PMDA drug package insert

ジフェンヒドラミン塩酸塩注10mg「日新」

PMDA Prescription drug · 日新製薬株式会社 · package insert Aug 24, 2023

Key facts

Brand names ジフェンヒドラミン塩酸塩注10mg「日新」, ジフェンヒドラミン塩酸塩注30mg「日新」
Nonproprietary names ジフェンヒドラミン塩酸塩
Companies 製造販売元/日新製薬株式会社
Product type Prescription drug
Therapeutic category アレルギー性疾患治療剤
Therapeutic category codes 874411
YJ codes 4411400A1033, 4411400A2030
Approval numbers 22700AMX00196, 22700AMX00132
Package insert edition 第1版
Package insert date Aug 24, 2023
PMDA document key 530113_4411400A1033_1
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:

Browse all PMDA approved drugs and package inserts (Japan)