PMDA drug package insert

ミゾリビン錠25mg「サワイ」

PMDA Prescription drug · 沢井製薬株式会社 · package insert Jan 24, 2024

Key facts

Brand names ミゾリビン錠25mg「サワイ」, ミゾリビン錠50mg「サワイ」
Nonproprietary names ミゾリビン
Companies 製造販売元/沢井製薬株式会社
Product type Prescription drug
Therapeutic category 免疫抑制剤
Therapeutic category codes 873999
YJ codes 3999002F1039, 3999002F2035
Approval numbers 22000AMX00456000, 22000AMX00457000
Package insert edition 第1版
Package insert date Jan 24, 2024
PMDA document key 300119_3999002F1039_2
PMDA company code 300119

At a glance

  • 1–9 Package insert revisions
  • 10–99 Related PMDA documents
  • 1–9 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:

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