Европска Унија - Холандски - EMA (European Medicines Agency)

novartis vaccines and diagnostics s.r.l. - influenza-virus oppervlakte-antigenen (hemagglutinine en neuraminidase) van stam a / viet nam / 1194/2004 (h5n1) - influenza, human; immunization; disease outbreaks - vaccins - actieve immunisatie tegen het h5n1-subtype van influenza a-virus. , , this indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing a/vietnam/1194/2004 (h5n1)-like strain. , , prepandemic influenza vaccine (h5n1) novartis vaccines and diagnostic should be used in accordance with official recommendations.

Холандија - Холандски - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

zoetis b.v. - levend infectieus aviair bronchitisvirus - lyofilisaat voor oculonasale suspensie - avian infectious bronchitis virus - kippen

Белгија - Холандски - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

hikma farmacêutica s.a. - cytarabine 1 g/10 ml - oplossing voor injectie - 100 mg/ml - cytarabine 2000 mg - cytarabine

Европска Унија - Холандски - EMA (European Medicines Agency)

ceva santé animale - geïnactiveerd coxiella burnetii-vaccin, stam nine mile - immunologicals for bovidae, inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia) - goats; cattle - cattle: , for the active immunisation of cattle to lower the risk for non-infected animals vaccinated when non-pregnant to become shedder (5 times lower probability in comparison with animals receiving a placebo), and to reduce shedding of coxiella burnetii in these animals via milk and vaginal mucus. , onset of immunity: not established. , duration of immunity: 280 days after completion of the primary vaccination course. , goats: , for the active immunisation of goats to reduce abortion caused by coxiella burnetii and to reduce shedding of the organism via milk, vaginal mucus, faeces and placenta. , onset of immunity: not established. , duration of immunity: one year after completion of the primary vaccination course.

Европска Унија - Холандски - EMA (European Medicines Agency)

zoetis belgium sa - live recombinant e2 gene-deleted bovine viral diarrhoea virus containing classical swine fever virus e2 gene (cp7_e2alf) - live viral vaccines, immunologicals for suidae - varkens - voor actieve immunisatie van varkens vanaf de leeftijd van 7 weken om sterfte te voorkomen en infectie en ziekten veroorzaakt door het klassieke varkenspestvirus (csfv) te verminderen. onset of immunity: 14 days after vaccinationduration of immunity: at least 6 months after vaccinationfor active immunisation of breeding females to reduce transplacental infection caused by csfv. onset of immunity: 21 days after vaccinationduration of immunity has not been demonstrated.

Европска Унија - Холандски - EMA (European Medicines Agency)

fondazione telethon ets - autologe cd34 + verrijkt cel breuk met cd34 + cellen getransduceerde met de retrovirale vector dat voor de menselijke adenosine dipyridamol (ada) cdna opeenvolging van menselijke hematopoïetische stamcellen / (cd34 +) voorlopercellen codeert - ernstige gecombineerde immunodeficiëntie - immunostimulants, - strimvelis is geïndiceerd voor de behandeling van patiënten met strenge gecombineerde immunodeficiency als gevolg van adenosine dipyridamol deficiëntie (ada-scid), voor wie geen geschikte menselijke leukocyten antigeen (hla)-gecompenseerde verwante stamcel donor beschikbaar is (zie punt 4. 2 en sectie 4.

Европска Унија - Холандски - EMA (European Medicines Agency)

laboratorios hipra, s.a. - mycoplasma hyopneumoniae, strain 7304 (nexhyon), expressing the capsid protein of porcine circovirus type 2a, inactivated - immunologicals for suidae, inactivated viral and inactivated bacterial vaccines - varkens - for the active immunisation of pigs:to reduce lung lesions associated with porcine enzootic pneumonia caused by mycoplasma hyopneumoniae. also, to reduce the incidence of these lesions (as observed in field studies). to reduce viraemia, virus load in lungs and lymphoid tissues and the duration of the viraemic period associated with diseases caused by porcine circovirus type 2 (pcv2). efficacy against pcv2 genotypes a, b and d has been demonstrated in field studies. to reduce culling rate and the loss of daily weight gain caused by mycoplasma hyopneumoniae and/or pcv2 related diseases (as observed at 6 months of age in field studies). mycoplasma hyopneumoniae: onset of immunity: 3 weeks after vaccinationduration of immunity: 23 weeks after vaccinationporcine circovirus type 2:onset of immunity: 2 weeks after vaccinationduration of immunity: 22 weeks after vaccinationin addition, a reduction in nasal and faecal shedding and the duration of nasal excretion of pcv2 was demonstrated in animals challenged at 4 weeks and at 22 weeks after vaccination.

Европска Унија - Холандски - EMA (European Medicines Agency)

intervet international bv - bluetonguevirusvaccin, serotype 8 (geïnactiveerd) - geïnactiveerde virale vaccins, blauwtong-virus, schapen - sheep; cattle - cattle to stimulate active immunity in sheep from 6 weeks of age against bluetongue virus serotype 8 to reduce viraemia sheep to stimulate active immunity in sheep from 1 month of age against bluetongue virus serotype 8 to prevent viraemia,.

Европска Унија - Холандски - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - attenuated feline rhinotracheitis herpesvirus (fhv f2 strain), inactivated feline calicivirosis antigens (fcv 431 and g1 strains) - immunologicals voor felidae, - cats - active immunisation of cats aged eight weeks and older:against feline viral rhinotracheitis to reduce clinical signs;against calicivirus infection to reduce clinical signs. onsets of immunity isone week after primary vaccination course. the duration of immunity is one year after primary vaccination course and three years after the last re-vaccination.

Европска Унија - Холандски - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - attenuated feline panleucopenia virus (pli iv) - immunologicals voor felidae, - cats - active immunisation of cats aged eight weeks and older:against feline viral rhinotracheitis to reduce clinical signs;against calicivirus infection to reduce clinical signs;against feline panleucopenia to prevent mortality and clinical signs. onset of immunity is one week after primary vaccination course the duration of immunity is one year after the primary vaccination course and three years after the last re-vaccination.