PMDA drug package insert

ボルタレンEXスプレー

PMDA OTC drug · グラクソ・スミスクライン・コンシューマー・ヘルスケア・ジャパン(株) · package insert May 13, 2023

Key facts

Brand names ボルタレンEXスプレー
Companies 製造販売元/同仁医薬化工(株),販売会社/グラクソ・スミスクライン・コンシューマー・ヘルスケア・ジャパン(株)
Product type OTC drug
OTC risk class 第2類医薬品
OTC dosage form 噴霧剤
OTC effect category 鎮痛・鎮痒・収れん・消炎薬(パップ剤を含む)
Package insert date May 13, 2023
PMDA document key 471825_J1401000230
PMDA company code 471825

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)