PMDA drug package insert
ニシスタゴンカプセル50mg
PMDA Prescription drug · ヴィアトリス製薬合同会社 · package insert Sep 19, 2025
Key facts
| Brand names | ニシスタゴンカプセル50mg, ニシスタゴンカプセル150mg |
|---|---|
| Nonproprietary names | システアミン酒石酸塩 |
| Companies | 製造販売元／ヴィアトリス製薬合同会社 |
| Product type | Prescription drug |
| Therapeutic category | 腎性シスチン症治療剤 |
| Therapeutic category codes | 873929 |
| YJ codes | 3929009M1027, 3929009M2023 |
| Approval numbers | 22600AMX00766, 22600AMX00767 |
| Package insert edition | 第4版 |
| Package insert date | Sep 19, 2025 |
| PMDA document key | 671450_3929009M1027_2 |
| PMDA company code | 671450 |
At a glance
- 1–9 Package insert revisions
- 10–99 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: