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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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1415528
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Name of medicinal product:
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SAIZEN 5,83 MG/ML
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Active substances:
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ATC code:
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H01AC01
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Dosage form:
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solution for injection in cartridge
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Route of administration:
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subcutaneous use
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Strengh:
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5,83mg 1ml
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Amount in package:
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1.03ml 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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Saizen is indicated in the treatment of:
Children and adolescents:
- Growth failure in children caused by decreased or absent secretion of endogenous growth hormone.
- Growth failure in girls with gonadal dysgenesis (Turner syndrome), confirmed by chromosomal analysis.
- Growth failure in prepubertal children due to chronic renal failure (CRF).
- Growth disturbance (current height SDS <-2.5 and parental adjusted height SDS <-1) in short children born small for gestational age (SGA) with a birth weight and/or length below -2 SD, who failed to show catch-up growth (HV SDS <0 during the last year) by 4 years of age or later.
Adults:
- Replacement therapy in adults with pronounced growth hormone deficiency as diagnosed by a single dynamic test for growth hormone deficiency. Patients must also fulfil the following criteria:
- Childhood onset:
Patients who were diagnosed as growth hormone deficient during childhood must be retested and their growth hormone deficiency confirmed before replacement therapy with Saizen is started.
- Adult onset:
Patients must have growth hormone deficiency as a result of hypothalamic or pituitary disease and at least one other hormone deficiency diagnosed (except for prolactin) and adequate replacement therapy instituted, before replacement therapy using growth hormone may begin.
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Safety features:
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Yes
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Summary of product characteristics (SPC):
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 (last updated August 4, 2023)
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Package information leaflet (PIL):
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EST (last updated August 4, 2023)
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Labelling:
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(last updated March 27, 2020)
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Last imported to Estonia:
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November 23, 2023
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Marketing authorization holder:
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Merck Serono S.p.A.
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Marketing authorization number:
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741811
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Marketing authorization issued on:
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May 3, 2011
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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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Decentralised
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Percent
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Valid from
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Valid until
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Valid
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Diagnosis
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Doctor's speciality
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Primary
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Age
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Other
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50
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24.10.2023
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Yes
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No
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100
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24.10.2023
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Yes
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E89.3-E89.3; E23-E23; Q96-Q96; Q87.1-Q87.1; P05.1-P05.1; N18-N18
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Endokrinoloog, Pediaater – endokrinoloog
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No
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kuni kasvutsoonide sulgumiseni
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100
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24.10.2023
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Yes
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E89.3-E89.3; E23-E23; Q96-Q96; Q87.1-Q87.1; P05.1-P05.1; N18-N18
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Endokrinoloog, Pediaater – endokrinoloog
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No
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until 4 years
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kuni kasvutsoonide sulgumiseni
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100
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24.10.2023
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Yes
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No
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until 4 years
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Reference price:
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93,78 EUR
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Under reference price:
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Yes
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Reference price of daily dose:
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10,42 EUR
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Entry/Changing date:
August 4, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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