PMDA drug package insert
リツキサン点滴静注100mg
PMDA Prescription drug · 全薬工業株式会社 · package insert Jun 19, 2026
Key facts
| Brand names | リツキサン点滴静注100mg, リツキサン点滴静注500mg |
|---|---|
| Nonproprietary names | リツキシマブ（遺伝子組換え） |
| Companies | 製造販売元／全薬工業株式会社, 発売元／全薬販売株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗CD20モノクローナル抗体 |
| Therapeutic category codes | 874291 |
| YJ codes | 4291407A1035, 4291407A2031 |
| Approval numbers | 23000AMX00185, 23000AMX00186 |
| Package insert edition | 第15版 |
| Package insert date | Jun 19, 2026 |
| PMDA document key | 380101_4291407A1035_1 |
| PMDA company code | 380101 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- 1–9 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: