PMDA drug package insert
オプチレイ320注20mL
PMDA Prescription drug · ゲルベ・ジャパン株式会社 · package insert Sep 19, 2023
Key facts
| Brand names | オプチレイ320注20mL, オプチレイ320注50mL, オプチレイ320注100mL, オプチレイ350注20mL, オプチレイ350注50mL, オプチレイ350注100mL |
|---|---|
| Nonproprietary names | イオベルソール |
| Companies | 製造販売元／ゲルベ・ジャパン株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 非イオン性造影剤 |
| Therapeutic category codes | 877219 |
| YJ codes | 7219416A8030, 7219416A9036, 7219416H1033, 7219416H2030, 7219416H3036, 7219416H4032 |
| Approval numbers | 22100AMX00412, 22100AMX00413, 22100AMX00415, 22100AMX00416, 22100AMX00417, 22100AMX00418 |
| Package insert edition | 第1版 |
| Package insert date | Sep 19, 2023 |
| PMDA document key | 260106_7219416A8030_5 |
| PMDA company code | 260106 |
At a glance
- 1–9 Package insert revisions
- 10–99 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: