PMDA drug package insert
ドジョルビ内用液100%
PMDA Prescription drug · Ultragenyx Japan株式会社 · package insert May 22, 2026
Key facts
| Brand names | ドジョルビ内用液100% |
|---|---|
| Nonproprietary names | トリヘプタノイン |
| Companies | 製造販売業者／Ultragenyx Japan株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 長鎖脂肪酸代謝異常症治療薬 |
| Therapeutic category codes | 873999 |
| YJ codes | 3999070S1025 |
| Approval numbers | 30800AMX00122000 |
| Package insert edition | 第2版 |
| Package insert date | May 22, 2026 |
| PMDA document key | 166617_3999070S1025_1 |
| PMDA company code | 166617 |
At a glance
- 1–9 Package insert revisions
- 1–9 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: