PMDA drug package insert

ファモチジン錠10mg「ZE」

PMDA Prescription drug · 全星薬品工業株式会社 · package insert Jan 30, 2024

Key facts

Brand names ファモチジン錠10mg「ZE」, ファモチジン錠20mg「ZE」
Nonproprietary names ファモチジン
Companies 製造販売元/全星薬品工業株式会社, 発売元/全星薬品株式会社
Product type Prescription drug
Therapeutic category H2受容体拮抗剤
Therapeutic category codes 872325
YJ codes 2325003F1393, 2325003F2411
Approval numbers 30100AMX00077, 30100AMX00078
Package insert edition 第1版
Package insert date Jan 30, 2024
PMDA document key 380087_2325003F1393_1
PMDA company code 380087

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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