Medicinal product name | Ambrisentan Norameda 10 mg film-coated tablets |
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Pharmaceutical form | Film-coated tablet | ||||||
Strength | 10 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.)||||||
Summary of product characteristics | 12-05-2020 | ||||||
Package leaflet | 23-01-2020 | ||||||
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 (10 mg) |
PVC/PVDC/Al blister | 20-0010-01 |
Labelling text Jan 23, 2020 |
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Is available (according to the information provided by wholesalers) (5 containers) |
Tamro |
N30 (10 mg) |
PVC/PVDC/Al blister |
€ 301.31 * |
20-0010-02 |
Labelling text Jan 23, 2020 |
Not available (according to the information provided by wholesalers) | currently no information on availability from any wholesaler |
N10 (10 mg) |
PVC/PE/PVDC/Al blister | 20-0010-03 |
Labelling text Jan 23, 2020 |
|
Not available (according to the information provided by wholesalers) | currently no information on availability from any wholesaler |
N30 (10 mg) |
PVC/PE/PVDC/Al blister | 20-0010-04 |
Labelling text Jan 23, 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 (10 mg) |
PVC/PVDC/Al unit-dose blister | 20-0010-05 |
Labelling text Jan 23, 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 (10 mg) |
PVC/PVDC/Al unit-dose blister | 20-0010-06 |
Labelling text Jan 23, 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 (10 mg) |
PVC/PE/PVDC/Al unit-dose blister | 20-0010-07 |
Labelling text Jan 23, 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 (10 mg) |
PVC/PE/PVDC/Al unit-dose blister | 20-0010-08 |
Labelling text Jan 23, 2020 |
Registration information
Marketing authorisation No. | 20-0010 |
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Date of authorisation | Jan 24, 2020 |
Marketing authorisation holder, country | Norameda UAB, Lithuania |