PMDA drug package insert
ビルテプソ点滴静注250mg
PMDA Prescription drug · 日本新薬株式会社 · package insert Aug 7, 2026
Key facts
| Brand names | ビルテプソ点滴静注250mg |
|---|---|
| Nonproprietary names | ビルトラルセン |
| Companies | 製造販売元／日本新薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | デュシェンヌ型筋ジストロフィー治療剤 |
| Therapeutic category codes | 87190 |
| YJ codes | 1900400A1025 |
| Approval numbers | 30200AMX00428000 |
| Package insert edition | 第5版 |
| Package insert date | Aug 7, 2026 |
| PMDA document key | 530263_1900400A1025_1 |
| PMDA company code | 530263 |
At a glance
- 1–9 Package insert revisions
- 10–99 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: