PMDA drug package insert
オプフォルダカプセル65mg
PMDA Prescription drug · アミカス・セラピューティクス株式会社 · package insert Aug 27, 2025
Key facts
| Brand names | オプフォルダカプセル65mg |
|---|---|
| Nonproprietary names | ミグルスタット |
| Companies | 製造販売元／アミカス・セラピューティクス株式会社 |
| Product type | Prescription drug |
| Therapeutic category | ポンペ病治療用酵素安定化剤 |
| Therapeutic category codes | 873999 |
| YJ codes | 3999030M2028 |
| Approval numbers | 30700AMX00096000 |
| Package insert edition | 第2版 |
| Package insert date | Aug 27, 2025 |
| PMDA document key | 112604_3999030M2028_1 |
| PMDA company code | 112604 |
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: