United States - English - NLM (National Library of Medicine)

ani pharmaceuticals, inc. - metoclopramide hydrochloride (unii: w1792a2rvd) (metoclopramide - unii:l4yeb44i46) - metoclopramide 5 mg - reglan tablets are indicated for the: limitations of use : reglan tablets are not recommended for use in pediatric patients due to the risk of developing tardive dyskinesia (td) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates [see use in specific populations (8.4)]. reglan is contraindicated: risk summary published studies, including retrospective cohort studies, national registry studies, and meta-analyses, do not report an increased risk of adverse pregnancy-related outcomes with use of metoclopramide during pregnancy. there are potential risks to the neonate following exposure in utero to metoclopramide during delivery [see clinical considerations] . in animal reproduction studies, no adverse developmental effects were observed with oral administration of metoclopramide to pregnant rats and rabbits at exposures about 6 and 12 times the maximum recommended human dose (mrhd) [see data] . the estimated background risk of major birth defects and miscarriage for the indic

United States - English - NLM (National Library of Medicine)

stat rx usa llc - metoclopramide hydrochloride (unii: w1792a2rvd) (metoclopramide - unii:l4yeb44i46) - metoclopramide hydrochloride 10 mg - the use of reglan® tablets is recommended for adults only. therapy should not exceed 12 weeks in duration. reglan® tablets are indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy. the principal effect of metoclopramide is on symptoms of postprandial and daytime heartburn with less observed effect on nocturnal symptoms. if symptoms are confined to particular situations, such as following the evening meal, use of metoclopramide as single doses prior to the provocative situation should be considered, rather than using the drug throughout the day. healing of esophageal ulcers and erosions has been endoscopically demonstrated at the end of a 12-week trial using doses of 15 mg q.i.d. as there is no documented correlation between symptoms and healing of esophageal lesions, patients with documented lesions should be monitored endoscopically. reglan® tablets (metoclopramide tablets, usp) is indicated for the reli

European Union - English - EMA (European Medicines Agency)

biogen netherlands b.v. - diroximel fumarate (biib098) - multiple sclerosis, relapsing-remitting - immunosuppressants - vumerity is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (see section 5.1 for important information on the populations for which efficacy has been established).

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - fingolimod hydrochloride  - multiple sclerosis, relapsing-remitting - immunosuppressants, selective immunosuppressants - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult patients and paediatric patients aged 10 years and older:patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapyorpatients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

European Union - English - EMA (European Medicines Agency)

mylan ireland limited - fingolimod hydrochloride  - multiple sclerosis, relapsing-remitting - immunosuppressants - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older:patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4.4 and 5.1)orpatients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

European Union - English - EMA (European Medicines Agency)

mylan ireland limited - fingolimod hydrochloride  - multiple sclerosis, relapsing-remitting - immunosuppressants - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4.4 and 5.1) or patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.,

European Union - English - EMA (European Medicines Agency)

merck europe b.v.  - interferon beta-1a - multiple sclerosis - immunostimulants, - rebif is indicated for the treatment of:patients with a single demyelinating event with an active inflammatory process, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis;patients with relapsing multiple sclerosis. in clinical trials, this was characterised by two or more acute exacerbations in the previous two years.efficacy has not been demonstrated in patients with secondary progressive multiple sclerosis without ongoing relapse activity.

European Union - English - EMA (European Medicines Agency)

sandoz gmbh - natalizumab - multiple sclerosis, relapsing-remitting; multiple sclerosis - immunosuppressants - tyruko is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (rrms) for the following patient groups: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4.4 and 5.1), or, patients with rapidly evolving severe rrms defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain magnetic resonance imaging (mri) or a significant increase in t2 lesion load as compared to a previous recent mri.,

European Union - English - EMA (European Medicines Agency)

mylan ireland limited - dimethyl fumarate - multiple sclerosis, relapsing-remitting - immunosuppressants - dimethyl fumarate mylan is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

European Union - English - EMA (European Medicines Agency)

zaklady farmafarmaceutyczne polpharma s.aceutyczne polpharma s.a. - dimethyl fumarate - multiple sclerosis, relapsing-remitting - immunosuppressants - dimethyl fumarate polpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.