PMDA drug package insert
アフィニトール錠2.5mg
PMDA Prescription drug · ノバルティスファーマ株式会社 · package insert Jun 3, 2024
Key facts
| Brand names | アフィニトール錠2.5mg, アフィニトール錠5mg |
|---|---|
| Nonproprietary names | エベロリムス |
| 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 | 抗悪性腫瘍剤 （mTOR阻害剤） |
| Therapeutic category codes | 874291 |
| YJ codes | 4291023F2027, 4291023F1020 |
| Approval numbers | 22400AMX01370000, 22200AMX00246000 |
| Package insert edition | 第3版、再審査結果 |
| Package insert date | Jun 3, 2024 |
| PMDA document key | 300242_4291023F1020_1 |
| PMDA company code | 300242 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- 1–9 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: