PMDA drug package insert
ゾレア皮下注75mgシリンジ
PMDA Prescription drug · ノバルティスファーマ株式会社 · package insert Jan 15, 2025
Key facts
| Brand names | ゾレア皮下注75mgシリンジ, ゾレア皮下注150mgシリンジ, ゾレア皮下注75mgペン, ゾレア皮下注150mgペン, ゾレア皮下注300mgペン |
|---|---|
| Nonproprietary names | オマリズマブ（遺伝子組換え） |
| Companies | 製造販売（輸入）／ノバルティスファーマ株式会社 |
| 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 | 2290400G1021, 2290400G2028, 2290400G3024, 2290400G4020, 2290400G5027 |
| Approval numbers | 23100AMX00313000, 23100AMX00312000, 30600AMX00104000, 30600AMX00105000, 30600AMX00106000 |
| Package insert edition | 第6版 |
| Package insert date | Jan 15, 2025 |
| PMDA document key | 300242_2290400G1021_1 |
| PMDA company code | 300242 |
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: