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Medicinal products containing somatropin: EMA confirms positive benefit/risk balance. Prescribers are reminded to adhere strictly to authorised indications and dosage recommendations

Active substance: somatropin

In the course of the risk assessment procedure for medicinal products containing somatropin, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a recommendation confirming that the benefit/risk balance of these medicinal products remains positive. However, the CHMP does consider it necessary to remind prescribers to adhere strictly to the approved indications and dosage recommendations and to consider warnings and precautions carefully when administering medicines containing somatropin.

risk information - full text (available in German only)