PMDA drug package insert
ポラキス錠1
PMDA Prescription drug · チェプラファーム株式会社 · package insert Jul 1, 2024
Key facts
| Brand names | ポラキス錠1, ポラキス錠2, ポラキス錠3 |
|---|---|
| Nonproprietary names | オキシブチニン塩酸塩 |
| Companies | 製造販売元／チェプラファーム株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 尿失禁・尿意切迫感・頻尿治療剤 |
| Therapeutic category codes | 87259 |
| YJ codes | 2590005F3025, 2590005F1022, 2590005F2029 |
| Approval numbers | 20400AMZ00551, 16300AMZ00503, 16300AMZ00504 |
| Package insert edition | 第3版 |
| Package insert date | Jul 1, 2024 |
| PMDA document key | 450900_2590005F1022_3 |
| PMDA company code | 450900 |
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: