EUSA Pharma: Product Summary

Product Summary

Product	Availability	Description
Caphosol®: super saturated calcium phosphate mouth rinse	US	An FDA-approved medical device, CAPHOSOL® is a topical oral agent indicated in the U.S. as an adjunct to standard oral care in treating oral mucositis caused by radiation or high dose chemotherapy. CAPHOSOL® is also indicated for dryness of the mouth (hyposalivation) or dryness of the throat (xerostomia) regardless of the cause or whether the conditions are temporary or permanent. Full prescribing information for CAPHOSOL® can be found at www.caphosol.com
Caphosol®: super saturated calcium phosphate mouth rinse	Europe: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Republic of Ireland, Italy, Latvia, Lithuania, Luxembourg, The Netherlands , Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom Rest of World: Albania, Andorra, Australia, Bosnia, Croatia, Herzegovina, Iceland, India, Kosovo, Jordan, Macedonia, Malta, Montenegro, New Zealand, San Marino, Serbia, South Korea, Vatican City	Caphosol® is a CE marked Class I Medical device. Caphosol is indicated for dryness of the mouth and oropharynx (hyposalivation, xerostomia), regardless of the cause and regardless of whether the condition is temporary or permanent. Caphosol is also indicated as an adjunct to standard oral care in the prevention and treatment of the mucositis that may be caused by radiation or high dose chemotherapy. Relief of dryness of the oral mucosa in these conditions is associated with amelioration of pain.
Collatamp®: gentamicine impregnated collagen sponge	• Drug Europe: Austria, Belgium, Czech Republic, Denmark, Finland, Germany, Hungary, Iceland, Liechtenstein, Luxembourg, Malta, The Netherlands, Poland, Portugal, Slovakia, Switzerland Rest of World: Argentina, Chile, Colombia, Dominican Republic, Dutch Islands, Hong Kong, Mexico, Namibia, South Africa, South Korea • Medical Device Europe: UK, Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, France, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Northern Ireland, Norway, Poland, Republic of Ireland, Romania, Slovenia, Spain, Sweden Rest of World: Australia, Brazil, Canada, Iran, Jordan, Kuwait, Lebanon, Malaysia, New Zealand, Philippines, Russia, Singapore, Saudi Arabia, Turkey, United Arab Emirates	Collatamp® a lyophilized bovine or equine collagen sponge impregnated with the aminoglycoside antibiotic gentamicin, is indicated for local haemostasis of capillary, parenchymatous and seeping haemorrhages in areas with a high risk of infection.
Erwinase®: Lyophilisate for solution for injection (Erwinia chrysanthemi L-asparaginase; crisantaspase). ¹Local Marketing Authorisation Holder : the Health Protection Agency ²Erwinase® is not yet fully approved in these countries but upon the request of a physician, Erwinase® may be made available to named patients who fulfil a defined criteria. ³Only available as part of a treatment IND.	Europe: Austria, Cyprus², Czech Republic², Denmark, Estonia², Finland², France, Germany, Greece, Hungary², Republic of Ireland, Latvia², Lithuania², The Netherlands, Norway, Poland², Portugal, Romania², Slovakia², Slovenia², Spain², Sweden, United Kingdom¹ Rest of World: Albania², Algeria², Andorra², Argentina², Australia², Bolivia², Bosnia², Brazil², Canada, Columbia², Croatia Ecuador², Egypt, Herzigovina², Hong Kong, Iceland², India², Israel², Kosovo², Lebanon, Macedonia², Malaysia, Mexico², Montenegro², New Zealand², Palestine², Paraguay², Peru², Philippines², Saudi Arabia², Serbia², Singapore², South Africa², South Korea, Taiwan², Thailand, Tunisia², Turkey², Uruguay², US³	Erwinase® is used in combination with other anti-neoplastic agents to treat Acute Lymphoblastic Leukemia. It may also be used in other neoplastic conditions where depletion of asparagine might be expected to have a useful effect. Patients receiving treatment with L-asparaginase derived from Escherichia coli, who develop hypersensitivity to that enzyme, may be able to continue treatment with ERWINASE® as the enzymes are immunologically distinct.*
Fomepizole: 5 mg/ml concentrate for solution for infusion	Europe: Austria, Belgium, Denmark, Estonia, Finland, France, Germany, Iceland, Republic of Ireland, Latvia, Lithuania, Luxembourg, Norway, Sweden, The Netherlands Rest of World: Australia, Brazil, Canada, Iran, Jordan, Kuwait, Lebanon, Malaysia, New Zealand, Philippines, Russia, Singapore, Saudi Arabia, Turkey, United Arab Emirates	This specific pharmacological antidote is indicated for the treatment of ethylene glycol poisoning. This compound is commonly used in automotive coolants and antifreeze.
Kidrolase®: powder for solution for injection (Escherichia coli L-asparaginase). *= Kidrolase® is not yet fully approved in these countries but upon the request of a physician, Kidrolase® may be made available to named patients who fulfil a defined criteria	Europe: Austria, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Republic of Ireland, Latvia, Lithuania, Norway, Poland, Romania, Slovakia, Slovenia, Spain, Sweden Rest of World: Albania, Algeria, Andorra, Argentina, Bolivia, Bosnia, Canada, Chile, Colombia, Croatia, Ecuador, Egypt, Herzegovina, Iceland, Kosovo, Israel, Lebanon, Macedonia, Morocco, Montenegro, Palestine, Paraguay, Peru, Saudi Arabia, Serbia, Tunisia, Turkey, Uruguay	KIDROLASE® is indicated in the treatment of Acute Lymphoblastic Leukaemia, Leukaemic meningitis and Non-Hodgkin’s lymphoma.
ProstaScint®:kit for the preparation of Indium In 111 Capromab Pendetide for intravenous use.	US Singapore	PROSTASCINT® is a PSMA-targeting monoclonal antibody-based agent to image the extent and spread of prostate cancer. Full prescribing information for PROSTASCINT® can be found at www.prostascintimaging.com
QuadraMet®: isotonic solution of samarium-153 lexidronam for intravenous administration.	US	QUADRAMET® is a radiopharmaceutical for the treatment of pain in patients whose cancer has spread to the bone. Full prescribing information for QUADRAMET® can be found at www.quadrametinfo.com
Xenazine®: 25 mg, scored tablets (INN: tetrabenazine)	France	Xenazine® was developed by Cambridge Laboratories (UK) and is indicated for the movement disorders associated with Huntington’s chorea and Hemiballismus.