PMDA drug package insert
エムガルティ皮下注120mgオートインジェクター
PMDA Prescription drug · 日本イーライリリー株式会社 · package insert May 2, 2022
Key facts
| Brand names | エムガルティ皮下注120mgオートインジェクター, エムガルティ皮下注120mgシリンジ |
|---|---|
| Nonproprietary names | ガルカネズマブ（遺伝子組換え） |
| Companies | 製造販売元／日本イーライリリー株式会社, 販売元／第一三共株式会社 |
| 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 | 871190 |
| YJ codes | 1190404G2026, 1190404G1020 |
| Approval numbers | 30300AMX00004, 30300AMX00005 |
| Package insert edition | 第4版 |
| Package insert date | May 2, 2022 |
| PMDA document key | 530471_1190404G1020_1 |
| PMDA company code | 530471 |
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: