PMDA drug package insert
オキサロール注2.5μg
PMDA Prescription drug · LTLファーマ株式会社 · package insert Jan 31, 2025
Key facts
| Brand names | オキサロール注2.5μg, オキサロール注5μg, オキサロール注10μg |
|---|---|
| Nonproprietary names | マキサカルシトール |
| Companies | 製造販売／LTLファーマ株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 二次性副甲状腺機能亢進症治療剤 |
| Therapeutic category codes | 873112 |
| YJ codes | 3112401A1026, 3112401A2022, 3112401A3029 |
| Approval numbers | 21200AMZ00458, 21200AMZ00459, 21200AMZ00460 |
| Package insert edition | 第3版 |
| Package insert date | Jan 31, 2025 |
| PMDA document key | 171911_3112401A1026_3 |
| PMDA company code | 171911 |
At a glance
- 1–9 Package insert revisions
- 1–9 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: