PMDA drug package insert
ベンリスタ皮下注200mgオートインジェクター
PMDA Prescription drug · グラクソ・スミスクライン株式会社 · package insert Nov 21, 2025
Key facts
| Brand names | ベンリスタ皮下注200mgオートインジェクター, ベンリスタ皮下注200mgシリンジ |
|---|---|
| Nonproprietary names | ベリムマブ（遺伝子組換え） |
| Companies | 製造販売元／グラクソ・スミスクライン株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 完全ヒト型抗BLyS モノクローナル抗体製剤 |
| Therapeutic category codes | 87399 |
| YJ codes | 3999445G2023, 3999445G1027 |
| Approval numbers | 22900AMX00987, 22900AMX00988 |
| Package insert edition | 第3版 |
| Package insert date | Nov 21, 2025 |
| PMDA document key | 340278_3999445G1027_1 |
| PMDA company code | 340278 |
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: