PMDA drug package insert
タンボコール錠50mg
PMDA Prescription drug · エーザイ株式会社 · package insert Dec 27, 2021
Key facts
| Brand names | タンボコール錠50mg, タンボコール錠100mg, タンボコール細粒10％ |
|---|---|
| Nonproprietary names | フレカイニド酢酸塩 |
| Companies | 製造販売元／エーザイ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 頻脈性不整脈治療剤 |
| Therapeutic category codes | 872129 |
| YJ codes | 2129009F1020, 2129009F2026, 2129009C1023 |
| Approval numbers | 20300AMZ00442000, 20300AMZ00443000, 22700AMX00341000 |
| Package insert edition | 第1版 |
| Package insert date | Dec 27, 2021 |
| PMDA document key | 170033_2129009F1020_1 |
| PMDA company code | 170033 |
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: