PMDA drug package insert
フレカイニド酢酸塩錠50mg「TE」
PMDA Prescription drug · トーアエイヨー株式会社 · package insert Jan 31, 2024
Key facts
| Brand names | フレカイニド酢酸塩錠50mg「TE」, フレカイニド酢酸塩錠100mg「TE」 |
|---|---|
| Nonproprietary names | フレカイニド酢酸塩 |
| Companies | 製造販売元／トーアエイヨー株式会社, 販売元／株式会社フェルゼンファーマ |
| Product type | Prescription drug |
| Therapeutic category | 頻脈性不整脈治療剤 |
| Therapeutic category codes | 872129 |
| YJ codes | 2129009F1054, 2129009F2050 |
| Approval numbers | 30100AMX00206000, 30100AMX00207000 |
| Package insert edition | 第1版 |
| Package insert date | Jan 31, 2024 |
| PMDA document key | 480008_2129009F1054_2 |
| PMDA company code | 480008 |
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: