Colmed – Medicinal Product Register of Latvia

Paracetamolum, Pseudoephedrini hydrochloridum, Dextromethorphani hydrobromidum

Search by the name of the active substance

Medicinal product name	Colmed 500 mg/30 mg/15 mg film-coated tablets
Pharmaceutical form	Film-coated tablet
Strength	500 mg/30 mg/15 mg
Information from the MAH on shortages	Not notified
Legal status	OTC OTC
Package leaflet	15-02-2024
Summary of product characteristics	15-02-2024
Additional information	Publiskais novērtējuma ziņojums
ATC code	N02BE51 – Analgesics
Information for Marketing authorisation holders	View

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

Package leaflet	15-02-2024
Summary of product characteristics	15-02-2024

Medicinal products (5)

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	N6 (1 UD)	PVC/PVDC/Al blister	21-0174-01	Labelling text Mar 29, 2022
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N10 (1 UD)	PVC/PVDC/Al blister	21-0174-02	Labelling text Mar 29, 2022
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N12 (1 UD)	PVC/PVDC/Al blister	21-0174-03	Labelling text Mar 29, 2022
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N20 (1 UD)	PVC/PVDC/Al blister	21-0174-04	Labelling text Mar 29, 2022
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N24 (1 UD)	PVC/PVDC/Al blister	21-0174-05	Labelling text Mar 29, 2022

Registration information

Marketing authorisation No.	21-0174
Date of authorisation	Oct 19, 2021
Marketing authorisation holder, country	US Pharmacia Sp. z o.o., Poland

Return to the results

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.