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ANMAT: Recall of all batches of injectable products from Lemax Laboratorios S.R.L

Murilo Freitas - 11:37, 23 de February de 2018858

The ANMAT informs the professionals that it has been ordered by Disposition ANMAT N ° 337-E / 2018 the start of the recall of all the current lots of injectable products prepared by LEMAX LABORATORIOS S.R.L. in the plant located in Neuquén 623, Lomas del Mirador, province of Buenos Aires, with expiration date until January 2020 inclusive.

The measure was adopted as a result of an inspection carried out at the establishment, during which critical breaches were detected and greater than the Good Manufacturing Practices and Control regulations during the preparation of the lots. This National Administration is monitoring the recall from the market and recommends that professionals abstain from using these products.

Source: http://www.anmat.gov.ar/comunicados/Retiro_del_mercado_LEMAX_21-2-18.pdf

 
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The Global Cancer Clinical Research, Drug Development and Therapeutic Accessibility Workshop

Murilo Freitas - 17:01, 22 de February de 2018950

April 30 – May 1, 2018

The Global Cancer Clinical Research, Drug Development and Therapeutic Accessibility Workshop is a collaborative effort between the Duke University Center for Applied Therapeutics and the National Cancer Institute’s Center for Global Health.

The availability of new cancer treatments varies widely around the world. This workshop will focus on the clinical testing and development, regulatory approval, and access to/reimbursement for anticancer drug activity that occurs internationally. It will deal with the complex issues specific to international oncology drug development, focusing on molecular subtypes of cancer, rare cancers and pediatric cancers.

The Workshop aims to develop research networks to facilitate collaboration and increase efforts to reduce the global burden of cancer.

For more information go to https://www.globalcancerdrugdevelopment.org/

 
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PAHO will support Dominican Republic public health system

Murilo Freitas - 15:53, 22 de February de 20181,112

[Original text in Spanish]

President Danilo Medina received today the visit of the director of the Pan American Health Organization (PAHO), Carissa Etienne, in which they discussed the progress and challenges of the health sector in the Dominican Republic.

Along with Etienne, was Alma Morales Salinas who, on behalf of the director of PAHO, explained the interest of that organization in supporting the public health system of the country, making available technical cooperation to address noncommunicable diseases.

He also said that PAHO will support the Dominican Republic in what it requires for the development of the health city within the framework of strengthening the integrated health service networks.

The meeting was framed in the meeting of managers of the PAHO sub-region, as well as the subregion of Central America, Cuba, Mexico and the Dominican Republic and heads of departments of the regional headquarters of that organization.

For more information go to: https://presidencia.gob.do/noticias/salud-grandes-avances-y-retos-ops-apoyara-sistema-de-salud-publica-y-9-1-1

 
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Ecuador: ARCSA – Alert on illegitimate lots of medicines COPAXONE, TASIGNA, AVASTIN and KIVEXA

Murilo Freitas - 14:05, 20 de February de 20181,143

The National Agency of Health Regulation, Control and Surveillance (Arcsa) informs the Ecuadorian population of the alert published by the National Administration of Medicines, Food and Medical Technology (ANMAT) of Argentina, which informs the population that has been detected the existence of medicinal specialties:

• COPAXONE 40 mg / ml, active ingredient Glatiramer Acetate. Lot C42234. Exp. 04/2018.
• TASIGNA, active ingredient Nilotinib Chloride 200 mg, 112 capsules. Lot SF432. Exp 06/2019.
• AVASTIN, active ingredient Bevacizumab 400 mg / ml, per 1 vial for I.V. after dissolution. Lot H179810. Exp. 02/2018.
• KIVEXA for 30 coated tablets, orally. Lot KC7W. Exp. 10/2019.

The warning arises as a result of having conducted a series of raids in different cities of Argentina, during which units were removed from the items detailed in sample character. After the relevant verifications were made to the respective registry holders, it could be verified that they are illegitimate.

For more information go to http://www.controlsanitario.gob.ec/alerta-sobre-lotes-ilegitimos-de-medicamentos-copaxone-tasigna-avastin-y-kivexa/

 
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Colombia: Invima Alert No. 010-2018 – “Vita-Gest”. Product with false marketing authorization

Murilo Freitas - 13:53, 20 de February de 2018777

Bogotá, February 15, 2018

Product name: Vita-Gest

Sanitary registry: RSAD16I47707 false  marketing authorization (registry)

Commercial presentation: Bottle for 700 grams

Manufacturer (s) / Importer (s): “Laboratorio Salud Natural”

Source:  https://www.invima.gov.co/alimentos-y-bebidas-aler-sani/alerta-sanitaria-numero-010-2018-vita-gest-pdf/download.html

 
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President Tabaré Vázquez of Uruguay is a co-chair of The WHO Independent Global High-level Commission on noncommunicable diseases

Murilo Freitas - 13:33, 20 de February de 20181,132

16 February 2018 | Geneva – WHO is announcing today a new high-level commission, comprised of heads of state and ministers, leaders in health and development and entrepreneurs. The group will propose bold and innovative solutions to accelerate prevention and control of the leading killers on the planet – noncommunicable diseases (NCDs) like heart and lung disease, cancers, and diabetes.

The WHO Independent Global High-level Commission on NCDs is co-chaired by President Tabaré Vázquez of Uruguay; President Maithripala Sirisena of Sri Lanka; President Sauli Niinistö of Finland; Veronika Skvortsova, Minister of Healthcare of the Russian Federation; and Sania Nishtar, former Federal Minister of Pakistan.

(…)

The new Commission was established by WHO Director-General Dr Tedros Adhanom Ghebreyesus and runs until October 2019. It will provide actionable recommendations to contribute to the Third United Nations General Assembly High-level Meeting on NCDs scheduled for the second half of 2018. This will include the submission of its first report to Dr Tedros in early June.

(…)

For more information go to http://www.who.int/mediacentre/news/releases/2018/world-leaders-ncds/en/

 
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TECENTRIQ (atezolizumab) – Risk of Myocarditis

Murilo Freitas - 13:25, 20 de February de 20181,508

Audiences

Healthcare professionals including oncologists, uro-oncologists, urologists, oncology nurses, oncology pharmacists, emergency room staff, and other healthcare professionals providing care to cancer patients, including those working in hospitals, cancer centers, oncology clinics, and pharmacies.

Key messages

  • Severe cases of myocarditis have been reported in patients being treated with TECENTRIQ (atezolizumab) in clinical trials.
  • Healthcare professionals are advised to:
    • monitor patients receiving TECENTRIQ for signs and symptoms of myocarditis.
    • withhold TECENTRIQ therapy in patients with Grade 2 myocarditis.
    • permanently discontinue TECENTRIQ treatment in patients with Grade 3 or 4 myocarditis.
    • administer corticosteroids and/or additional immunosuppressive agents as clinically indicated to TECENTRIQ treated patients who develop myocarditis.
  • The Canadian Product Monograph has been updated to include this new safety information.

For more information go to http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2018/65990a-eng.php

Posting date: February 14, 2018

 
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Mexico promotes opportunities for expansion and access to the pharmaceutical and medical device market

Murilo Freitas - 19:35, 16 de February de 20181,613

As part of the strategy to strengthen links at a global level, the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) participated in the work of India Pharma 2018, where it presented the regulatory advances reported by Mexico to expedite the population’s access to medicines and supplies for quality, safety and efficacy.

For more information go to https://www.gob.mx/cofepris/articulos/fortalece-la-cofepris-vinculos-internacionales-147624?idiom=es

 
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