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OMNITROPE

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Opinions on drugs - Posted on Mar 19 2013

Reason for request

Reassessment of the AB in accordance with Article R 163-21 of the Social Security Code.

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Clinical Benefit

Low

The actual benefit of OMNITROPE in children born small for gestational age with a birth weight and/or length of < -2 SD who failed to show catch-up growth (growth rate < 0 SD during the last year) by 4 years of age or later and with growth failure (current height less than or equal to -3 SD and parental adjusted height < -1 DS) is low.

Substantial

The actual benefit of OMNITROPE in Turner syndrome is substantial.

The actual benefit of OMNITROPE in chronic renal disease is substantial.

The actual benefit of OMNITROPE in Prader-Willi syndrome is substantial.


Clinical Added Value

minor

OMNITROPE provides a minor improvement in actual benefit (IAB IV) in the management of Turner syndrome, chronic renal insufficiency and Prader-Willi syndrome.

no clinical added value

OMNITROPE does not bring about an improvement in actual benefit (IAB V) in the therapeutic strategy in children born small for gestational age.


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