PMDA drug package insert
乾燥HBグロブリン筋注用200単位「ニチヤク」
PMDA Prescription drug · 武田薬品工業株式会社 · package insert Sep 1, 2023
Key facts
| Brand names | 乾燥HBグロブリン筋注用200単位「ニチヤク」, 乾燥HBグロブリン筋注用1000単位「ニチヤク」 |
|---|---|
| Nonproprietary names | 乾燥抗ＨＢｓ人免疫グロブリン |
| Companies | 製造販売元／武田薬品工業株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 血漿分画製剤 |
| Therapeutic category codes | 876343 |
| YJ codes | 6343423X1050, 6343423X2057 |
| Approval numbers | 22100AMX01498, 22100AMX01499 |
| Package insert edition | 第1版 |
| Package insert date | Sep 1, 2023 |
| PMDA document key | 400256_6343423X1050_2 |
| PMDA company code | 400256 |
At a glance
- 1–9 Package insert revisions
- 1–9 Related PMDA documents
- None Safety communications
- Yes 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: