PMDA drug package insert
エンレスト錠50mg
PMDA Prescription drug · ノバルティスファーマ株式会社 · package insert Oct 1, 2026
Key facts
| Brand names | エンレスト錠50mg, エンレスト錠100mg, エンレスト錠200mg, エンレスト粒状錠小児用12.5mg, エンレスト粒状錠小児用31.25mg |
|---|---|
| Nonproprietary names | サクビトリルバルサルタンナトリウム水和物 |
| Companies | 製造販売（輸入）／ノバルティスファーマ株式会社, 提携／大塚製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | アンジオテンシン受容体ネプリライシン阻害薬（ARNI） |
| Therapeutic category codes | 872149, 87219 |
| YJ codes | 2190041F1027, 2190041F2023, 2190041F3020, 2190041F4026, 2190041F5022 |
| Approval numbers | 30200AMX00504000, 30200AMX00502000, 30200AMX00503000, 30600AMX00113000, 30600AMX00114000 |
| Package insert edition | 第10版 |
| Package insert date | Oct 1, 2026 |
| PMDA document key | 300242_2190041F1027_1 |
| PMDA company code | 300242 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- 1–9 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: