PMDA drug package insert
アジョビ皮下注225mgシリンジ
PMDA Prescription drug · 大塚製薬株式会社 · package insert Dec 6, 2023
Key facts
| Brand names | アジョビ皮下注225mgシリンジ |
|---|---|
| Nonproprietary names | フレマネズマブ（遺伝子組換え） |
| Companies | 製造販売元／大塚製薬株式会社, 提携／Teva Pharmaceutical Industries Ltd. |
| Product type | Prescription drug |
| Therapeutic category | ヒト化抗CGRPモノクローナル抗体製剤 |
| Therapeutic category codes | 87119 |
| YJ codes | 1190407G1023 |
| Approval numbers | 30300AMX00279 |
| Package insert edition | 第2版 |
| Package insert date | Dec 6, 2023 |
| PMDA document key | 180078_1190407G1023_1 |
| PMDA company code | 180078 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- None Safety communications
- Yes PMDA review report published
- Yes 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: