PMDA drug package insert

ロルカム錠2mg

PMDA Prescription drug · 大正製薬株式会社 · package insert May 12, 2025

Key facts

Brand names ロルカム錠2mg, ロルカム錠4mg
Nonproprietary names ロルノキシカム
Companies 製造販売/大正製薬株式会社
Product type Prescription drug
Therapeutic category 非ステロイド性消炎・鎮痛剤
Therapeutic category codes 871149
YJ codes 1149036F1025, 1149036F2021
Approval numbers 21200AMZ00644000, 21200AMZ00643000
Package insert edition 第3版
Package insert date May 12, 2025
PMDA document key 400059_1149036F1025_1
PMDA company code 400059

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • 1–9 Safety communications
  • Yes 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)