PMDA drug package insert
オプチレイ240注シリンジ100mL
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240注シリンジ100mL, オプチレイ320注シリンジ75mL, オプチレイ320注シリンジ100mL, オプチレイ350注シリンジ100mL, オプチレイ350注シリンジ135mL |
|---|---|
| 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 | 7219416G1038, 7219416G3030, 7219416G4037, 7219416G9039, 7219416P1020 |
| Approval numbers | 22100AMX00858, 22100AMX00884, 22100AMX00848, 22100AMX00805, 22900AMX00526 |
| Package insert edition | 第1版 |
| Package insert date | Sep 19, 2023 |
| PMDA document key | 260106_7219416G1038_4 |
| 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: