PMDA drug package insert
ペグフィルグラスチムBS皮下注3.6mg「GRP」
PMDA Prescription drug · グローバルレギュラトリーパートナーズ合同会社 · package insert Sep 14, 2026
Key facts
| Brand names | ペグフィルグラスチムBS皮下注3.6mg「GRP」 |
|---|---|
| Nonproprietary names | ペグフィルグラスチム（遺伝子組換え） |
| Companies | 製造販売元／グローバルレギュラトリーパートナーズ合同会社, 販売元／サンド株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 持続型G-CSF製剤 |
| Therapeutic category codes | 873399 |
| YJ codes | 33994A9G1021 |
| Approval numbers | 30800AMX00316000 |
| Package insert edition | 第1版 |
| Package insert date | Sep 14, 2026 |
| PMDA document key | 252200_33994A9G1021_1 |
| PMDA company code | 252200 |
At a glance
- 1–9 Package insert revisions
- 1–9 Related PMDA documents
- None Safety communications
- Yes PMDA review report published
- Yes 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: