PMDA drug package insert
プラリアHI皮下注60mgシリンジ0.5mL
PMDA Prescription drug · 第一三共株式会社 · package insert Jun 13, 2025
Key facts
| Brand names | プラリアHI皮下注60mgシリンジ0.5mL |
|---|---|
| Nonproprietary names | デノスマブ（遺伝子組換え） |
| Companies | 製造販売元／第一三共株式会社, 提携／AMGEN |
| Product type | Prescription drug |
| Therapeutic category | ヒト型抗RANKLモノクローナル抗体製剤 |
| Therapeutic category codes | 873999 |
| YJ codes | 3999435G3026 |
| Approval numbers | 30700AMX00015 |
| Package insert edition | 第2版 |
| Package insert date | Jun 13, 2025 |
| PMDA document key | 430574_3999435G3026_1 |
| PMDA company code | 430574 |
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: