Cibinqo

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

Abrocitinib

Saatavilla:

Pfizer Europe MA EEIG 

ATC-koodi:

D11AH08

INN (Kansainvälinen yleisnimi):

abrocitinib

Terapeuttinen ryhmä:

Other dermatological preparations

Terapeuttinen alue:

Dermatitis, Atopic

Käyttöaiheet:

Cibinqo is indicated for the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy.

Tuoteyhteenveto:

Revision: 5

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2021-12-09

Pakkausseloste

44
B. PACKAGE LEAFLET
45
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CIBINQO 50 MG FILM-COATED TABLETS
CIBINQO 100 MG FILM-COATED TABLETS
CIBINQO 200 MG FILM-COATED TABLETS
abrocitinib
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
In addition to this leaflet, your doctor will give you a patient card,
which contains important safety
information that you need to be aware of. Keep this patient card with
you.
WHAT IS IN THIS LEAFLET
1.
What Cibinqo is and what it is used for
2.
What you need to know before you take Cibinqo
3.
How to take Cibinqo
4.
Possible side effects
5.
How to store Cibinqo
6.
Contents of the pack and other information
1.
WHAT CIBINQO IS AND WHAT IT IS USED FOR
Cibinqo contains the active substance abrocitinib. It belongs to a
group of medicines called Janus
kinase inhibitors, which help to reduce inflammation. It works by
reducing the activity of an enzyme
in the body called ‘Janus kinase’, which is involved in
inflammation.
Cibinqo is used to treat adults and adolescents 12 years and older
with moderate-to-severe atopic
dermatitis, also known as atopic eczema. By reducing the activity of
Janus kinase enzymes, Cibinqo
lessens itching and inflammation of the skin. This in turn can reduce
sleep disturbances and other
consequences of atopic eczema such as anxiety or depression and
i

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Cibinqo 50 mg film-coated tablets
Cibinqo 100 mg film-coated tablets
Cibinqo 200 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cibinqo 50 mg film-coated tablets
Each film-coated tablet contains 50 mg of abrocitinib.
_Excipient with known effect _
Each film-coated tablet contains 1.37 mg of lactose monohydrate.
Cibinqo 100 mg film-coated tablets
Each film-coated tablet contains 100 mg of abrocitinib.
_ _
_Excipient with known effect _
Each film-coated tablet contains 2.73 mg of lactose monohydrate.
Cibinqo 200 mg film-coated tablets
Each film-coated tablet contains 200 mg of abrocitinib.
_Excipient with known effect _
Each film-coated tablet contains 5.46 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Cibinqo 50 mg film-coated tablets
_ _
Pink, approximately 11 mm long and 5 mm wide oval tablet debossed with
“PFE” on one side and
“ABR 50” on the other.
Cibinqo 100 mg film-coated tablets
_ _
Pink, approximately 9 mm in diameter round tablet debossed with
“PFE” on one side and “ABR 100”
on the other.
3
Cibinqo 200 mg film-coated tablets
_ _
Pink, approximately 18 mm long and 8 mm wide oval tablet debossed with
“PFE” on one side and
“ABR 200” on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cibinqo 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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated and supervised by a healthcare
professional experienced in the diagnosis
and treatment of atopic dermatitis.
Posology
The recom