PMDA drug package insert
オンデキサ静注用200mg
PMDA Prescription drug · アストラゼネカ株式会社 · package insert Nov 26, 2025
Key facts
| Brand names | オンデキサ静注用200mg |
|---|---|
| Nonproprietary names | アンデキサネット アルファ（遺伝子組換え） |
| Companies | 製造販売／アストラゼネカ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 直接作用型第Xa因子阻害剤中和剤 |
| Therapeutic category codes | 873399 |
| YJ codes | 3399414D1022 |
| Approval numbers | 30400AMX00178000 |
| Package insert edition | 第6版 |
| Package insert date | Nov 26, 2025 |
| PMDA document key | 670227_3399414D1022_2 |
| PMDA company code | 670227 |
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: