PMDA drug package insert
ブフェニール錠500mg
PMDA Prescription drug · 株式会社オーファンパシフィック · package insert Aug 24, 2026
Key facts
| Brand names | ブフェニール錠500mg, ブフェニール顆粒94% |
|---|---|
| Nonproprietary names | フェニル酪酸ナトリウム |
| Companies | 製造販売元／株式会社オーファンパシフィック |
| Product type | Prescription drug |
| Therapeutic category | 尿素サイクル異常症用薬; 進行性家族性肝内胆汁うっ滞症1型及び2型用薬 |
| Therapeutic category codes | 873999, 873919 |
| YJ codes | 3999032F1021, 3999032D1020 |
| Approval numbers | 22400AMX01398000, 22400AMX01399000 |
| Package insert edition | 第3版 |
| Package insert date | Aug 24, 2026 |
| PMDA document key | 181251_3999032D1020_1 |
| PMDA company code | 181251 |
At a glance
- 1–9 Package insert revisions
- 10–99 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: