Rösch AG Medizintechnik
Rösch AG Medizintechnik english
Approval of syringe without a needle -INJEX- as combination with growth hormone
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Approval of syringe without a needle -INJEX- as combination with growth hormone
Rösch AG Medizintechnik (WKN 529140) today announced its needle-free delivery
device, INJEX(TM), has received approval for a type II variation to be used as a
delivery system for the administration of Genotropin(R) (somatropin rDNA
origin injection). This variation was carried out using the European Union
Mutual Recognition procedure and the approval will apply to all EU member states
where Genotropin is registered, once national documentation is finalised in
each country.
‘This is the first time that a pharmaceutical product has been licenced to be
used with our INJEX(TM) system, which we take as a confirmation of the value and
innovation of our new delivery technology’ said Prof. Weidler, CEO of Rösch AG.
‘This approval – relevant for the EU – will clearly facilitate our negotiations
with pharma companies for cooperations.’
Rösch AG announced the signing of a worldwide exclusive contract with Pharmacia
AB, Stockholm, in January 2001. Pharmacia was granted exclusive rights to the
INJEXTM needle free delivery system developed by Rösch AG for use with its
growth hormones Genotropin(R). The five-year contract will run until 2006 with
the option of renewal for a further 2 years.
Pharmacia is a world leader in endocrine care and has been actively involved in
developing clinical applications for growth hormone for more than 30 years.
Available in more than 50 countries, Genotropin is the leading brand of growth
hormones in the world. Genotropin is approved for the long-term treatment of
children and adults with growth hormone deficiency (GHD), for children suffering
from growth failure due to Prader-Willi syndrome, chronic renal insufficiency
and Turner syndrome, and for children born small for gestational age (not all
indications are licensed in all countries). Genotropin is available by
prescription only.
Executive Board
Further information:
Rösch AG Medizintechnik
Investor Relations
Buckower Damm 114
Tel.: 030-667915-0
Fax: 030-667915-66
e-mail: vorstand@roesch-ag.de
end of message, (c)DGAP 06.06.2002
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