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

endo pharmaceuticals inc. - collagenase clostridium histolyticum (unii: 9x7o8v25it) (collagenase clostridium histolyticum - unii:9x7o8v25it) - collagenase clostridium histolyticum 0.9 mg - xiaflex is indicated for the treatment of adult patients with dupuytren’s contracture with a palpable cord. xiaflex is indicated for the treatment of adult men with peyronie’s disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. xiaflex is contraindicated in: - the treatment of peyronie’s plaques that involve the penile urethra due to potential risk to this structure. - patients with a history of hypersensitivity to xiaflex or to collagenase used in any other therapeutic application or application method [see warnings and precautions (5.4)] . pregnancy category b there are no adequate and well-controlled studies of xiaflex in pregnant women. because animal reproduction studies are not always predictive of human response, xiaflex should be used during pregnancy only if clearly needed. risk summary based on animal data, xiaflex is not predicted to increase the risk for major developmental abnormalities in humans. human data human pharmacokinetic studies

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

janssen-cilag pty ltd - collagenase clostridium histolyticum -

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

smith & nephew, inc - collagenase clostridium histolyticum (unii: 9x7o8v25it) (collagenase clostridium histolyticum - unii:9x7o8v25it) - collagenase clostridium histolyticum 250 [arb'u] in 1 g - collagenase santyl◊  ointment is indicated for debriding chronic dermal ulcers 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 and severely burned areas. 3, 4, 5, 7, 16, 19, 20, 21 collagenase santyl◊  ointment is contraindicated in patients who have shown local or systemic hypersensitivity to collagenase.

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

endo aesthetics llc - collagenase clostridium histolyticum (unii: 9x7o8v25it) (collagenase clostridium histolyticum - unii:9x7o8v25it) - qwo is indicated for the treatment of moderate to severe cellulite in the buttocks of adult women. qwo is contraindicated in: - patients with a history of hypersensitivity to collagenase or to any of the excipients [see warnings and precautions (5.1)] . - the presence of infection at the injection sites. risk summary there are no available data on collagenase clostridium histolyticum use in pregnant women to evaluate for a drug- associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. following subcutaneous injection, the systemic concentrations for qwo were below the bioanalytical assay limit of quantification [see clinical pharmacology (12.3)] . in animal reproduction studies, intravenous administration of collagenase clostridium histolyticum to pregnant rats during organogenesis at doses up to 0.13 mg/rat (43 × human equivalent dose [hed] on a mg/kg basis) revealed no evidence of harm to the fetus. the estimated background risk of major birth defects and miscarriage for

Israel - English - Ministry of Health

megapharm ltd - collagenase clostridium histolyticum - powder and solvent for solution for injection - collagenase clostridium histolyticum 0.9 mg/vial - collagenase clostridium histolyticum - xiapex is indicated for the treatment of dupuytren’s contracture in adult patients with a palpable cord.the treatment of adult men with peyronie’s disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - collagenase clostridium histolyticum 900ug;   - powder for injection - 900 mcg - active: collagenase clostridium histolyticum 900ug   excipient: hydrochloric acid sucrose trometamol calcium chloride dihydrate sodium chloride water for injection - xiaflex is indicated for the treatment of dupuytren's contracture in adult patients with palpable cord.

European Union - English - EMA (European Medicines Agency)

swedish orphan biovitrum ab - collagenase clostridium histolyticum - dupuytren contracture - other drugs for disorders of the musculo-skeletal system - , the treatment of dupuytren’s contracture in adult patients with a palpable cord., the treatment of adult men with peyronie’s disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.

Canada - English - Health Canada

endo ventures ltd. - collagenase clostridium histolyticum - powder for solution - 0.9mg - collagenase clostridium histolyticum 0.9mg - enzymes

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

swedish orphan biovitrum ltd - collagenase clostridium histolyticum - powder and solvent for solution for injection - 900microgram

Canada - English - Health Canada

smith & nephew inc - collagenase - ointment - 250unit - collagenase 250unit - misc. skin and mucous membrane agents