PMDA drug package insert
トラクリア小児用分散錠32mg
PMDA Prescription drug · ヤンセンファーマ株式会社 · package insert Nov 26, 2025
Key facts
| Brand names | トラクリア小児用分散錠32mg |
|---|---|
| Nonproprietary names | ボセンタン水和物 |
| Companies | 製造販売元（輸入）／ヤンセンファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | エンドセリン受容体拮抗薬 |
| Therapeutic category codes | 87219 |
| YJ codes | 2190026X1028 |
| Approval numbers | 22700AMX01006000 |
| Package insert edition | 第2版 |
| Package insert date | Nov 26, 2025 |
| PMDA document key | 800155_2190026X1028_2 |
| 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: