Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1305874
Name of medicinal product: INCRELEX
Active substances:
Mecasermin
Estonian, English, Latin
ATC code: H01AC03
Dosage form: solution for injection
Route of administration: subcutaneous use
Strengh: 10mg 1ml
Amount in package: 4ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: For the long-term treatment of growth failure in children and adolescents from 2 to 18 years with severe primary insulin-like growth factor-1 deficiency (Primary IGFD). Severe Primary IGFD is defined by: - height standard deviation score <= –3.0 and - basal IGF-1 levels below the 2.5th percentile for age and gender and - GH sufficiency. - Exclusion of secondary forms of IGF-1 deficiency, such as malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids. Severe Primary IGFD includes patients with mutations in the GH receptor (GHR), post-GHR signaling pathway, and IGF-1 gene defects; they are not GH deficient, and therefore, they cannot be expected to respond adequately to exogenous GH treatment. In some cases, when deemed necessary, the physician may decide to assist in the diagnosis by performing an IGF-I generation test.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: September 6, 2011
: This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Patients and healthcare professionals are asked to report any suspected adverse reactions to State Agency of Medicines.State Agency of Medicines
Marketing authorization holder: Ipsen Pharma 
Marketing authorization number: EU/1/07/402 
Marketing authorization issued on: August 3, 2007 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: May 19, 2021
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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