PMDA drug package insert

ブロムフェナクNa点眼液0.1%「日新」

PMDA Prescription drug · 日新製薬株式会社 · package insert Mar 30, 2026

Key facts

Brand names ブロムフェナクNa点眼液0.1%「日新」
Nonproprietary names ブロムフェナクナトリウム水和物
Companies 製造販売元/日新製薬株式会社, 発売元/テイカ製薬株式会社
Product type Prescription drug
Therapeutic category codes 871319
YJ codes 1319743Q1041
Approval numbers 22500AMX01498000
Package insert edition 第2版
Package insert date Mar 30, 2026
PMDA document key 530113_1319743Q1041_3
PMDA company code 530113

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:

Browse all PMDA approved drugs and package inserts (Japan)