欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号DE/H/0304/001
药品名称Novofem Filmtabletten
活性成分
    • estradiol 1.0 mg
    • norethisterone acetate 1.0 mg
剂型Film-coated tablet
上市许可持有人Novo Nordisk Pharma GmbH Brucknerstr. 1 D-55127 Mainz
参考成员国 - 产品名称Germany (DE)
Novofem Filmtabletten
互认成员国 - 产品名称
    • Denmark (DK)
    • Iceland (IS)
    • United Kingdom (Northern Ireland) (XI)
    • Ireland (IE)
    • France (FR)
    • Spain (ES)
    • Portugal (PT)
    • Sweden (SE)
    • Norway (NO)
    • Finland (FI)
    • Poland (PL)
    • Latvia (LV)
    • Lithuania (LT)
    • Estonia (EE)
    • Czechia (CZ)
    • Slovakia (SK)
    • Slovenia (SI)
    • Croatia (HR)
许可日期2001/10/02
最近更新日期2023/12/21
药物ATC编码
    • G03 SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
    • G03FB Progestogens and estrogens, sequential preparations
    • G03FB05 norethisterone and estrogen
申请类型
  • TypeLevel1：Known Active Substance
  • TypeLevel2：Initial Application
  • TypeLevel3：Full Dossier Article 4.8 Di 65/65
  • TypeLevel4：Chemical Substance
  • TypeLevel5：Prescription Only
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市场状态Positive
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