PMDA drug package insert
ゴナールエフ皮下注ペン150
PMDA Prescription drug · メルクバイオファーマ株式会社 · package insert Jan 24, 2025
Key facts
| Brand names | ゴナールエフ皮下注ペン150, ゴナールエフ皮下注ペン300, ゴナールエフ皮下注ペン450, ゴナールエフ皮下注ペン900 |
|---|---|
| Nonproprietary names | ホリトロピン アルファ（遺伝子組換え） |
| Companies | 製造販売元／メルクバイオファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 遺伝子組換えヒト卵胞刺激ホルモン（FSH）製剤 |
| Therapeutic category codes | 872413 |
| YJ codes | 2413404G4020, 2413404G3024, 2413404G1021, 2413404G2028 |
| Approval numbers | 30500AMX00169000, 22000AMX02408000, 22000AMX02409000, 22000AMX02410000 |
| Package insert edition | 第7版 |
| Package insert date | Jan 24, 2025 |
| PMDA document key | 380079_2413404G1021_1 |
| PMDA company code | 380079 |
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: