Page 416 - Programme book for The International Liver Congress 2015, EASL ILC 2015
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OLYSIO® – At the Core of HCV Cure PHAT/OLYS/0115/0001
Ground-breaking first 12 week IFN-free† and ribavirin independent‡ DAA doublet
HCV regimen for patients with HCV G1 or G41–4
High SVR12 rates (93%), regardless of prior treatment experience or disease
severity1–4
Simple, all-oral, once-daily dosing with a good safety and tolerability profile1
For more information please visit the Janssen stand at EASL
† For treatment of intolerant/ineligible patients who are in urgent need of treatment. ‡ Based on clinical assessment of each individual patient.
References: 1. OLYSIO® Summary of Product Characteristics. Janssen-Cilag Ltd, 2014. 2. Lawitz E, et al. The Lancet 2014;384(9956)1756–65.
doi: 10.1016/50140–6736(14)61036–9. 3. Sulkowski M, et al. J Hepatol. 2014;60:S4. Oral presentation O7. 4. Lawitz E, et al. J Hepatol.
2014;60:S524. Late breaking abstract O165. Date of preparation: January 2015. © 2014 Janssen Pharmaceutica N.V.
PRESCRIBING INFORMATION
Name of the medicinal product: OLYSIO 150 mg hard capsules
Qualitative and quantitative composition: Each hard capsule contains simeprevir sodium equivalent to 150 mg of simeprevir. List of
excipients: each capsule contains 78.4 mg of lactose (as monohydrate). Sodium lauryl sulfate, Magnesium stearate, Colloidal anhydrous
silica, Croscarmellose sodium, Lactose monohydrate, Gelatin, Titanium dioxide (E171), Black printing ink, Shellac (E904), Iron oxide black
(E172). Therapeutic indications: OLYSIO is indicated in combination with other medicinal products for the treatment of chronic hepatitis C
(CHC) in adult patients. For hepatitis C virus (HCV) genotype specific activity, see sections “Special warnings and precautions for use” and
“Pharmacodynamic properties”. Contraindications: Hypersensitivity to the active substance or to any of the excipients listed. Marketing
Authorisation Holder: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium. Available with prescription, in pharmacies
only. ATC-code: J05AE14. Refer to SmPC for full details on special warnings and precautions for use, interaction with other medicinal
products and other forms of interaction, pregnancy and lactation, and undesirable effects. (109300)
This medicinal product is subject to additional monitoring and it is therefore important to report any suspect adverse reactions related
to OLYSIO®.
Janssen-Cilag Pharma GmbH
Ground-breaking first 12 week IFN-free† and ribavirin independent‡ DAA doublet
HCV regimen for patients with HCV G1 or G41–4
High SVR12 rates (93%), regardless of prior treatment experience or disease
severity1–4
Simple, all-oral, once-daily dosing with a good safety and tolerability profile1
For more information please visit the Janssen stand at EASL
† For treatment of intolerant/ineligible patients who are in urgent need of treatment. ‡ Based on clinical assessment of each individual patient.
References: 1. OLYSIO® Summary of Product Characteristics. Janssen-Cilag Ltd, 2014. 2. Lawitz E, et al. The Lancet 2014;384(9956)1756–65.
doi: 10.1016/50140–6736(14)61036–9. 3. Sulkowski M, et al. J Hepatol. 2014;60:S4. Oral presentation O7. 4. Lawitz E, et al. J Hepatol.
2014;60:S524. Late breaking abstract O165. Date of preparation: January 2015. © 2014 Janssen Pharmaceutica N.V.
PRESCRIBING INFORMATION
Name of the medicinal product: OLYSIO 150 mg hard capsules
Qualitative and quantitative composition: Each hard capsule contains simeprevir sodium equivalent to 150 mg of simeprevir. List of
excipients: each capsule contains 78.4 mg of lactose (as monohydrate). Sodium lauryl sulfate, Magnesium stearate, Colloidal anhydrous
silica, Croscarmellose sodium, Lactose monohydrate, Gelatin, Titanium dioxide (E171), Black printing ink, Shellac (E904), Iron oxide black
(E172). Therapeutic indications: OLYSIO is indicated in combination with other medicinal products for the treatment of chronic hepatitis C
(CHC) in adult patients. For hepatitis C virus (HCV) genotype specific activity, see sections “Special warnings and precautions for use” and
“Pharmacodynamic properties”. Contraindications: Hypersensitivity to the active substance or to any of the excipients listed. Marketing
Authorisation Holder: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium. Available with prescription, in pharmacies
only. ATC-code: J05AE14. Refer to SmPC for full details on special warnings and precautions for use, interaction with other medicinal
products and other forms of interaction, pregnancy and lactation, and undesirable effects. (109300)
This medicinal product is subject to additional monitoring and it is therefore important to report any suspect adverse reactions related
to OLYSIO®.
Janssen-Cilag Pharma GmbH
