Buccolam

RSS

midazolam

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 20/08/2018

Authorisation details

Product details
Name
Buccolam
Agency product number
EMEA/H/C/002267
Active substance
midazolam
International non-proprietary name (INN) or common name
midazolam
Therapeutic area (MeSH)
Epilepsy
Anatomical therapeutic chemical (ATC) code
N05CD08
Publication details
Marketing-authorisation holder
Shire Services BVBA
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
05/09/2011
Contact address
Rue Montoyer 47
B-1000 Brussels
Belgium

Product information

25/07/2018 Buccolam - EMEA/H/C/002267 - N/0038

Contents

  • 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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

PSYCHOLEPTICS

Therapeutic indication

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.

Assessment history

Patient Safety

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