PMDA drug package insert
ゾテピン細粒10％「タカタ」
PMDA Prescription drug · 高田製薬株式会社 · package insert Oct 29, 2024
Key facts
| Brand names | ゾテピン細粒10％「タカタ」, ゾテピン細粒50％「タカタ」, ゾテピン錠25mg「タカタ」, ゾテピン錠50mg「タカタ」, ゾテピン錠100mg「タカタ」 |
|---|---|
| Nonproprietary names | ゾテピン |
| Companies | 製造販売元／高田製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 統合失調症治療剤 |
| Therapeutic category codes | 871179 |
| YJ codes | 1179024C1106, 1179024C2080, 1179024F1099, 1179024F2095, 1179024F3083 |
| Approval numbers | 23000AMX00502, 23000AMX00503, 23000AMX00504, 23000AMX00505, 23000AMX00506 |
| Package insert edition | 第2版 |
| Package insert date | Oct 29, 2024 |
| PMDA document key | 400186_1179024C1106_1 |
| PMDA company code | 400186 |
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: