PMDA drug package insert
エパデールEMカプセル2g
PMDA Prescription drug · 持田製薬株式会社 · package insert Nov 13, 2024
Key facts
| Brand names | エパデールEMカプセル2g |
|---|---|
| Nonproprietary names | イコサペント酸エチル |
| Companies | 製造販売元／持田製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | EPA製剤 |
| Therapeutic category codes | 872189 |
| YJ codes | 2189021M1028 |
| Approval numbers | 30400AMX00207000 |
| Package insert edition | 第5版 |
| Package insert date | Nov 13, 2024 |
| PMDA document key | 790005_2189021M1028_1 |
| PMDA company code | 790005 |
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: