PMDA drug package insert
プロチレリン酒石酸塩注0.5mg「NP」
PMDA Prescription drug · ニプロ株式会社 · package insert Jun 16, 2025
Key facts
| Brand names | プロチレリン酒石酸塩注0.5mg「NP」 |
|---|---|
| Nonproprietary names | プロチレリン酒石酸塩水和物 |
| Companies | 製造販売元／ニプロ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 遷延性意識障害治療剤; 脊髄小脳変性症治療剤; TSH分泌機能検査用剤; TSH（Thyroid Stimulating Hormone）：甲状腺刺激ホルモン |
| Therapeutic category codes | 87119, 877223 |
| YJ codes | 7223401A1120 |
| Approval numbers | 22500AMX00807 |
| Package insert edition | 第1版 |
| Package insert date | Jun 16, 2025 |
| PMDA document key | 530100_7223401A1120_1 |
| PMDA company code | 530100 |
At a glance
- 1–9 Package insert revisions
- 1–9 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: