Product class:
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Medicinal product with marketing authorization
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Medicinal product class:
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Human medicine
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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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Strength:
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40mg 0.8ml
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Legal status for supply*:
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Subject to medicinal prescription
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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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Indication:
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Rheumatoid arthritis
Amsparity in combination with methotrexate, is indicated for:
-the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response
to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.
-the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated
with methotrexate.
Amsparity can be given as monotherapy in case of intolerance to methotrexate or when continued
treatment with methotrexate is inappropriate.
Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray
and to improve physical function, when given in combination with methotrexate.
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).
Axial spondyloarthritis
Ankylosing spondylitis (AS)
Amsparity is indicated for the treatment of adults with severe active ankylosing spondylitis who have
had an inadequate response to conventional therapy.
Axial spondyloarthritis without radiographic evidence of AS
Amsparity is indicated for the treatment of adults with severe axial spondyloarthritis without
radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI,
who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs
(NSAIDs).
Psoriatic arthritis
Amsparity is indicated for the treatment of active and progressive psoriatic arthritis in adults when the
response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Adalimumab
has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in
patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve
physical function.
Psoriasis
Amsparity is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult
patients who are candidates for systemic therapy.
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.
Hidradenitis suppurativa
Amsparity is indicated for the treatment of active moderate to severe hidradenitis suppurativa (HS)
(acne inversa) in adults and adolescents from 12 years of age with an inadequate response to
conventional systemic HS therapy (see sections 5.1 and 5.2).
Crohns disease
Amsparity is indicated for treatment of moderately to severely active Crohns disease, in adult patients
who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an
immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
Paediatric Crohns disease
Amsparity is indicated for the treatment of moderately to severely active Crohns 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 contraindica
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Safety features:
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Yes
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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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Assessment report:
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Package code
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Name of medicinal product
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Dosage form
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Package
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Legal status
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Reimbursements
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Reference price
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Last imported
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PƤritolumaa
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Additional information
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1811438
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AMSPARITY
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solution for injection in pre-filled syringe
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40mg 0.8ml 0.8ml 1TK
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Prescription
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1811449
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AMSPARITY
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solution for injection in pre-filled syringe
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40mg 0.8ml 0.8ml 2TK
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Prescription
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1811450
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AMSPARITY
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solution for injection in pre-filled syringe
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40mg 0.8ml 0.8ml 4TK
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Prescription
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1811461
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AMSPARITY
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solution for injection in pre-filled syringe
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40mg 0.8ml 0.8ml 6TK
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Prescription
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Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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