PMDA drug package insert
アクテムラ点滴静注用80mg
PMDA Prescription drug · 中外製薬株式会社 · package insert Sep 30, 2026
Key facts
| Brand names | アクテムラ点滴静注用80mg, アクテムラ点滴静注用200mg, アクテムラ点滴静注用400mg |
|---|---|
| Nonproprietary names | トシリズマブ（遺伝子組換え） |
| Companies | 製造販売元／中外製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | ヒト化抗ヒトIL-6レセプターモノクローナル抗体 |
| Therapeutic category codes | 876399 |
| YJ codes | 6399421A2026, 6399421A1020, 6399421A3022 |
| Approval numbers | 22000AMX01593, 21900AMX01337, 22000AMX01594 |
| Package insert edition | 第8版 |
| Package insert date | Sep 30, 2026 |
| PMDA document key | 450045_6399421A1020_1 |
| PMDA company code | 450045 |
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: