Solymbic

Country: European Union

Language: Italian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
10-07-2018
Summary of Product characteristics Summary of Product characteristics (SPC)
10-07-2018
Public Assessment Report Public Assessment Report (PAR)
07-04-2017

Active ingredient:

adalimumab

Available from:

Amgen Europe B.V.

ATC code:

L04AB04

INN (International Name):

adalimumab

Therapeutic group:

immunosoppressori

Therapeutic area:

Arthritis, Psoriatic; Spondylitis, Ankylosing; Crohn Disease; Colitis, Ulcerative; Hidradenitis Suppurativa; Psoriasis; Arthritis, Rheumatoid

Therapeutic indications:

Si prega di fare riferimento alla sezione 4. 1 del Riassunto delle caratteristiche del prodotto nel documento informativo del prodotto.

Product summary:

Revision: 2

Authorization status:

Ritirato

Authorization date:

2017-03-22

Patient Information leaflet

                                1
ALLEGATO I
RIASSUNTO DELLE CARATTERISTICHE DEL PRODOTTO
2
Medicinale sottoposto a monitoraggio addizionale. Ciò permetterà la
rapida identificazione di nuove
informazioni sulla sicurezza. Agli operatori sanitari è richiesto di
segnalare qualsiasi reazione avversa
sospetta. Vedere paragrafo 4.8 per informazioni sulle modalità di
segnalazione delle reazioni avverse.
1.
DENOMINAZIONE DEL MEDICINALE
SOLYMBIC 20 mg soluzione iniettabile in siringa preriempita.
SOLYMBIC 40 mg soluzione iniettabile in siringa preriempita.
SOLYMBIC 40 mg soluzione iniettabile in penna preriempita.
2.
COMPOSIZIONE QUALITATIVA E QUANTITATIVA
SOLYMBIC 20 mg soluzione iniettabile in siringa preriempita
Ogni siringa preriempita monodose contiene 20 mg di adalimumab in 0,4
ml di soluzione (50 mg/ml).
SOLYMBIC 40 mg soluzione iniettabile in siringa preriempita
Ogni siringa preriempita monodose contiene 40 mg di adalimumab in 0,8
ml di soluzione (50 mg/ml).
SOLYMBIC 40 mg soluzione iniettabile in penna preriempita
Ogni penna preriempita monodose contiene 40 mg di adalimumab in 0,8 ml
di soluzione (50 mg/ml).
Adalimumab è un anticorpo monoclonale umano ricombinante espresso in
cellule ovariche di criceto
(Chinese Hamster Ovary).
Per l’elenco completo degli eccipienti, vedere paragrafo 6.1.
3.
FORMA FARMACEUTICA
SOLYMBIC 20 mg soluzione iniettabile in siringa preriempita.
SOLYMBIC 40 mg soluzione iniettabile in siringa preriempita.
Soluzione iniettabile.
SOLYMBIC 40 mg soluzione iniettabile in penna preriempita (SureClick).
Soluzione iniettabile.
Soluzione limpida e da incolore a leggermente gialla.
4.
INFORMAZIONI CLINICHE
4.1
INDICAZIONI TERAPEUTICHE
Artrite reumatoide
SOLYMBIC, in combinazione con metotressato, è indicato per:
•
il trattamento di pazienti adulti affetti da artrite reumatoide attiva
di grado da moderato a severo
quando la risposta ai farmaci anti-reumatici modificanti la malattia,
compreso il
metotressato, risulta inadeguata.
•
il trattamento dell’artrite reumatoide grave, attiva e progressiva
in adulti non prece
                                
