PMDA drug package insert

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PMDA Prescription drug · シオノギファーマ株式会社 · package insert Mar 23, 2026

Key facts

Brand names リンデロン点眼液0.01%
Nonproprietary names ベタメタゾンリン酸エステルナトリウム
Companies 製造販売元/シオノギファーマ株式会社, 販売元/塩野義製薬株式会社
Product type Prescription drug
Therapeutic category 眼科用合成副腎皮質ホルモン剤
Therapeutic category codes 871315
YJ codes 1315706Q1025
Approval numbers 15600AMZ00989000
Package insert edition 第2版
Package insert date Mar 23, 2026
PMDA document key 343018_1315706Q1025_2
PMDA company code 343018

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)