Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Buccolam   
Auth. number : EU/1/11/709
Active substance : midazolam
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N05 - Psycholeptics
Pharmacological subgroup: N05C - Hypnotics and sedatives
Chemical subgroup: N05CD - Benzodiazepine derivatives
Chemical substance: N05CD08 - Midazolam
(See WHO ATC Index)
Indication: Treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents (from 3 months to < 18 years).
BUCCOLAM must only be used by parents/carers where the patient has been diagnosed to have
Epilepsy For infants between 3-6 months of age treatment should be in a hospital setting where monitoring is possible and resuscitation equipment is available.
Marketing Authorisation Holder: Shire Services BVBA
rue Montoyer 47, 1000 Bruxelles, Belgique / Montoyerstraat 47, 1000 Brussel, België
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
07/09/2011 Centralised - Authorisation EMEA/H/C/2267 (2011)6372 of 05/09/2011
13/12/2012 Centralised - Variation EMEA/H/C/2267/IA/4/G
Updated with Decision(2013)9726 of 18/12/2013
19/12/2013 Centralised - Yearly update (2013)9726 of 18/12/2013
17/01/2014 Centralised - Notification EMEA/H/C/2267/N/11
Updated with Decision(2015)1565 of 05/03/2015
27/02/2014 Centralised - Variation EMEA/H/C/2267:/IA/22
Updated with Decision(2015)1565 of 05/03/2015
20/03/2014 Centralised - Variation EMEA/H/C/2267:/IB/19
Updated with Decision(2015)1565 of 05/03/2015
06/03/2015 Centralised - Yearly update (2015)1565 of 05/03/2015
03/12/2015 Centralised - Variation EMEA/H/C/2267:/IG/603/G
Updated with Decision(2016)3315 of 26/05/2016
30/05/2016 Centralised - Renewal EMEA/H/C/2267:/R/32 (2016)3315 of 26/05/2016