PMDA drug package insert
ミレーナ52mg
PMDA Prescription drug · バイエル薬品株式会社 · package insert Aug 7, 2026
Key facts
| Brand names | ミレーナ52mg |
|---|---|
| Nonproprietary names | レボノルゲストレル |
| Companies | 製造販売元／バイエル薬品株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 子宮内黄体ホルモン放出システム |
| Therapeutic category codes | 872549, 872529 |
| YJ codes | 2529710X1027 |
| Approval numbers | 21900AMY00008000 |
| Package insert edition | 第2版 |
| Package insert date | Aug 7, 2026 |
| PMDA document key | 630004_2529710X1027_1 |
| PMDA company code | 630004 |
At a glance
- 1–9 Package insert revisions
- 1–9 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: