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 11/02/2022

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
Laboratorios Lesvi S.L.
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
04/09/2011
Contact address

Avinguda Barcelona 69
Sant Joan Despi
08970 Barcelona
Spain

Product information

10/02/2022 Buccolam - EMEA/H/C/002267 - IAIN/0054

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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

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