PMDA drug package insert
オキシコドン徐放カプセル5mg「テルモ」
PMDA Prescription drug · 帝國製薬株式会社 · package insert Aug 27, 2026
Key facts
| Brand names | オキシコドン徐放カプセル5mg「テルモ」, オキシコドン徐放カプセル10mg「テルモ」, オキシコドン徐放カプセル20mg「テルモ」, オキシコドン徐放カプセル40mg「テルモ」 |
|---|---|
| Nonproprietary names | オキシコドン塩酸塩水和物 |
| Companies | 製造販売元／帝國製薬株式会社, 販売元／テルモ株式会社, 提携／Ethypharm |
| Product type | Prescription drug |
| Therapeutic category | 持続性がん疼痛治療剤 |
| Therapeutic category codes | 878119 |
| YJ codes | 8119002N1023, 8119002N2020, 8119002N3026, 8119002N4022 |
| Approval numbers | 22500AMX01401000, 22500AMX01402000, 22500AMX01403000, 22500AMX01404000 |
| Package insert edition | 第3版 |
| Package insert date | Aug 27, 2026 |
| PMDA document key | 470006_8119002N1023_1 |
| PMDA company code | 470006 |
At a glance
- 1–9 Package insert revisions
- 10–99 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: