Alprazolam Orion – Medicinal Product Register of Latvia

Alprazolamum

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Medicinal product name

Alprazolam Orion 1 mg tablets

Pharmaceutical form

Tablet

Strength

1 mg

Information from the MAH on shortages

No information on expected shortages

Availability of medicinal product

Product No.	Package size	Wholesalers' stock state
11-0077-02 KZSL1	N30	Is available

Legal status

Rx Prescription (Pr.III)
KZSL1 Next lowest cost medicine

Package leaflet

22-02-2024

Summary of product characteristics

22-02-2024

ATC code

N05BA12 – Psycholeptics

Information for Marketing authorisation holders

View

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

Package leaflet	22-02-2024
Summary of product characteristics	22-02-2024

Important notice

Additional information regarding the use for persons aged 75+

If used as "PSYCHOLEPTICS"
Substance	Class	Comment
Alprazolamum	D	Avoid use in older adults. Sedative. A long-acting. Increases the risk of drug addiction, cognitive disorder and traffic accidents. Increases risk of falls. Paradoxically, may increase anxiety, restlessness and aggression.

Medicinal products (4)

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
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N20 (1 mg)	HDPE		11-0077-01	Labelling text Oct 4, 2018
Is available (according to the information provided by wholesalers) (1787 containers)	Tamro, Recipe Plus, Magnum Medical, Baltfarm "Vita-Farm", Oribalt Rīga	N30 (1 mg)	HDPE	€ 7.07 KZSL1*	11-0077-02	Labelling text Oct 4, 2018
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N50 (1 mg)	HDPE		11-0077-03	Labelling text Oct 4, 2018
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N100 (1 mg)	HDPE		11-0077-04	Labelling text Oct 4, 2018

* 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.	11-0077
Date of authorisation	Mar 10, 2011
Marketing authorisation holder, country	Orion Corporation, Finland

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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 May 7, 2024.