PMDA drug package insert
ジェミーナ配合錠
PMDA Prescription drug · ノーベルファーマ株式会社 · package insert Nov 1, 2023
Key facts
| Brand names | ジェミーナ配合錠 |
|---|---|
| Nonproprietary names | レボノルゲストレル・エチニルエストラジオール |
| Companies | 製造販売元／ノーベルファーマ株式会社, 提携／あすか製薬株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 月経困難症治療剤 |
| Therapeutic category codes | 872482 |
| YJ codes | 2482012F1025 |
| Approval numbers | 23000AMX00484000 |
| Package insert edition | 第5版 |
| Package insert date | Nov 1, 2023 |
| PMDA document key | 620095_2482012F1025_1 |
| PMDA company code | 620095 |
At a glance
- 1–9 Package insert revisions
- 10–99 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: