PMDA drug package insert

ゾコーバ錠25mg

PMDA Prescription drug · 塩野義製薬株式会社 · package insert Aug 17, 2026

Key facts

Brand names ゾコーバ錠25mg, ゾコーバ錠125mg
Nonproprietary names エンシトレルビル フマル酸
Companies 製造販売元/塩野義製薬株式会社
Product type Prescription drug
Therapeutic category 抗SARS-CoV-2剤
Therapeutic category codes 87625
YJ codes 6250052F2020, 6250052F1023
Approval numbers 30800AMX00156000, 30400AMX00205000
Package insert edition 第30版、用量変更
Package insert date Aug 17, 2026
PMDA document key 340018_6250052F1023_2
PMDA company code 340018

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:

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