Medicinal product name Ambrisentan Norameda 5 mg film-coated tablets
Pharmaceutical form Film-coated tablet
Strength 5 mg 
Information from the MAH on shortages No information on expected shortages
Legal status Rx Prescription (Pr.)
KZSR Reimbursed medicines reference product
Summary of product characteristicsMS Word document 12-05-2020
Package leafletMS Word document 23-01-2020
Risk minimisation measuresIzglītojošie materiāli pacientam 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
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N10
(5 mg)
PVC/PVDC/Al blister    20-0009-01 Labelling text Labelling text Jan 23, 2020
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N30
(5 mg)
PVC/PVDC/Al blister 518.19 
KZSR*
20-0009-02 Labelling text Labelling text Jan 23, 2020
 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    20-0009-03 Labelling text Labelling text Jan 23, 2020
 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    20-0009-04 Labelling text Labelling text Jan 23, 2020
 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    20-0009-05 Labelling text Labelling text Jan 23, 2020
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N30: 30 × 1
(5 mg)
PVC/PVDC/Al unit-dose blister    20-0009-06 Labelling text Labelling text Jan 23, 2020
 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    20-0009-07 Labelling text Labelling text Jan 23, 2020
 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    20-0009-08 Labelling text Labelling text Jan 23, 2020
* Indication about medicine on the List of state reimbursed medicines is just informative. Source of the information is the National Health Service. For details please visit the NHS website.

Registration information

Marketing authorisation No. 20-0009
Date of authorisation Jan 24, 2020
Marketing authorisation holder, country Norameda UAB, Lithuania