PMDA drug package insert
モディオダール錠100mg
PMDA Prescription drug · アルフレッサ ファーマ株式会社 · package insert Dec 1, 2025
Key facts
| Brand names | モディオダール錠100mg |
|---|---|
| Nonproprietary names | モダフィニル |
| Companies | 製造販売元／アルフレッサ ファーマ株式会社, 販売元／田辺ファーマ株式会社, 提携先／Cephalon |
| Product type | Prescription drug |
| Therapeutic category | 精神神経用剤 |
| Therapeutic category codes | 871179 |
| YJ codes | 1179047F1022 |
| Approval numbers | 21900AMZ00005 |
| Package insert edition | 第2版 |
| Package insert date | Dec 1, 2025 |
| PMDA document key | 530258_1179047F1022_2 |
| PMDA company code | 530258 |
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: