PMDA drug package insert

アジマイシン点眼液1%

PMDA Prescription drug · 千寿製薬株式会社 · package insert Nov 4, 2022

Key facts

Brand names アジマイシン点眼液1%
Nonproprietary names アジスロマイシン水和物
Companies 製造販売元/千寿製薬株式会社, 販売/武田薬品工業株式会社
Product type Prescription drug
Therapeutic category 15員環マクロライド系抗生物質点眼剤
Therapeutic category codes 871317
YJ codes 1317714Q1024
Approval numbers 30100AMX00011
Package insert edition 第3版
Package insert date Nov 4, 2022
PMDA document key 380086_1317714Q1024_1
PMDA company code 380086

At a glance

  • 1–9 Package insert revisions
  • 1–9 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)