בילווי 400 מיקרוגרם

Country: Israel

Language: Hebrew

Source: Ministry of Health

Buy It Now

Active ingredient:

ODEVIXIBAT AS SESQUIHYDRATE

Available from:

MEDISON PHARMA LTD

ATC code:

A05AX05

Pharmaceutical form:

קפסולה קשיחה

Composition:

ODEVIXIBAT AS SESQUIHYDRATE 400 MCG

Administration route:

פומי

Prescription type:

מרשם נדרש

Manufactured by:

ALBIREO AB, SWEDEN

Therapeutic area:

ODEVIXIBAT

Authorization date:

2023-01-05

Patient Information leaflet

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200 mcg odevixibat (as sesquihydrate)
400 "
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400 mcg odevixibat (as sesquihydrate)
600 "
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600 mcg odevixibat (as sesquihydrate)
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Microcrystalline cellulose (MCC) spheres 700
Hypromellose 3mPa.s
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Hypromellose
Titanium dioxide
Yellow iron oxide (E172)
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Hypromellose
Titanium dioxide
Yellow iron oxide (E172)
Red iron oxide (E172)
Shellac glaze in ethanol
Black iron oxide
N-butyl alcohol
Isopropyl alcohol
Propylene glycol
Ammonia hydroxide 28%
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7090
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.
:
Albireo AB
Arvid Wallgrens backe 20
413 46 Göteborg
Sweden
2023
.
:
6
200
:
171-41-37197-99
400
:
171-42-37198-99
600
:
171-43-37199-99
1,200
:
171-44-37200-99
,
.
, .
Bylvay 200 mcg, 400 mcg, 600 mcg, 1200 mcg-PIL-1
2
23-V1
                                
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Documents in other languages

Patient Information leaflet Patient Information leaflet English 14-11-2023
Public Assessment Report Public Assessment Report English 27-02-2023
Patient Information leaflet Patient Information leaflet Arabic 16-03-2023