OSELFLU Gelatin capsule Ref.[50457] Active ingredients: Oseltamivir

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2020  Publisher: Strides Pharma SA (Pty) Ltd, 106 16<sup>th</sup> Road, Building 2, Midrand, 1686

Product name and form

OSELFLU (Capsules).

Pharmaceutical Form

OSELFLU 75 mg gelatin capsule.

White to off white powder filled in size “2” hard gelatin capsule with cream cap and brown body printed OP on cap and 75 on body in black.

Qualitative and quantitative composition

Each capsule contains oseltamivir phosphate equivalent to 75 mg oseltamivir.

For full list of excipients, see section 6.1.

Active Ingredient Description
Oseltamivir

Oseltamivir (oseltamivir carboxylate) is a selective inhibitor of influenza virus neuraminidase enzymes, which are glycoproteins found on the virion surface. Viral neuraminidase enzyme activity is important both for viral entry into uninfected cells and for the release of recently formed virus particles from infected cells, and for the further spread of infectious virus in the body.
List of Excipients

Granules:

Croscarmellose sodium
Pregelatinized maize starch
Povidone
Sodium stearyl fumarate
Talc

Hard gelatin capsule:

Gelatin
Sodium laureth sulfate
Water
Iron oxide yellow
Iron oxide red
Titanium dioxide

Imprinting ink:

Ammonia
Black iron oxide
Butyl alcohol
Dehydrated alcohol
Isopropyl alcohol
Potassium hydroxide
Propylene glycol
Shellac

Pack sizes and marketing

Carton containing 10 capsules in blister pack. Blister packs are composed of plastic (PVC/PE/PVDC) and aluminium foil.

Marketing authorization holder

Strides Pharma SA (Pty) Ltd, 106 16th Road, Building 2, Midrand, 1686

Marketing authorization dates and numbers

41/20.2.8/0798

Renewal: April 2019

Drugs

Drug Countries
OSELFLU Brazil, South Africa
 
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