PMDA drug package insert
アトモキセチンカプセル5mg「アメル」
PMDA Prescription drug · 共和薬品工業株式会社 · package insert Dec 25, 2023
Key facts
| Brand names | アトモキセチンカプセル5mg「アメル」, アトモキセチンカプセル10mg「アメル」, アトモキセチンカプセル25mg「アメル」, アトモキセチンカプセル40mg「アメル」 |
|---|---|
| Nonproprietary names | アトモキセチン塩酸塩 |
| Companies | 製造販売元／共和薬品工業株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 注意欠陥／多動性障害治療剤（選択的ノルアドレナリン再取り込み阻害剤） |
| Therapeutic category codes | 871179 |
| YJ codes | 1179050M1066, 1179050M2062, 1179050M3069, 1179050M4065 |
| Approval numbers | 23100AMX00267, 23100AMX00268, 23100AMX00269, 23100AMX00270 |
| Package insert edition | 第1版 |
| Package insert date | Dec 25, 2023 |
| PMDA document key | 672173_1179050M1066_2 |
| PMDA company code | 672173 |
At a glance
- 1–9 Package insert revisions
- 10–99 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: