PMDA drug package insert
ミカムロ配合錠AP
PMDA Prescription drug · ⽇本ベーリンガーインゲルハイム株式会社 · package insert Oct 2, 2026
Key facts
| Brand names | ミカムロ配合錠AP, ミカムロ配合錠BP |
|---|---|
| Nonproprietary names | テルミサルタン・アムロジピンベシル酸塩配合剤 |
| Companies | 製造販売元／⽇本ベーリンガーインゲルハイム株式会社 |
| Product type | Prescription drug |
| Therapeutic category | 胆汁排泄型持続性AT1受容体ブロッカー/持続性Ca拮抗薬合剤 |
| Therapeutic category codes | 872149 |
| YJ codes | 2149117F1025, 2149117F2021 |
| Approval numbers | 22200AMX00868000, 22400AMX01480000 |
| Package insert edition | 第5版 |
| Package insert date | Oct 2, 2026 |
| PMDA document key | 650168_2149117F1025_1 |
| PMDA company code | 650168 |
At a glance
- 1–9 Package insert revisions
- 10–99 Related PMDA documents
- 1–9 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: