PMDA drug package insert
ゴナックス皮下注用80mg
PMDA Prescription drug · フェリング・ファーマ株式会社 · package insert Apr 1, 2026
Key facts
| Brand names | ゴナックス皮下注用80mg, ゴナックス皮下注用120mg, ゴナックス皮下注用240mg |
|---|---|
| Nonproprietary names | デガレリクス酢酸塩 |
| Companies | 製造販売元（輸入）／フェリング・ファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | GnRHアンタゴニスト（徐放性）／前立腺癌治療剤 |
| Therapeutic category codes | 872499 |
| YJ codes | 2499412D3027, 2499412D4023, 2499412D5020 |
| Approval numbers | 22400AMX00729, 22400AMX00730, 23100AMX00021 |
| Package insert edition | 第4版 |
| Package insert date | Apr 1, 2026 |
| PMDA document key | 670666_2499412D3027_2 |
| PMDA company code | 670666 |
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: