BUCCOLAM

This brand name is authorized in Austria, Croatia, Estonia, Finland, France, Ireland, Israel, Japan, Lithuania, Poland, Romania, Spain, UK.

Active ingredients

The drug BUCCOLAM contains one active pharmaceutical ingredient (API):

1
UNII W7TTW573JJ - MIDAZOLAM HYDROCHLORIDE
 

Midazolam is a derivative of the imidazobenzodiazepine group. The free base is a lipophilic substance with low solubility in water. The basic nitrogen in position 2 of the imidazobenzodiazepine ring system enables the active ingredient of midazolam to form water-soluble salts with acids.

 
Read more about Midazolam

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 BUCCOLAM Oromucosal solution MPI, EU: SmPC European Medicines Agency (EU)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group Classification
N05CD08 Midazolam N Nervous system → N05 Psycholeptics → N05C Hypnotics and sedatives → N05CD Benzodiazepine derivatives
Discover more medicines within N05CD08

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
EE Ravimiamet 1539402, 1539413, 1539424, 1539435
ES Centro de información online de medicamentos de la AEMPS 11709001, 11709002, 11709003, 11709004
FI Lääkealan turvallisuus- ja kehittämiskeskus 063940, 435882, 450537, 491660
FR Base de données publique des médicaments 60034085, 60673389, 61623065, 65629845
GB Medicines & Healthcare Products Regulatory Agency 325189, 325192, 325195, 325199, 374321, 374323, 374325, 376233, 376235, 381231, 381233, 381235
IE Health Products Regulatory Authority 14356, 14361, 14378, 14385
IL מִשְׂרַד הַבְּרִיאוּת 7127, 7128, 7129, 7130
JP 医薬品医療機器総合機構 1139700Q1029, 1139700Q2025, 1139700Q3021, 1139700Q4028
LT Valstybinė vaistų kontrolės tarnyba 1063633, 1063634, 1063635, 1063636
PL Rejestru Produktów Leczniczych 100308829, 100308835, 100308841, 100308858
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale W68893001, W68893002, W68894001, W68894002, W68895001, W68895002, W68896001, W68896002

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