PMDA drug package insert

ノルバスク錠2.5mg

PMDA Prescription drug · ヴィアトリス製薬合同会社 · package insert May 20, 2026

Key facts

Brand names ノルバスク錠2.5mg, ノルバスク錠5mg, ノルバスク錠10mg, ノルバスクOD錠2.5mg, ノルバスクOD錠5mg, ノルバスクOD錠10mg
Nonproprietary names アムロジピンベシル酸塩
Companies 製造販売元/ヴィアトリス製薬合同会社
Product type Prescription drug
Therapeutic category 高血圧症・狭心症治療薬; 持続性Ca拮抗薬
Therapeutic category codes 872171
YJ codes 2171022F1029, 2171022F2025, 2171022F5032, 2171022F3048, 2171022F4044, 2171022F6039
Approval numbers 20500AMZ00550, 20500AMZ00551, 22200AMX00424, 22000AMX00051, 22000AMX00052, 22200AMX00728
Package insert edition 第8版
Package insert date May 20, 2026
PMDA document key 671450_2171022F1029_4
PMDA company code 671450

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:

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