27 results
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Referral: Genotropin
somatropin, associated names: Genotonorm, Article 6(12) referrals (prior to January 2010)
Status: European Commission final decision, opinion/position date: 24/06/2010, EC decision date: 02/09/2010, Last updated: 26/04/2011Genotropin … arbitration procedure for Genotropin and associated names. The … marketing authorisation for Genotropin to include a new indication … -
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Referral: Genotropin
somatropin, Article 6(12) referrals (prior to January 2010)
Status: European Commission final decision, opinion/position date: 20/03/2003, EC decision date: 26/06/2003, Last updated: 29/08/2003Genotropin … Commission final decision Overview Genotropin, which contains the active … the benefit/risk profile of Genotropin in the indication “growth … -
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Human medicine European public assessment report (EPAR): Omnitrope
somatropin, Turner Syndrome; Prader-Willi Syndrome; Dwarfism, Pituitary
Date of authorisation: 12/04/2006,
, Revision: 21, Authorised, Last updated: 23/01/2023
to the reference medicine, Genotropin. Omnitrope was compared with Genotropin in 89 children with a lack … Omnitrope was as effective as Genotropin in improving growth. Children … medicine for Omnitrope is Genotropin. For more information on biosimilar … -
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Press release: European Medicines Agency adopts first positive opinion for a similar biological medicinal product
Last updated: 27/01/2006authorised in the EU, namely Genotropin. The European Commission and … authorised in the EU, namely Genotropin. The European Commission … -
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Press release: Update on somatropin-containing medicines
CHMP, Last updated: 16/12/20102001/83/EC. These medicines include Genotropin, Humatrope, Norditropin, Saizen … 2001/83/EC. These medicines include Genotropin, Humatrope, Norditropin, Saizen … -
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Press release: European Medicines Agency confirms positive benefit-risk balance of somatropin-containing medicines
CHMP, Last updated: 21/12/20112001/83/EC. These medicines include Genotropin, Humatrope, Norditropin, Saizen … These medicines include Genotropin, Humatrope, Norditropin, Saizen … -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP), 21-24 June 2010
CHMP, Last updated: 25/06/2010Genotropin … therapeutic indications for Genotropin (somatropin) and associated … -
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Human medicine European public assessment report (EPAR): Skytrofa (previously Lonapegsomatropin Ascendis Pharma)
Lonapegsomatropin, Growth and Development
Date of authorisation: 11/01/2022,
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, Revision: 3, Authorised, Last updated: 31/01/2023
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Human medicine European public assessment report (EPAR): Ngenla
somatrogon, Growth and Development
Date of authorisation: 14/02/2022,, , Revision: 4, Authorised, Last updated: 06/12/2022
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Human medicine European public assessment report (EPAR): Somatropin Biopartners
somatropin, Growth
Date of authorisation: 05/08/2013, Revision: 3, Withdrawn, Last updated: 01/12/2017somatropin-containing medicine called Genotropin given once a day. The main … Biopartners was as effective as Genotropin at promoting growth: children … cm in children receiving Genotropin. Somatropin Biopartners … -
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Human medicine European public assessment report (EPAR): Sogroya
Somapacitan, Growth
Date of authorisation: 31/03/2021,, , Revision: 1, Authorised, Last updated: 01/08/2022
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Human medicine European public assessment report (EPAR): NutropinAq
somatropin, Turner Syndrome; Dwarfism, Pituitary
Date of authorisation: 15/02/2001, Revision: 19, Authorised, Last updated: 21/04/2022 -
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Human medicine European public assessment report (EPAR): Valtropin
somatropin, Turner Syndrome; Dwarfism, Pituitary
Date of authorisation: 24/04/2006,, Revision: 5, Withdrawn, Last updated: 14/08/2012
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Referral: Somatropin
somatropin, associated names: Genotropin, Humatrope, Maxomat, Norditropin, Saizen, Zomacton, Article 107 procedures (prior to July 2012)
Status: European Commission final decision, opinion/position date: 15/12/2011, EC decision date: 27/02/2012, Last updated: 23/04/2012authorised medicines are Genotropin, Humatrope, Maxomat, Norditropin … -
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Public data from Article 57 database
Last updated: 17/10/2022 -
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Press release: European Medicines Agency: Committee for Medicinal Products for Human Use 23-26 January 2006
CHMP, Last updated: 27/01/2006adults. Omnitrope is similar to Genotropin, the reference medicinal product … -
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Press release: European Agency for the evaluation of medicinal products: Committee for Proprietary Medicinal Products, meeting of 18 to 19 March 2003
Last updated: 20/03/2003Community-wide reviews for Genotropin and Norditropin (somatropin … arbitration were made for Genotropin by Germany and Sweden in … -
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News: CHMP re-elects its Chair and Vice-Chair
Last updated: 02/07/2010 -
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Committee for Medicinal Products for Human Use (CHMP): 21-24 June 2010
European Medicines Agency, London, UK, from 21/06/2010 to 24/06/2010, Last updated: 16/02/2010 -
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BMWP/BWP Workshop on Immunogenicity Assessment of Therapeutic Proteins
London, 04/09/2007, Last updated: 01/09/2007 -
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Gulf Cooperation Council (GCC) Biosimilar Medicinal Products Workshop
Riyadh, Saudi Arabia, from 19/04/2011 to 20/04/2011, Last updated: 23/06/2011 -
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CHMP: meeting archive 2010-2012
Last updated: 17/12/2013 -
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CHMP: meeting archive 2001-2009
Last updated: 18/11/2013 -
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Management Board meeting: 6 October 2011
European Medicines Agency, London, UK, 06/10/2011, Last updated: 07/10/2011 -
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News: Annual report 2009 published: "Agency achieved very good results in one of the most challenging years in its history"
Last updated: 20/05/2010