Nowa Zelandia - angielski - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - peginterferon alfa-2a 270 µg/ml; ribavirin 200mg;  ;   - combination - 135µg/0.5ml + 200mg - active: peginterferon alfa-2a 270 µg/ml excipient: benzyl alcohol glacial acetic acid polysorbate 80 sodium acetate trihydrate sodium chloride water for injection active: ribavirin 200mg     excipient: ethylcellulose hypromellose as a component of opadry 03a14309 iron oxide red as a component of opadry 03a14309 iron oxide yellow as a component of opadry 03a14309 magnesium stearate maize starch microcrystalline cellulose pregelatinised maize starch purified talc as a component of opadry 03a14309 sodium starch glycolate titanium dioxide as a component of opadry 03a14309 triacetin - pegasys rbv is indicated for the treatment of chronic hepatitis c (chc) in: · non-cirrhotic patients · cirrhotic patients with compensated liver disease

Nowa Zelandia - angielski - Medsafe (Medicines Safety Authority)

roche products (nz) ltd - peginterferon alfa-2a 360 µg/ml; ribavirin 200mg;  ;   - combination - 180µg/0.5ml + 200mg - active: peginterferon alfa-2a 360 µg/ml excipient: benzyl alcohol glacial acetic acid polysorbate 80 sodium acetate trihydrate sodium chloride water for injection active: ribavirin 200mg     excipient: ethylcellulose hypromellose as a component of opadry 03a14309 iron oxide red as a component of opadry 03a14309 iron oxide yellow as a component of opadry 03a14309 magnesium stearate maize starch microcrystalline cellulose pregelatinised maize starch purified talc as a component of opadry 03a14309 sodium starch glycolate titanium dioxide as a component of opadry 03a14309 triacetin - pegasys rbv is indicated for the treatment of chronic hepatitis c (chc) in: · non-cirrhotic patients · cirrhotic patients with compensated liver disease

Unia Europejska - angielski - EMA (European Medicines Agency)

pharmaand gmbh - peginterferon alfa-2a - hepatitis c, chronic; hepatitis b, chronic - immunostimulants, - chronic hepatitis b adult patients pegasys is indicated for the treatment of hepatitis b envelope antigen (hbeag)-positive or hbeag-negative chronic hepatitis b (chb) in adult patients with compensated liver disease and evidence of viral replication, increased alanine aminotransferase (alt) and histologically verified liver inflammation and/or fibrosis (see sections 4.4 and 5.1). paediatric patients 3 years of age and older pegasys is indicated for the treatment of hbeag-positive chb in non-cirrhotic children and adolescents 3 years of age and older with evidence of viral replication and persistently elevated serum alt levels. with respect to the decision to initiate treatment in paediatric patients see sections 4.2, 4.4 and 5.1. chronic hepatitis c adult patients pegasys is indicated in combination with other medicinal products, for the treatment of chronic hepatitis c (chc) in patients with compensated liver disease (see sections 4.2, 4.4 and 5.1). for hepatitis c virus (hcv) genotype specific activity, see sections 4.2 and 5.1. paediatric patients 5 years of age and older pegasys in combination with ribavirin is indicated for the treatment of chc in treatment-naïve children and adolescents 5 years of age and older who are positive for serum hcv-rna. when deciding to initiate treatment in childhood, it is important to consider growth inhibition induced by combination therapy. the reversibility of growth inhibition is uncertain. the decision to treat should be made on a case by case basis (see section 4.4).,

Unia Europejska - angielski - EMA (European Medicines Agency)

merck sharp & dohme b.v. - peginterferon alfa-2b - hepatitis c, chronic - immunostimulants, - adults (tritherapy)pegintron in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic-hepatitis-c (chc) genotype-1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy.please refer to the ribavirin and boceprevir summaries of product characteristics (smpcs) when pegintron is to be used in combination with these medicines.adults (bitherapy and monotherapy)pegintron is indicated for the treatment of adult patients (18 years of age and older) with chc who are positive for hepatitis-c-virus rna (hcv-rna), including patients with compensated cirrhosis and / or co-infected with clinically stable hiv.pegintron in combination with ribavirin (bitherapy) is indicated for the treatment of chc infection in adult patients who are previously untreated including patients with clinically stable hiv co-infection and in adult patients who have failed previous treatment with interferon-alpha (pegylated or non-pegylated) and ribavirin combination therapy or interferon-alpha monotherapy.interferon monotherapy, including pegintron, is indicated mainly in case of intolerance or contraindication to ribavirin.please refer to the ribavirin smpc when pegintron is to be used in combination with ribavirin.paediatric population (bitherapy)pegintron is indicated in a combination regimen with ribavirin for the treatment of children three years of age and older and adolescents who have chc, previously untreated, without liver decompensation, and who are positive for hcv-rna.when deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that may be irreversible in some patients. the decision to treat should be made on a case-by-case basis.please refer to the ribavirin smpc for capsules or oral solution when pegintron is to be used in combination with ribavirin.

Unia Europejska - angielski - EMA (European Medicines Agency)

merck sharp dohme ltd  - peginterferon alfa-2b - hepatitis c, chronic - immunostimulants, - adults (tritherapy)viraferonpeg in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic-hepatitis-c (chc) genotype-1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy.please refer to the ribavirin and boceprevir summaries of product characteristics (smpcs) when viraferonpeg is to be used in combination with these medicines.adults (bitherapy and monotherapy)viraferonpeg is indicated for the treatment of adult patients (18 years of age and older) with chc who are positive for hepatitis-c-virus rna (hcv-rna), including patients with compensated cirrhosis and / or co-infected with clinically stable hiv.viraferonpeg in combination with ribavirin (bitherapy) is indicated for the treatment of chc infection in adult patients who are previously untreated including patients with clinically stable hiv co-infection and in adult patients who have failed previous treatment with interferon alpha (pegylated or non-pegylated) and ribavirin combination therapy or interferon alpha monotherapy.interferon monotherapy, including viraferonpeg, is indicated mainly in case of intolerance or contraindication to ribavirin.please refer to the ribavirin smpc when viraferonpeg is to be used in combination with ribavirin.paediatric population (bitherapy)viraferonpeg is indicated in a combination regimen with ribavirin for the treatment of children three years of age and older and adolescents, who have chronic hepatitis c, previously untreated, without liver decompensation, and who are positive for hcv-rna.when deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that may be irreversible in some patients. the decision to treat should be made on a case-by-case basis.please refer to the ribavirin smpc for capsules or oral solution when viraferonpeg is to be used in combination with ribavirin.

Kenia - angielski - Pharmacy and Poisons Board

f. hoffman-la roche ltd capitol hill towerscathedral road. p.o. box - peginterferon alfa-2a - solution for injection in pre-filled syringe - peginterferon alfa-2a 180mcg - immunostimulants: interferons

Kanada - angielski - Health Canada

pharmaand gmbh - peginterferon alfa-2a - solution - 180mcg - peginterferon alfa-2a 180mcg - interferons

Kanada - angielski - Health Canada

hoffmann-la roche limited - peginterferon alfa-2a - solution - 180mcg - peginterferon alfa-2a 180mcg - interferons

Wielka Brytania - angielski - MHRA (Medicines & Healthcare Products Regulatory Agency)

roche products ltd - peginterferon alfa-2a - solution for injection - 270microgram/1ml

Wielka Brytania - angielski - MHRA (Medicines & Healthcare Products Regulatory Agency)

roche products ltd - peginterferon alfa-2a - solution for injection - 360microgram/1ml