PMDA drug package insert

プロテカジン錠5

PMDA Prescription drug · 大鵬薬品工業株式会社 · package insert Jun 16, 2026

Key facts

Brand names プロテカジン錠5, プロテカジン錠10
Nonproprietary names ラフチジン
Companies 製造販売元/大鵬薬品工業株式会社
Product type Prescription drug
Therapeutic category H2受容体拮抗剤
Therapeutic category codes 872325
YJ codes 2325006F1036, 2325006F2032
Approval numbers 21200AMZ00032000, 21200AMZ00033000
Package insert edition 第2版
Package insert date Jun 16, 2026
PMDA document key 400107_2325006F1036_1
PMDA company code 400107

At a glance

  • 1–9 Package insert revisions
  • 10–99 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:

Browse all PMDA approved drugs and package inserts (Japan)