PMDA drug package insert

アムロジピンOD錠2.5mg「NS」

PMDA Prescription drug · 日新製薬株式会社 · package insert Jun 25, 2026

Key facts

Brand names アムロジピンOD錠2.5mg「NS」, アムロジピンOD錠5mg「NS」, アムロジピンOD錠10mg「NS」
Nonproprietary names アムロジピンベシル酸塩
Companies 製造販売元/日新製薬株式会社, 販売元/第一三共エスファ株式会社, 販売提携/第一三共株式会社
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 2171022F3080, 2171022F4087, 2171022F6187
Approval numbers 22100AMX02035, 22100AMX02034, 22500AMX01663
Package insert edition 第3版
Package insert date Jun 25, 2026
PMDA document key 530113_2171022F3080_2
PMDA company code 530113

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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