PMDA drug package insert

マキサカルシトール静注透析用2.5μg「ニプロ」

PMDA Prescription drug · シオノギファーマ株式会社 · package insert Oct 1, 2023

Key facts

Brand names マキサカルシトール静注透析用2.5μg「ニプロ」, マキサカルシトール静注透析用5μg「ニプロ」, マキサカルシトール静注透析用10μg「ニプロ」
Nonproprietary names マキサカルシトール
Companies 製造販売元/シオノギファーマ株式会社, 販売/ニプロ株式会社
Product type Prescription drug
Therapeutic category 二次性副甲状腺機能亢進症治療剤
Therapeutic category codes 873112
YJ codes 3112401A1050, 3112401A2057, 3112401A3053
Approval numbers 22700AMX00872000, 22700AMX00873000, 22700AMX00874000
Package insert edition 第1版
Package insert date Oct 1, 2023
PMDA document key 343018_3112401A1050_2
PMDA company code 343018

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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