PMDA drug package insert
ユルトミリスHI点滴静注300mg/3mL
PMDA Prescription drug · アレクシオンファーマ合同会社 · package insert Apr 2, 2025
Key facts
| Brand names | ユルトミリスHI点滴静注300mg/3mL, ユルトミリスHI点滴静注1100mg/11mL |
|---|---|
| Nonproprietary names | ラブリズマブ（遺伝子組換え） |
| Companies | 製造販売元／アレクシオンファーマ合同会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗補体（C5）モノクローナル抗体製剤 |
| Therapeutic category codes | 876399 |
| YJ codes | 6399427A2023, 6399427A3020 |
| Approval numbers | 30300AMX00316000, 30300AMX00315000 |
| Package insert edition | 第10版 |
| Package insert date | Apr 2, 2025 |
| PMDA document key | 870056_6399427A2023_1 |
| PMDA company code | 870056 |
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: