PMDA drug package insert
レギュニール HCa 1.5腹膜透析液
PMDA Prescription drug · 製造販売業者（輸入元）株式会社ヴァンティブ · package insert Jun 16, 2026
Key facts
| Brand names | レギュニール HCa 1.5腹膜透析液, レギュニール HCa 2.5腹膜透析液, レギュニール HCa 4.25腹膜透析液 |
|---|---|
| Nonproprietary names | 腹膜透析液 |
| Companies | 製造販売元／製造販売業者（輸入元）株式会社ヴァンティブ |
| Product type | Prescription drug |
| Therapeutic category | 腹膜透析用剤 |
| Therapeutic category codes | 87342 |
| YJ codes | 3420433A1024, 3420433A2020, 3420433A3027, 3420433A4023, 3420433A5020, 3420434A1029, 3420434A2025, 3420434A3021, 3420434A4028, 3420434A5024, 3420435A1023, 3420435A2020 |
| Approval numbers | 22500AMX01821000, 22500AMX01823000, 22500AMX01822000 |
| Package insert edition | 第3版 |
| Package insert date | Jun 16, 2026 |
| PMDA document key | 480348_3420433A1024_1 |
| PMDA company code | 480348 |
At a glance
- 1–9 Package insert revisions
- 1–9 Related PMDA documents
- None Safety communications
- Yes 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: