PMDA drug package insert
ヒスタグロビン皮下注用
PMDA Prescription drug · KMバイオロジクス株式会社 · package insert Oct 5, 2026
Key facts
| Brand names | ヒスタグロビン皮下注用 |
|---|---|
| Nonproprietary names | ヒスタミン加人免疫グロブリン（乾燥） |
| Companies | 製造販売元／KMバイオロジクス株式会社, 販売元／日本臓器製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 好酸球浸潤抑制 アレルギー疾患治療剤（注射剤・乾燥・バイアル） |
| Therapeutic category codes | 876399 |
| YJ codes | 6399500D2037 |
| Approval numbers | 22100AMX01057 |
| Package insert edition | 第3版 |
| Package insert date | Oct 5, 2026 |
| PMDA document key | 261976_6399500D2037_2 |
| PMDA company code | 261976 |
At a glance
- 1–9 Package insert revisions
- 1–9 Related PMDA documents
- None Safety communications
- No PMDA review report published
- No 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: