Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: ABSEAMED
Active substances:
Erythropoietin
Estonian, English, Latin
ATC code: B03XA01
Dosage form: solution for injection in pre-filled syringe
Strength: 3000RÜ 0.3ml
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Indication: Abseamed is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (CRF): - in adults and children aged 1 to 18 years on haemodialysis and adult patients on peritoneal dialysis (see section 4.4). - in adults with renal insufficiency not yet undergoing dialysis for the treatment of severe anaemia of renal origin accompanied by clinical symptoms in patients (see section 4.4). Abseamed is indicated in adults receiving chemotherapy for solid tumours, malignant lymphoma 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) for the treatment of anaemia and reduction of transfusion requirements. Abseamed is indicated in adults in a predonation programme to increase the yield of autologous blood. Treatment should only be given to patients with moderate anaemia (haemoglobin [Hb] concentration range between 10 to 13 g/dl [6.2 to 8.1 mmol/l], no iron deficiency), if blood saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males). Abseamed is indicated for non-iron deficient adults prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications to reduce exposure to allogeneic blood transfusions. Use should be restricted to patients with moderate anaemia (e.g. haemoglobin concentration range between 10 to 13 g/dl or 6.2 to 8.1 mmol/l) who do not have an autologous predonation programme available and with expected moderate blood loss (900 to 1,800 ml). Abseamed is indicated for the treatment of symptomatic anaemia (haemoglobin concentration of <= 10 g/dl) in adults with low- or intermediate-1-risk primary myelodysplastic syndromes (MDS) who have low serum erythropoietin (< 200 mU/ml).
Safety features: Yes
Marketing authorization holder: Medice Arzneimittel Puetter GmbH & Co. KG 
Marketing authorization number: EU/1/07/412 
Marketing authorization issued on: August 28, 2007 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1325876  ABSEAMED  solution for injection in pre-filled syringe  3000RÜ 0.3ml 0.3ml 1TK  Prescription           
1325887  ABSEAMED  solution for injection in pre-filled syringe  3000RÜ 0.3ml 0.3ml 6TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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