PMDA drug package insert
リツキシマブBS点滴静注100mg「KHK」
PMDA Prescription drug · サンド株式会社 · package insert Apr 22, 2026
Key facts
| Brand names | リツキシマブBS点滴静注100mg「KHK」, リツキシマブBS点滴静注500mg「KHK」 |
|---|---|
| Nonproprietary names | リツキシマブ（遺伝子組換え） |
| Companies | 製造販売／サンド株式会社, 販売／協和キリン株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗CD20モノクローナル抗体 |
| Therapeutic category codes | 874291 |
| YJ codes | 4291439A1027, 4291439A2023 |
| Approval numbers | 22900AMX00970000, 22900AMX00971000 |
| Package insert edition | 第11版 |
| Package insert date | Apr 22, 2026 |
| PMDA document key | 270428_4291439A1027_1 |
| PMDA company code | 270428 |
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: