MULTIROS glatiramer acetate 20 mg/1mL solution for injection prefilled syringe

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

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PAR PAR (PAR)
13-01-2021

active_ingredient:

glatiramer acetate, Quantity: 20 mg/mL

MAH:

Juno Pharmaceuticals Pty Ltd

pharmaceutical_form:

Injection, solution

composition:

Excipient Ingredients: mannitol; water for injections

administration_route:

Subcutaneous

units_in_package:

28

prescription_type:

(S4) Prescription Only Medicine

therapeutic_indication:

Reduction of the frequency of relapses in patients with Relapsing Remitting Multiple Sclerosis.,Treatment of patients with a single clinical event suggestive of multiple sclerosis and at least two clinically silent MRI lesions characteristic of multiple sclerosis, if alternative diagnoses have been excluded.

leaflet_short:

Visual Identification: Clear solution in a clear, colourless glass syringe equipped with needle covered by a needle shield, stopper and piston rod.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

authorization_status:

Registered

authorization_date:

2020-11-12