Den Europæiske Union - dansk - EMA (European Medicines Agency)

zoetis belgium sa - dirlotapid - antiobesity preparations, excl. diætprodukter - hunde - som hjælp til håndtering af overvægt og fedme hos voksne hunde. at blive brugt som en del af et overordnet vægtstyringsprogram, der også omfatter passende kostændringer og træningspraksis.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

zoetis belgium sa - inaktiverede bluetongue virus, serotype 1, stamme btv-1/alg2006/01 e1 rp, inaktiveret, bluetongue virus, serotype 8, stamme btv-8/bel2006/02 - bluetongue virus, immunologicals, immunologicals for bovidae, kvæg, inaktiveret, viral vacciner - kvæg - aktiv immunisering af kvæg fra 3 måneder for forebyggelse * af viraæmi forårsaget af bluetongue virus (btv), serotyper 1 og 8. * (cykelværdi (ct) ≥ 36 ved en valideret rt-pcr-metode, der indikerer ingen tilstedeværelse af virusgenomet).

Den Europæiske Union - dansk - EMA (European Medicines Agency)

ratiopharm gmbh - desloratadin - rhinitis, allergic, perennial; urticaria; rhinitis, allergic, seasonal - antihistaminer til systemisk brug, - desloratadine ratiopharm is indicated in adults for the relief of symptoms associated with:allergic rhinitischronic idiopathic urticaria as initially diagnosed by a physician.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

recordati rare diseases - betain vandfri - homocystinuri - andre alimentary tract and metabolism produkter, - adjunctive treatment of homocystinuria, involving deficiencies or defects in:cystathionine beta-synthase (cbs);5,10-methylene-tetrahydrofolate reductase (mthfr);cobalamin cofactor metabolism (cbl). cystadane should be used as supplement to other therapies such as vitamin b6 (pyridoxine), vitamin b12 (cobalamin), folate and a specific diet.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

biomarin international limited - sapropterin dihydrochlorid - phenylketonurias - andre alimentary tract and metabolism produkter, - kuvan er indiceret til behandling af hyperphenylalaninæmi (hpa) hos voksne og pædiatriske patienter i alle aldre med phenylketonuri (pku), som har vist sig at være responsive over for sådan behandling. kuvan er også indiceret til behandling af hyperphenylalaninaemia (hpa) hos voksne og pædiatriske patienter i alle aldre med tetrahydrobiopterin (bh4) - mangel, som har vist sig at være lydhør over for en sådan behandling,.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

swedish orphan biovitrum international ab - nitisinon - tyrosinemias - andre alimentary tract and metabolism produkter, - hereditary tyrosinemia type 1 (ht 1)orfadin is indicated for the treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (ht 1) in combination with dietary restriction of tyrosine and phenylalanine. alkaptonuria (aku)orfadin is indicated for the treatment of adult patients with alkaptonuria (aku).

Den Europæiske Union - dansk - EMA (European Medicines Agency)

serb sa - betaine - homocystinuri - andre alimentary tract and metabolism produkter, - amversio is indicated as adjunctive treatment of homocystinuria, involving deficiencies or defects in:•         cystathionine beta-synthase (cbs),•         5,10 methylene tetrahydrofolate reductase (mthfr),•         cobalamin cofactor metabolism (cbl).

Den Europæiske Union - dansk - EMA (European Medicines Agency)

les laboratoires servier - pegaspargase - forløbercellelimfoblastisk leukæmi-lymfom - antineoplastiske midler - oncaspar er indiceret som en komponent i antineoplastisk kombinationsbehandling i akut lymfoblastisk leukæmi (all) hos pædiatriske patienter fra fødsel til 18 år og voksne patienter.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

dipharma arzneimittel gmbh - sapropterin dihydrochlorid - phenylketonurias - andre alimentary tract and metabolism produkter, - sapropterin dipharma is indicated for the treatment of hyperphenylalaninaemia (hpa) in adults and paediatric patients of all ages with phenylketonuria (pku) who have been shown to be responsive to such treatment. sapropterin dipharma is also indicated for the treatment of hyperphenylalaninaemia (hpa) in adults and paediatric patients of all ages with tetrahydrobiopterin (bh4) deficiency who have been shown to be responsive to such treatment.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

csl behring gmbh - human normal immunoglobulin (scig) - immunologiske mangelsyndromer - immune sera og immunoglobuliner, - replacement therapy in adults, children and adolescents (0-18 years) in:- primary immunodeficiency syndromes with impaired antibody production (see section 4. - secondary immunodeficiencies (sid) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (psaf)* or serum igg level of.