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Product class:
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Medicinal product with marketing authorization
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Medicinal product class:
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Human medicine
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Name of medicinal product:
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SAIZEN 8 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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Strength:
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8mg 1ml
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Legal status for supply*:
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Subject to medicinal prescription
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Summary of product characteristics (SPC):
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 (last updated January 13, 2022)
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Package information leaflet (PIL):
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EST (last updated January 13, 2022)
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Labelling:
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(last updated March 27, 2020)
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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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Marketing authorization holder:
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Merck Serono S.p.A.
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Marketing authorization number:
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741911
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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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Assessment report:
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Package code
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Name of medicinal product
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Dosage form
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Package
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Legal status
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Reimbursements
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Reference price
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Last imported
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PƤritolumaa
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Additional information
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1415540
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SAIZEN 8 MG/ML
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solution for injection in cartridge
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8mg 1ml 1.5ml 1TK
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Prescription
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50% 100%
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187,56
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21.03.2023
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1415551
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SAIZEN 8 MG/ML
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solution for injection in cartridge
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8mg 1ml 2.5ml 1TK
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Prescription
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01.09.2020
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1415562
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SAIZEN 8 MG/ML
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solution for injection in cartridge
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8mg 1ml 1.5ml 5TK
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Prescription
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1415573
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SAIZEN 8 MG/ML
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solution for injection in cartridge
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8mg 1ml 2.5ml 5TK
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Prescription
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Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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