PMDA drug package insert
ジセレカ錠200mg
PMDA Prescription drug · ギリアド・サイエンシズ株式会社 · package insert Jan 23, 2026
Key facts
| Brand names | ジセレカ錠200mg, ジセレカ錠100mg |
|---|---|
| Nonproprietary names | フィルゴチニブマレイン酸塩 |
| Companies | 製造販売元／ギリアド・サイエンシズ株式会社, 販売元／エーザイ株式会社, プロモーション提携／EAファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | ヤヌスキナーゼ（JAK）阻害剤 |
| Therapeutic category codes | 873999 |
| YJ codes | 3999053F2020, 3999053F1023 |
| Approval numbers | 30200AMX00940000, 30200AMX00939000 |
| Package insert edition | 第6版 |
| Package insert date | Jan 23, 2026 |
| PMDA document key | 230867_3999053F1023_1 |
| PMDA company code | 230867 |
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: