PMDA drug package insert
パロキセチン錠5mg「SPKK」
PMDA Prescription drug · サンドファーマ株式会社 · package insert Dec 11, 2023
Key facts
| Brand names | パロキセチン錠5mg「SPKK」, パロキセチン錠10mg「SPKK」, パロキセチン錠20mg「SPKK」 |
|---|---|
| Nonproprietary names | パロキセチン塩酸塩水和物 |
| Companies | 製造販売／サンドファーマ株式会社, 販売／サンド株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 選択的セロトニン再取り込み阻害剤 |
| Therapeutic category codes | 871179 |
| YJ codes | 1179041F3354, 1179041F1360, 1179041F2366 |
| Approval numbers | 30300AMX00300000, 30300AMX00301000, 30300AMX00302000 |
| Package insert edition | 第1版 |
| Package insert date | Dec 11, 2023 |
| PMDA document key | 112268_1179041F1360_1 |
| PMDA company code | 112268 |
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: