PMDA drug package insert
フォリスチム注300IUカートリッジ
PMDA Prescription drug · オルガノン株式会社 · package insert Jun 3, 2024
Key facts
| Brand names | フォリスチム注300IUカートリッジ, フォリスチム注600IUカートリッジ, フォリスチム注900IUカートリッジ |
|---|---|
| Nonproprietary names | フォリトロピン ベータ（遺伝子組換え） |
| Companies | 製造販売元／オルガノン株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 遺伝子組換えヒト卵胞刺激ホルモン製剤 |
| Therapeutic category codes | 872413 |
| YJ codes | 2413405G4025, 2413405G5021, 2413405G6028 |
| Approval numbers | 30600AMX00003000, 30600AMX00001000, 30600AMX00002000 |
| Package insert edition | 第1版 |
| Package insert date | Jun 3, 2024 |
| PMDA document key | 181615_2413405G4025_1 |
| PMDA company code | 181615 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- None 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: