PMDA drug package insert
ラメルテオン錠8mg「日新」
PMDA Prescription drug · 日新製薬株式会社 · package insert Jun 12, 2026
Key facts
| Brand names | ラメルテオン錠8mg「日新」 |
|---|---|
| Nonproprietary names | ラメルテオン |
| Companies | 製造販売元／日新製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | メラトニン受容体アゴニスト |
| Therapeutic category codes | 87119 |
| YJ codes | 1190016F1083 |
| Approval numbers | 30400AMX00388000 |
| Package insert edition | 第2版 |
| Package insert date | Jun 12, 2026 |
| PMDA document key | 530113_1190016F1083_1 |
| PMDA company code | 530113 |
At a glance
- 1–9 Package insert revisions
- 1–9 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: