Embolization particle, non-bioabsorbable

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Available from:

Merit Medical Australia Pty Ltd

Class:

Class IIb

Manufactured by:

Biosphere Medical SA Parc des Nations - Paris Nord 2 383 rue de la Belle Etoile, Roissy en France, 95700 France

Therapeutic area:

60938 - Embolization particle, non-bioabsorbable

Therapeutic indications:

HepaSphere Microspheres are indicated for use in embolization of blood vessels with or without delivery of doxorubicin HCI for therapeutic or preoperative purposes in the following procedures; Embolization of hepatocellular carcinoma -Embolization of metastases to the liver. HepaSphere Microspheres loaded with Irinotecan are indicated for use in: Embolization of metastatic colorectal cancer (mCRC)to the liver.

Authorization status:

A

Authorization date:

2016-05-31

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