PMDA drug package insert
シムレクト静注用20mg
PMDA Prescription drug · ノバルティスファーマ株式会社 · package insert Jun 19, 2026
Key facts
| Brand names | シムレクト静注用20mg |
|---|---|
| Nonproprietary names | バシリキシマブ（遺伝子組換え） |
| Companies | 製造販売／ノバルティスファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 急性拒絶反応抑制剤 （抗CD25モノクローナル抗体） |
| Therapeutic category codes | 876399 |
| YJ codes | 6399418D1032 |
| Approval numbers | 22000AMX01626000 |
| Package insert edition | 第5版 |
| Package insert date | Jun 19, 2026 |
| PMDA document key | 300242_6399418D1032_1 |
| PMDA company code | 300242 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- 1–9 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: