PMDA drug package insert
メラトベル顆粒小児用0.2%
PMDA Prescription drug · ノーベルファーマ株式会社 · package insert Sep 17, 2026
Key facts
| Brand names | メラトベル顆粒小児用0.2%, メラトベル錠小児用1mg, メラトベル錠小児用2mg |
|---|---|
| Nonproprietary names | メラトニン |
| Companies | 製造販売元／ノーベルファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | メラトニン受容体作動性入眠改善剤 |
| Therapeutic category codes | 871190 |
| YJ codes | 1190028D1026, 1190028F1027, 1190028F2023 |
| Approval numbers | 30200AMX00439000, 30700AMX00060000, 30700AMX00061000 |
| Package insert edition | 第7版 |
| Package insert date | Sep 17, 2026 |
| PMDA document key | 620095_1190028D1026_1 |
| PMDA company code | 620095 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- None Safety communications
- Yes PMDA review report published
- Yes 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: