Ezaprev – Medicinal Product Register of Latvia

Pramipexolum

Search by the name of the active substance

Medicinal product name	Ezaprev 0.088 mg tablets
Pharmaceutical form	Tablet
Strength	0.088 mg
Information from the MAH on shortages	Not available predicted availability date: not notified
Legal status	Rx Prescription (Pr.)
Package leaflet	01-02-2018
Summary of product characteristics	01-02-2018
ATC code	N04BC05 – Anti-parkinson drugs

Important notice

Additional information regarding the use for persons aged 75+

If used as "ANTI-PARKINSON DRUGS"
Substance	Class	Comment
Pramipexolum	C	Suitable for older persons, with specific cautions. Sedative. Start therapy under specialist supervision. Reduce the dose in even moderate renal insufficiency. The most common adverse effects are orthostatic hypotension, gastrointestinal symptoms, drowsiness, hallucinations, confusion and sudden bouts of falling asleep. Take interactions into account, especially with antipsychotics.

Medicinal products (3)

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	Product No.	Labelling
Not available (according to the information provided by wholesalers) predicted availability date: not notified	currently no information on availability from any wholesaler	N30 (0,088 mg)	PA/Al/PVC/Al blister	09-0159-01	Labelling text Feb 1, 2018
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N100 (0,088 mg)	PA/Al/PVC/Al blister	09-0159-02	Labelling text Feb 1, 2018
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N10 (0,088 mg)	PA/Al/PVC/Al blister	09-0159-03	Labelling text Feb 1, 2018

Registration information

Marketing authorisation No.	09-0159
Date of authorisation	Apr 30, 2009
MA valid until	For unlimited time
Marketing authorisation holder, country	Norameda UAB, Lithuania

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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 Mar 30, 2021.