תאריך רישום: July 30, 2018

מסלול הגשה: מולקולה חדשה

יצרן: CATALENT CTS (EDINBURGH) LIMITED, UK

בעל רישום: NOVARTIS ISRAEL LTD

:ATC Code

4.1 Therapeutic indications Luxturna is indicated for the treatment of adult and paediatric patients with vision loss due to LUX API DEC23 V5 Based on EU SmPC JUL23 inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells.

תאריך רישום: July 28, 1977

מסלול הגשה: מולקולה חדשה

יצרן: RAFA LABORATORIES LTD., ISRAEL

בעל רישום: RAFA LABORATORIES LTD

N02CX02 :ATC Code

4.1 Therapeutic indications Prophylaxis of migraine and recurrent vascular headache, but not acute attacks. Treatment of menopausal flushing.

תאריך רישום: July 19, 1998

מסלול הגשה: מולקולה חדשה

יצרן: N.V. ORGANON, THE NETHERLANDS

בעל רישום: ORGANON PHARMA ISRAEL LTD., ISRAEL

G03DC05 :ATC Code

4.1 Therapeutic indications • Complaints resulting from the natural or artificial menopause. Treatment of oestrogen deficiency symptoms in postmenopausal women, more than one year after menopause. Women above 60 years of age should only start with Livial treatment when they are intolerant of, or contraindicated for, other medicinal products approved for the treatment of oestrogen deficiency symptoms. • 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. (See also section 5.1.) For all women the decision to prescribe Livial should be based on an assessment of the individual patient’s overall risks and, particularly in the over 60s, should include consideration of the risk of stroke (see sections 4.4 and 4.8).

תאריך רישום: January 5, 2004

מסלול הגשה: מולקולה חדשה

יצרן: GE HEALTHCARE B.V., THE NETHERLAND

בעל רישום: ELDAN ELECTRONIC INSTRUMENTS CO LTD

V09AB03 :ATC Code

4.1 Therapeutic indications This medicinal product is for diagnostic use only. DaTSCAN is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum: • In adult patients with clinically uncertain Parkinsonian Syndromes, for example those with early symptoms, in order to help differentiate Essential Tremor from Parkinsonian Syndromes related to idiopathic Parkinson’s Disease, Multiple System Atrophy and Progressive Supranuclear Palsy. DaTSCAN is unable to discriminate between Parkinson's Disease, Multiple System Atrophy and Progressive Supranuclear Palsy. • In adult patients, to help differentiate probable dementia with Lewy bodies from Alzheimer's disease. DaTSCAN is unable to discriminate between dementia with Lewy bodies and Parkinson's disease dementia.

תאריך רישום: April 6, 2011

מסלול הגשה: מולקולה חדשה

יצרן: ASTREA FONTAINE SAS, FRANCE

בעל רישום: NEOPHARM LTD, ISRAEL

N07XX06 :ATC Code

4.1 Therapeutic Indications Movement disorders, associated with organic central nervous system conditions, e.g. Huntington's chorea, hemiballismus and senile chorea. Moderate to severe tardive dyskinesia, which is disabling and/or socially embarrassing. The condition should be persistent despite a switch to atypical antipsychotic medication and/or reduction in dosage of antipsychotic medication, when withdrawal of antipsychotic medication is not a realistic option.

תאריך רישום: March 1, 2015

מסלול הגשה: מולקולה חדשה

יצרן: N.V. ORGANON, THE NETHERLANDS

בעל רישום: ORGANON PHARMA ISRAEL LTD., ISRAEL

G03CA01 :ATC Code

4.1 Therapeutic indications Contraception. The safety and efficacy have been established in women aged 18 to 40 years. The decision to prescribe NuvaRing should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with NuvaRing compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4).