PMDA drug package insert
ランマーク皮下注120mg
PMDA Prescription drug · 第一三共株式会社 · package insert Jul 20, 2021
Key facts
| Brand names | ランマーク皮下注120mg |
|---|---|
| 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 | 3999435A1020 |
| Approval numbers | 22400AMX00035 |
| Package insert edition | 第2版 |
| Package insert date | Jul 20, 2021 |
| PMDA document key | 430574_3999435A1020_1 |
| PMDA company code | 430574 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- 1–9 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: