PMDA drug package insert

アズロキサ錠15mg

PMDA Prescription drug · 寿製薬株式会社 · package insert Apr 4, 2023

Key facts

Brand names アズロキサ錠15mg, アズロキサ顆粒2.5%
Nonproprietary names エグアレンナトリウム水和物
Companies 製造販売元/寿製薬株式会社
Product type Prescription drug
Therapeutic category 胃潰瘍治療剤
Therapeutic category codes 872323
YJ codes 2323002F1025, 2323002D1032
Approval numbers 22300AMX00366000, 22100AMX00934000
Package insert edition 第1版
Package insert date Apr 4, 2023
PMDA document key 270139_2323002D1032_1
PMDA company code 270139

At a glance

  • 1–9 Package insert revisions
  • 1–9 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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