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Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: SAIZEN 8 MG/ML
Active substances:
Somatropin
Estonian, English, Latin
ATC code: H01AC01
Dosage form: solution for injection in cartridge
Strength: 8mg 1ml
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):  (last updated April 3, 2024)
Package information leaflet (PIL): EST  (last updated August 4, 2023)
Labelling:  (last updated March 27, 2020)
Indication: 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.
Safety features: Yes
Marketing authorization holder: Merck Serono S.p.A. 
Marketing authorization number: 741911 
Marketing authorization issued on: May 3, 2011 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1415540  SAIZEN 8 MG/ML  solution for injection in cartridge  8mg 1ml 1.5ml 1TK  Prescription  100% 50%  187,56  11.06.2024     
1415551  SAIZEN 8 MG/ML  solution for injection in cartridge  8mg 1ml 2.5ml 1TK  Prescription      01.09.2020     
1415562  SAIZEN 8 MG/ML  solution for injection in cartridge  8mg 1ml 1.5ml 5TK  Prescription           
1415573  SAIZEN 8 MG/ML  solution for injection in cartridge  8mg 1ml 2.5ml 5TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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