PMDA drug package insert
エディロールカプセル0.5μg
PMDA Prescription drug · 中外製薬株式会社 · package insert Feb 5, 2024
Key facts
| Brand names | エディロールカプセル0.5μg, エディロールカプセル0.75μg |
|---|---|
| Nonproprietary names | エルデカルシトール |
| Companies | 製造販売元／中外製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 骨粗鬆症治療剤（活性型ビタミンD3製剤） |
| Therapeutic category codes | 873112 |
| YJ codes | 3112006M1022, 3112006M2029 |
| Approval numbers | 22300AMX00416, 22300AMX00417 |
| Package insert edition | 第4版 |
| Package insert date | Feb 5, 2024 |
| PMDA document key | 450045_3112006M1022_1 |
| PMDA company code | 450045 |
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: