PMDA drug package insert

アムロジピン錠2.5mg「イセイ」

PMDA Prescription drug · コーアイセイ株式会社 · package insert Aug 4, 2026

Key facts

Brand names アムロジピン錠2.5mg「イセイ」, アムロジピン錠5mg「イセイ」, アムロジピン錠10mg「イセイ」
Nonproprietary names アムロジピンベシル酸塩
Companies 製造販売元/コーアイセイ株式会社
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 2171022F1215, 2171022F2211, 2171022F5326
Approval numbers 22000AMX01228000, 22000AMX01220000, 22500AMX00351000
Package insert edition 第4版
Package insert date Aug 4, 2026
PMDA document key 130107_2171022F1215_1
PMDA company code 130107

At a glance

  • 1–9 Package insert revisions
  • 10–99 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:

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