ARIPLY 5

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

ARIPIPRAZOLE

Tilgængelig fra:

UNIPHARM LTD, ISRAEL

ATC-kode:

N05AX12

Lægemiddelform:

TABLETS

Sammensætning:

ARIPIPRAZOLE 5 MG

Indgivelsesvej:

PER OS

Recept type:

Required

Fremstillet af:

TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD, ISRAEL

Terapeutisk gruppe:

ARIPIPRAZOLE

Terapeutisk område:

ARIPIPRAZOLE

Terapeutiske indikationer:

Ariply is indicated for the treatment of schizophrenia, for the treatment of moderate to severe manic episodes in Bipolar I disorder and for the prevention of a new manic episode in patient who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.Ariply is indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD). Efficacy was established in two 6-week trials in adults with MDD who had an inadequate response to antidepressant therapy during the current episode.Ariply is indicated for the treatment of irritability associated with autistic disorder. Efficacy was established in two 8-week trials in pediatric patients (aged 6 to 17 years) with irritability associated with autistic disorder (including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods).

Autorisation dato:

2017-12-31

Produktets egenskaber

1215E
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
_ARIPLY 5 _
tablets
_ARIPLY 10 _
tablets
_ARIPLY 15 _
tablets
_ARIPLY 30_
tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: Aripiprazole
_ARIPLY 5: Each tablet contains 5 mg of aripiprazole and excipient: 26
mg lactose _
_ARIPLY 10: Each tablet contains 10 mg of aripiprazole and excipient:
52 mg lactose _
_ARIPLY 15: Each tablet contains 15 mg of aripiprazole and excipient:
78 mg lactose _
_ARIPLY 30: Each tablet contains 30 mg of aripiprazole and excipient:
156 mg lactose _
_ _
_For a full list of excipients, see section 6.1. _
3. DOSAGE FORM
Film-coated tablets
_ARIPLY_
are yellow, circular, biconvex, film-coated tablets.
_ _
4. CLINICAL DATA
4.1 THERAPEUTIC INDICATIONS
_ARIPLY_
is indicated for the treatment of schizophrenia.
_ _
_ARIPLY_
is indicated for the treatment of moderate to severe manic episodes in
Bipolar I
Disorder and for the prevention of a new manic episode in patients who
experienced
predominantly manic episodes and whose manic episodes responded to
aripiprazole
treatment (see section 5.1).
_ _
_ARIPLY_
5, 10, 15 is indicated for use as an adjunctive therapy to
antidepressants for the
treatment of major depressive disorder (MDD). Efficacy was established
in two 6-week
trials in adults with MDD who had an inadequate response to
antidepressant therapy
during the current episode (see section 5.1).
_ARIPLY_
5, 10, 15 is indicated for the treatment of irritability associated
with autistic
disorder. Efficacy was established in two 8-week trials in pediatric
patients (aged 6 to 17
years) with irritability associated with autistic disorder (including
symptoms of
aggression towards others, deliberate self-injuriousness, temper
tantrums, and quickly
changing moods) (see section 5.1).
SPECIAL CONSIDERATIONS IN TREATING PEDIATRIC SCHIZOPHRENIA AND
IRRITABILITY
ASSOCIATED WITH AUTISTIC DISORDER
Psychiatric disorders in children and adolescents are often serious
mental disorders with
variable symptom profiles that a