PMDA drug package insert
ファセンラ皮下注30mgシリンジ
PMDA Prescription drug · アストラゼネカ株式会社 · package insert May 18, 2026
Key facts
| Brand names | ファセンラ皮下注30mgシリンジ, ファセンラ皮下注30mgペン, ファセンラ皮下注10mgシリンジ |
|---|---|
| Nonproprietary names | ベンラリズマブ（遺伝子組換え） |
| Companies | 製造販売元／アストラゼネカ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | ヒト化抗IL-5受容体αモノクローナル抗体製剤 |
| Therapeutic category codes | 87229 |
| YJ codes | 2290402G1020, 2290402G3023, 2290402G2027 |
| Approval numbers | 23000AMX00016, 30600AMX00312, 30600AMX00129 |
| Package insert edition | 第5版 |
| Package insert date | May 18, 2026 |
| PMDA document key | 670227_2290402G1020_1 |
| PMDA company code | 670227 |
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: