This is a summary of the European public assessment report (EPAR) for Buccolam. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Buccolam.
Buccolam : EPAR - Summary for the public (PDF/50.45 KB)
First published: 19/09/2011
Last updated: 19/09/2011
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Shire Services BVBA
|Date of issue of marketing authorisation valid throughout the European Union||
27/07/2020 Buccolam - EMEA/H/C/002267 - PSUSA/00010118/201909
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents (from three months to less than 18 years).
Buccolam must only be used by parents / carers where the patient has been diagnosed to have epilepsy.
For infants between three and six months of age, treatment should be in a hospital setting where monitoring is possible and resuscitation equipment is available.