Estradiol/norethisterone oral - Novo Nordisk

Drug Profile

Estradiol/norethisterone oral - Novo Nordisk

Alternative Names: Activella; Activelle; Estradiol/norethisterone acetate oral - Novo Nordisk; Kliovance; Norethisterone/estradiol oral - Novo Nordisk; Nuvera

Latest Information Update: 09 Mar 2015

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At a glance

  • Originator Novo Nordisk
  • Developer Novo Nordisk; Pfizer
  • Class Estradiol congeners; Estrenes; Hormonal contraceptives; Hormonal replacements; Norpregnenes; Oral contraceptives; Small molecules
  • 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.

  • New Molecular Entity No

Highest Development Phases

  • Marketed Menopausal syndrome; Postmenopausal osteoporosis

Most Recent Events

  • 20 Nov 2014 Amneal Pharmaceuticals launches Lopreeza™ as first Authorized Generic of Activella® for Menopausal syndrome in USA
  • 10 Jun 2011 Generic equivalent approved in USA for Menopausal syndrome
  • 30 Dec 2005 Phase III trials with an ultra-low dose version of estradiol/norethisterone have been completed for Menopausal syndrome and Postmenopausal osteoporosis prevention in Europe
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