PMDA drug package insert
ドロエチ配合錠「バイエル」
PMDA Prescription drug · バイエル ライフサイエンス株式会社 · package insert Aug 17, 2026
Key facts
| Brand names | ドロエチ配合錠「バイエル」 |
|---|---|
| Nonproprietary names | ドロスピレノン・エチニルエストラジオール ベータデクス |
| Companies | 製造販売元／バイエル ライフサイエンス株式会社, 発売元／久光製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 月経困難症治療剤 |
| Therapeutic category codes | 872482 |
| YJ codes | 2482011F1047 |
| Approval numbers | 30700AMX00033000 |
| Package insert edition | 第2版 |
| Package insert date | Aug 17, 2026 |
| PMDA document key | 641522_2482011F1047_1 |
| PMDA company code | 641522 |
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: