PMDA drug package insert
ハイゼット錠25mg
PMDA Prescription drug · 大塚製薬株式会社 · package insert Nov 7, 2022
Key facts
| Brand names | ハイゼット錠25mg, ハイゼット錠50mg |
|---|---|
| Nonproprietary names | ガンマオリザノール |
| Companies | 製造販売元／大塚製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 高脂血症治療剤; 心身症（更年期障害、過敏性腸症候群）治療剤 |
| Therapeutic category codes | 872189, 871129 |
| YJ codes | 2900002F4065, 2900002F5274 |
| Approval numbers | 21800AMX10145, 21800AMX10146 |
| Package insert edition | 第1版 |
| Package insert date | Nov 7, 2022 |
| PMDA document key | 180078_2900002F4065_1 |
| PMDA company code | 180078 |
At a glance
- 1–9 Package insert revisions
- 1–9 Related PMDA documents
- None Safety communications
- No 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: