PMDA drug package insert
献血アルブミン25%静注5g/20mL「ベネシス」
PMDA Prescription drug · 一般社団法人日本血液製剤機構 · package insert May 9, 2023
Key facts
| Brand names | 献血アルブミン25%静注5g/20mL「ベネシス」, 献血アルブミン25%静注12.5g/50mL「ベネシス」 |
|---|---|
| Nonproprietary names | 人血清アルブミン |
| Companies | 製造販売元／一般社団法人日本血液製剤機構 |
| Product type | Prescription drug |
| Therapeutic category | 血漿分画製剤 |
| Therapeutic category codes | 876343 |
| YJ codes | 6343410X4087, 6343410X5199 |
| Approval numbers | 22000AMX02344, 22000AMX02343 |
| Package insert edition | 第1版 |
| Package insert date | May 9, 2023 |
| PMDA document key | 580842_6343410X4087_2 |
| PMDA company code | 580842 |
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: