New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - follitropin alfa 300 [iu] (22 mcg) - solution for injection - 600 iu/ml - active: follitropin alfa 300 [iu] (22 mcg) excipient: dibasic sodium phosphate dihydrate methionine monobasic sodium phosphate dihydrate phosphoric acid poloxamer sucrose water for injection - in adult men: bemfola is indicated with concomitant human chorionic gonadotrophin (hcg) therapy for the stimulation of spermatogenesis in gonadotrophin-deficient men in whom hcg alone is ineffective.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - follitropin alfa 450 [iu] (33 mcg) - solution for injection - 600 iu/ml - active: follitropin alfa 450 [iu] (33 mcg) excipient: dibasic sodium phosphate dihydrate methionine monobasic sodium phosphate dihydrate phosphoric acid poloxamer sucrose water for injection - in adult men: bemfola is indicated with concomitant human chorionic gonadotrophin (hcg) therapy for the stimulation of spermatogenesis in gonadotrophin-deficient men in whom hcg alone is ineffective.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - follitropin alfa 75 [iu] (5.5 mcg) - solution for injection - 600 iu/ml - active: follitropin alfa 75 [iu] (5.5 mcg) excipient: dibasic sodium phosphate dihydrate methionine monobasic sodium phosphate dihydrate phosphoric acid poloxamer sucrose water for injection - in adult men: bemfola is indicated with concomitant human chorionic gonadotrophin (hcg) therapy for the stimulation of spermatogenesis in gonadotrophin-deficient men in whom hcg alone is ineffective.

European Union - English - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - tocilizumab - arthritis, rheumatoid; cytokine release syndrome; arthritis, juvenile rheumatoid; covid-19 virus infection; giant cell arteritis - immunosuppressants - tyenne, in combination with methotrexate (mtx), is indicated for- the treatment of severe, active and progressive rheumatoid arthritis (ra) in adults not previously treated with mtx.- the treatment of moderate to severe active ra in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (dmards) or tumour necrosis factor (tnf) antagonists.in these patients, tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate.tocilizumab has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function when given in combination with methotrexate.tyenne is indicated for the treatment of coronavirus disease 2019 (covid-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.tyenne is indicated for the treatment of active systemic juvenile idiopathic arthritis (sjia) in patients 1 year of age and older, who have responded inadequately to previous therapy with nsaids and systemic corticosteroids. tyenne can be given as monotherapy (in case of intolerance to mtx or where treatment with mtx is inappropriate) or in combination with mtx.tyenne in combination with methotrexate (mtx) is indicated for the treatment of juvenile idiopathic polyarthritis (pjia; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with mtx.tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate.tyenne is indicated for the treatment of chimeric antigen receptor (car) t cell-induced severe or life-threatening cytokine release syndrome (crs) in adults and paediatric patients 2 years of age and older.tyenne is indicated for the treatment of giant cell arteritis (gca) in adult patients.

Singapore - English - HSA (Health Sciences Authority)

healthgate technology pte ltd - general & plastic surgery - the product is applicable to rebuilding, repairing or fixing the fracture or defect of cranium and facial bone.

Australia - English - Department of Health (Therapeutic Goods Administration)

solta medical australia pty ltd - 45048 - skin contouring system applicator tip, radio-frequency - a removable end-piece that is attached to a radiofrequency (rf) skin contouring system applicator (hand-piece), used to regulate the delivery of rf energy to the patient during treatment. it may also be used to cool the skin and monitor its temperature to protect the epidermis during treatment. thermage treatment tips are supplied non-sterile and should be cleaned prior to use, as per the manufacturer's instructions. this device is for single patient use only.

Australia - English - Department of Health (Therapeutic Goods Administration)

solta medical australia pty ltd - 45214 - skin contouring system applicator, radio-frequency, monopolar - a monopolar hand-piece that is part of a skin contouring system that uses radiofrequency (rf) energy to provide a capacitively coupled electrical connection for the transfer of radiated energy through a patients skin in deep heat-mediated skin modification. the current passes from this device to an indifferent return electrode placed on the patient. this device is connected to a generator and is applied by the practitioner or staff directly to the area to be treated. this is a reusable device.

Australia - English - Department of Health (Therapeutic Goods Administration)

solta medical australia pty ltd - 45049 - skin contouring system electrode, return, radio-frequency - a non-active conductor that is part of a skin contouring system that uses radiofrequency (rf) energy and that is placed on a patients skin to provide a complete electrical circuit for energy transferred to a patient from a monopolar applicator. this device is affixed to the patients body typically where the greatest surface area is utilized during treatment and helps to prevent the occurrence of electrical burns. it may have a mat-like design, and is a single-use device.

Australia - English - Department of Health (Therapeutic Goods Administration)

solta medical australia pty ltd - 45218 - skin contouring system generator, radio-frequency - a device that is part of a skin contouring system that generates radiofrequency (rf) energy (typically in the bands below 7 megahertz (mhz)) to generate heat deep within body tissues to contour both the skin and underlying tissues through a process of skin regrowth and tightening. the energy generated by this device is conducted through dedicated applicators that are moved across a patients skin by a practitioner or staff for treatment.

Australia - English - Department of Health (Therapeutic Goods Administration)

indiba australia pty ltd - 45218 - skin contouring system generator, radio-frequency - this is a non-invasive wrinkle treatment that is intended to be used for the improvement of skin laxity through wrinkle reduction on the neck, face, and other areas of the body. cellulite reduction;mobilization of local fat and reduction of fatty nodules. body contouring / body shaping circumferential reduction.body shaping via cellulite treatment.postpartum body contouring.pre- and post- surgery pre and post aesthetic and reconstructive surgery.promote wound care and wound healing by improving wound drainage and facilitating healing process.