PMDA drug package insert
グーフィス錠5mg
PMDA Prescription drug · EAファーマ株式会社 · package insert Apr 11, 2022
Key facts
| Brand names | グーフィス錠5mg |
|---|---|
| Nonproprietary names | エロビキシバット水和物 |
| Companies | 製造販売元／EAファーマ株式会社, 販売／持田製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 胆汁酸トランスポーター阻害剤 |
| Therapeutic category codes | 872359 |
| YJ codes | 2359008F1025 |
| Approval numbers | 23000AMX00013 |
| Package insert edition | 第2版 |
| Package insert date | Apr 11, 2022 |
| PMDA document key | 111890_2359008F1025_2 |
| PMDA company code | 111890 |
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: