PMDA drug package insert

クエン酸第一鉄ナトリウム錠50mg「ツルハラ」

PMDA Prescription drug · 鶴原製薬株式会社 · package insert Jul 6, 2026

Key facts

Brand names クエン酸第一鉄ナトリウム錠50mg「ツルハラ」, クエン酸第一鉄ナトリウム顆粒8.3%「ツルハラ」
Nonproprietary names クエン酸第一鉄ナトリウム
Companies 製造販売元/鶴原製薬株式会社
Product type Prescription drug
Therapeutic category 可溶性の非イオン型鉄剤
Therapeutic category codes 873222
YJ codes 3222013F1165, 3222013D1075
Approval numbers 22600AMX00141000, 22600AMX00142000
Package insert edition 第2版
Package insert date Jul 6, 2026
PMDA document key 460028_3222013D1075_1
PMDA company code 460028

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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