Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: BUCCOLAM
Active substances:
Midazolam
Estonian, English, Latin
ATC code: N05CD08
Dosage form: oromucosal solution
Strength: 2,5mg 0.5ml
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
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
Marketing authorization holder: Neuraxpharm Pharmaceuticals S.L. 
Marketing authorization number: EU/1/11/709 
Marketing authorization issued on: September 5, 2011 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Assessment report:   
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
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1539402  BUCCOLAM  oromucosal solution  2,5mg 0.5ml 0.5ml 4TK  Prescription           
3045181  BUCCOLAM  oromucosal solution  2,5mg 0.5ml 0.5ml 2TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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