PMDA drug package insert
デュタステリド錠0.5mgAV「NS」
PMDA Prescription drug · 日新製薬株式会社 · package insert Dec 28, 2023
Key facts
| Brand names | デュタステリド錠0.5mgAV「NS」 |
|---|---|
| Nonproprietary names | デュタステリド |
| Companies | 製造販売元／日新製薬株式会社, 販売元／日本ケミファ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 5α還元酵素阻害薬; 前立腺肥大症治療薬 |
| Therapeutic category codes | 87249 |
| YJ codes | 2499011F1036 |
| Approval numbers | 30200AMX00286000 |
| Package insert edition | 第1版 |
| Package insert date | Dec 28, 2023 |
| PMDA document key | 530113_2499011F1036_2 |
| PMDA company code | 530113 |
At a glance
- 1–9 Package insert revisions
- 1–9 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: