AMBISOME

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

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 more about Amphotericin B

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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