PMDA drug package insert
レミケード点滴静注用100
PMDA Prescription drug · 田辺ファーマ株式会社 · package insert Apr 21, 2026
Key facts
| Brand names | レミケード点滴静注用100 |
|---|---|
| Nonproprietary names | インフリキシマブ（遺伝子組換え） |
| Companies | 製造販売元／田辺ファーマ株式会社, 製造元／Janssen Biotech, Inc. |
| Product type | Prescription drug |
| Therapeutic category | 抗ヒトTNFαモノクローナル抗体製剤 |
| Therapeutic category codes | 87239 |
| YJ codes | 2399402F1026 |
| Approval numbers | 21400AMY00013 |
| Package insert edition | 第4版 |
| Package insert date | Apr 21, 2026 |
| PMDA document key | 400315_2399402F1026_1 |
| PMDA company code | 400315 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- 1–9 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: