<p>This is a summary of the European public assessment report (EPAR) for Aripiprazole Mylan Pharma. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Aripiprazole Mylan Pharma.</p><p>For practical information about using Aripiprazole Mylan Pharma, patients should read the package leaflet or contact their doctor or pharmacist.</p>
Therapeutic Indication
<div class="subsection mt-3-5"> <h3>Therapeutic indication</h3><p>Aripiprazole Mylan Pharma is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.</p> <p>Aripiprazole Mylan Pharma 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 adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.</p> <p>Aripiprazole Mylan Pharma is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.</p> </div>
Therapeutic Area (MeSH)
ATC Code
N05AX12
ATC Item
N/A
Pharmacotherapeutic Group
Psycholeptics
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| aripiprazole | N/A | aripiprazole |
EMA Name
Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen)
Medicine Name
Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen)
Aliases
N/ANo risk management plan link.
