Product class:
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Authorized package
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Medicinal product class:
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For human use
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Package code:
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1811427
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Name of medicinal product:
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AMSPARITY
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Active substances:
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ATC code:
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L04AB04
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Dosage form:
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solution for injection in pre-filled syringe
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Route of administration:
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subcutaneous use
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Strengh:
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20mg 0.4ml
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Amount in package:
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0.4ml 2TK
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Legal status for supply*:
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Subject to medicinal prescription
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Class of active substance:
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Additional information:
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Indication:
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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.
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Safety features:
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Yes
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Summary of product characteristics (SPC):
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Package information leaflet (PIL):
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EST
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Labelling:
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Last imported to Estonia:
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Never imported to Estonia
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:
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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
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Marketing authorization holder:
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Pfizer Europe MA EEIG
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Marketing authorization number:
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EU/1/19/1415
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Marketing authorization issued on:
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February 13, 2020
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Marketing authorization expires on:
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February 17, 2025
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Marketing authorization procedure type:
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Centralised
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Reference price:
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Under reference price:
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Reference price of daily dose:
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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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