Pragiola – Medicinal Product Register of Latvia

Pregabalinum

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Medicinal product name	Pragiola 150 mg capsules, hard
Pharmaceutical form	Capsule, hard
Strength	150 mg
Information from the MAH on shortages	Not available predicted availability date: not notified
Legal status	Rx Prescription (Pr.III)
Package leaflet	04-04-2024
Summary of product characteristics	04-04-2024
ATC code	N02BF02 – Analgesics
Information for Marketing authorisation holders	View

Product information leaflet and summary of product characteristics in MS Word format.

Package leaflet	04-04-2024
Summary of product characteristics	04-04-2024

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	Product No.	Labelling
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N14 (150 mg)	PVC/PVDC/Al blister	15-0079-01	Labelling text Apr 20, 2023 Labelling text Apr 20, 2023
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N28 (150 mg)	PVC/PVDC/Al blister	15-0079-02	Labelling text Apr 20, 2023 Labelling text Apr 20, 2023
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N30 (150 mg)	PVC/PVDC/Al blister	15-0079-03	Labelling text Apr 20, 2023 Labelling text Apr 20, 2023
Not available (according to the information provided by wholesalers) predicted availability date: not notified	currently no information on availability from any wholesaler	N56 (150 mg)	PVC/PVDC/Al blister	15-0079-04	Labelling text Apr 20, 2023 Labelling text Apr 20, 2023
Not available (according to the information provided by wholesalers) predicted availability date: not notified	currently no information on availability from any wholesaler	N60 (150 mg)	PVC/PVDC/Al blister	15-0079-05	Labelling text Apr 20, 2023 Labelling text Apr 20, 2023
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N84 (150 mg)	PVC/PVDC/Al blister	15-0079-06	Labelling text Apr 20, 2023 Labelling text Apr 20, 2023
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N90 (150 mg)	PVC/PVDC/Al blister	15-0079-07	Labelling text Apr 20, 2023 Labelling text Apr 20, 2023
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N100 (150 mg)	PVC/PVDC/Al blister	15-0079-08	Labelling text Apr 20, 2023 Labelling text Apr 20, 2023
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N98 (150 mg)	PVC/PVDC/Al blister	15-0079-09	Labelling text Apr 20, 2023 Labelling text Apr 20, 2023

Registration information

Marketing authorisation No.	15-0079
Date of authorisation	May 7, 2015
Marketing authorisation holder, country	KRKA, d.d., Novo mesto, Slovenia

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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.