Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

biocon pharma inc., - esomeprazole magnesium (unii: r6dxu4way9) (esomeprazole - unii:n3pa6559ft) - adults esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed ee in adults. for those patients who have not healed after 4 to 8 weeks of treatment, an additional 4- to 8- week course of esomeprazole magnesium delayed-release capsules may be considered. pediatric patients 12 years to 17 years of age esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) for the healing of ee in pediatric patients 12 years to 17 years of age. esomeprazole magnesium delayed-release capsules are indicated for the maintenance of healing of ee in adults. controlled studies do not extend beyond 6 months. adults esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with gerd in adults. pediatric patients 12 years to 17 years of age esomeprazole magnesium delayed-release capsu

Tanzania - Tiếng Anh - Tanzania Medicinces & Medical Devices Authority

biocon biologics limited, india - trastuzumab - powder for solution for injection - 440

Singapore - Tiếng Anh - HSA (Health Sciences Authority)

pharma to market pte. ltd. - trastuzumab - injection, powder, lyophilized, for solution - trastuzumab 440 mg/vial

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

biocon phama inc. - posaconazole (unii: 6tk1g07bhz) (posaconazole - unii:6tk1g07bhz) - posaconazole delayed-release tablets are indicated for the prophylaxis of invasive aspergillus and candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (hsct) recipients with graft-versus- host disease (gvhd) or those with hematologic malignancies with prolonged neutropenia from chemotherapy [see clinical studies (14.2) ] as follows • posaconazole delayed-release tablets: adults and pediatric patients 13 years of age and older. additional pediatric use information is approved for merck sharp & dohme corp.’s noxafil (posaconazole delayed-release tablets). however, due to merck sharp & dohme corp.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. posaconazole is contraindicated in persons with known hypersensitivity to posaconazole or other azole antifungal agents. posaconazole is contraindicated with sirolimus. concomitant administration of posaconazo

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

biocon pharma inc. - teriflunomide (unii: 1c058ikg3b) (teriflunomide - unii:1c058ikg3b) - teriflunomide tablet is indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. teriflunomide tablets are contraindicated in/with: - patients with severe hepatic impairment [see warnings and precautions (5.1) ]. - pregnant women and females of reproductive potential not using effective contraception. teriflunomide tablet may cause fetal harm [see warnings and precautions (5.2, 5.3) and use in specific populations (8.1) ]. - patients with a history of a hypersensitivity reaction to teriflunomide, leflunomide, or to any of the inactive ingredients in teriflunomide tablet. reactions have included anaphylaxis, angioedema, and serious skin reactions [see warnings and precautions (5.5)]. - coadministration with leflunomide [see clinical pharmacology (12.3)]. risk summary teriflunomide is contraindicated for use in pregnant women and females of reproductive potential

Singapore - Tiếng Anh - HSA (Health Sciences Authority)

zuellig pharma pte. ltd. - insulin aspart (rdna origin) - injection, solution - insulin aspart (rdna origin) 100 u/ml

Singapore - Tiếng Anh - HSA (Health Sciences Authority)

zuellig pharma pte. ltd. - insulin aspart (rdna origin) - injection, solution - insulin aspart (rdna origin) 100 u/ml

Israel - Tiếng Anh - Ministry of Health

medison pharma ltd - ivabradine as hydrochloride - film coated tablets - ivabradine as hydrochloride 7.5 mg - ivabradine - ivabradine - symptomatic treatment of chronic stable angina pectoris in patients with normal sinus rhythm, who have a contra-indication or intolerance for beta-blockers.treatment of chronic heart failureivabradine is indicated in chronic heart failure nyha ii to iv class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.

Israel - Tiếng Anh - Ministry of Health

medison pharma ltd - ivabradine as hydrochloride - film coated tablets - ivabradine as hydrochloride 5 mg - ivabradine - ivabradine - symptomatic treatment of chronic stable angina pectoris in patients with normal sinus rhythm, who have a contra-indication or intolerance for beta-blockers.treatment of chronic heart failureivabradine is indicated in chronic heart failure nyha ii to iv class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.

Israel - Tiếng Anh - Ministry of Health

glaxo smith kline (israel) ltd - dutasteride; tamsulosin hydrochloride - capsules - dutasteride 0.5 mg; tamsulosin hydrochloride 0.4 mg - tamsulosin - tamsulosin - treatment of moderate to severe symptoms of benign prostatic hyperplasia (bph). reduction in the risk of acute urinary retention (aur) and surgery in patients with moderate to severe symptoms of bph.