Estradiol valerate/dienogest

Drug Profile

Estradiol valerate/dienogest

Alternative Names: Climodien; Climodiène; Dienogest/estradiol valerate; DNG/E2V; E2V/DNG; Klimodien; Lafamme

Latest Information Update: 02 Feb 2017

Price : $50

At a glance

  • Originator Jenapharm
  • Developer Bayer HealthCare Pharmaceuticals
  • Class Estradiol congeners; Estrenes; Hormonal replacements
  • Mechanism of Action Estrogen receptor agonists; Progesterone receptor agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

  • New Molecular Entity No

Highest Development Phases

  • Marketed Menopausal syndrome; Postmenopausal osteoporosis
  • Preregistration Acne
  • Discontinued Contraception

Most Recent Events

  • 27 Jan 2017 The Committee for Medicinal Products for Human Use (CHMP) adopts positive opinion for estradiol valerate/dienogest for Acne (treatment-resistant) in European Union
  • 31 Dec 2016 Preregistration for Acne (Treatment-resistant) in European Union (PO)
  • 05 Feb 2015 Launched for Menopausal syndrome in France, Belgium, Greece, Portugal, the Czech Republic, Spain, Russia and Turkey (PO) before February 2015
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