PMDA drug package insert

ロゼックスゲル0.75%

PMDA Prescription drug · マルホ株式会社 · package insert Oct 7, 2026

Key facts

Brand names ロゼックスゲル0.75%
Nonproprietary names メトロニダゾール
Companies 製造販売(輸入)/マルホ株式会社, 提携/GALDERMA
Product type Prescription drug
Therapeutic category がん性皮膚潰瘍臭改善薬; 酒さ治療薬
Therapeutic category codes 872699
YJ codes 2699713Q1026
Approval numbers 22600AMX01405000
Package insert edition 第3版
Package insert date Oct 7, 2026
PMDA document key 730155_2699713Q1026_2
PMDA company code 730155

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • None Safety communications
  • Yes PMDA review report published
  • Yes 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)