                                Read the complete document

Summary of Product characteristics

                                1
ALLEGATO I
RIASSUNTO DELLE CARATTERISTICHE DEL PRODOTTO
2
Medicinale sottoposto a monitoraggio addizionale. Ciò permetterà la
rapida identificazione di nuove
informazioni sulla sicurezza. Agli operatori sanitari è richiesto di
segnalare qualsiasi reazione avversa
sospetta. Vedere paragrafo 4.8 per informazioni sulle modalità di
segnalazione delle reazioni avverse.
1.
DENOMINAZIONE DEL MEDICINALE
SOLYMBIC 20 mg soluzione iniettabile in siringa preriempita.
SOLYMBIC 40 mg soluzione iniettabile in siringa preriempita.
SOLYMBIC 40 mg soluzione iniettabile in penna preriempita.
2.
COMPOSIZIONE QUALITATIVA E QUANTITATIVA
SOLYMBIC 20 mg soluzione iniettabile in siringa preriempita
Ogni siringa preriempita monodose contiene 20 mg di adalimumab in 0,4
ml di soluzione (50 mg/ml).
SOLYMBIC 40 mg soluzione iniettabile in siringa preriempita
Ogni siringa preriempita monodose contiene 40 mg di adalimumab in 0,8
ml di soluzione (50 mg/ml).
SOLYMBIC 40 mg soluzione iniettabile in penna preriempita
Ogni penna preriempita monodose contiene 40 mg di adalimumab in 0,8 ml
di soluzione (50 mg/ml).
Adalimumab è un anticorpo monoclonale umano ricombinante espresso in
cellule ovariche di criceto
(Chinese Hamster Ovary).
Per l’elenco completo degli eccipienti, vedere paragrafo 6.1.
3.
FORMA FARMACEUTICA
SOLYMBIC 20 mg soluzione iniettabile in siringa preriempita.
SOLYMBIC 40 mg soluzione iniettabile in siringa preriempita.
Soluzione iniettabile.
SOLYMBIC 40 mg soluzione iniettabile in penna preriempita (SureClick).
Soluzione iniettabile.
Soluzione limpida e da incolore a leggermente gialla.
4.
INFORMAZIONI CLINICHE
4.1
INDICAZIONI TERAPEUTICHE
Artrite reumatoide
SOLYMBIC, in combinazione con metotressato, è indicato per:
•
il trattamento di pazienti adulti affetti da artrite reumatoide attiva
di grado da moderato a severo
quando la risposta ai farmaci anti-reumatici modificanti la malattia,
compreso il
metotressato, risulta inadeguata.
•
il trattamento dell’artrite reumatoide grave, attiva e progressiva
in adulti non prece
                                
                                Read the complete document

Similar products

Active ingredient adalimumab

adalimumab

ATC code L04AB04

L04AB04

Marketed by Amgen Europe B.V.

Amgen Europe B.V.

