PMDA drug package insert
サークリサ点滴静注100mg
PMDA Prescription drug · サノフィ株式会社 · package insert Feb 20, 2025
Key facts
| Brand names | サークリサ点滴静注100mg, サークリサ点滴静注500mg |
|---|---|
| Nonproprietary names | イサツキシマブ（遺伝子組換え） |
| Companies | 製造販売元／サノフィ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗CD38モノクローナル抗体 |
| Therapeutic category codes | 874291 |
| YJ codes | 4291454A1021, 4291454A2028 |
| Approval numbers | 30200AMX00511, 30200AMX00512 |
| Package insert edition | 第4版 |
| Package insert date | Feb 20, 2025 |
| PMDA document key | 780069_4291454A1021_1 |
| PMDA company code | 780069 |
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: