PMDA drug package insert
シムジア皮下注200㎎シリンジ
PMDA Prescription drug · ユーシービージャパン株式会社 · package insert Jul 1, 2025
Key facts
| Brand names | シムジア皮下注200㎎シリンジ, シムジア皮下注200㎎オートクリックス |
|---|---|
| Nonproprietary names | セルトリズマブ ペゴル（遺伝子組換え） |
| Companies | 製造販売元／ユーシービージャパン株式会社 |
| Product type | Prescription drug |
| Therapeutic category | TNFα阻害薬 （ペグヒト化抗ヒトTNFαモノクローナル抗体Fab’断片製剤） |
| Therapeutic category codes | 873999 |
| YJ codes | 3999437G1022, 3999437G2029 |
| Approval numbers | 22400AMX01488000, 23000AMX00796000 |
| Package insert edition | 第7版 |
| Package insert date | Jul 1, 2025 |
| PMDA document key | 820110_3999437G1022_1 |
| PMDA company code | 820110 |
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: