QUETIAPINE MEDIS XR quetiapine (as fumarate) 300mg modified release tablets blister pack

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

即購入

ダウンロード 公開評価報告書 (PAR)
25-11-2017

有効成分:

quetiapine fumarate, Quantity: 345.45 mg (Equivalent: quetiapine, Qty 300 mg)

から入手可能:

Medis Pharma Pty Ltd

INN(国際名):

Quetiapine fumarate

医薬品形態:

Tablet, modified release

構図:

Excipient Ingredients: sodium chloride; purified talc; magnesium stearate; lactose monohydrate; hypromellose; povidone; titanium dioxide; iron oxide yellow; macrogol 400

投与経路:

Oral

パッケージ内のユニット:

10, 30, 60, 100

処方タイプ:

(S4) Prescription Only Medicine

適応症:

Bipolar disorder,? Maintenance treatment of bipolar I disorder, as monotherapy or in combination with lithium or sodium valproate, for the prevention of relapse/recurrence of manic, depressive or mixed episodes ? Treatment of depressive episodes associated with bipolar disorder (see DOSAGE AND ADMINISTRATION) ? Treatment of acute mania associated with bipolar I disorder as monotherapy or in combination with lithium or sodium valproate,Efficacy of quetiapine modified release tablets in the treatment of bipolar disorder indications was established in part, on the basis of extrapolation from the established effectiveness of quetiapine immediate release tablets.,Schizophrenia Treatment of schizophrenia, prevention of relapse and maintenance of clinical improvement during continuation therapy.,Major depressive disorder Treatment of recurrent major depressive disorder (MDD) in patients who are intolerant of, or who have an inadequate response to alternative therapies.,Generalised anxiety disorder Treatment of generalised anxiety disorder (GAD).

製品概要:

Visual Identification: Light yellow coloured, round shaped, biconvex film coated tablets, debossed with 'Q300' on one side and plain on other.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

認証ステータス:

Licence status A

承認日:

2016-03-21