MAGRILAN Hard capsule Ref.[28190] Active ingredients: Fluoxetine

Source: Υπουργείο Υγείας (CY)  Revision Year: 2021  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Magrilan 20mg capsules.

Pharmaceutical Form

Hard capsule.

Yellow-violet hard gelatine capsules, size “4”.

Qualitative and quantitative composition

Each Magrilan 20mg capsule contains fluoxetine hydrochloride equivalent to 20mg of fluoxetine base.

Excipients with known effect: lactose monohydrate, sunset yellow.

Each 20 mg capsule contains 105.0 mg lactose monohydrate and 0.0024 mg sunset yellow.

For the full list of excipients see section 6.1.

Active Ingredient Description
Fluoxetine

Fluoxetine is a selective inhibitor of serotonin reuptake, and this probably accounts for the mechanism of action. Fluoxetine has practically no affinity to other receptors such as α1, α2, and β-adrenergic; serotonergic; dopaminergic; histaminergic1; muscarinic; and GABA receptors.

List of Excipients

Violet/Yellow capsules:

Lactose monohydrate
Cellulose microcrystalline
Magnesium stearate

Capsule shell consisting of sunset yellow FCF (E110), titanium dioxide (E171), iron oxide yellow (E172), brilliant blue FCF (E133), erythrosine (E127) and gelatin.

Pack sizes and marketing

PVC Al blisters. Boxes of 10, and 30 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

19891

Date of first authorization: 28/12/2005
Date of Renewal of the Authorisation: 14/09/2011

Drugs

Drug Countries
MAGRILAN Cyprus, Hong Kong, Lithuania, Malta, Romania, Singapore

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