PMDA drug package insert
オムニパーク300注20mL
PMDA Prescription drug · GEヘルスケアファーマ株式会社 · package insert Apr 26, 2024
Key facts
| Brand names | オムニパーク300注20mL, オムニパーク300注50mL, オムニパーク300注100mL, オムニパーク350注20mL, オムニパーク350注50mL, オムニパーク350注100mL |
|---|---|
| Nonproprietary names | イオヘキソール |
| Companies | 製造販売元／GEヘルスケアファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 非イオン性造影剤 |
| Therapeutic category codes | 877219 |
| YJ codes | 7219415A9066, 7219415H1071, 7219415H2078, 7219415H3066, 7219415H4062, 7219415H5069 |
| Approval numbers | 22100AMX01024, 22100AMX01025, 22100AMX01026, 22100AMX01028, 22100AMX01029, 22100AMX01030 |
| Package insert edition | 第4版 |
| Package insert date | Apr 26, 2024 |
| PMDA document key | 343048_7219415A9066_1 |
| PMDA company code | 343048 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- None Safety communications
- No 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: