PMDA drug package insert
オマリズマブBS皮下注75mgシリンジ「CT」
PMDA Prescription drug · セルトリオン・ヘルスケア・ジャパン株式会社 · package insert Mar 24, 2026
Key facts
| Brand names | オマリズマブBS皮下注75mgシリンジ「CT」, オマリズマブBS皮下注150mgシリンジ「CT」, オマリズマブBS皮下注75mgペン「CT」, オマリズマブBS皮下注150mgペン「CT」 |
|---|---|
| Nonproprietary names | オマリズマブ（遺伝子組換え） |
| Companies | 製造販売元（輸入）／セルトリオン・ヘルスケア・ジャパン株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 気管支喘息治療剤 季節性アレルギー性鼻炎治療剤 慢性蕁麻疹治療剤 ヒト化抗ヒトIgEモノクローナル抗体製剤 |
| Therapeutic category codes | 87229, 87449 |
| YJ codes | 22904A5G1028, 22904A5G2024, 22904A5G3020, 22904A5G4027 |
| Approval numbers | 30800AMX00111000, 30800AMX00112000, 30800AMX00113000, 30800AMX00114000 |
| Package insert edition | 第1版 |
| Package insert date | Mar 24, 2026 |
| PMDA document key | 381103_22904A5G1028_1 |
| PMDA company code | 381103 |
At a glance
- 1–9 Package insert revisions
- 1–9 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: