PMDA drug package insert
シンポニー皮下注50mgシリンジ
PMDA Prescription drug · ヤンセンファーマ株式会社 · package insert Dec 1, 2025
Key facts
| Brand names | シンポニー皮下注50mgシリンジ, シンポニー皮下注50mgオートインジェクター |
|---|---|
| Nonproprietary names | ゴリムマブ（遺伝子組換え） |
| Companies | 製造販売元（輸入）／ヤンセンファーマ株式会社, 発売元／田辺ファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | ヒト型抗ヒトTNFαモノクローナル抗体製剤 |
| Therapeutic category codes | 873999 |
| YJ codes | 3999433G1024, 3999433G2020 |
| Approval numbers | 22300AMX00596000, 23100AMX00278000 |
| Package insert edition | 第8版 |
| Package insert date | Dec 1, 2025 |
| PMDA document key | 800155_3999433G1024_1 |
| PMDA company code | 800155 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- 1–9 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: