RINVOQ 15 MG

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

UPADACITINIB AS HEMIHYDRATE

Beschikbaar vanaf:

ABBVIE BIOPHARMACEUTICALS LTD, ISRAEL

ATC-code:

L04AA44

farmaceutische vorm:

TABLETS PROLONGED RELEASE

Samenstelling:

UPADACITINIB AS HEMIHYDRATE 15 MG

Toedieningsweg:

PER OS

Prescription-type:

Required

Geproduceerd door:

ABBVIE DEUTSCHLAND GMBH & CO. KG, GERMANY

Therapeutisch gebied:

UPADACITINIB

therapeutische indicaties:

Rheumatoid arthritisRINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs).RINVOQ may be used as monotherapy or in combination with methotrexate.Psoriatic arthritis RINVOQ is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate.Ankylosing spondylitisRINVOQ is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.Atopic dermatitisRINVOQ is indicated for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.Ulcerative colitisRINVOQ is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.Crohn’s diseaseRINVOQ is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

Autorisatie datum:

2020-04-07

Bijsluiter

وأ يفدصلا لصافملا باهتلإ
،يمزيتامورلا لصافملا باهتلإ
ينايثرلا راقفلا باهتلإ
.مويلا يف ةدحاو ةرم غلم 15 يه ةداع
ةيدايتعلإا ةيئاودلا ةعرجلا
يبتأتلا دلجلا باهتلإ
:رابكلا
ةدحاو ةرم غلم 30 وأ غلم 15 ةداع يه
ةيدايتعلإا ةيئاودلا ةعرجلا
عفر ررقي نأ بيبطلا نأش نم .كبيبط لب
ِ
ق نم فص
ُ
و امك ،مويلا يف
.مسجلا يف ءاودلا لمعل
ً
اقفو كب ةصاخلا ةيئاودلا ةعرجلا ضفخ وأ
:نونسملا
يه ةيدايتعلإا ةيئاودلا ةعرجلا نإف
،قوف امو ةنس 65 كرمع ناك اذإ
.مويلا يف ةدحاو ةرم غلم 15 ةداع
_:لقلأا ىلع غلك 30 نونزي نيذلا )ةنس 12-17
رامعأب( نوقهارملا_
.مويلا يف ةدحاو ةرم غلم 15 ةداع يه
ةيدايتعلإا ةيئاودلا ةعرجلا
يحرقتلا نولوقلا باهتلإ
ةدمل مويلا يف ةرم غلم 45 ةداع يه
ةيدايتعلإا ةيئاودلا ةعرجلا
ةيئاودلا ةعرجلا ةدم ةلاطإب
ً
ارارق ذختي نأ كبيبط نأش نم .عيباسأ 8
.)
ً
اعوبسأ 16 لامجلإاب( ةيفاضإ عيباسأ 8 ةدمل
غلم 45 تاذ ةيئادتبلإا
غلم 30 وأ غلم 15 ةداع يه ةيدايتعلإا
ةيئاودلا ةعرجلا نإف كلذ دعب
وأ عفر ررقي نأ بيبطلا نأش نم .دملأا
ليوط جلاعك مويلا يف ةرم
.ءاودلل كتباجتسإ ةيفيكل
ً
اقفو ةيئاودلا ةعرجلا ضفخ
:نونسملا
يه ةيدايتعلإا ةيئاودلا ةعرجلا نإف
،قوف امو ةنس 65 كرمع ناك اذإ
.دملأا ليوط جلاعك مويلا يف ةرم غلم 15
ةداع
لكاشم كيدل تدج
ُ
و اذإ ةيئاودلا ةعرجلا ضفخ ررقي نأ
بيبطلا نأش نم
.ىرخأ ة

Productkenmerken

Page 1 of 49
RIN API DEC23
RINVOQ
®
1.
NAME OF THE MEDICINAL PRODUCT
RINVOQ 15 mg prolonged-release tablets
RINVOQ 30 mg prolonged-release tablets
RINVOQ 45 mg prolonged-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
RINVOQ 15 mg prolonged-release tablets
Each prolonged-release tablet contains upadacitinib hemihydrate,
equivalent to 15 mg of upadacitinib.
RINVOQ 30 mg prolonged-release tablets
Each prolonged-release tablet contains upadacitinib hemihydrate,
equivalent to 30 mg of upadacitinib.
RINVOQ 45 mg prolonged-release tablets
Each prolonged-release tablet contains upadacitinib hemihydrate,
equivalent to 45 mg of upadacitinib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet
RINVOQ 15 mg prolonged-release tablets
Purple 14 x 8 mm, oblong biconvex prolonged-release tablets imprinted
on one side with ‘a15’.
RINVOQ 30 mg prolonged-release tablets
Red 14 x 8 mm, oblong biconvex prolonged-release tablets imprinted on
one side with ‘a30’.
RINVOQ 45 mg prolonged-release tablets
Yellow to mottled yellow 14 x 8 mm, oblong biconvex prolonged-release
tablets imprinted on one side
with ‘a45’.
4.
CLINICAL PARTICULARS
PATIENT SAFETY INFORMATION CARD
The marketing of RINVOQ is subject to a risk management plan (RMP)
including a
'Patient safety information card'. The 'Patient safety information
card', emphasizes
important safety information that the patient should be aware of
before and during
treatment. Please explain to the patient the need to review the card
before starting
treatment.
Page 2 of 49
RIN API DEC23
4.1
THERAPEUTIC INDICATIONS
Rheumatoid arthritis
RINVOQ is indicated for the treatment of moderate to severe active
rheumatoid arthritis in adult
patients who have responded inadequately to, or who are intolerant to
one or more disease-modifying
anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in
combination with
methotrexate.
Psoriatic arthritis
RINVOQ is indicated for the treatment of active psoriatic arthritis in
adult