PMDA drug package insert
アナエブリ皮下注200mgペン
PMDA Prescription drug · CSLベーリング株式会社 · package insert May 1, 2026
Key facts
| Brand names | アナエブリ皮下注200mgペン |
|---|---|
| Nonproprietary names | ガラダシマブ（遺伝子組換え） |
| Companies | 製造販売（輸入）／CSLベーリング株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 遺伝性血管性浮腫発作抑制用 活性化第XII因子阻害剤 ヒト抗活性化第XII因子モノクローナル抗体 |
| Therapeutic category codes | 87449 |
| YJ codes | 4490411G1020 |
| Approval numbers | 30700AMX00056 |
| Package insert edition | 第2版 |
| Package insert date | May 1, 2026 |
| PMDA document key | 100806_4490411G1020_1 |
| PMDA company code | 100806 |
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: