Israel - English - Ministry of Health

glaxo smith kline (israel) ltd - clobetasol 17- propionate - cream - clobetasol 17- propionate 0.05 %w/w - clobetasol - clobetasol - clobetasol is a very potent topical corticosteroid indicated for adults, elderly and children over 1 year for the short term treatment only of more resistant inflammatory and pruritic manifestations of steroid responsive dermatoses unresponsive to less potent corticosteroids. these include the following:• psoriasis (excluding widespread plaque psoriasis)• recalcitrant dermatoses • lichen planus• discoid lupus erythematosus • other skin conditions which do not respond satisfactorily to less potent steroids.

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

pfizer australia pty ltd - clindamycin phosphate, quantity: 22.8 mg/g (equivalent: clindamycin, qty 20 mg/g) - cream - excipient ingredients: purified water; polysorbate 60; benzyl alcohol; stearic acid; cetyl esters wax; propylene glycol; liquid paraffin; sorbitan monostearate; cetostearyl alcohol - dalacin v cream 2% is indicated for the treatment of symptomatic bacterial vaginosis. note: for the purposes of this indication bacterial vaginosis is usually defined by positive results to at least three of the four following criteria: 1. vaginal discharge with ph > 4.5; 2. vaginal discharge demonstrating an amine ("fishy") odour with the addition of 10% potassium hydroxide; 3. vaginal discharge with "clue cells" on microscopy, and; 4. a gram stain consistent with a diagnosis of bacterial vaginosis (lactobacillus morphotype absent or markedly decreased; gardnerella morphotype predominant flora; white blood cells absent or few; mobiluncus morphotype may or may not be present). other pathogens which may be associated with genital infection such as trichomonas vaginalis, candida albicans, chlamydia trachomatis and neisseria gonorrhoeae should be ruled out by appropriate laboratory means.

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

viatris pty ltd - pimecrolimus, quantity: 10 mg/g - cream - excipient ingredients: sodium hydroxide; citric acid; benzyl alcohol; sodium cetostearyl sulfate; mono- and di- glycerides; cetyl alcohol; stearyl alcohol; propylene glycol; oleyl alcohol; medium chain triglycerides; purified water - elidel 1% cream is indicated for patients 3 months of age and older with atopic dermatitis (eczema) for: short term treatment of signs and symptoms; intermittent long-term treatment of emerging and resolving lesions in atopic dermatitis where the use of a topical corticosteroid is not yet warranted, no longer needed, or is inadvisable (according to the usage restrictions in the respective topical corticosteroid product information).

United States - English - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - tisagenlecleucel (unii: q6c9whr03o) (tisagenlecleucel - unii:q6c9whr03o) - tisagenlecleucel 2000000 - kymriah is a cd19-directed genetically modified autologous t cell immunotherapy indicated for the treatment of: patients up to 25 years of age with b-cell precursor acute lymphoblastic leukemia (all) that is refractory or in second or later relapse. adult patients with relapsed or refractory (r/r) large b-cell lymphoma after two or more lines of systemic therapy including diffuse large b-cell lymphoma (dlbcl) not otherwise specified, high grade b-cell lymphoma and dlbcl arising from follicular lymphoma. limitation of use: kymriah is not indicated for treatment of patients with primary central nervous system lymphoma. adult patients with relapsed or refractory (r/r) follicular lymphoma (fl) after two or more lines of systemic therapy. this indication is approved under accelerated approval based on response rate and duration of response [see clinical studies (14.3)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). none. risk summary there are no available data with kymriah use in pregnant women. no animal reproductive and developmental toxicity studies have been conducted with kymriah to assess whether it can cause fetal harm when administered to a pregnant woman. it is not known if kymriah has the potential to be transferred to the fetus. based on the mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity, including b-cell lymphocytopenia. therefore, kymriah is not recommended for women who are pregnant, and pregnancy after kymriah administration should be discussed with the treating physician. report pregnancies to novartis pharmaceuticals corporation at 1-888-669-6682.  in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. risk summary there is no information regarding the presence of kymriah in human milk, the effect on the breastfed infant, and the effects on milk production. a risk to the breastfed infant cannot be excluded. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for kymriah and any potential adverse effects on the breastfed infant from kymriah or from the underlying maternal condition. pregnancy testing pregnancy status of females with reproductive potential should be verified. sexually-active females of reproductive potential should have a pregnancy test prior to starting treatment with kymriah. contraception see the prescribing information for fludarabine and cyclophosphamide for information on the need for effective contraception in patients who receive the lymphodepleting chemotherapy. there are insufficient exposure data to provide a recommendation concerning duration of contraception following treatment with kymriah. infertility there are no data on the effect of kymriah on male and female fertility. the safety and efficacy of kymriah have been established in pediatric patients with r/r b-cell all. use of kymriah is supported by a single-arm trial [see clinical studies (14.1)] that included 61 pediatric patients with r/r b-cell precursor all in the following age groups: 40 children (ages 2 years to less than 12 years) and 21 adolescents (ages 12 years to less than 17 years). no differences in efficacy or safety were observed between the different age subgroups or in comparison to the young adults in the trial. the safety and efficacy of kymriah in pediatric patients with r/r dlbcl and r/r fl have not been established. the safety and effectiveness of kymriah have not been established in geriatric patients with r/r b-cell all. clinical studies of kymriah did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

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

strides pharma science pty ltd - imiquimod, quantity: 12.5 mg - cream - excipient ingredients: benzyl alcohol; purified water; methyl hydroxybenzoate; isostearic acid; xanthan gum; glycerol; white soft paraffin; polysorbate 60; stearyl alcohol; propyl hydroxybenzoate; sorbitan monostearate; cetyl alcohol - ? treatment of solar (actinic) keratosis on the face and scalp (see precautions), and ,? primary treatment of confirmed superficial basal cell carcinoma where surgery is considered inappropriate, and ,? treatment of external genital and perianal warts/condyloma acuminata in adults (see precautions).

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

aspen pharmacare australia pty ltd - estriol, quantity: 1 mg/g - cream - excipient ingredients: sodium hydroxide; stearyl alcohol; lactic acid; cetyl esters wax; purified water; chlorhexidine hydrochloride; sorbitan monostearate; octyldodecanol; glycerol; polysorbate 60; cetyl alcohol - indications as at 18 december 2001. vulvo-vaginal complaints due to oestrogen deficiency associated with the climacteric and the postmenopause or after ovariectomy: atrophic vaginitis. puritis vulvae. dyspareunia due to vulvo-vaginal atrophy. as auxiliary therapy in the treatment of vaginal infections. as pre-operative therapy for vulvo-vaginal surgery and during subsequent convalescence. ulcers in the case of prolapse of the uterus or vagina. to avoid misinterpretation of a cytological smear.

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

inova pharmaceuticals (australia) pty ltd - imiquimod, quantity: 50 mg/g - cream - excipient ingredients: benzyl alcohol; glycerol; white soft paraffin; stearyl alcohol; isostearic acid; sorbitan monostearate; propyl hydroxybenzoate; xanthan gum; polysorbate 60; purified water; methyl hydroxybenzoate; cetyl alcohol - aldara 5% cream is indicated for treatment of solar (actinic) keratosis on the face and the scalp (see precautions), and primary treatment of confirmed superficial basal cell carcinoma where surgery is considered inappropriate, and the treatment of external genital and peri-anal warts (condyloma acuminata) in adults (see precautions).

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

galderma australia pty ltd - adapalene, quantity: 1 mg/g - cream - excipient ingredients: propyl hydroxybenzoate; carbomer 934p; methyl hydroxybenzoate; cyclomethicone; squalane; sodium hydroxide; purified water; disodium edetate; methyl glucose sesquistearate; phenoxyethanol; peg-20 methyl glucose sesquistearate; glycerol - differin topical cream 0.1% is indicated for the topical treatment of comedo, papular and pustular acne (acne vulgaris) of the face, chest or back.

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

inova pharmaceuticals (australia) pty ltd - imiquimod, quantity: 50 mg/g - cream - excipient ingredients: methyl hydroxybenzoate; cetyl alcohol; xanthan gum; propyl hydroxybenzoate; polysorbate 60; isostearic acid; glycerol; white soft paraffin; benzyl alcohol; stearyl alcohol; purified water; sorbitan monostearate - aldara 5% cream is indicated for treatment of solar (actinic) keratosis on the face and the scalp (see precautions), and primary treatment of confirmed superficial basal cell carcinoma where surgery is considered inappropriate, and the treatment of external genital and peri-anal warts (condyloma acuminata) in adults (see precautions).

New Zealand - English - Medsafe (Medicines Safety Authority)

bayer new zealand limited - clotrimazole 10%{relative} (micronised ) - vaginal cream - 10 % - active: clotrimazole 10%{relative} (micronised ) excipient: benzyl alcohol cetostearyl alcohol cetyl palmitate isopropyl myristate polysorbate 60 purified water sorbitan stearate - canesten clotrimazole thrush treatment once, 3 day and 6 day creams are indicated for the topical treatment of vulvovaginal candidiasis. canesten clotrimazole cream may also be used in conjunction with canesten clotrimazole vaginal pessaries in the management of candida vulvovaginitis or infection of the peri-anal area, while application of the cream to the glans penis of the partner may help prevent re-infection of the female.