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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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1742318
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Name of medicinal product:
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AMGEVITA
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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 pen
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Route of administration:
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subcutaneous use
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Strengh:
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40mg 0.8ml
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Amount in package:
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0.8ml 6TK
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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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Rheumatoid arthritis
AMGEVITA 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.
AMGEVITA can be given as monotherapy in case of intolerance to methotrexate or when continued
treatment with methotrexate is inappropriate.
AMGEVITA reduces the rate of progression of joint damage as measured by x-ray and improves
physical function, when given in combination with methotrexate.
Juvenile idiopathic arthritis
Polyarticular juvenile idiopathic arthritis
AMGEVITA 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). AMGEVITA 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
AMGEVITA 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)
AMGEVITA 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
AMGEVITA 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.
Psoriatic arthritis
AMGEVITA 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.
AMGEVITA reduces 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 improves
physical function.
Psoriasis
AMGEVITA is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult
patients who are candidates for systemic therapy.
Paediatric plaque psoriasis
AMGEVITA 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 (HS)
AMGEVITA is indicated for the treatment of active moderate to severe hidradenitis suppurativa (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).
Crohn’s disease
AMGEVITA is indicated for treatment of moderately to severely active Crohn’s 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 Crohn's disease
AMGEVITA 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.
Ulcerative colitis
AMGEVITA is indica
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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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Marketing authorization holder:
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Amgen Europe B.V.
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Marketing authorization number:
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EU/1/16/1164
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Marketing authorization issued on:
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March 24, 2017
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Marketing authorization expires on:
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Unlimited
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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:
December 1, 2021
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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