Medicinal product name | Ambrisentan Zentiva 5 mg film-coated tablets |
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Pharmaceutical form | Film-coated tablet | ||||||
Strength | 5 mg | ||||||
Information from the MAH on shortages | No information on expected shortages | ||||||
Availability of medicinal product |
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Legal status | Reimbursed medicines reference product |
Prescription (Pr.)||||||
Package leaflet | 24-03-2022 | ||||||
Summary of product characteristics | 24-03-2022 | ||||||
Risk minimisation measures | Izglītojošie materiāli pacientam | ||||||
ATC code | C02KX02 – Antihypertensives |
Medicinal products (8)
Availability of medicinal product | Wholesalers | Package size, content | Primary packaging | Maximum admissible pharmacy price (€ incl. VAT) | Product No. | Labelling |
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Not available (according to the information provided by wholesalers) | currently no information on availability from any wholesaler |
N10 (5 mg) |
PVC/PE/PVDC/Al blister | 20-0141-01 |
Labelling text Nov 26, 2020 |
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Not available (according to the information provided by wholesalers) | currently no information on availability from any wholesaler |
N30 (5 mg) |
PVC/PE/PVDC/Al blister | 20-0141-02 |
Labelling text Nov 26, 2020 |
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Not available (according to the information provided by wholesalers) | currently no information on availability from any wholesaler |
N10: 10 × 1 (5 mg) |
PVC/PE/PVDC/Al unit-dose blister | 20-0141-03 |
Labelling text Nov 26, 2020 |
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Not available (according to the information provided by wholesalers) | currently no information on availability from any wholesaler |
N30: 30 × 1 (5 mg) |
PVC/PE/PVDC/Al unit-dose blister | 20-0141-04 |
Labelling text Nov 26, 2020 |
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Not available (according to the information provided by wholesalers) | currently no information on availability from any wholesaler |
N10 (5 mg) |
PVC/PVDC/Al blister | 20-0141-05 |
Labelling text Nov 26, 2020 |
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Not available (according to the information provided by wholesalers) | currently no information on availability from any wholesaler |
N30 (5 mg) |
PVC/PVDC/Al blister | 20-0141-06 |
Labelling text Nov 26, 2020 |
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Not available (according to the information provided by wholesalers) | currently no information on availability from any wholesaler |
N10: 10 × 1 (5 mg) |
PVC/PVDC/Al unit-dose blister | 20-0141-07 |
Labelling text Nov 26, 2020 |
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Is available (according to the information provided by wholesalers) (25 containers) |
Tamro, Recipe Plus, Magnum Medical, Euroaptieka |
N30: 30 × 1 (5 mg) |
PVC/PVDC/Al unit-dose blister |
€ 861.02 * |
20-0141-08 |
Labelling text Nov 26, 2020 |
Registration information
Marketing authorisation No. | 20-0141 |
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Date of authorisation | Dec 2, 2020 |
Marketing authorisation holder, country | Zentiva, k.s., Czech Republic |