AMBISOME

This brand name is authorized in Austria, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

Active ingredients

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

1 Amphotericin B UNII 7XU7A7DROE - AMPHOTERICIN B

Amphotericin B is a macrocyclic, polyene antifungal antibiotic produced by Streptomyces nodosus. The molecule is thought to act by binding to sterols in the fungal cell membrane, with a resulting change in membrane permeability, allowing leakage of a variety of small molecules. Read about Amphotericin B

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
AMBISOME Powder for solution for infusion	Medicines & Healthcare Products Regulatory Agency (GB)	MPI, EU: SmPC

Medicine classification

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

ATC code	Group title	Classification
J02AA01	Amphotericin B	J Antiinfectives for systemic use → J02 Antimycotics for systemic use → J02A Antimycotics for systemic use → J02AA Antibiotics
Discover more medicines within J02AA01

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 533200101151412
Country: CA	Health Products and Food Branch	Identifier(s): 02241630
Country: EE	Ravimiamet	Identifier(s): 1022544, 1556793, 1857450
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 61117
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 153379
Country: FR	Base de données publique des médicaments	Identifier(s): 65964911
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 211958
Country: HK	Department of Health Drug Office	Identifier(s): 43591
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 7809
Country: JP	医薬品医療機器総合機構	Identifier(s): 6173400D2023
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1090494, 1092972
Country: MT	Medicines Authority	Identifier(s): AA1306/00102
Country: MX	Comisión Federal para la Protección contra Riesgos Sanitarios	Identifier(s): 050M2014
Country: NL	Z-Index G-Standaard	Identifier(s): 13807374
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 38849
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 7576
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100000310
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W68367001
Country: SG	Health Sciences Authority	Identifier(s): 12021P
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8698760790068, 8698760790075
Country: US	FDA, National Drug Code	Identifier(s): 0469-3051
Country: ZA	Health Products Regulatory Authority	Identifier(s): 36/20.2.2/0453