Ursosan – Medicinal Product Register of Latvia

Acidum ursodeoxycholicum

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Medicinal product name

Ursosan 500 mg film-coated tablets

Pharmaceutical form

Film-coated tablet

Strength

500 mg

Information from the MAH on shortages

Not notified

Availability of medicinal product

Product No.	Package size	Wholesalers' stock state
18-0116-01	N10	Is available

Legal status

Rx Prescription (Pr.)

Package leaflet

05-07-2018

Summary of product characteristics

05-07-2018

ATC code

A05AA02 – Bile and liver therapy

Medicinal products (9)

Display only medicinal products with a declared price

Display only medicinal products available in wholesalers' stock

Availability of medicinal product	Wholesalers	Package size, content	Primary packaging	Maximum admissible pharmacy price (€ incl. VAT)	Product No.	Labelling
Is available (according to the information provided by wholesalers) (123 containers)	Tamro, Magnum Medical	N10 (500 mg)	PVC/PVDC/Al blister	€ 9.96	18-0116-01	Labelling text Jul 5, 2018
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N20 (500 mg)	PVC/PVDC/Al blister		18-0116-02	Labelling text Jul 5, 2018
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N30 (500 mg)	PVC/PVDC/Al blister		18-0116-03	Labelling text Jul 5, 2018
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N40 (500 mg)	PVC/PVDC/Al blister		18-0116-04	Labelling text Jul 5, 2018
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N50 (500 mg)	PVC/PVDC/Al blister		18-0116-05	Labelling text Jul 5, 2018
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N60 (500 mg)	PVC/PVDC/Al blister		18-0116-06	Labelling text Jul 5, 2018
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N80 (500 mg)	PVC/PVDC/Al blister		18-0116-07	Labelling text Jul 5, 2018
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N90 (500 mg)	PVC/PVDC/Al blister		18-0116-08	Labelling text Jul 5, 2018
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N100 (500 mg)	PVC/PVDC/Al blister		18-0116-09	Labelling text Jul 5, 2018

Registration information

Marketing authorisation No.	18-0116
Date of authorisation	Jul 10, 2018
Marketing authorisation holder, country	PRO.MED.CS Praha a.s., Czech Republic

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Icon explanation

– Medicine is available
– Medicine is not available
– Distribution permitted for a limited time span
– Without a prescription
– Prescription medicine

– Medicine is listed on the Latvian National Health Service (NHS) list of state reimbursed medicines. (source of the information – the NHS)
– Reference medicine on the NHS List of state reimbursed medicines
– Lowest cost medicine within its therapeutic effectiveness class in cases where no reference medicine is available
- – Next lowest cost medicine after or (in ascending order)

Class A A (green): Suitable for the older persons. The medicinal substance can be used as in younger patients. Changes due to aging do not affect the dose or frequency of administration, and the adverse reaction profile is not different from that of younger patients.

Class B B (grey): There is little research evidence, practical experience or efficacy in older persons.

Class C C (yellow): Suitable for older persons, with specific cautions. The medicinal substance can be used by older persons, but the dose might either have to be reduced, or the frequency of administration decreased due to mild or moderate renal insufficiency or a significant risk of interactions or adverse reactions.

Class D D (red): Avoid use in older persons. Use is possible only in exceptional cases or on a one-off basis. Changes due to aging predispose older persons to adverse or dangerous reactions to the drug. The risk of adverse reactions typically exceeds the benefits.

Meds75+ data source is Finnish Medicines Agency Fimea (licensed under CC BY 4.0).
Data updated on Apr 19, 2024.