Somatropin Biopartners Cessation of validity of the marketing authorisation in the European Union
On 9 November 2017, the marketing authorisation of Somatropin Biopartners (somatropin) ceased to be valid in the European Union (EU). The cessation of validity is due to the fact that the marketing authorisation holder, BioPartners GmbH, had not marketed Somatropin Biopartners in the EU since its initial marketing authorisation. In accordance with the provisions of Article 14(4) of Regulation (EC) No 726/2004 ("sunset clause"), the marketing authorisation of the medicinal product lapsed as the product had not been marketed in any of the EU Member States within three years of its initial authorisation. The European Commission had granted an exemption from the ‘sunset clause’ for Somatropin Biopartners; however the exemption expired on 8 November 2017. BioPartners GmbH confirmed that the product had not been marketed as they were unable to supply it. Somatropin Biopartners was granted marketing authorisation in the EU on 5 August 2013 for the replacement therapy of endogenous growth hormone in adults with growth hormone deficiency. The European Public Assessment Report (EPAR) for Somatropin Biopartners will be updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Send a question via our website www.ema.europa.eu/contact
Public statement on Somatropin Biopartners: Cessation of validity of ...
Nov 29, 2017 - The cessation of validity is due to the fact that the marketing authorisation holder, BioPartners GmbH, had not marketed Somatropin Biopartners in the EU since its initial marketing authorisation. In accordance with the provisions of Article 14(4) of Regulation (EC) No 726/2004 ("sunset clause"), the.
May 31, 2016 - that both species are included in the analytical determinations. ... The HMPC considered that, following a review of the available data, a Public.
inhabiting large home ranges. In open .... necessarily differ in behaviour, which will result in a trade-off ... large home ranges, such as red fox and wolverine. .... grid. Ecological Applications, 21, 2908â2916. O'Brien, T.G., Baillie, J.E.M., Kr
achievement is a construct, usually inferred from per- formance on assessments such as written tests over some well-defined domain of knowledge, oral exami-.
Social psychologists have recently shown great interest in implicit attitudes, but questions remain as to the boundary conditions .... Hilton (2001)), nearly all were focused on the ability ..... information about his name, address, social security.
information about his name, address, social security number, place of birth, current ...... These include individual difference variables (self-moni- toring, private ...
However,. Luiz Cruz is a Ph.D. student of economics at the University of California at Berkeley. .... confidence intervals have coverage probability much smaller than the commonly ...... Journal of Business and Economic Statistics 13:225â35.
of Simulating Stagewise Development by Means of PDP Networks: Application of Catastrophe Analysis and an Experimental. Test of Rule-Like Network Performance. MAARTJE E. J. RAIJMAKERS. SYLVESTER VAN KOTEN. PETER C. M. MOLENAAR. University of Amsterdam
implications for the degree to which people use/apply their attitudes ... A total of 85 non-Black college undergraduates par- ...... San Diego, CA: Academic Press.
Page 1 of 1. Page 1 of 1. Statement of CPFinland on the demis of late Comrade Nelson Mandela.pdf. Statement of CPFinland on the demis of late Comrade Nelson Mandela.pdf. Open. Extract. Open with. Sign In. Main menu. Displaying Statement of CPFinland
merged; thus the number of clusters prior to the merger is the most probable solution' (Aldenderfer ..... Integration of climate and leadership: Examination of.
Crests Costs. $0.00. $0.00. Total Expenses. $1,229.56. $1,425.00. $96.25. $0.00. $1,325.81. Revenue over Expenses. $273.45. $0.00. -$96.25. $0.00. $177.20. 16-Feb-17. Curl BC Region 11. For the Fiscal Year 1 April 2016 to 31 March 2017. Statement of
ARTICLE I: STATEMENT OF FAITH. We believe that the Bible (the sixty-six books of the Old and New Testaments) is God's infallible written Word. It stands.
Accounts Payable. $0.00. $0.00. $0.00. $0.00. Total Liabilities. $0.00. $0.00. $0.00. $0.00. Net Assets. Reserves Account (CU Shares). $5.32. $5.32. Current Net Assets. $2,105.71. $4,979.86. $0.00. $7,085.57. Total Net Assets. $2,111.03. $4,979.86. $
very basic concept and was correctly formulated, for instance, by. Kelley (1927, p. 14) when he stated that a test is ... likely to find this type of idea in a discussion of historical con- ceptions of validity (Kane, 2001, pp. .... 1952), the mornin
Apr 21, 2005 - Social Science & Medicine 61 (2005) 1576â1596. Experiences of ... a,Ð. , Kevin Smith b,1. , Deepa Naishadham b. , Cathy Hartman .... computer (in either English or Spanish), followed by a ... Eligible: 25 â 64 years old; employed
You have successfully completed the online Machine Learn- ... not confer a Stanford grade; it does not confer Stanford credit; it does not confer a Stanford ...
one is likely to build ever more complicated systems covering different aspects of .... metaphysics changes the rules of the game considerably. In some highly ...
Apr 21, 2005 - (Appendix 1), based on the prior closed-format ques- tions developed by ..... times more likely than white Americans to file com- plaints about ...
.edu/techreports/dissemination.html#TechRep. Graduate ... get/procedures_and_materials/index.html. All research .... (Missail et ai., 2006). Kindergarten ...
Nov 17, 2007 - 2. In this experiment flowing of the electric current I in the direction shown in Fig. 2 will exert a force in the direction ON on the pole N of the magnetic needle and a force in the direction OS on the pole S of this needle. Reaction
Page 1 of 3. FOR IMMEDIATE RELEASE. October 9, 2017. HEALTH ADVOCATES' STATEMENT OF SUPPORT. FOR SECRETARY OF HEALTH. To the Members of the Commission on Appointment especially those who are known to. support health advocacies in the past. We, health
