PMDA drug package insert
クエチアピン錠12.5mg「アメル」
PMDA Prescription drug · 共和薬品工業株式会社 · package insert Sep 18, 2026
Key facts
| Brand names | クエチアピン錠12.5mg「アメル」, クエチアピン錠25mg「アメル」, クエチアピン錠50mg「アメル」, クエチアピン錠100mg「アメル」, クエチアピン錠200mg「アメル」, クエチアピン細粒10％「アメル」, クエチアピン細粒50％「アメル」 |
|---|---|
| Nonproprietary names | クエチアピンフマル酸塩 |
| Companies | 製造販売元／共和薬品工業株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗精神病剤 |
| Therapeutic category codes | 871179 |
| YJ codes | 1179042F4029, 1179042F1100, 1179042F5041, 1179042F2107, 1179042F3103, 1179042C2020, 1179042C1040 |
| Approval numbers | 22400AMX01254, 22400AMX01041, 22500AMX00078, 22400AMX01039, 22400AMX01040, 22700AMX00327, 22400AMX01038 |
| Package insert edition | 第5版 |
| Package insert date | Sep 18, 2026 |
| PMDA document key | 672173_1179042C1040_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: