Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

endotherapeutics pty ltd - 47764 - wound hydrogel dressing, sterile - highly viscous absorbable anti-adhesion barrier gel. the gel is applied to the surgical site where it adheres to the tissue surface and creates an anti-adhesion barrier, keeping adjacent tissues separated following surgery. the gel is intended to be absorbed within 30 days of application. hyaregen gel is indicated for the prevention or reduction of post-surgical adhesion formation in the abdomino-pelvicarea after laparoscopic/hysteroscopic and open gynaecological surgical procedures.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

endotherapeutics pty ltd - 64309 - ureteral sheath - the ureteral access sheath is intended to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

endotherapeutics pty ltd - 46452 - endotherapy stone removal basket - the urological stone extraction basket is intended to be used endoscopically to grasp, manipulate and remove calculi and other foreign objects from the urinary tract.

Malaizija - angļu - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

zuellig pharma sdn bhd - loxoprofen sodium hydrate -

Eiropas Savienība - angļu - EMA (European Medicines Agency)

united therapeutics europe ltd - dinutuximab - neuroblastoma - antineoplastic agents - unituxin is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months to 17years, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and autologous stem cell transplantation (asct). it is administered in combination with granulocyte-macrophage colony-stimulating factor (gm-csf), interleukin-2 (il-2), and isotretinoin.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

echo therapeutics pty ltd - trimethoprim, quantity: 160 mg; sulfamethoxazole, quantity: 800 mg - tablet - excipient ingredients: magnesium stearate; povidone; sodium starch glycollate; docusate sodium - upper and lower respiratory tract infections, renal and urinary tract infections; genital tract infections; gastrointestinal tract infections; skin and wound infections; septicaemias and other infections caused by sensitive organisms.

Eiropas Savienība - angļu - EMA (European Medicines Agency)

incline therapeutics europe ltd - fentanyl hydrochloride - pain, postoperative - analgesics - ionsys is indicated for the management of acute moderate to severe post-operative pain in adult patients.

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

amicus therapeutics pty ltd - migalastat hydrochloride, quantity: 150 mg - capsule, hard - excipient ingredients: magnesium stearate; pregelatinised maize starch; indigo carmine; titanium dioxide; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide; gelatin; sodium lauryl sulfate - galafold is indicated for long-term treatment of adult and adolescent patients 12 years and older with a confirmed diagnosis of fabry disease (alpha-galactosidase a deficiency) and who have an amenable mutation (see the table in section 5.1 pharmacodynamic properties, mechanism of action).

Īrija - angļu - HPRA (Health Products Regulatory Authority)

aclaris therapeutics international ltd - hydrogen peroxide - cutaneous solution - 685 milligram(s)

Austrālija - angļu - Department of Health (Therapeutic Goods Administration)

echo therapeutics pty ltd - peginterferon alfa-2a, quantity: 180 microgram - injection, solution - excipient ingredients: acetic acid; water for injections; sodium acetate; sodium chloride; polysorbate 80; benzyl alcohol - chronic hepatitis c (chc): the combination of pegasys and copegus is indicated for the treatment of chronic heptitis c in patients who have received no prior interferon therapy (treatment naive patients) and patients who have failed previous treatment with interferon alfa (pegylated or non-pegylated) alone or in combination therapy with ribavirin. the combination of pegasys and copegus is also indicated for the treatment of chronic hepatitis c in patients with clinically stable human immunodeficiency virus (hiv) co-infection who have previously not received interferon therapy. pegasys monotherapy is indicated for the for the treatment of chronic heptitis c in treatment naive patients (see dosage and administration; chronic hepatitis c: treatment naive patients). patients must be 18 years of age or older and have compensated liver disease. chronic hepatitis b (chb): pegasys is indicated for the treatment of chronic heptitis b in adult patients with evidence of viral replication and liver inflammation and compensated liver disease.