PMDA drug package insert
フェントステープ0.5mg
PMDA Prescription drug · 久光製薬株式会社 · package insert Jan 15, 2025
Key facts
| Brand names | フェントステープ0.5mg, フェントステープ1mg, フェントステープ2mg, フェントステープ4mg, フェントステープ6mg, フェントステープ8mg |
|---|---|
| Nonproprietary names | フェンタニルクエン酸塩 |
| Companies | 製造販売元／久光製薬株式会社, 発売元／協和キリン株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 経皮吸収型 持続性疼痛治療剤 |
| Therapeutic category codes | 878219 |
| YJ codes | 8219701S6027, 8219701S1025, 8219701S2021, 8219701S3028, 8219701S4024, 8219701S5020 |
| Approval numbers | 23000AMX00487000, 22200AMX00301000, 22200AMX00302000, 22200AMX00303000, 22200AMX00304000, 22200AMX00305000 |
| Package insert edition | 第4版 |
| Package insert date | Jan 15, 2025 |
| PMDA document key | 650034_8219701S1025_1 |
| PMDA company code | 650034 |
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: