PMDA drug package insert
トレプロスト注射液20mg
PMDA Prescription drug · 持田製薬株式会社 · package insert Sep 24, 2024
Key facts
| Brand names | トレプロスト注射液20mg, トレプロスト注射液50mg, トレプロスト注射液100mg, トレプロスト注射液200mg |
|---|---|
| Nonproprietary names | トレプロスチニル |
| Companies | 製造販売元／持田製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | プロスタグランジンI2誘導体製剤 |
| Therapeutic category codes | 87219 |
| YJ codes | 2190416A1024, 2190416A2020, 2190416A3027, 2190416A4023 |
| Approval numbers | 22600AMX00544000, 22600AMX00545000, 22600AMX00546000, 22600AMX00547000 |
| Package insert edition | 第5版 |
| Package insert date | Sep 24, 2024 |
| PMDA document key | 790005_2190416A1024_1 |
| PMDA company code | 790005 |
At a glance
- 1–9 Package insert revisions
- 10–99 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: