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Marvel LifeSciences Ltd Withdraws Its Marketing Authorisation Applications For Insulin Human Rapid Marvel, Insulin Human Long Marvel
The European Medicines Agency (EMEA) has been formally notified by
Marvel LifeSciences Ltd of its decision to withdraw its applications for
a centralised marketing authorisation for the medicines Insulin Human
Rapid Marvel, Insulin Human Long Marvel and Insulin Human 30/70 Mix
Marvel.
These medicines were expected to be used for the treatment of patients
with diabetes mellitus who require insulin for the maintenance of
glucose homeostasis and for the initial control of diabetes mellitus and
diabetes mellitus in pregnancy.
The applications for marketing authorisation of the three insulins were
made as applications for similar biological medicinal products, claiming
that the medicines are biologically similar to a reference medicine
already authorised in the European Union (Humulin, from Eli Lilly). The
applications were submitted to the EMEA on 2 March 2007. At the time of
the withdrawal, they were under review by the Agency's Committee for
Medicinal Products for Human Use (CHMP).
In its official letter, the company stated that the withdrawal of the
three applications was based on the decision of the CHMP not to grant an
extension to the timeframe given to them to respond to a list of
questions. This request was in addition to an earlier extension of three
months that had been granted by the CHMP.
More information about Insulin Human Rapid Marvel, Insulin Human Long
Marvel and Insulin Human 30/70 Mix Marvel and the state of the
scientific assessment at the time of withdrawal will be made available
in a question-and-answer document. This document, together with the
withdrawal letter from the company, will be published on the EMEA
website shortly.
Notes:
1. Withdrawal of an application does not prejudice the possibility of a
company making a new application at a later stage.
2. This press release, together with other information on the work of
the EMEA, can be found on the EMEA website: http://www.emea.europa.eu.
Minuna LifeSciences SRL cu retragerea autorizaþiei de comercializare pentru cererile de insulinã umanã rapidã minuna, de insulinã umanã de mult se minuna - Marvel LifeSciences Ltd Withdraws Its Marketing Authorisation Applications For Insulin Human Rapid Marvel, Insulin Human Long Marvel - articole medicale engleza - startsanatate