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Product class:
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Authorized package
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Medicinal product class:
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For human use
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Package code:
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1305874
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Name of medicinal product:
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INCRELEX
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Active substances:
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ATC code:
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H01AC03
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Dosage form:
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solution for injection
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Route of administration:
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subcutaneous use
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Strengh:
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10mg 1ml
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Amount in package:
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4ml 1TK
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Legal status for supply*:
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Subject to medicinal prescription
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Class of active substance:
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Additional information:
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Indication:
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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.
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Safety features:
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Yes
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Summary of product characteristics (SPC):
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Package information leaflet (PIL):
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EST
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Labelling:
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Last imported to Estonia:
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September 6, 2011
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 :
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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
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Marketing authorization holder:
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Ipsen Pharma
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Marketing authorization number:
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EU/1/07/402
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Marketing authorization issued on:
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August 3, 2007
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Marketing authorization expires on:
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Unlimited
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Marketing authorization procedure type:
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Centralised
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Reference price:
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Under reference price:
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Reference price of daily dose:
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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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