PMDA drug package insert

硫酸バリウム散99.5%「FSK」

PMDA Prescription drug · 株式会社伏見製薬所 · package insert Dec 1, 2021

Key facts

Brand names 硫酸バリウム散99.5%「FSK」
Nonproprietary names 硫酸バリウム
Companies 製造販売元/株式会社伏見製薬所, 発売元/伏見製薬株式会社
Product type Prescription drug
Therapeutic category 上部消化管X線造影剤
Therapeutic category codes 877212
YJ codes 7212034B1035
Approval numbers 22700AMX00336000
Package insert edition 第1版
Package insert date Dec 1, 2021
PMDA document key 670137_7212034B1035_1
PMDA company code 670137

At a glance

  • 1–9 Package insert revisions
  • 1–9 Related PMDA documents
  • None 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:

Browse all PMDA approved drugs and package inserts (Japan)