http://portal.anvisa.gov.br/web/guest/rss/-/asset_publisher/Zk4q6UQCj9Pn/content/id/3803983
La ANMAT informa a la población que, a requerimiento de esta Administración Nacional, la firma VEINFAR ICSA ha iniciado el retiro del mercado de la siguiente especialidad medicinal:
– HEPARINA VEINFAR/HEPARINA SÓDICA 5000 UI/ml – solución inyectable SC-IV – frasco ampolla por 5 ml en envase hospitalario por
100 unidades – Certificado N° 52974 – Lote 13122 con vencimiento 12/2018.
El producto es utilizado como anticoagulante. La medida fue adoptada luego de que se obtuvieran resultados fuera de especificación en la determinación de la potencia.
Esta Administración Nacional se encuentra realizando el seguimiento del retiro del mercado.
Se ha detectado mediante denuncia la comercialización de este producto, cuya composición
legítima es desconocida y no posee registro sanitario Invima, su comercialización en Colombia
es ilegal y se considera un producto fraudulento. Al desconocer su composición, este producto
puede contener sustancias que pueden afectar su estado de salud e incluso comprometer su vida.
Mas informaciones por el enlace: https://www.invima.gov.co/alimentos-y-bebidas-aler-sani/alerta-sanitaria-numero-078-riqueso-pdf/download.html
December 1, 2017
Health Canada is advising consumers and health care professionals that complaints have been received for packages of Alesse 21 (21 active pills) and Alesse 28 (21 active pills, 7 that contain no hormones). The blister packages for both contained an active (pink) pill that was roughly half the proper size.
Alesse 21 and Alesse 28 are prescription drugs used to prevent pregnancy.
For more information go to
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2017/65306a-eng.php
http://portal.anvisa.gov.br/web/guest/rss/-/asset_publisher/Zk4q6UQCj9Pn/content/id/3800131
[Texto original en inglés]
On Tuesday, December 5th, the Caribbean Public Health Agency/Caribbean Regulatory System (CARPHA/CRS) recommended its 15th medicine for marketing authorization/import permit in the CARICOM block of countries. The product, Efavirenz, Emtricitabine, and Tenofovir (600/200/300mg), is listed on the WHO Essential Medicine List and is a first line treatment according to WHO HIV treatment guidelines. The initiative is intended to strengthen regulation in these small states, which are primarily comprised of the English speaking Caribbean, plus the French and Dutch speaking Haiti and Suriname, respectively. In addition to the focus on marketing authorization, the CRS also helps countries monitor medicines in the market by setting up a regional reporting system. To date, it has received over 70 reports, including for substandard and falsified medicines. For more information on the CARPHA/CRS please visit the website at: http://carpha.org/What-We-Do/Laboratory-Services-and-Networks/CRS
http://portal.anvisa.gov.br/web/guest/rss/-/asset_publisher/Zk4q6UQCj9Pn/content/id/3796872
http://portal.anvisa.gov.br/web/guest/rss/-/asset_publisher/Zk4q6UQCj9Pn/content/id/3796622
[Texto original en inglés]
SUMMARY: The Center for Drug Evaluation and Research (CDER) in the Food and Drug Administration (FDA) is announcing the 2018 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program. The purpose of this document is to invite pharmaceutical companies interested in participating in this program to submit a site visit proposal to CDER’s OPQ.
DATES: Submit either an electronic or written proposal to participate in this program by February 2, 2018. See section IV of this document for information on what to include in such proposals.
For more go to information https://www.gpo.gov/fdsys/pkg/FR-2017-12-04/pdf/2017-26055.pdf
