PMDA drug package insert

アゼルニジピン錠8mg「トーワ」

PMDA Prescription drug · 東和薬品株式会社 · package insert Aug 25, 2026

Key facts

Brand names アゼルニジピン錠8mg「トーワ」, アゼルニジピン錠16mg「トーワ」
Nonproprietary names アゼルニジピン
Companies 製造販売元/東和薬品株式会社
Product type Prescription drug
Therapeutic category 持続性Ca拮抗剤
Therapeutic category codes 872149
YJ codes 2149043F1127, 2149043F2123
Approval numbers 22500AMX00334, 22500AMX00335
Package insert edition 第5版
Package insert date Aug 25, 2026
PMDA document key 480235_2149043F1127_1
PMDA company code 480235

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:

Browse all PMDA approved drugs and package inserts (Japan)