PMDA drug package insert
タクロリムスカプセル0.5mg「サンド」
PMDA Prescription drug · ニプロファーマ株式会社 · package insert Mar 19, 2026
Key facts
| Brand names | タクロリムスカプセル0.5mg「サンド」, タクロリムスカプセル1mg「サンド」 |
|---|---|
| Nonproprietary names | タクロリムス水和物 |
| Companies | 製造販売／ニプロファーマ株式会社, 販売／サンド株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 免疫抑制剤 |
| Therapeutic category codes | 873999 |
| YJ codes | 3999014M2053, 3999014M1057 |
| Approval numbers | 22600AMX01035000, 22600AMX01036000 |
| Package insert edition | 第5版 |
| Package insert date | Mar 19, 2026 |
| PMDA document key | 650037_3999014M1057_2 |
| PMDA company code | 650037 |
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: