Malta - enska - Medicines Authority

ucb pharma sa - meclozine hydrochloride 25 mg - tablet

Malta - enska - Medicines Authority

ucb pharma sa 60 allee de la recherche, b-1070 brussels, belgium - piracetam - film-coated tablet - piracetam 800 mg - psychoanaleptics

Malta - enska - Medicines Authority

ucb pharma sa 60 allee de la recherche, b-1070 brussels, belgium - levocetirizine dihydrochloride - oral solution - levocetirizine dihydrochloride 0.5 mg/ml - antihistamines for systemic use

Malta - enska - Medicines Authority

ucb pharma sa 60 allee de la recherche, b-1070 brussels, belgium - cetirizine hydrochloride - film-coated tablet - cetirizine hydrochloride 10 mg - antihistamines for systemic use

Malta - enska - Medicines Authority

ucb pharma sa 60 allee de la recherche, b-1070 brussels, belgium - cetirizine hydrochloride - oral solution - cetirizine hydrochloride 1 mg/ml - antihistamines for systemic use

Evrópusambandið - enska - EMA (European Medicines Agency)

ucb pharma sa - levetiracetam - epilepsy - antiepileptics, - keppra is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.keppra is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one month of age with epilepsy;in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.

Bandaríkin - enska - NLM (National Library of Medicine)

ucb, inc. - lacosamide (unii: 563ks2pqy5) (lacosamide - unii:563ks2pqy5) - lacosamide 50 mg - vimpat is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. vimpat is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as vimpat, during pregnancy. encourage women who are taking vimpat during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. risk summary available data from the north american antiepileptic drug (naaed) pregnancy registry, a prospective cohort study, case reports, and a case series with vimpat use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. lacosamide produced developmental toxicity (increased em

Bandaríkin - enska - NLM (National Library of Medicine)

ucb pharma, inc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - tablet - 5 mg - attention deficit disorders (previously known as minimal brain dysfunction in children). other terms being used to describe the behavioral syndrome below include: hyperkinetic child syndrome, minimal brain damage, minimal cerebral dysfunction, minor cerebral dysfunction. methylphenidate hydrochloride is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. the diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. nonlocalizing (soft) neurological signs, learning disability, and abnormal eeg may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. spec

Bandaríkin - enska - NLM (National Library of Medicine)

ucb, inc. - brivaracetam (unii: u863jgg2ia) (brivaracetam - unii:u863jgg2ia) - brivaracetam 10 mg - briviact is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. hypersensitivity to brivaracetam or any of the inactive ingredients in briviact (bronchospasm and angioedema have occurred) [see warnings and precautions (5.4)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as briviact, during pregnancy. encourage patients who are taking briviact during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling the toll free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. risk summary available data from the north american antiepileptic drug (naaed) pregnancy registry, a prospective cohort study, case reports, and a case series are insufficient to identify a risk of major birth defects, miscarriage or other maternal or fetal outcomes associated with briviact use during pregnancy. in animal studies, briva

Bandaríkin - enska - NLM (National Library of Medicine)

ucb, inc. - certolizumab pegol (unii: umd07x179e) (certolizumab pegol - unii:umd07x179e) - certolizumab pegol 200 mg in 1 ml - cimzia is indicated for reducing signs and symptoms of crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. cimzia is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis (ra). cimzia is indicated for the treatment of adult patients with active psoriatic arthritis (psa). cimzia is indicated for the treatment of adults with active ankylosing spondylitis (as). [see clinical studies (14.4)] cimzia is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axspa) with objective signs of inflammation [see clinical studies (14.5)]. cimzia is indicated for the treatment of adults with moderate-to-severe plaque psoriasis (pso) who are candidates for systemic therapy or phototherapy [see clinical studies (14.6)] cimzia is con