PMDA drug package insert
トライコア錠53.3mg
PMDA Prescription drug · ヴィアトリス製薬合同会社 · package insert Jul 1, 2024
Key facts
| Brand names | トライコア錠53.3mg, トライコア錠80mg |
|---|---|
| Nonproprietary names | フェノフィブラート |
| Companies | 製造販売元／ヴィアトリス製薬合同会社, 発売元／あすか製薬株式会社, 販売元／武田薬品工業株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 高脂血症治療剤 |
| Therapeutic category codes | 872183 |
| YJ codes | 2183006F3031, 2183006F4038 |
| Approval numbers | 22300AMX00500, 22300AMX00501 |
| Package insert edition | 第4版 |
| Package insert date | Jul 1, 2024 |
| PMDA document key | 671450_2183006F3031_3 |
| PMDA company code | 671450 |
At a glance
- 1–9 Package insert revisions
- 1–9 Related PMDA documents
- None Safety communications
- Yes 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: