PMDA drug package insert
ベイフォータス筋注50mgシリンジ
PMDA Prescription drug · サノフィ株式会社 · package insert Jun 26, 2026
Key facts
| Brand names | ベイフォータス筋注50mgシリンジ, ベイフォータス筋注100mgシリンジ |
|---|---|
| Nonproprietary names | ニルセビマブ（遺伝子組換え） |
| Companies | 製造販売元／サノフィ株式会社, プロモーション提携／アストラゼネカ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 抗RSウイルスヒトモノクローナル抗体製剤 |
| Therapeutic category codes | 87625 |
| YJ codes | 6250411G1022, 6250411G2029 |
| Approval numbers | 30600AMX00127, 30600AMX00128 |
| Package insert edition | 第3版 |
| Package insert date | Jun 26, 2026 |
| PMDA document key | 780069_6250411G1022_2 |
| PMDA company code | 780069 |
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: