PMDA drug package insert
ゾルピデム酒石酸塩錠5mg「アメル」
PMDA Prescription drug · 共和薬品工業株式会社 · package insert Jan 24, 2025
Key facts
| Brand names | ゾルピデム酒石酸塩錠5mg「アメル」, ゾルピデム酒石酸塩錠10mg「アメル」 |
|---|---|
| Nonproprietary names | ゾルピデム酒石酸塩 |
| Companies | 製造販売元／共和薬品工業株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 入眠剤 |
| Therapeutic category codes | 871129 |
| YJ codes | 1129009F1203, 1129009F2200 |
| Approval numbers | 22400AMX00207, 22400AMX00208 |
| Package insert edition | 第3版 |
| Package insert date | Jan 24, 2025 |
| PMDA document key | 672173_1129009F1203_2 |
| PMDA company code | 672173 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- 1–9 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: