PMDA drug package insert
シクレスト舌下錠5mg
PMDA Prescription drug · Meiji Seika ファルマ株式会社 · package insert Jun 18, 2025
Key facts
| Brand names | シクレスト舌下錠5mg, シクレスト舌下錠10mg |
|---|---|
| Nonproprietary names | アセナピンマレイン酸塩 |
| Companies | 製造販売元／Meiji Seika ファルマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗精神病剤 |
| Therapeutic category codes | 871179 |
| YJ codes | 1179056F1021, 1179056F2028 |
| Approval numbers | 22800AMX00377000, 22800AMX00378000 |
| Package insert edition | 第5版、承認条件の項削除 |
| Package insert date | Jun 18, 2025 |
| PMDA document key | 780009_1179056F1021_1 |
| PMDA company code | 780009 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- None Safety communications
- Yes 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: