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Proveca medicines for children

This section is intended for Healthcare Professionals only and relates to paediatric medicines developed and licensed by Proveca.  Proveca also invests in the provision of educational items which are listed within the ‘Healthcare Professionals’ tab on the main menu, these can be utilised by healthcare professionals and provided to parents, carers and patients.

Sialanar®

(320mcg/ml glycopyrronium equivalent to 400mcg/ml glycopyrronium bromide)

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UK Prescribing Information

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Ireland Prescribing Information

Sialanar® received a Paediatric Use Marketing Authorisation (PUMA) in September 2016 for the symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders.

Pheburane®

(sodium phenylbutyrate 483 mg/g granules)

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Ireland Prescribing Information

Pheburane® is indicated as adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase or argininosuccinate synthetase.

Proveca only market Pheburane® in Ireland.

Please see information below to report adverse events in the UK

Adverse events should be reported. Reporting forms and information can be found at: www.mhra.gov.uk/yellowcard.
Adverse events should also be reported to Proveca Limited.
Phone: 0333 200 1866 E-mail: medinfo@proveca.com

Please see information below to report adverse events in the Republic of Ireland

Adverse events should be reported. Reporting forms and information can be found at: www.hpra.ie.
Adverse events should also be reported to Proveca Limited.
Phone: +44 333 200 1866 E-mail: medinfo@proveca.com

UK-SIA-23-0032
Updated March 2023

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