PMDA drug package insert
フリウェル配合錠LD「モチダ」
PMDA Prescription drug · 持田製薬販売株式会社 · package insert May 26, 2023
Key facts
| Brand names | フリウェル配合錠LD「モチダ」, フリウェル配合錠ULD「モチダ」 |
|---|---|
| Nonproprietary names | ノルエチステロン・エチニルエストラジオール |
| Companies | 製造販売元／持田製薬販売株式会社, 販売／持田製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 月経困難症治療剤 |
| Therapeutic category codes | 872482 |
| YJ codes | 2482009F1058, 2482009F2062 |
| Approval numbers | 22900AMX00635000, 23000AMX00684000 |
| Package insert edition | 第1版 |
| Package insert date | May 26, 2023 |
| PMDA document key | 790250_2482009F1058_1 |
| PMDA company code | 790250 |
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: