Allergodil – Medicinal Product Register of Latvia

Azelastini hydrochloridum

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Medicinal product name

Allergodil 0.05% eye drops, solution

Pharmaceutical form

Eye drops, solution

Strength

0.05%

Information from the MAH on shortages

No information on expected shortages

Availability of medicinal product

Product No.	Package size	Wholesalers' stock state
98-0067-01	N1	Is available

Legal status

OTC OTC

Package leaflet

02-03-2023

Summary of product characteristics

02-03-2023

ATC code

S01GX07 – Ophthalmologicals

Information for Marketing authorisation holders

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

Package leaflet	02-03-2023
Summary of product characteristics	02-03-2023

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) (388 containers)	Baltfarm "Vita-Farm", Euroaptieka, Oribalt Rīga, Jelgavfarm, Tamro, Recipe Plus, Medelens+	N1 (3 mg/6 ml)	HDPE bottle	€ 9.25	98-0067-01	Labelling text Mar 2, 2023 Labelling text Mar 2, 2023
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N1 (5 mg/10 ml)	HDPE bottle		98-0067-02	Labelling text Mar 2, 2023 Labelling text Mar 2, 2023
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N1 (2 mg/4 ml)	HDPE bottle		98-0067-03	Labelling text Mar 2, 2023 Labelling text Mar 2, 2023
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N1 (4 mg/8 ml)	HDPE bottle		98-0067-04	Labelling text Mar 2, 2023 Labelling text Mar 2, 2023

Registration information

Marketing authorisation No.	98-0067
Date of authorisation	Jan 21, 1998
Marketing authorisation holder, country	Viatris Healthcare Limited, Ireland

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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 15, 2024.