PMDA drug package insert
アムノレイク錠2mg
PMDA Prescription drug · 東光薬品工業株式会社 · package insert Dec 23, 2022
Key facts
| Brand names | アムノレイク錠2mg |
|---|---|
| Nonproprietary names | タミバロテン |
| Companies | 製造販売元／東光薬品工業株式会社, 販売／日本新薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 再発・難治性急性前骨髄球性白血病治療剤 |
| Therapeutic category codes | 874291 |
| YJ codes | 4291014F1021 |
| Approval numbers | 21700AMZ00597000 |
| Package insert edition | 第1版 |
| Package insert date | Dec 23, 2022 |
| PMDA document key | 480114_4291014F1021_1 |
| PMDA company code | 480114 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- None Safety communications
- Yes 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: