PMDA drug package insert
アムロジピン錠2.5mg「DSEP」
PMDA Prescription drug · 第一三共エスファ株式会社 · package insert Jun 25, 2026
Key facts
| Brand names | アムロジピン錠2.5mg「DSEP」, アムロジピン錠5mg「DSEP」, アムロジピン錠10mg「DSEP」 |
|---|---|
| Nonproprietary names | アムロジピンベシル酸塩 |
| Companies | 製造販売元／第一三共エスファ株式会社, 販売／株式会社エッセンシャルファーマ |
| Product type | Prescription drug |
| Therapeutic category | 高血圧症・狭心症治療薬/持続性Ca拮抗薬 |
| Therapeutic category codes | 872171 |
| YJ codes | 2171022F1401, 2171022F2408, 2171022F5253 |
| Approval numbers | 22000AMX01032, 22000AMX01033, 22500AMX00254 |
| Package insert edition | 第4版 |
| Package insert date | Jun 25, 2026 |
| PMDA document key | 430773_2171022F1401_2 |
| PMDA company code | 430773 |
At a glance
- 1–9 Package insert revisions
- 10–99 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: