Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: ASTATOR
Active substances:
Estonian, English, Latin
ATC code: C10AA05
Dosage form: film-coated tablet
Strength: 30mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):  (last updated October 4, 2022)
Package information leaflet (PIL): EST  (last updated October 4, 2022)
Labelling:  (last updated August 30, 2021)
Indication: Hypercholesterolaemia Atorvastatin Miklich is indicated as an adjunct to diet for reduction of elevated total cholesterol (total­C), LDL-cholesterol (LDL-C), apolipoprotein B, and triglycerides in adults, adolescents and children aged 10 years or older with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (Corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. Atorvastatin Miklich is also indicated to reduce total-C and LDL-C in adults with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable. Prevention of cardiovascular disease Prevention of cardiovascular events in adult patients estimated to have a high risk for a first cardiovascular event (see section 5.1), as an adjunct to correction of other risk factors.
Safety features: Yes
Marketing authorization holder: KRKA, d.d., Novo mesto 
Marketing authorization number: 742311 
Marketing authorization issued on: May 3, 2011 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Assessment report:   
Description Additional condition
Perearsti õel on õigus välja kirjutada Välja arvatud esmane retsept
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1470035  ASTATOR  film-coated tablet  30mg 4TK  Prescription           
1470046  ASTATOR  film-coated tablet  30mg 7TK  Prescription           
1470057  ASTATOR  film-coated tablet  30mg 10TK  Prescription           
1470068  ASTATOR  film-coated tablet  30mg 14TK  Prescription           
1470079  ASTATOR  film-coated tablet  30mg 20TK  Prescription           
1470080  ASTATOR  film-coated tablet  30mg 28TK  Prescription           
1470091  ASTATOR  film-coated tablet  30mg 30TK  Prescription           
1470103  ASTATOR  film-coated tablet  30mg 50TK  Prescription           
1470114  ASTATOR  film-coated tablet  30mg 56TK  Prescription           
1470125  ASTATOR  film-coated tablet  30mg 60TK  Prescription           
1470136  ASTATOR  film-coated tablet  30mg 84TK  Prescription           
1470147  ASTATOR  film-coated tablet  30mg 90TK  Prescription           
1470158  ASTATOR  film-coated tablet  30mg 98TK  Prescription           
1470169  ASTATOR  film-coated tablet  30mg 100TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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