Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
Norvir 100 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. White, oval, debossed with “NK” on one side. |
Each film-coated tablet contains 100 mg ritonavir.
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 |
|---|
|
ablet: Copovidone Film-coating: Hypromellose |
Norvir tablets are supplied in white high density polyethylene (HDPE) bottles closed with polypropylene caps.
Three pack sizes are available for Norvir tablets:
Not all pack sizes may be marketed.
AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
EU/1/96/016/005-007
Date of first authorisation: 26 August 1996
Date of latest renewal: 26 August 2006
| Drug | Countries | |
|---|---|---|
| NORVIR | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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