Evrópusambandið - þýska - EMA (European Medicines Agency)

merck sharp dohme ltd - boceprevir - hepatitis c, chronisch - antivirale mittel zur systemischen anwendung - victrelis ist indiziert für die behandlung der chronischen hepatitis c (chc)-genotyp-1-infektion in kombination mit peginterferon alfa und ribavirin bei erwachsenen patienten mit kompensierter lebererkrankung, die zuvor unbehandelten oder nicht gelungen, die bisherige therapie.

Evrópusambandið - þýska - EMA (European Medicines Agency)

janssen-cilag international nv - darunavir - hiv-infektionen - antivirale mittel zur systemischen anwendung - prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). in deciding to initiate treatment with prezista co administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista 75 mg, 150 mg, and 600 mg tablets may be used to provide suitable dose regimens:for the treatment of hiv 1 infection in antiretroviral treatment (art) experienced adult patients, including those that have been highly pre treated. for the treatment of hiv 1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight. in deciding to initiate treatment with prezista co administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). prezista 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv 1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:antiretroviral therapy (art) naïve. art experienced with no darunavir resistance associated mutations (drv rams) and who have plasma hiv 1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 106/l. in deciding to initiate treatment with prezista in such art experienced patients, genotypic testing should guide the use of prezista.

Evrópusambandið - þýska - EMA (European Medicines Agency)

gilead sciences ireland uc - cobicistat - hiv-infektionen - antivirale mittel zur systemischen anwendung - tybost is indicated as a pharmacokinetic enhancer of atazanavir 300 mg once daily or darunavir 800 mg once daily as part of antiretroviral combination therapy in human immunodeficiency virus-1 (hiv-1) infected adults and adolescents aged 12 years and older:weighing at least 35 kg co‑administered with atazanavir orweighing at least 40 kg co‑administered with darunavir.

Evrópusambandið - þýska - EMA (European Medicines Agency)

merck sharp & dohme b.v. - elbasvir, grazoprevir - hepatitis c, chronisch - direct acting antivirals, antivirals for systemic use, antivirals for treatment of hcv infections - zepatier is indicated for the treatment of chronic hepatitis c (chc) in adult and paediatric patients 12 years of age and older who weigh at least 30 kg (see sections 4. 2, 4. 4 und 5. für hepatitis-c-virus (hcv) genotyp-spezifische aktivität, siehe abschnitte 4. 4 und 5.

Evrópusambandið - þýska - EMA (European Medicines Agency)

merck sharp & dohme b.v. - efavirenz - hiv-infektionen - antivirale mittel zur systemischen anwendung - stocrin ist indiziert in antiviraler kombinationstherapie von hiv-1-infizierten erwachsenen, jugendlichen und kindern ab drei jahren. stocrin wurde nicht ausreichend untersucht bei patienten mit fortgeschrittener hiv-erkrankung, nämlich bei patienten mit cd4 zählt < 50 zellen/mm3 oder nach versagen von protease-inhibitor (pi)-haltige therapien. obwohl eine kreuzresistenz von efavirenz mit pis wurde nicht dokumentiert, es gibt derzeit keine ausreichenden daten über die wirksamkeit der nachfolgenden nutzung des pi-basierenden kombinationstherapie nach versagen von therapien mit stocrin.

Evrópusambandið - þýska - EMA (European Medicines Agency)

mylan s.a.s - ritonavir - hiv-infektionen - antivirale mittel zur systemischen anwendung - ritonavir ist in kombination mit anderen antiretroviralen arzneimitteln zur behandlung von hiv-infizierten patienten (erwachsene und kinder ab 2 jahren) indiziert..

Þýskaland - þýska - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

t.j.smith and nephew,limited - mikrobielle collagenase, proteasen - salbe - mikrobielle collagenase 1.2i.e.; proteasen 0.24i.e.

Þýskaland - þýska - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

vivanta generics s.r.o. (8174834) - darunavir - filmtablette - 600 mg - teil 1 - filmtablette; darunavir (32142) 600 milligramm

Þýskaland - þýska - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

eurimpharm arzneimittel gmbh (8050167) - mikrobielle collagenase ((mit angaben zur herkunft des enzyms)); proteasen - salbe - 1,2 i.e/g+0,24 i.e/g - teil 1 - salbe; mikrobielle collagenase ((mit angaben zur herkunft des enzyms)) (05467) 1,2 internationale einheit; proteasen (09876) 0,24 internationale einheit

Þýskaland - þýska - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

janssen-cilag gmbh (8009839) - ethinylestradiol; norethisteron - tablette - teil 1 - tablette; ethinylestradiol (02200) 0,035 milligramm; norethisteron (02862) 0,5 milligramm; teil 2 - tablette; ethinylestradiol (02200) 0,035 milligramm; norethisteron (02862) 0,75 milligramm; teil 3 - tablette; ethinylestradiol (02200) 0,035 milligramm; norethisteron (02862) 1 milligramm