, 2026
Key facts
| Brand names | リバーロキサバンOD錠10mg「バイエル」, リバーロキサバンOD錠15mg「バイエル」 |
|---|---|
| Nonproprietary names | リバーロキサバン |
| Companies | 製造販売元／バイエル ライフサイエンス株式会社, 販売元／第一三共エスファ株式会社, 販売提携／第一三共株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 選択的直接作用型第Ⅹa因子阻害剤 |
| Therapeutic category codes | 873339 |
| YJ codes | 3339003F3094, 3339003F4090 |
| Approval numbers | 30400AMX00057, 30400AMX00056 |
| Package insert edition | 第5版 |
| Package insert date | Aug 19, 2026 |
| PMDA document key | 641522_3339003F3094_1 |
| PMDA company code | 641522 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- None Safety communications
- No PMDA review report published
- No 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: