PMDA drug package insert
オプスミット小児用分散錠1mg
PMDA Prescription drug · ヤンセンファーマ株式会社 · package insert Mar 18, 2026
Key facts
| Brand names | オプスミット小児用分散錠1mg, オプスミット小児用分散錠2.5mg |
|---|---|
| Nonproprietary names | マシテンタン |
| Companies | 製造販売元（輸入）／ヤンセンファーマ株式会社, 販売提携先／日本新薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | エンドセリン受容体拮抗薬 |
| Therapeutic category codes | 87219 |
| YJ codes | 2190035X1027, 2190035X2023 |
| Approval numbers | 30700AMX00275000, 30700AMX00271000 |
| Package insert edition | 第1版 |
| Package insert date | Mar 18, 2026 |
| PMDA document key | 800155_2190035X1027_1 |
| PMDA company code | 800155 |
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: