PMDA drug package insert
グルトパ注600万
PMDA Prescription drug · 田辺ファーマ株式会社 · package insert Dec 1, 2025
Key facts
| Brand names | グルトパ注600万, グルトパ注1200万, グルトパ注2400万 |
|---|---|
| Nonproprietary names | アルテプラーゼ（遺伝子組換え） |
| Companies | 製造販売元／田辺ファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 血栓溶解剤（静注用rt-PA製剤） |
| Therapeutic category codes | 873959 |
| YJ codes | 3959402D1035, 3959402D2031, 3959402D3038 |
| Approval numbers | 20300AMZ00233, 20300AMZ00234, 20300AMZ00235 |
| Package insert edition | 第3版 |
| Package insert date | Dec 1, 2025 |
| PMDA document key | 400315_3959402D1035_3 |
| PMDA company code | 400315 |
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: