component observed in the milk of lactating rats, without effect on nursing pups. Ombitasvir-derived material was minimally transferred through the placenta in pregnant rats.
Paritaprevir/ritonavir
Paritaprevir was positive in an in vitro human chromosome aberration test. Paritaprevir was negative in a bacterial mutation assay, and in two in vivo genetic toxicology assays (rat bone marrow micronucleus and rat liver Comet tests).
Paritaprevir /ritonavir was not carcinogenic in a 6-month transgenic mouse study up to the highest dosage tested (300 mg/30 mg/kg/day), resulting in paritaprevir AUC exposures approximately 38-fold higher than those in humans at the recommended dose of 150 mg. Similarly, paritaprevir/ritonavir was not carcinogenic in a 2-year rat study up to the highest dosage tested (300 mg/30 mg/kg/day), resulting in paritaprevir AUC exposures approximately 8-fold higher than those in humans at 150 mg.
Paritaprevir/ritonavir has shown malformations (open eye lids) at a low incidence in mice at exposures 32/8-fold higher than the exposure in humans at the recommended clinical dose. Paritaprevir/ritonavir had no effects on embryo-foetal viability or on fertility when eva luated in rats at exposures 2- to 8-fold higher than the exposure in humans at the recommended clinical dose.
Paritaprevir and its hydrolysis product M13 were the predominant components observed in the milk of lactating rats, without effect on nursing pups. Paritaprevir -derived material was minimally transferred through the placenta in pregnant rats.
Tablet core
Copovidone
Vitamin E polyethylene glycol succinate
Propylene glycol monolaurate
Sorbitan monolaurate
Colloidal anhydrous silica (E551)
Sodium stearyl fumarate
Film-coating
Polyvinyl alcohol (E1203)
Polyethylene glycol 3350
Talc (E553b)
Titanium dioxide (E171)
Iron oxide red (E172)
This medicinal product does not require any special storage conditions.
PVC/PE/PCTFE aluminium foil blister packs.
56 tablets (multipack carton containing 4 inner cartons of 14 tablets each).
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
AbbVie Ltd
Maidenhead
SL6 4XE
United Kingdom
Date of first authorisation: 15 January 2015
01/2015
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.