European Union - English - EMA (European Medicines Agency)

amryt pharmaceuticals dac - dry extract from birch bark (der 5-10 : 1), extraction solvent n-heptane 95% (w/w) - epidermolysis bullosa dystrophica; epidermolysis bullosa, junctional - preparations for treatment of wounds and ulcers - treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (eb) in patients 6 months and older.

European Union - English - EMA (European Medicines Agency)

amryt ag - betulae cortex - wounds and injuries; wound healing - preparations for treatment of wounds and ulcers - treatment of partial thickness wounds in adults. see sections 4.4 and 5.1 in product information with respect to type of wounds studied.,

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

mineral medix solutions inc - betula pubescens bark (unii: 3r504894l9) (omega-3 fatty acids - unii:71m78end5s), betulin (unii: 6w70hn7x7o) (betulin - unii:6w70hn7x7o), omega-3 fatty acids (unii: 71m78end5s) (omega-3 fatty acids - unii:71m78end5s), clinoptilolite (unii: k8a69pj2vm) (clinoptilolite - unii:k8a69pj2vm) - topical hoof putty to help with most common hoof related issues equine one hoof mender putty  is a unique restorative hoof putty based on birch bark extract, betulin, clinoptilolite, omega 3 with vitamins a & d for professional care of horses' hooves. it is a non-caustic product easily applied to the white line, hoof wall separations, and the hoof frog. - restores strong and healthy hooves in all weather conditions - maintains a germ-free hoof environment-helps avoid crumbling horn, white line disease, and thrush - non-irritating and safe to apply without wearing gloves - the product does not dry out, but keep container tightly closed when not in use - can be used under pads to keep soles and frogs in healthy condition - can be used for horses, ponies, donkeys and other hooved animals - made with a non-caustic formulation—contains no copper sulfate, no harmful or petroleum-based products - please note the equine care product is for hoof use only. - the product has a distinctive smoky smell

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

betula spp) 10,000du/ml odc solution for skin prick test (allergy therapeutics (uk) ltd - birch (betula species) pollen allergen extract - solution for skin-prick test

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

uriel pharmacy inc. - betula pendula bark (unii: 40s83y133c) (betula pendula bark - unii:40s83y133c), juniper berry (unii: o84b5194rl) (juniper berry - unii:o84b5194rl) - directions: for oral use only. use: supports normal kidney function.* *this statement has not been evaluated by the food and drug administration. this product is not intended to diagnose, treat, cure or prevent any disease.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

silver birch) 10hep solution for skin prick test (alk-abello ltd - birch (betula verrucosa) pollen allergen extract - solution for skin-prick test

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

betula alba) pollen 50,000sbu/ml solution for skin prick test (allergopharma - birch (betula alba) pollen allergen extract - solution for skin-prick test

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

betula verrucosa) pollen 50hep/ml solution for skin prick test (inmunotek - birch (betula verrucosa) pollen allergen extract - solution for skin-prick test

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

antigen laboratories, inc. - salix lucida ssp. lasiandra pollen (unii: 9p9t267qmr) (salix lucida ssp. lasiandra pollen - unii:9p9t267qmr) - salix lucida ssp. lasiandra pollen 0.05 g in 1 ml - allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. confirmation is determined by skin testing. diagnostic use of allergenic extracts usually begins with direct skin testing. this product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing. do not administer in the presence of diseases characterized by bleeding diathesis. individuals with autoimmune disease may be at risk of exacerbating symptoms of the underlying disease, possibly due to routine immunization. patients who have experienced a recent myocardial infarction may not be tolerant of immunotherapy. children with nephrotic syndrome probably should not receive injections due to immunization causing exacerbation of nephrotic disease.

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

amryt pharmaceuticals dac - birch triterpenes (unii: bx09b0rqr0) (birch triterpenes - unii:bx09b0rqr0) - filsuvez is indicated for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa (eb) in adult and pediatric patients 6 months of age and older. none. risk summary there are no available data with use of filsuvez in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in an animal reproduction study, oral administration of birch triterpenes to pregnant rats during the period of organogenesis had no effects on reproductive or fetal parameters (see data) . systemic absorption of filsuvez in humans is low following topical administration of filsuvez, and maternal use is not expected to result in fetal exposure to the drug [see pharmacokinetics (12.3)] . the background risk of major birth defects and miscarriage for the indicated population is unknown. 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. data animal data in an embryofetal development study, birch triterpenes were orally administered to pregnant rats at doses of 10, 30, or 100 mg/kg/day during the period of organogenesis. birch triterpenes did not cause maternal toxicity or fetal malformations at doses up to 100 mg/kg/day. in a prenatal and postnatal development study, birch triterpenes were orally administered to pregnant rats at doses of 10, 30, or 100 mg/kg/day from gestation day 5 through lactation day 20. birch triterpenes did not affect development at doses up to 100 mg/kg/day. the available data do not support relevant comparisons of systemic birch triterpenes exposures achieved in the animal studies to exposures observed in humans after topical use of filsuvez. risk summary there are no data on the presence of birch triterpenes or metabolites in human milk, the effects on the breastfed infant, or the effect on milk production. no effects on the breastfed infant are anticipated since the systemic exposure of the breastfeeding woman to filsuvez would be low. therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for filsuvez and any potential adverse effects on the breastfed infant from filsuvez or from the underlying maternal condition [see pharmacokinetics (12.3)]. the safety and effectiveness of filsuvez for the treatment of wounds associated with dystrophic and junctional eb have been established in pediatric patients 6 months of age and older. use of filsuvez in this age group is supported by evidence from a single randomized, placebo-controlled trial in 156 subjects 6 months to 17 years of age [see clinical studies (14)] . the safety and effectiveness of filsuvez have not been established in pediatric patients younger than 6 months of age. clinical studies of filsuvez did not include sufficient numbers of eb subjects 65 years of age and older to determine whether they respond differently from younger subjects. important information: filsuvez is for use on the skin (topical use) only. do not use filsuvez in or around your eyes or mucous membranes (for example, the mouth, vagina, or anus). this instructions for use contains information on how to apply filsuvez. read this instructions for use before you start using filsuvez. ask your healthcare provider if you have any questions. important information you need to know before applying filsuvez - use filsuvez exactly as your healthcare provider tells you to use it. - apply filsuvez directly to the wound or to the dressing surface that will be in contact with the wound. - clean wounds before applying filsuvez as instructed by your healthcare provider. - apply filsuvez with a clean or gloved hand. - apply filsuvez at each dressing change until the wound is completely healed. - do not get filsuvez in or apply around the eyes, or mucous membranes (for example, mouth, vagina, or anus). if you get filsuvez in your eyes or mucous membranes, rinse with clean water right away. contact your healthcare provider if you have any discomfort. - wash hands after applying filsuvez and caring for wounds. - the tube of filsuvez is for one-time use only. after the tube has been opened, apply the filsuvez gel right away. throw away any remaining gel and the tube after use. - check the expiration date on the filsuvez tube. do not use filsuvez if the expiration date has passed. call your pharmacist or healthcare provider for instructions. gather your supplies - a new tube of filsuvez - gloves (if using) - sterile, non-adhesive dressing applying filsuvez - wash your hands with soap and water or wear gloves. - open a new tube of filsuvez. apply the gel right away. - you can apply filsuvez in 2 ways, either directly to the wound or to the non-adhesive dressing surface that will be in contact with the wound. option 1: apply filsuvez directly to wound. apply a 1 mm layer of filsuvez to the wound (see step 1). cover the entire wound surface with a 1 mm layer of filsuvez (step 2). do not rub in the gel. cover the wound with a sterile, non-adhesive wound dressing (see step 3). step 1 step 2 step 3 or option 2: apply filsuvez directly to sterile, non-adhesive dressing. apply a generous layer of filsuvez directly to the sterile, non-adhesive dressing (see step 1). cover the entire non-adhesive dressing with filsuvez (step 2). cover the wound with the dressing so that the gel is in direct contact with the wound (see step 3). secure the non-adhesive wound dressing as directed by your healthcare provider . step 1 step 2 step 3 - apply a 1 mm layer of filsuvez to the wound (see step 1). cover the entire wound surface with a 1 mm layer of filsuvez (step 2). do not rub in the gel. cover the wound with a sterile, non-adhesive wound dressing (see step 3). - apply a generous layer of filsuvez directly to the sterile, non-adhesive dressing (see step 1). cover the entire non-adhesive dressing with filsuvez (step 2). cover the wound with the dressing so that the gel is in direct contact with the wound (see step 3). secure the non-adhesive wound dressing as directed by your healthcare provider . how should i store filsuvez? store filsuvez at room temperature between 68°f to 77°f (20°c to 25°c). do not freeze. keep filsuvez and all medicines out of the reach of children. how should i throw away (dispose of) filsuvez? throw away (dispose of) any remaining filsuvez and the tube right away after use in household trash or through a drug take-back option, if available. go to www.fda.gov/drugdisposal for more information on drug disposal. manufactured by: lichtenheldt gmbh, pharmazeutische fabrik, werk 1, industriestr. 7-11, 23812 wahlstedt, germany for more information, call 1-855-303-2347 or go to www.filsuvez.com this instructions for use has been approved by the u.s. food and drug administration. approved: december-2023