PMDA drug package insert
ジレニアカプセル0.5mg
PMDA Prescription drug · ノバルティスファーマ株式会社 · package insert Dec 17, 2021
Key facts
| Brand names | ジレニアカプセル0.5mg |
|---|---|
| Nonproprietary names | フィンゴリモド塩酸塩 |
| Companies | 製造販売／ノバルティスファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 多発性硬化症治療剤 |
| Therapeutic category codes | 873999 |
| YJ codes | 3999029M1037 |
| Approval numbers | 22300AMX01208000 |
| Package insert edition | 第2版 |
| Package insert date | Dec 17, 2021 |
| PMDA document key | 300242_3999029M1037_1 |
| PMDA company code | 300242 |
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: