PMDA device listing

ジェノトロピンペン G12

PMDA Medical device listing · 222ADBZX00072000 · Class II

Key facts

PMDA document key 672212_222ADBZX00072000_A_02
Brand names ジェノトロピンペン G12
General names (JMDN) 医薬品ペン型注入器
Product type Medical device
Device class (Japan) Class II
Approval, certification or notification number 222ADBZX00072000
JMDN codes 70391000
Category code A7400
Marketing authorization holder 製造販売/ファイザー株式会社
Package insert date Dec 10, 2020
Latest revision 2017-11
PMDA product page pmda.go.jp
Package insert on pmda.go.jp pmda.go.jp

At a glance

  • 1–9 Package insert revisions
  • None Related PMDA documents
  • Listed Listed on the PMDA site
  • Yes Refers to a technical manual

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About PMDA medical device and IVD listings (Japan)

Medical devices and in vitro diagnostics sold in Japan are approved by the MHLW, certified by a registered certification body or notified, depending on class, and the PMDA publishes each product's package insert. Only identifiers, names and dates are shown here; package insert text and review reports are not reproduced.

Source: Pharmaceuticals and Medical Devices Agency (PMDA), Japan, medical device package insert database · Source date:

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