PMDA drug package insert
スピロペント錠10μg
PMDA Prescription drug · 帝人ファーマ株式会社 · package insert Mar 11, 2024
Key facts
| Brand names | スピロペント錠10μg |
|---|---|
| Nonproprietary names | クレンブテロール塩酸塩 |
| Companies | 製造販売元／帝人ファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 持続性気管支拡張剤; 腹圧性尿失禁治療剤 |
| Therapeutic category codes | 872259, 87259 |
| YJ codes | 2259006F1080 |
| Approval numbers | 22100AMX01347000 |
| Package insert edition | 第2版 |
| Package insert date | Mar 11, 2024 |
| PMDA document key | 470310_2259006F1080_1 |
| PMDA company code | 470310 |
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: