Product class: Authorized package
Medicinal product class: For human use
Package code: 3045192
Name of medicinal product: BUCCOLAM
Active substances:
Midazolam
Estonian, English, Latin
ATC code: N05CD08
Dosage form: oromucosal solution
Route of administration: oromucosal use
Strengh: 7,5mg 1.5ml
Amount in package: 1.5ml 2TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance: Psychotropic
Additional information:  
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. See section 4.2.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Neuraxpharm Pharmaceuticals S.L. 
Marketing authorization number: EU/1/11/709 
Marketing authorization issued on: 05 September 2011 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Description Additional condition
Ei ole lubatud väljastada korduvretsepti
Hambaarstil on õigus välja kirjutada Väikseima müügiloleva ravimpakendi suuruses, kuid mitte üle 20 tableti
Ravi alustamisel kehtib koguseline piirang 30 tabletti või 20 ampulli või 20 suposiiti või 10 rektaaltuubi või tilgad 25ml
Korduval väljakirjutamisel kehtib koguseline piirang 60 tabletti või 20 ampulli või 20 suposiiti või 10 rektaaltuubi või tilgad 25ml
Entry/Changing date: 05 October 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription