PMDA drug package insert

経口用トロンビン細粒0.5万単位「サワイ」

PMDA Prescription drug · 沢井製薬株式会社 · package insert Mar 15, 2024

Key facts

Brand names 経口用トロンビン細粒0.5万単位「サワイ」, 経口用トロンビン細粒1万単位「サワイ」
Nonproprietary names トロンビン
Companies 製造販売元/沢井製薬株式会社
Product type Prescription drug
Therapeutic category 上部消化管用止血剤
Therapeutic category codes 873323
YJ codes 3323001C3056, 3323001C1053
Approval numbers 21800AMX10115000, 21800AMX10116000
Package insert edition 第1版
Package insert date Mar 15, 2024
PMDA document key 300119_3323001C1053_1
PMDA company code 300119

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)