PMDA drug package insert

アムロジン錠2.5mg

PMDA Prescription drug · 住友ファーマ株式会社 · package insert Apr 21, 2026

Key facts

Brand names アムロジン錠2.5mg, アムロジン錠5mg, アムロジン錠10mg, アムロジンOD錠2.5mg, アムロジンOD錠5mg, アムロジンOD錠10mg
Nonproprietary names アムロジピンベシル酸塩
Companies 製造販売元/住友ファーマ株式会社
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 2171022F1045, 2171022F2041, 2171022F5024, 2171022F3021, 2171022F4028, 2171022F6020
Approval numbers 21900AMX01285, 21900AMX01286, 22200AMX00425, 21800AMZ10263, 21800AMZ10264, 22200AMX00727
Package insert edition 第5版
Package insert date Apr 21, 2026
PMDA document key 400093_2171022F1045_3
PMDA company code 400093

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:

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