PMDA drug package insert
マグネスコープ静注38%シリンジ10mL
PMDA Prescription drug · ゲルベ・ジャパン株式会社 · package insert Jul 10, 2023
Key facts
| Brand names | マグネスコープ静注38%シリンジ10mL, マグネスコープ静注38%シリンジ11mL, マグネスコープ静注38%シリンジ13mL, マグネスコープ静注38%シリンジ15mL, マグネスコープ静注38%シリンジ20mL |
|---|---|
| Nonproprietary names | ガドテル酸メグルミン |
| Companies | 製造販売元／ゲルベ・ジャパン株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 環状型MRI用造影剤 |
| Therapeutic category codes | 87729 |
| YJ codes | 7290411G1030, 7290411G4021, 7290411G5028, 7290411G2037, 7290411G3033 |
| Approval numbers | 22300AMX00405, 22600AMX00981, 22600AMX00982, 22300AMX00406, 22300AMX00407 |
| Package insert edition | 第1版 |
| Package insert date | Jul 10, 2023 |
| PMDA document key | 260106_7290411G1030_1 |
| PMDA company code | 260106 |
At a glance
- 1–9 Package insert revisions
- 1–9 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: