PMDA drug package insert
セトロタイド注射用0.25mg
PMDA Prescription drug · 日本化薬株式会社 · package insert Aug 18, 2026
Key facts
| Brand names | セトロタイド注射用0.25mg |
|---|---|
| Nonproprietary names | セトロレリクス酢酸塩 |
| Companies | 製造販売元／日本化薬株式会社, 販売元／メルクバイオファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | GnRHアンタゴニスト製剤 |
| Therapeutic category codes | 872499 |
| YJ codes | 2499421D1023 |
| Approval numbers | 21800AMY10090 |
| Package insert edition | 第5版 |
| Package insert date | Aug 18, 2026 |
| PMDA document key | 530191_2499421D1023_1 |
| PMDA company code | 530191 |
At a glance
- 1–9 Package insert revisions
- 1–9 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: