CHEMMART Perindopril Arginine/Amlodipine 5/10 perindopril arginine 5 mg and amlodipine (as besilate) 10 mg uncoated tablet blister pack

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)
25-11-2017

Aktivna sestavina:

perindopril arginine, Quantity: 5 mg; amlodipine besilate, Quantity: 13.87 mg (Equivalent: amlodipine, Qty 10 mg)

Dostopno od:

Arrotex Pharmaceuticals Pty Ltd

INN (mednarodno ime):

amlodipine besilate,perindopril arginine

Farmacevtska oblika:

Tablet

Sestava:

Excipient Ingredients: magnesium stearate; colloidal anhydrous silica; microcrystalline cellulose; croscarmellose sodium

Pot uporabe:

Oral

Enote v paketu:

30

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

Perindopril arginine and amlodipine combination tablet is indicated as substitution therapy for the treatment of hypertension and/or stable coronary heart disease in patients already controlled with separate doses of perindopril and amlodipine, given concurrently at the same dose level. Treatment should not be initiated with this combination.

Povzetek izdelek:

Visual Identification: White to off-white coloured, square-shaped biconvex tablets engraved with 'APO' on one side and '5/10' on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius

Status dovoljenje:

Licence status A

Datum dovoljenje:

2016-01-12