PMDA drug package insert
イコサペント酸エチル粒状カプセル300mg「TC」
PMDA Prescription drug · 東洋カプセル株式会社 · package insert Sep 10, 2025
Key facts
| Brand names | イコサペント酸エチル粒状カプセル300mg「TC」, イコサペント酸エチル粒状カプセル600mg「TC」, イコサペント酸エチル粒状カプセル900mg「TC」 |
|---|---|
| Nonproprietary names | イコサペント酸エチル |
| Companies | 製造販売／東洋カプセル株式会社, 販売／ニプロ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | EPA製剤 |
| Therapeutic category codes | 873399872189 |
| YJ codes | 3399004M2030, 3399004M3045, 3399004M4041 |
| Approval numbers | 22000AMX01245000, 22000AMX01246000, 22000AMX01250000 |
| Package insert edition | 第3版 |
| Package insert date | Sep 10, 2025 |
| PMDA document key | 480187_3399004M2030_1 |
| PMDA company code | 480187 |
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: