PMDA drug package insert

エバスチン錠5mg「科研」

PMDA Prescription drug · ダイト株式会社 · package insert Sep 29, 2023

Key facts

Brand names エバスチン錠5mg「科研」, エバスチン錠10mg「科研」, エバスチンOD錠5mg「科研」, エバスチンOD錠10mg「科研」
Nonproprietary names エバスチン
Companies 製造販売元/ダイト株式会社, 発売元/科研製薬株式会社
Product type Prescription drug
Therapeutic category 持続性選択H1受容体拮抗剤
Therapeutic category codes 87449
YJ codes 4490019F1095, 4490019F2091, 4490019F3080, 4490019F4086
Approval numbers 22000AMX01154, 22000AMX01149, 22000AMX01142, 22000AMX01143
Package insert edition 第1版
Package insert date Sep 29, 2023
PMDA document key 400073_4490019F1095_1
PMDA company code 400073

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)