Methotrexate Accord – Medicinal Product Register of Latvia

Methotrexatum

Search by the name of the active substance

Medicinal product name	Methotrexate Accord 100 mg/ml concentrate for solution for infusion
Pharmaceutical form	Concentrate for solution for infusion
Strength	100 mg/ml
Information from the MAH on shortages	Not available predicted availability date: Aug 31, 2024
Legal status	Rx Prescription (Pr.)
Package leaflet	17-10-2023
Summary of product characteristics	17-10-2023
Risk minimisation measures	Vēstule veselības aprūpes speciālistam
ATC code	L01BA01 – Antineoplastic agents
Information for Marketing authorisation holders	View

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

Package leaflet	17-10-2023
Summary of product characteristics	17-10-2023

Medicinal products (6)

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	N1 (500 mg/5 ml)	Glass vial		16-0035-01	Labelling text Oct 14, 2021
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N5 (500 mg/5 ml)	Glass vial		16-0035-02	Labelling text Oct 14, 2021
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N1 (1000 mg/10 ml)	Glass vial		16-0035-03	Labelling text Oct 14, 2021
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N5 (1000 mg/10 ml)	Glass vial		16-0035-04	Labelling text Oct 14, 2021
Not available (according to the information provided by wholesalers) predicted availability date: Aug 31, 2024	currently no information on availability from any wholesaler	N1 (5000 mg/50 ml)	Glass vial	€ 309.22	16-0035-05	Labelling text Oct 14, 2021
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N5 (5000 mg/50 ml)	Glass vial		16-0035-06	Labelling text Oct 14, 2021

Registration information

Marketing authorisation No.	16-0035
Date of authorisation	Mar 8, 2016
Marketing authorisation holder, country	Accord Healthcare B.V., Netherlands

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 25, 2024.