INN (International Name) adalimumab

adalimumab

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 10-07-2018
Summary of Product characteristics Summary of Product characteristics Bulgarian 10-07-2018
Public Assessment Report Public Assessment Report Bulgarian 07-04-2017
Patient Information leaflet Patient Information leaflet Spanish 10-07-2018
Summary of Product characteristics Summary of Product characteristics Spanish 10-07-2018
Public Assessment Report Public Assessment Report Spanish 07-04-2017
Patient Information leaflet Patient Information leaflet Czech 10-07-2018
Summary of Product characteristics Summary of Product characteristics Czech 10-07-2018
Public Assessment Report Public Assessment Report Czech 07-04-2017
Patient Information leaflet Patient Information leaflet Danish 10-07-2018
Summary of Product characteristics Summary of Product characteristics Danish 10-07-2018
Public Assessment Report Public Assessment Report Danish 07-04-2017
Patient Information leaflet Patient Information leaflet German 10-07-2018
Summary of Product characteristics Summary of Product characteristics German 10-07-2018
Public Assessment Report Public Assessment Report German 07-04-2017
Patient Information leaflet Patient Information leaflet Estonian 10-07-2018
Summary of Product characteristics Summary of Product characteristics Estonian 10-07-2018
Public Assessment Report Public Assessment Report Estonian 07-04-2017
Patient Information leaflet Patient Information leaflet Greek 10-07-2018
Summary of Product characteristics Summary of Product characteristics Greek 10-07-2018
Public Assessment Report Public Assessment Report Greek 07-04-2017
Patient Information leaflet Patient Information leaflet English 10-07-2018
Summary of Product characteristics Summary of Product characteristics English 10-07-2018
Public Assessment Report Public Assessment Report English 07-04-2017
Patient Information leaflet Patient Information leaflet French 10-07-2018
Summary of Product characteristics Summary of Product characteristics French 10-07-2018
Public Assessment Report Public Assessment Report French 07-04-2017
Patient Information leaflet Patient Information leaflet Latvian 10-07-2018
Summary of Product characteristics Summary of Product characteristics Latvian 10-07-2018
Public Assessment Report Public Assessment Report Latvian 07-04-2017
Patient Information leaflet Patient Information leaflet Lithuanian 10-07-2018
Summary of Product characteristics Summary of Product characteristics Lithuanian 10-07-2018
Public Assessment Report Public Assessment Report Lithuanian 07-04-2017
Patient Information leaflet Patient Information leaflet Hungarian 10-07-2018
Summary of Product characteristics Summary of Product characteristics Hungarian 10-07-2018
Public Assessment Report Public Assessment Report Hungarian 07-04-2017
Patient Information leaflet Patient Information leaflet Maltese 10-07-2018
Summary of Product characteristics Summary of Product characteristics Maltese 10-07-2018
Public Assessment Report Public Assessment Report Maltese 07-04-2017
Patient Information leaflet Patient Information leaflet Dutch 10-07-2018
Summary of Product characteristics Summary of Product characteristics Dutch 10-07-2018
Public Assessment Report Public Assessment Report Dutch 07-04-2017
Patient Information leaflet Patient Information leaflet Polish 10-07-2018
Summary of Product characteristics Summary of Product characteristics Polish 10-07-2018
Public Assessment Report Public Assessment Report Polish 07-04-2017
Patient Information leaflet Patient Information leaflet Portuguese 10-07-2018
Summary of Product characteristics Summary of Product characteristics Portuguese 10-07-2018
Public Assessment Report Public Assessment Report Portuguese 07-04-2017
Patient Information leaflet Patient Information leaflet Romanian 10-07-2018
Summary of Product characteristics Summary of Product characteristics Romanian 10-07-2018
Public Assessment Report Public Assessment Report Romanian 07-04-2017
Patient Information leaflet Patient Information leaflet Slovak 10-07-2018
Summary of Product characteristics Summary of Product characteristics Slovak 10-07-2018
Public Assessment Report Public Assessment Report Slovak 07-04-2017
Patient Information leaflet Patient Information leaflet Slovenian 10-07-2018
Summary of Product characteristics Summary of Product characteristics Slovenian 10-07-2018
Public Assessment Report Public Assessment Report Slovenian 07-04-2017
Patient Information leaflet Patient Information leaflet Finnish 10-07-2018
Summary of Product characteristics Summary of Product characteristics Finnish 10-07-2018
Public Assessment Report Public Assessment Report Finnish 07-04-2017
Patient Information leaflet Patient Information leaflet Swedish 10-07-2018
Summary of Product characteristics Summary of Product characteristics Swedish 10-07-2018
Public Assessment Report Public Assessment Report Swedish 07-04-2017
Patient Information leaflet Patient Information leaflet Norwegian 10-07-2018
Summary of Product characteristics Summary of Product characteristics Norwegian 10-07-2018
Patient Information leaflet Patient Information leaflet Icelandic 10-07-2018
Summary of Product characteristics Summary of Product characteristics Icelandic 10-07-2018
Patient Information leaflet Patient Information leaflet Croatian 10-07-2018
Summary of Product characteristics Summary of Product characteristics Croatian 10-07-2018
Public Assessment Report Public Assessment Report Croatian 07-04-2017

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