PMDA drug package insert
レグパラ錠12.5mg
PMDA Prescription drug · 協和キリン株式会社 · package insert Nov 1, 2019
Key facts
| Brand names | レグパラ錠12.5mg, レグパラ錠25mg, レグパラ錠75mg |
|---|---|
| Nonproprietary names | シナカルセト塩酸塩 |
| Companies | 製造販売元／協和キリン株式会社 |
| Product type | Prescription drug |
| Therapeutic category | カルシウム受容体作動薬 |
| Therapeutic category codes | 873999 |
| YJ codes | 3999023F3025, 3999023F1022, 3999023F2029 |
| Approval numbers | 22700AMX00169, 21900AMX01750, 21900AMX01751 |
| Package insert edition | 第1版 |
| Package insert date | Nov 1, 2019 |
| PMDA document key | 230124_3999023F1022_2 |
| PMDA company code | 230124 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- None Safety communications
- Yes PMDA review report published
- Yes 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: