PMDA drug package insert
イコサペント酸エチル粒状カプセル300mg「サワイ」
PMDA Prescription drug · 沢井製薬株式会社 · package insert Mar 27, 2026
Key facts
| Brand names | イコサペント酸エチル粒状カプセル300mg「サワイ」, イコサペント酸エチル粒状カプセル600mg「サワイ」, イコサペント酸エチル粒状カプセル900mg「サワイ」 |
|---|---|
| Nonproprietary names | イコサペント酸エチル |
| Companies | 製造販売元／沢井製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | EPA製剤 |
| Therapeutic category codes | 873399872189 |
| YJ codes | 3399004M2057, 3399004M3061, 3399004M4068 |
| Approval numbers | 22000AMX00335000, 22000AMX00336000, 22000AMX00337000 |
| Package insert edition | 第3版 |
| Package insert date | Mar 27, 2026 |
| PMDA document key | 300119_3399004M2057_2 |
| PMDA company code | 300119 |
At a glance
- 1–9 Package insert revisions
- 1–9 Related PMDA documents
- None Safety communications
- No 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: