PMDA drug package insert

エバスチンOD錠5mg「NS」

PMDA Prescription drug · 日新製薬株式会社 · package insert Jan 19, 2024

Key facts

Brand names エバスチンOD錠5mg「NS」, エバスチンOD錠10mg「NS」
Nonproprietary names エバスチン
Companies 製造販売元/日新製薬株式会社, 販売元/共創未来ファーマ株式会社
Product type Prescription drug
Therapeutic category 持続性選択H1受容体拮抗剤
Therapeutic category codes 87449
YJ codes 4490019F3144, 4490019F4140
Approval numbers 22100AMX01965, 22100AMX01966
Package insert edition 第1版
Package insert date Jan 19, 2024
PMDA document key 530113_4490019F3144_2
PMDA company code 530113

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:

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