PMDA drug package insert

アプレゾリン錠10mg

PMDA Prescription drug · サンファーマ株式会社 · package insert Aug 1, 2025

Key facts

Brand names アプレゾリン錠10mg, アプレゾリン錠25mg
Nonproprietary names ヒドララジン塩酸塩
Companies 製造販売元/サンファーマ株式会社
Product type Prescription drug
Therapeutic category 血圧降下剤
Therapeutic category codes 872142
YJ codes 2142004F1053, 2142004F2025
Approval numbers 13528KUZ10354002, 15200AMZ01135000
Package insert edition 第4版
Package insert date Aug 1, 2025
PMDA document key 480866_2142004F2025_1
PMDA company code 480866

At a glance

  • 1–9 Package insert revisions
  • 1–9 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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