Page 7 - 09 EMA
P. 7
ndication
undergoing superovulation for assisted reproductive
technologies (ART) such as in vitro fertilisation (IVF), gamete
intra-fallopian transfer (GIFT) and zygote intra-fallopian
transfer (ZIFT)
Follitropin alfa in association with a luteinising hormone (LH)
preparation is recommended for the stimulation of follicular
development in women with severe LH and FSH deficiency. In clinical
rials these patients were defined by an endogenous serum LH level 1.2
U/l
n adult men
Follitropin alfa is indicated for the stimulation of
spermatogenesis in men who have congenital or acquired
hypogonadotrophic hypogonadism with concomitant human
Chorionic Gonadotrophin (hCG) therapy
Treatment of symptomatic anaemia associated with chronic renal failure
CRF) in adult and paediatric patients:
treatment of anaemia associated with chronic renal failure in
paediatric and adult patients on haemodialysis and adult
patients on peritoneal dialysis;
treatment of severe anaemia of renal origin accompanied by
clinical symptoms in adult patients with renal insufficiency not
yet undergoing dialysis;
Treatment of anaemia and reduction of transfusion requirements in
adult patients receiving chemotherapy for solid tumours, malignant
ymphoma or multiple myeloma, and at risk of transfusion as assessed
by the patient's general status (e.g. cardiovascular status, pre-existing
anaemia at the start of chemotherapy).
Biograstim is indicated for the reduction in the duration of neutropenia
and the incidence of febrile neutropenia in patients treated with
stablished cytotoxic chemotherapy for malignancy (with the exception
f chronic myeloid leukaemia and myelodysplastic syndromes) and for
-4-
undergoing superovulation for assisted reproductive
technologies (ART) such as in vitro fertilisation (IVF), gamete
intra-fallopian transfer (GIFT) and zygote intra-fallopian
transfer (ZIFT)
Follitropin alfa in association with a luteinising hormone (LH)
preparation is recommended for the stimulation of follicular
development in women with severe LH and FSH deficiency. In clinical
rials these patients were defined by an endogenous serum LH level 1.2
U/l
n adult men
Follitropin alfa is indicated for the stimulation of
spermatogenesis in men who have congenital or acquired
hypogonadotrophic hypogonadism with concomitant human
Chorionic Gonadotrophin (hCG) therapy
Treatment of symptomatic anaemia associated with chronic renal failure
CRF) in adult and paediatric patients:
treatment of anaemia associated with chronic renal failure in
paediatric and adult patients on haemodialysis and adult
patients on peritoneal dialysis;
treatment of severe anaemia of renal origin accompanied by
clinical symptoms in adult patients with renal insufficiency not
yet undergoing dialysis;
Treatment of anaemia and reduction of transfusion requirements in
adult patients receiving chemotherapy for solid tumours, malignant
ymphoma or multiple myeloma, and at risk of transfusion as assessed
by the patient's general status (e.g. cardiovascular status, pre-existing
anaemia at the start of chemotherapy).
Biograstim is indicated for the reduction in the duration of neutropenia
and the incidence of febrile neutropenia in patients treated with
stablished cytotoxic chemotherapy for malignancy (with the exception
f chronic myeloid leukaemia and myelodysplastic syndromes) and for
-4-