|
Product class:
|
Medicinal product with marketing authorization
|
|
Medicinal product class:
|
Human medicine
|
|
Name of medicinal product:
|
SAIZEN 5,83 MG/ML
|
|
Active substances:
|
|
|
ATC code:
|
H01AC01
|
|
Dosage form:
|
solution for injection in cartridge
|
|
Strength:
|
5,83mg 1ml
|
|
Legal status for supply*:
|
Subject to medicinal prescription
|
|
Summary of product characteristics (SPC):
|
 (last updated January 13, 2022)
|
|
Package information leaflet (PIL):
|
EST (last updated January 13, 2022)
|
|
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:
|
741811
|
|
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
|
|
1415528
|
SAIZEN 5,83 MG/ML
|
solution for injection in cartridge
|
5,83mg 1ml 1.03ml 1TK
|
Prescription
|
50% 100%
|
93,78
|
21.03.2023
|
|
|
|
1415539
|
SAIZEN 5,83 MG/ML
|
solution for injection in cartridge
|
5,83mg 1ml 1.03ml 5TK
|
Prescription
|
|
|
|
|
|
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
You can download Acrobat Reader fromhere