PMDA drug package insert
オプソ内服液5mg
PMDA Prescription drug · 住友ファーマ株式会社 · package insert Mar 17, 2026
Key facts
| Brand names | オプソ内服液5mg, オプソ内服液10mg |
|---|---|
| Nonproprietary names | モルヒネ塩酸塩水和物 |
| Companies | 製造販売元／住友ファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | がん疼痛治療用内服液剤 |
| Therapeutic category codes | 878114 |
| YJ codes | 8114005S1024, 8114005S2020 |
| Approval numbers | 21500AMZ00335, 21500AMZ00336 |
| Package insert edition | 第4版 |
| Package insert date | Mar 17, 2026 |
| PMDA document key | 400093_8114005S1024_1 |
| PMDA company code | 400093 |
At a glance
- 1–9 Package insert revisions
- 1–9 Related PMDA documents
- None Safety communications
- Yes 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: