Product class: Authorized package
Medicinal product class: For human use
Package code: 1415540
Name of medicinal product: SAIZEN 8 MG/ML
Active substances:
Estonian, English, Latin
ATC code: H01AC01
Dosage form: solution for injection in cartridge
Route of administration: subcutaneous use
Strengh: 8mg 1ml
Amount in package: 1.5ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
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
Summary of product characteristics (SPC):  (last updated 13 January 2022)
Package information leaflet (PIL): EST  (last updated 13 January 2022)
Labelling:  (last updated 27 March 2020)
Last imported to Estonia: 21 March 2023
Marketing authorization holder: Merck Serono S.p.A. 
Marketing authorization number: 741911 
Marketing authorization issued on: 03 May 2011 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Percent Valid from Valid until Valid Diagnosis Doctor's speciality Primary Age Other
50  12/01/2023  01/04/2023  Yes      No      
100  12/01/2023  01/04/2023  Yes  E89.3-E89.3; E23-E23; Q96-Q96; Q87.1-Q87.1; P05.1-P05.1; N18-N18  Endokrinoloog, Pediaater – endokrinoloog  No  until 4 years  kuni kasvutsoonide sulgumiseni 
100  12/01/2023  01/04/2023  Yes  E89.3-E89.3; E23-E23; Q96-Q96; Q87.1-Q87.1; P05.1-P05.1; N18-N18  Pediaater – endokrinoloog, Endokrinoloog  No     kuni kasvutsoonide sulgumiseni 
100  12/01/2023  01/04/2023  Yes      No  until 4 years   
Reference price: 187.56 EUR 
Under reference price: Yes 
Reference price of daily dose: 10.42 EUR 
Entry/Changing date: 23 September 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription