Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1765649
Name of medicinal product: ANAGRELIDE VIATRIS
Active substances:
Anagrelide
Estonian, English, Latin
ATC code: L01XX35
Dosage form: capsule, hard
Route of administration: oral use
Strengh: 0,5mg
Amount in package: 100TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Anagrelide is indicated for the reduction of elevated platelet counts in at risk essential thrombocythaemia (ET) patients who are intolerant to their current therapy or whose elevated platelet counts are not reduced to an acceptable level by their current therapy. An at risk patient An at risk essential thrombocythaemia patient is defined by one or more of the following features: - > 60 years of age or - a platelet count > 1,000 x 109/l or - a history of thrombo-haemorrhagic events.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: April 11, 2024
Marketing authorization holder: Viatris Limited 
Marketing authorization number: EU/1/17/1256 
Marketing authorization issued on: February 19, 2018 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Percent Valid from Valid until Valid Diagnosis Doctor's speciality Primary Age Other
100  05.04.2024     Yes  D47.3-D47.3  Hematoloog  No     patsientidele, kellel ravi alustamine on hinnatud konsiiliumi (vähemalt 3 hematoloogi) poolt vastavaks järgmistele kriteeriumidele: esmavaliku ravi (hüdroksüuurea annuses vähemalt 2g päevas vähemalt 3 kuu jooksul või alfainterferoon) on osutunud ebaefektiivseks või talumatuks ning esineb trombotsütoos 1000x109/l või on ilmnenud trombohemorraagilised juhud 
100  05.04.2024     Yes  D47.3-D47.3  Hematoloog  No  until 4 years  patsientidele, kellel ravi alustamine on hinnatud konsiiliumi (vähemalt 3 hematoloogi) poolt vastavaks järgmistele kriteeriumidele: esmavaliku ravi (hüdroksüuurea annuses vähemalt 2g päevas vähemalt 3 kuu jooksul või alfainterferoon) on osutunud ebaefektiivseks või talumatuks ning esineb trombotsütoos 1000x109/l või on ilmnenud trombohemorraagilised juhud 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: May 8, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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