EMA Confirms Positive Benefit-risk Balance of Somatropin-Containing Medicines

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) confirms that the benefit-risk balance of somatropin-containing medicines remains positive.

Finalising its review of somatropin-containing medicines, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) confirms that the benefit-risk balance of these medicines remains positive. However, the CHMP wished to remind prescribers to strictly follow the approved indications and doses and to carefully consider the warnings and precautions for somatropin-containing medicines.

Somatropin is used to treat a number of conditions associated with impaired growth and short stature. These include children who fail to grow adequately due to a lack of growth hormone, Turner syndrome or chronic renal insufficiency and short children born small for gestational age.

This review was initiated in December 2010 further to initial results from a long-term epide