PMDA drug package insert
オファコルカプセル50mg
PMDA Prescription drug · 株式会社レクメド · package insert Sep 24, 2026
Key facts
| Brand names | オファコルカプセル50mg |
|---|---|
| Nonproprietary names | コール酸 |
| Companies | 製造販売元／株式会社レクメド |
| Product type | Prescription drug |
| Therapeutic category | 先天性胆汁酸代謝異常症治療薬 |
| Therapeutic category codes | 873999 |
| YJ codes | 3999059M1020 |
| Approval numbers | 30500AMX00125000 |
| Package insert edition | 第3版 |
| Package insert date | Sep 24, 2026 |
| PMDA document key | 870207_3999059M1020_1 |
| PMDA company code | 870207 |
At a glance
- 1–9 Package insert revisions
- 1–9 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: