PMDA drug package insert
ガドビスト静注1.0mol/Lシリンジ5mL
PMDA Prescription drug · バイエル薬品株式会社 · package insert Sep 30, 2024
Key facts
| Brand names | ガドビスト静注1.0mol/Lシリンジ5mL, ガドビスト静注1.0mol/Lシリンジ7.5mL, ガドビスト静注1.0mol/Lシリンジ10mL |
|---|---|
| Nonproprietary names | ガドブトロール |
| Companies | 製造販売元／バイエル薬品株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 環状型非イオン性MRI用造影剤 |
| Therapeutic category codes | 87729 |
| YJ codes | 7290416G1025, 7290416G2021, 7290416G3028 |
| Approval numbers | 22700AMX00651000, 22700AMX00652000, 22700AMX00653000 |
| Package insert edition | 第3版 |
| Package insert date | Sep 30, 2024 |
| PMDA document key | 630004_7290416G1025_1 |
| PMDA company code | 630004 |
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: