PMDA drug package insert
クロザリル錠25mg
PMDA Prescription drug · ノバルティスファーマ株式会社 · package insert Oct 18, 2024
Key facts
| Brand names | クロザリル錠25mg, クロザリル錠100mg |
|---|---|
| Nonproprietary names | クロザピン |
| 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 | 治療抵抗性統合失調症治療薬 |
| Therapeutic category codes | 871179 |
| YJ codes | 1179049F1021, 1179049F2028 |
| Approval numbers | 22100AMX00660000, 22100AMX00661000 |
| Package insert edition | 第4版 |
| Package insert date | Oct 18, 2024 |
| PMDA document key | 300242_1179049F1021_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: