PMDA drug package insert

トラフルダイレクトa

PMDA OTC drug · 第一三共ヘルスケア株式会社 · package insert Nov 22, 2023

Key facts

Brand names トラフルダイレクトa
Companies 製造販売元/救急薬品工業株式会社,販売会社/第一三共ヘルスケア株式会社
Product type OTC drug
OTC risk class 第「2」類医薬品
OTC dosage form その他
OTC effect category 口内炎用薬
Package insert date Nov 22, 2023
PMDA document key 230064_K1907000009
PMDA company code 230064

At a glance

  • 1–9 Package insert revisions
  • None 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)