RILOVIA Film-coated tablet Ref.[50482] Active ingredients: Lopinavir Ritonavir

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: Mylan (Pty) Ltd, Building 6, Greenstone Hill Office Park, Emerald Boulevard, MODDERFONTEIN, 1645, Republic of South Africa

Product name and form

RILOVIA 100/25 (film-coated tablets).

RILOVIA 200/50 (film-coated tablets).

Pharmaceutical Form

Film-coated tablets.

RILOVIA 100/25: Light yellow to yellow coloured, round, biconvex, film-coated tablets, debossed with “M172” on one side and plain on other side.

RILOVIA 200/50: Light yellow to yellow coloured, film-coated ovaloid tablets debossed with “M124” on one side and plain on the other side.

Qualitative and quantitative composition

RILOVIA 100/25: Each film-coated tablet contains 100 mg lopinavir and 25 mg ritonavir. Sugar free.

RILOVIA 200/50: Each film-coated tablet contains 200 mg lopinavir and 50 mg ritonavir. Sugar free.

Active Ingredient Description
Lopinavir

Lopinavir is an inhibitor of the HIV-1 and HIV-2 proteases. Inhibition of HIV protease prevents cleavage of the gag-pol polyprotein resulting in the production of immature, non-infectious virus.

Ritonavir

Ritonavir is an orally active peptidomimetic inhibitor of the HIV-1 and HIV-2 aspartyl proteases. Inhibition of HIV protease renders the enzyme incapable of processing the gag-pol polyprotein precursor which leads to the production of HIV particles with immature morphology that are unable to initiate new rounds of infection. Ritonavir has selective affinity for the HIV protease and has little inhibitory activity against human aspartyl proteases. Pharmacokinetic enhancement by ritonavir is based on ritonavir’s activity as a potent inhibitor of CYP3A-mediated metabolism.

List of Excipients

Sodium stearyl fumarate, colloidal silicon dioxide, copovidone, sorbitan monolaurate, film-coat (hypromellose, titanium dioxide, polyethylene glycol 400, hydroxypropyl cellulose, iron oxide yellow, talc, polyethylene glycol 3350, polysorbate 80, colloidal anhydrous silica)

Pack sizes and marketing

RILOVIA 100/25 film-coated tablets will be packed in High Density Polyethylene (HDPE) bottle (Pill jar) pack (marketable pack) with white opaque polypropylene (PP) tamper evident closure with inbuilt desiccant packed into a carton in pack size of 56’s, 112’s and 120’s*.

RILOVIA 100/25 film-coated tablets will be packed in High Density Polyethylene (HDPE) bottle (Pill jar) pack (marketable pack) with white opaque polypropylene (PP) tamper evident closure with inbuilt desiccant in pack sizes of 56’s, 112’s and 120’s*.

RILOVIA 200/50 film-coated tablets will be packed in high density polyethylene (HDPE) bottle (Pill jar) pack (marketable pack) with white opaque polypropylene (PP) tamper evident closure with inbuilt desiccant packed into a carton in pack size of 112’s and 120’s*.

RILOVIA 200/50 film-coated tablets will be packed in high density polyethylene (HDPE) bottle (Pill jar) pack (marketable pack) with white opaque polypropylene (PP) tamper evident closure with inbuilt desiccant in pack sizes of 112’s and 120’s*.

High density polyethylene (HDPE) bottle pack (marketable pack) comprising of white opaque HDPE bottle with white opaque polypropylene (PP) child resistant closure with aluminium induction sealing wad packed into a carton in pack size of 112’s and 120’s*. Separate desiccant is included in the final pack.

High density polyethylene (HDPE) bottle pack (marketable pack) comprising of white opaque HDPE bottle with white opaque polypropylene (PP) child resistant closure with aluminium induction sealing wad in pack sizes of 112’s and 120’s*.

* Not all packs may be marketed.

Marketing authorization holder

Mylan (Pty) Ltd, Building 6, Greenstone Hill Office Park, Emerald Boulevard, MODDERFONTEIN, 1645, Republic of South Africa

Marketing authorization dates and numbers

RILOVIA 100/25: 45/20.2.8/0336
RILOVIA 200/50: 45/20.2.8/0111

Drugs

Drug Countries
RILOVIA South Africa

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