PMDA drug package insert
バイロテンシン錠5mg
PMDA Prescription drug · 田辺ファーマ株式会社 · package insert Dec 1, 2025
Key facts
| Brand names | バイロテンシン錠5mg, バイロテンシン錠10mg |
|---|---|
| Nonproprietary names | ニトレンジピン |
| Companies | 製造販売元／田辺ファーマ株式会社, 提携／Bayer AG, Germany |
| Product type | Prescription drug |
| Therapeutic category | 持続性Ca拮抗剤 |
| Therapeutic category codes | 872171 |
| YJ codes | 2171020F1020, 2171020F2026 |
| Approval numbers | 20200AMZ00096, 20200AMZ00097 |
| Package insert edition | 第2版 |
| Package insert date | Dec 1, 2025 |
| PMDA document key | 400315_2171020F1020_2 |
| PMDA company code | 400315 |
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: