In accordance with paragraph 8 of Section IV of the Procedure for Expert Evaluation, the applicant must amend the instructions for medical use of the medicinal product upon receipt of new data, including bringing the instructions for medical use into line with the approved instructions for medical use of the original (reference) medicinal product, and ensure that the information on the medicinal product corresponds to current scientific knowledge.
The Pharmacovigilance Risk Assessment Committee (PRAC), based on the analysis of Periodic Safety Update Reports (PSURs) for medicinal products containing meloxicam, drew the following conclusions.
З огляду на наявні дані про ризик розвитку фіксованого медикаментозного висипу з спонтанних повідомлень та наукової літератури, включаючи випадки з позитивним тестом на повторне призначення лікарського засобу (re-challenge) або підтвердженої алергії на мелоксикам (meloxicam), вважається, що причинно-наслідковий зв’язок між застосуванням мелоксикаму (meloxicam) та ризик розвитку фіксованого медикаментозного висипу є принаймні можливим. До інструкції для медичного застосування лікарських засобів, що містять мелоксикам (meloxicam), слід внести відповідні зміни.
The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) agrees with the scientific conclusions drawn by PRAC.
Based on the scientific conclusions, the CMDh considers that the benefit/risk balance of medicinal products containing meloxicam (meloxicam) remains unchanged, taking into account the proposed amendments to the instructions for medical use.
Amendments to be included in the relevant sections of the package inserts (new text underlined in bold, deleted text struck through).
Section “Special warnings and precautions for use”
Skin reactions
[…]
Cases of fixed drug eruption have been reported with the use of meloxicam.
Meloxicam should not be re-prescribed to patients who have a history of fixed drug eruption associated with the use of meloxicam.
Potential cross-reactivity may occur with other oxicams.
“Adverse reactions” section
Section “Skin and subcutaneous tissue disorders,” with frequency “not known”:
Fixed drug eruption (see section “Special warnings and precautions for use”).
List of medicinal products containing meloxicam (meloxicam) that are authorized for medical use in Ukraine (according to the State Register of Medicinal Products as of 29.05.2023) (20 KB) (Downloaded: 12.06.2023 12:54:10)
To analyze the published information, the applicant must use the original text available at the link:
