PMDA drug package insert
エナラプリルマレイン酸塩錠2.5mg「日新」
PMDA Prescription drug · 日新製薬株式会社 · package insert Sep 9, 2025
Key facts
| Brand names | エナラプリルマレイン酸塩錠2.5mg「日新」, エナラプリルマレイン酸塩錠5mg「日新」, エナラプリルマレイン酸塩錠10mg「日新」 |
|---|---|
| Nonproprietary names | エナラプリルマレイン酸塩 |
| Companies | 製造販売元／日新製薬株式会社, 販売元／第一三共エスファ株式会社, 販売提携／第一三共株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 持続性アンジオテンシン変換酵素阻害剤 |
| Therapeutic category codes | 872144, 872179 |
| YJ codes | 2144002F1342, 2144002F2390, 2144002F3310 |
| Approval numbers | 22700AMX00193, 22700AMX00194, 22700AMX00117 |
| Package insert edition | 第2版 |
| Package insert date | Sep 9, 2025 |
| PMDA document key | 530113_2144002F1342_2 |
| PMDA company code | 530113 |
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: