This brand name is authorized in Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Japan, Lithuania, Poland, Romania, United Kingdom
The drug BUCCOLAM contains one active pharmaceutical ingredient (API):
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1
Midazolam
UNII W7TTW573JJ - MIDAZOLAM HYDROCHLORIDE
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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. |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| BUCCOLAM Oromucosal solution | European Medicines Agency (EU) | MPI, EU: SmPC |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC code | Group title | Classification |
|---|---|---|
| N05CD08 | Midazolam | N Nervous system → N05 Psycholeptics → N05C Hypnotics and sedatives → N05CD Benzodiazepine derivatives |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| Country: EE | Ravimiamet | Identifier(s): 1539402, 1539413, 1539424, 1539435 |
| Country: ES | Centro de información online de medicamentos de la AEMPS | Identifier(s): 11709001, 11709002, 11709003, 11709004 |
| Country: FI | Lääkealan turvallisuus- ja kehittämiskeskus | Identifier(s): 063940, 435882, 450537, 491660 |
| Country: FR | Base de données publique des médicaments | Identifier(s): 60034085, 60673389, 61623065, 65629845 |
| Country: GB | Medicines & Healthcare Products Regulatory Agency | Identifier(s): 325189, 325192, 325195, 325199, 374321, 374323, 374325, 376233, 376235, 381231, 381233, 381235 |
| Country: IE | Health Products Regulatory Authority | Identifier(s): 14356, 14361, 14378, 14385 |
| Country: IL | מִשְׂרַד הַבְּרִיאוּת | Identifier(s): 7127, 7128, 7129, 7130 |
| Country: JP | 医薬品医療機器総合機構 | Identifier(s): 1139700Q1029, 1139700Q2025, 1139700Q3021, 1139700Q4028 |
| Country: LT | Valstybinė vaistų kontrolės tarnyba | Identifier(s): 1063633, 1063634, 1063635, 1063636 |
| Country: PL | Rejestru Produktów Leczniczych | Identifier(s): 100308829, 100308835, 100308841, 100308858 |
| Country: RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | Identifier(s): W68893001, W68893002, W68894001, W68894002, W68895001, W68895002, W68896001, W68896002 |
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