PMDA drug package insert

ラベプラゾールNa錠5mg「日新」

PMDA Prescription drug · 日新製薬株式会社 · package insert Jul 14, 2026

Key facts

Brand names ラベプラゾールNa錠5mg「日新」, ラベプラゾールNa錠10mg「日新」
Nonproprietary names ラベプラゾールナトリウム
Companies 製造販売元/日新製薬株式会社
Product type Prescription drug
Therapeutic category プロトンポンプ阻害剤
Therapeutic category codes 872329
YJ codes 2329028F3107, 2329028F1120
Approval numbers 30200AMX00249, 22200AMX00786
Package insert edition 第4版
Package insert date Jul 14, 2026
PMDA document key 530113_2329028F1120_1
PMDA company code 530113

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)