Pharmacovigilance

Grupo Neolpharma’s main goal is to protect the health and well-being of our patients and consumers. This is why we are committed to the development of high quality and innovative drug products that allow us to meet the needs of patients and consumers, thus ensuring the efficacy and safety of all of our commercially available products.

For these reasons, Grupo Neolpharma holds the Permanent Program of Pharmacovigilance in collaboration with the National Center of Pharmacovigilance (Centro Nacional de Farmacovigilancia), which systematically allows to document the safety profile of our products in open-population. If necessary, this information facilitates the corrective and timely actions focused on assuring the privilege of integrity and well-being to our patients. The Pharmacovigilance Unit is ruled by what is stated in the Mexican law by NOM-220-SSA1-2016 of Pharmacovigilance, which is focused on the detection, evaluation, comprehension and prevention of all the information about suspected adverse effects of any commercialized drug products.

FOR A RESPONSIBLE PRESCRIPTION

“Shared responsibility”

Pharmacovigilance refers to the activities related to the detection, evaluation, comprehension and prevention of adverse events, suspected adverse events, adverse reactions, Adverse Events Following Immunization, or any other safety concern related to the usage of drug products and vaccines.

Pharmacovigilance is a shared activity, responsible and mandatory among all Institutions and Organisms comprised in the National Health System, health professionals, Clinical Research Centers, Sanitary Registration Holders, distributors, and drug product vendors, including vaccines, as well as herbal remedies, that may be used in the treatment of human beings.

Nowadays, there is a great number of drug products in the market, nonetheless, in spite of all their therapeutic benefits, they can cause both expected and non-expected adverse reactions.

All of this is due to a common limitant. To evaluate a drug product, the experience of usage in big-sized and varied populations, can only be obtained when commercializing it. This is the period in which we are able to detect infrequent or not-known adverse reactions, allowing us to have the knowledge of the incidence and prevalence of these reactions presented in certain populations. In this sense, and because of the great importance that the patients’ safety implies, Pharmacovigilance is born.

In order to fulfill what is stated by the official Mexican regulation NOM-220-SSA1-2016, Grupo Neolpharma’s Pharmacovigilance Unit carries out activities oriented and specialized on detection, evaluation, assessment, comprehension, prevention and the follow-up of all the notifications of suspected adverse reactions that could be caused by any of our commercialized drug products. This activities also include the promotion and training of all the personnel involved in Pharmacovigilance activities, thus ensuring the safety of all of our patients when taking any of our drug products.

NOur commitment has always been to guarantee the safety and rational use of drug products in order to prevent or minimize any presented risk and bringing satisfaction to our patients and consumers.It is very important that you, as a physician or a patient, remember that in case of receiving any Suspected Adverse Reaction to Drug Productss commercialized by Grupo Neolpharma, contact the Pharmacovigilance Unit through any of the following means of communication mentioned below.

NOTIFICATION AND CONTACT CHANNELS OF SUSPECTED ADVERSE REACTIONS
Patients or Physicians, Healthcare Professionals or General Public.

In case of any adverse reaction following the consumption of any of our drug products, please fill in the following questionnaire with the minimum information and click Send. “Remember that all the given information is confidential in agreement with the corresponding Mexican privacy laws as published by Instituto Nacional de Transparencia, Acceso a la Información y Protección de Datos Personales”.

If you prefer so, please contact the following telephone numbers or send an e-mail to the addresses below:

Phone numbers:

Pharmacovigilance Unit (UFV): 01 (55) 5171 9005 y 5171 9006
Customer Support Call Center (CAT): 01 800 112 7346, 01 (55) 5171 9008
Mobile phone: 55 4332 5913 (24-hour) just for suspected reactions, events or serious adverse reactions.
Email: farmacovigilancia@neolpharma.com