Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1811427
Name of medicinal product: AMSPARITY
Active substances:
Adalimumab
Estonian, English, Latin
ATC code: L04AB04
Dosage form: solution for injection in pre-filled syringe
Route of administration: subcutaneous use
Strengh: 20mg 0.4ml
Amount in package: 0.4ml 2TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis Amsparity in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Amsparity can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). Adalimumab has not been studied in patients aged less than 2 years. Enthesitis-related arthritis Amsparity is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1). Paediatric plaque psoriasis Amsparity is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. Paediatric Crohn's disease Amsparity is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. Paediatric uveitis Amsparity is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: Never imported to Estonia
: This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Patients and healthcare professionals are asked to report any suspected adverse reactions to State Agency of Medicines.State Agency of Medicines
Marketing authorization holder: Pfizer Europe MA EEIG 
Marketing authorization number: EU/1/19/1415 
Marketing authorization issued on: February 13, 2020 
Marketing authorization expires on: February 17, 2025 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: February 20, 2020
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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