PMDA drug package insert

ノベルジン錠25mg

PMDA Prescription drug · ノーベルファーマ株式会社 · package insert Apr 6, 2026

Key facts

Brand names ノベルジン錠25mg, ノベルジン錠50mg, ノベルジン顆粒5%
Nonproprietary names 酢酸亜鉛水和物
Companies 製造販売元/ノーベルファーマ株式会社
Product type Prescription drug
Therapeutic category ウィルソン病治療剤(銅吸収阻害剤) 低亜鉛血症治療剤
Therapeutic category codes 873929
YJ codes 3929007F1029, 3929007F2025, 3929007D1028
Approval numbers 22600AMX01299000, 22600AMX01300000, 30300AMX00013000
Package insert edition 第6版
Package insert date Apr 6, 2026
PMDA document key 620095_3929007F1029_2
PMDA company code 620095

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)