Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Mylan S.A.S., 117 Allée des Parcs, Saint-Priest, 69800, France
Ritonavir Mylan 100 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Yellow, capsule shaped film-coated tablet, approximately 19.1 mm x 10.2 mm, debossed with ‘M163’ on one side and plain on the other side. |
Each film-coated tablet contains 100 mg of ritonavir.
Excipient with known effect: Each film-coated tablet contains 87.75 mg of sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| 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 |
|---|
|
Tablet: Copovidone Film-coating: Hypromellose |
HDPE bottle with polypropylene screw cap with inbuilt desiccant.
Pack sizes: 30, 90, 100 and multipack containing 90 (3 bottles of 30) film-coated tablets.
Not all pack sizes may be marketed.
Mylan S.A.S., 117 Allée des Parcs, Saint-Priest, 69800, France
EU/1/17/1242/001
EU/1/17/1242/002
EU/1/17/1242/003
EU/1/17/1242/004
Date of first authorisation: 10 November 2017
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