PMDA drug package insert
アトモキセチンカプセル5mg「サワイ」
PMDA Prescription drug · 沢井製薬株式会社 · package insert Sep 29, 2023
Key facts
| Brand names | アトモキセチンカプセル5mg「サワイ」, アトモキセチンカプセル10mg「サワイ」, アトモキセチンカプセル25mg「サワイ」, アトモキセチンカプセル40mg「サワイ」 |
|---|---|
| Nonproprietary names | アトモキセチン塩酸塩 |
| Companies | 製造販売元／沢井製薬株式会社 |
| 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 | 1179050M1031, 1179050M2038, 1179050M3034, 1179050M4030 |
| Approval numbers | 23000AMX00648000, 23000AMX00649000, 23000AMX00650000, 23000AMX00659000 |
| Package insert edition | 第1版 |
| Package insert date | Sep 29, 2023 |
| PMDA document key | 300119_1179050M1031_1 |
| PMDA company code | 300119 |
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: