Malta - English - Malta Medicines Authority

glaxo smithkline uk limited - dutasteride; tamsulosin hydrochloride - hard capsule - dutasteride 0.5 mg; tamsulosin hydrochloride 0.4 mg - urologicals

Ireland - English - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - dutasteride - capsule, soft - 0.5 milligram(s) - testosterone-5-alpha reductase inhibitors; dutasteride

Malta - English - Malta Medicines Authority

heaton k.s. na pankraci 14, 140 00 praha 4, czech republic - dutasteride, tamsulosin hydrochloride - hard capsule - dutasteride 0.5 mg tamsulosin hydrochloride 0.4 mg - urologicals

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

physicians total care, inc. - dutasteride (unii: o0j6xjn02i) (dutasteride - unii:o0j6xjn02i), tamsulosin hydrochloride (unii: 11sv1951mr) (tamsulosin - unii:g3p28oml5i) - dutasteride 0.5 mg - jalyn™ (dutasteride and tamsulosin hydrochloride) capsules are indicated for the treatment of symptomatic bph in men with an enlarged prostate. dutasteride-containing products, including jalyn, are not approved for the prevention of prostate cancer. jalyn is contraindicated for use in: - pregnancy. in animal reproduction and developmental toxicity studies, dutasteride inhibited development of male fetus external genitalia. therefore, jalyn may cause fetal harm when administered to a pregnant woman. if jalyn is used during pregnancy, or if the patient becomes pregnant while taking jalyn, the patient should be apprised of the potential hazard to the fetus [see warnings and precautions (5.6), use in specific populations (8.1)] . - women of childbearing potential [see warnings and precautions (5.6), use in specific populations (8.1)] . - pediatric patients [see use in specific populations (8.4)] . - patients with previously demonstrated, clinically significant hypersensitivity (e.g., serious skin reactions, angio

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

glaxosmithkline llc - dutasteride (unii: o0j6xjn02i) (dutasteride - unii:o0j6xjn02i), tamsulosin hydrochloride (unii: 11sv1951mr) (tamsulosin - unii:g3p28oml5i) - dutasteride 0.5 mg - jalyn (dutasteride and tamsulosin hydrochloride) capsules are indicated for the treatment of symptomatic bph in men with an enlarged prostate. dutasteride-containing products, including jalyn, are not approved for the prevention of prostate cancer. jalyn is contraindicated for use in: •   pregnancy. dutasteride use is contraindicated in females who are pregnant. in animal reproduction and developmental toxicity studies, dutasteride inhibited development of male fetus external genitalia. therefore, jalyn may cause fetal harm when administered to a pregnant female [see warnings and precautions ( 5.6), use in specific populations ( 8.1)] . •   patients with previously demonstrated, clinically significant hypersensitivity (e.g., serious skin reactions, angioedema, urticaria, pruritus, respiratory symptoms) to dutasteride, other 5-alpha-reductase inhibitors, tamsulosin, or any other component of jalyn [see adverse reactions (6.2) ] . risk summary jalyn is contraindicated for use in pregnancy because it may cause

Malta - English - Malta Medicines Authority

lavipharm s.a agias marinas str. 19002 peania attica, greece - dutasteride, tamsulosin hydrochloride - hard capsule - tamsulosin hydrochloride 0.4 mg dutasteride 0.5 mg - urologicals

Malta - English - Malta Medicines Authority

neofarma pharmaceuticals limited 42-46, mill street, qormi, qrm 3105, malta - dutasteride, tamsulosin hydrochloride - hard capsule - dutasteride 0.5 mg tamsulosin hydrochloride 0.4 mg - urologicals

Malta - English - Malta Medicines Authority

glaxo smithkline ireland limited 12, riverwalk, citywest business campus, dublin 24, ireland - dutasteride, tamsulosin hydrochloride - hard capsule - dutasteride 0.5 mg tamsulosin hydrochloride 0.4 mg - urologicals

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

accord healthcare b.v. - dutasteride 0,5 mg; tamsulosin hydrochloride 0,4 mg - eq. tamsulosin 0,367 mg - capsule, hard - tamsulosin and dutasteride

Kenya - English - Pharmacy and Poisons Board

galaxy pharmaceutical limited p.o. box 39107-00623, nairobi - tamsulosin & dutasteride - tablet - tamsulosin 0.4mg & dutasteride 0.5mg - tamsulosin