PMDA drug package insert
タクザイロ皮下注300mgシリンジ
PMDA Prescription drug · 武田薬品工業株式会社 · package insert Jul 28, 2026
Key facts
| Brand names | タクザイロ皮下注300mgシリンジ, タクザイロ皮下注300mgペン |
|---|---|
| Nonproprietary names | ラナデルマブ（遺伝子組換え） |
| Companies | 製造販売元（タクザイロ皮下注300mgシリンジ）／製造販売（輸入）元（タクザイロ皮下注300mgペン）／武田薬品工業株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 遺伝性血管性浮腫発作抑制用 血漿カリクレイン阻害剤; 完全ヒト型抗ヒト血漿カリクレインモノクローナル抗体 |
| Therapeutic category codes | 87449 |
| YJ codes | 4490407G1023, 4490407G2020 |
| Approval numbers | 30400AMX00179, 30700AMX00207 |
| Package insert edition | 第6版 |
| Package insert date | Jul 28, 2026 |
| PMDA document key | 400256_4490407G1023_1 |
| PMDA company code | 400256 |
At a glance
- 1–9 Package insert revisions
- 1–9 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: