PMDA drug package insert
トビエース錠4mg
PMDA Prescription drug · ファイザー株式会社 · package insert Mar 28, 2024
Key facts
| Brand names | トビエース錠4mg, トビエース錠8mg |
|---|---|
| Nonproprietary names | フェソテロジンフマル酸塩 |
| Companies | 製造販売元／ファイザー株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 過活動膀胱・神経因性膀胱治療剤 |
| Therapeutic category codes | 87259 |
| YJ codes | 2590015G1021, 2590015G2028 |
| Approval numbers | 22400AMX01484, 22400AMX01485 |
| Package insert edition | 第4版 |
| Package insert date | Mar 28, 2024 |
| PMDA document key | 672212_2590015G1021_2 |
| PMDA company code | 672212 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- None Safety communications
- Yes PMDA review report published
- Yes 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: