PMDA drug package insert
献血ベニロン−I静注用500mg
PMDA Prescription drug · KMバイオロジクス株式会社 · package insert Apr 1, 2026
Key facts
| Brand names | 献血ベニロン−I静注用500mg, 献血ベニロン−I静注用2500mg, 献血ベニロン−I静注用5000mg |
|---|---|
| Nonproprietary names | 乾燥スルホ化人免疫グロブリン |
| Companies | 製造販売元／KMバイオロジクス株式会社, 販売元／Meiji Seika ファルマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 血漿分画製剤 静注用人免疫グロブリン製剤 |
| Therapeutic category codes | 876343 |
| YJ codes | 6343400X1041, 6343400X3044, 6343400X5020 |
| Approval numbers | 22100AMX01040, 22100AMX01042, 22100AMX01043 |
| Package insert edition | 第6版 |
| Package insert date | Apr 1, 2026 |
| PMDA document key | 261976_6343400X1041_3 |
| PMDA company code | 261976 |
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: