תאריך רישום: July 15, 2014

מסלול הגשה: מולקולה חדשה

יצרן: MERCK SHARP & DOHME B.V, THE NETHERLANDS

בעל רישום: ORGANON PHARMA ISRAEL LTD., ISRAEL

A11CC05 :ATC Code

THERAPEUTIC INDICATIONS AND USAGE FOSAVANCE® 70 mg/ 5600 IU TABLETS are indicated for: 1.1 Treatment of Osteoporosis in Postmenopausal Women For the treatment of osteoporosis, FOSAVANCE 70 MG/ 5600 IU TABLETS increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures). Treatment to Increase Bone Mass in Men with Osteoporosis FOSAVANCE 70 MG/ 5600 IU TABLETS is indicated for treatment to increase bone mass in men with osteoporosis [see Clinical Studies (14.2)]. 1.2 Important Limitations of Use FOSAVANCE 70 MG/ 5600 IU TABLETS alone should not be used to treat vitamin D deficiency. The optimal duration of use has not been determined. The safety and effectiveness of FOSAVANCE 70 MG/ 5600 IU TABLETS for the treatment of osteoporosis are based on clinical data of four years duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.

תאריך רישום: January 20, 1999

מסלול הגשה: מולקולה חדשה

יצרן: NOVO NORDISK A/S, DENMARK

בעל רישום: NOVO NORDISK LTD., ISRAEL

G03AA05 :ATC Code

4.1 Therapeutic indications Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in women with more than one year after menopause. Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis. The experience treating women older than 65 years is limited.

תאריך רישום: October 29, 2012

מסלול הגשה: מולקולה חדשה

יצרן: CTS CHEMICAL INDUSTRIES LTD, ISRAEL

בעל רישום: CTS CHEMICAL INDUSTRIES LTD, ISRAEL

:ATC Code

תאריך רישום: December 9, 1992

מסלול הגשה: מולקולה חדשה

יצרן: GLAXO OPERATIONS UK LIMITED (TRADING AS GLAXO WELLCOME OPERATIONS)

בעל רישום: SANDOZ PHARMACEUTICALS ISRAEL LTD

J01DC02 :ATC Code

4.1 Therapeutic indications Zinnat is indicated for the treatment of the infections listed below in adults and children from the age of 3 months (see sections 4.4 and 5.1). • Acute streptococcal tonsillitis and pharyngitis. • Acute bacterial sinusitis. • Acute otitis media. • Acute exacerbations of chronic bronchitis. • Cystitis. • Pyelonephritis. • Uncomplicated skin and soft tissue infections. • Treatment of early Lyme disease. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

תאריך רישום: December 9, 1992

מסלול הגשה: מולקולה חדשה

יצרן: GLAXO OPERATIONS UK LIMITED (TRADING AS GLAXO WELLCOME OPERATIONS)

בעל רישום: SANDOZ PHARMACEUTICALS ISRAEL LTD

J01DC02 :ATC Code

4.1 Therapeutic indications Zinnat is indicated for the treatment of the infections listed below in adults and children from the age of 3 months (see sections 4.4 and 5.1). • Acute streptococcal tonsillitis and pharyngitis. • Acute bacterial sinusitis. • Acute otitis media. • Acute exacerbations of chronic bronchitis. • Cystitis. • Pyelonephritis. • Uncomplicated skin and soft tissue infections. • Treatment of early Lyme disease. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

תאריך רישום: December 9, 1992

מסלול הגשה: מולקולה חדשה

יצרן: GLAXO OPERATIONS UK LIMITED (TRADING AS GLAXO WELLCOME OPERATIONS)

בעל רישום: SANDOZ PHARMACEUTICALS ISRAEL LTD

J01DC02 :ATC Code

4.1 Therapeutic indications Zinnat is indicated for the treatment of the infections listed below in adults and children from the age of 3 months (see sections 4.4 and 5.1). • Acute streptococcal tonsillitis and pharyngitis. • Acute bacterial sinusitis. • Acute otitis media. • Acute exacerbations of chronic bronchitis. • Cystitis. • Pyelonephritis. • Uncomplicated skin and soft tissue infections. • Treatment of early Lyme disease. Consideration should be given to official guidance on the appropriate use of antibacterial agents.