PMDA drug package insert

ヒアルロン酸ナトリウム点眼液0.1%「ニッテン」

PMDA Prescription drug · ロートニッテンファーマ株式会社 · package insert Apr 20, 2023

Key facts

Brand names ヒアルロン酸ナトリウム点眼液0.1%「ニッテン」, ヒアルロン酸ナトリウム点眼液0.3%「ニッテン」
Nonproprietary names 精製ヒアルロン酸ナトリウム
Companies 製造販売元/ロートニッテンファーマ株式会社, 販売元/ロートニッテン株式会社
Product type Prescription drug
Therapeutic category 角結膜上皮障害治療用点眼剤
Therapeutic category codes 871319
YJ codes 1319720Q3124, 1319720Y2144
Approval numbers 22300AMX00012000, 23000AMX00623000
Package insert edition 第1版
Package insert date Apr 20, 2023
PMDA document key 531077_1319720Q3124_1
PMDA company code 531077

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)