Rinodeks – Medicinal Product Register of Latvia

Pseudoephedrini hydrochloridum, Chlorphenamini maleas

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Medicinal product name

Rinodeks sīrups

Pharmaceutical form

Syrup

Strength

Information from the MAH on shortages

No information on expected shortages

Availability of medicinal product

Product No.	Package size	Wholesalers' stock state
96-0466-01	N1	Is available
96-0466-02	N1	Is available

Legal status

OTC OTC

Package leaflet

04-01-2024

Summary of product characteristics

04-01-2024

Risk minimisation measures

Vēstule veselības aprūpes speciālistam

ATC code

R01BA52 – Nasal preparations

Information for Marketing authorisation holders

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

Package leaflet	04-01-2024
Summary of product characteristics	04-01-2024

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
Is available (according to the information provided by wholesalers) (13703 containers)	Grindeks, Tamro, Recipe Plus, Magnum Medical, Baltfarm "Vita-Farm", Euroaptieka, Jelgavfarm, Oribalt Rīga, Medelens+	N1 (100 ml)	Glass bottle	€ 13.26	96-0466-01	Labelling text Jan 4, 2024 Labelling text Jan 4, 2024
Is available (according to the information provided by wholesalers) (8451 containers)	Grindeks, Tamro, Recipe Plus, Magnum Medical, Baltfarm "Vita-Farm", Oribalt Rīga	N1 (180 ml)	Glass bottle	€ 18.59	96-0466-02	Labelling text Jan 4, 2024 Labelling text Jan 4, 2024
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N1 (100 ml)	PET bottle		96-0466-03	Labelling text Jan 4, 2024 Labelling text Jan 4, 2024
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N1 (180 ml)	PET bottle		96-0466-04	Labelling text Jan 4, 2024 Labelling text Jan 4, 2024

Registration information

Marketing authorisation No.	96-0466
Date of authorisation	Oct 24, 1996
Marketing authorisation holder, country	Grindeks, AS, Latvia

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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 18, 2024.