PMDA drug package insert
スマイラフ錠50mg
PMDA Prescription drug · アステラス製薬株式会社 · package insert Aug 29, 2023
Key facts
| Brand names | スマイラフ錠50mg, スマイラフ錠100mg |
|---|---|
| Nonproprietary names | ペフィシチニブ臭化水素酸塩 |
| Companies | 製造販売／アステラス製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | ヤヌスキナーゼ（JAK）阻害剤 |
| Therapeutic category codes | 873999 |
| YJ codes | 3999046F1023, 3999046F2020 |
| Approval numbers | 23100AMX00285, 23100AMX00286 |
| Package insert edition | 第3版 |
| Package insert date | Aug 29, 2023 |
| PMDA document key | 800126_3999046F1023_1 |
| PMDA company code | 800126 |
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: