PMDA drug package insert
エンブレル皮下注25mgペン0.5mL
PMDA Prescription drug · ファイザー株式会社 · package insert Apr 21, 2026
Key facts
| Brand names | エンブレル皮下注25mgペン0.5mL, エンブレル皮下注50mgペン1.0mL |
|---|---|
| Nonproprietary names | エタネルセプト（遺伝子組換え） |
| Companies | 製造販売元／ファイザー株式会社, 販売元／武田薬品工業株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 完全ヒト型可溶性TNFα/LTαレセプター製剤 |
| Therapeutic category codes | 873999 |
| YJ codes | 3999424G4024, 3999424G3028 |
| Approval numbers | 23000AMX00190, 22500AMX00866 |
| Package insert edition | 第5版 |
| Package insert date | Apr 21, 2026 |
| PMDA document key | 672212_3999424G3028_2 |
| PMDA company code | 672212 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- 1–9 Safety communications
- No 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: