ASTATOR

General data
Product class: Authorized package
Medicinal product class: For human use
Package code: 1470136
Name of medicinal product: ASTATOR
Active substances:
Atorvastatin
Estonian, English, Latin
ATC code: C10AA05
Dosage form: film-coated tablet
Route of administration: oral use
Strengh: 30mg
Amount in package: 84TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
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
Summary of product characteristics (SPC):  (last updated 04 October 2022)
Package information leaflet (PIL): EST  (last updated 04 October 2022)
Labelling:  (last updated 30 August 2021)
Last imported to Estonia: Never imported to Estonia
Marketing authorization
Marketing authorization holder: KRKA, d.d., Novo mesto 
Marketing authorization number: 742311 
Marketing authorization issued on: 03 May 2011 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Prices
Reference price:   
Under reference price:   
Reference price of daily dose:   
Perscription conditions and restrictions
Description Additional condition
Perearsti õel on õigus välja kirjutada Välja arvatud esmane retsept
Entry/Changing date: 30 October 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription