PMDA drug package insert
ピレスパ錠200mg
PMDA Prescription drug · 塩野義製薬株式会社 · package insert Sep 15, 2023
Key facts
| Brand names | ピレスパ錠200mg |
|---|---|
| Nonproprietary names | ピルフェニドン |
| Companies | 製造販売元／塩野義製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗線維化剤 |
| Therapeutic category codes | 873999 |
| YJ codes | 3999025F1021 |
| Approval numbers | 22000AMX02373000 |
| Package insert edition | 第1版 |
| Package insert date | Sep 15, 2023 |
| PMDA document key | 340018_3999025F1021_1 |
| PMDA company code | 340018 |
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: