PMDA drug package insert
ダルテパリンNa静注2500単位/10mLシリンジ「ニプロ」
PMDA Prescription drug · ニプロ株式会社 · package insert May 20, 2025
Key facts
| Brand names | ダルテパリンNa静注2500単位/10mLシリンジ「ニプロ」, ダルテパリンNa静注3000単位/12mLシリンジ「ニプロ」, ダルテパリンNa静注4000単位/16mLシリンジ「ニプロ」, ダルテパリンNa静注5000単位/20mLシリンジ「ニプロ」 |
|---|---|
| Nonproprietary names | ダルテパリンナトリウム |
| Companies | 製造販売元／ニプロ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 血液凝固阻止剤 |
| Therapeutic category codes | 873334 |
| YJ codes | 3334403G2022, 3334403G3029, 3334403G4025, 3334403G5021 |
| Approval numbers | 22200AMX00220, 22200AMX00221, 22200AMX00222, 22200AMX00223 |
| Package insert edition | 第4版 |
| Package insert date | May 20, 2025 |
| PMDA document key | 530100_3334403G2022_3 |
| PMDA company code | 530100 |
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: