Fluterol ECO

Información principal

  • Denominación comercial:
  • Fluterol ECO 250
  • formulario farmacéutico:
  • Cápsula para inhalación
  • Usar para:
  • Humanos
  • Tipo de medicina:
  • medicamento alopático

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  • para el público en general:
  • El prospecto de información de este producto no está disponible actualmente, puede enviar una petición a nuestro servicio al cliente y le notificaremos tan pronto como nos sea posible para conseguirlo.


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Localización

  • Disponible en:
  • Fluterol  ECO 250
    Cuba
  • Idioma:
  • español

Otros datos

Estado

  • Fuente:
  • CECMED - Autoridad Reguladora de Medicamentos, Equipos y Dispositivos Médicos - Cuba
  • Número de autorización:
  • 013-16d3
  • última actualización:
  • 10-05-2018

Ficha Técnica

RESUMEN DE LAS CARACTERÍSTICAS DEL PRODUCTO

Nombre del producto:

Fluterol® ECO 250

Forma farmacéutica:

Cápsula para inhalación

Fortaleza:

-

Presentación:

Estuche por una bolsa de AL con un inhalador y frasco

de PEAD con 60 cápsulas para inhalación.

Titular del Registro Sanitario, país:

LABORATORIO DE PRODUCTOS ÉTICOS C.E.I.S.A.,

SAN LORENZO, PARAGUAY.

Fabricante, país:

LABORATORIOS LICONSA S.A., GUADALAJARA,

ESPAÑA.

Número de Registro Sanitario:

013-16D3

Fecha de Inscripción:

1 de marzo 2016

Composición:

Cada cápsula para inhalación contiene:

propionato de fluticasona

salmeterol

250,00 µg

50,00 µg

lactosa monohidratada

12,20 mg

Plazo de validez:

24 meses

Condiciones de almacenamiento:

Almacenar por debajo de 30 ºC. No

refrigerar.

Indicaciones terapéuticas:

Tratamiento regular de la enfermedad obstructiva reversible de

las vías respiratorias,

incluyendo el asma en niños y adultos.

Bronquitis crónica y enfisema (enfermedad pulmonar obstructiva crónica, EPOC), así como

cuando la asociación de un broncodilatador y un esteroide inhalado sea apropiada. Esto

puede incluir:

Pacientes bajo dosis de mantenimiento efectivas de ß2 agonistas de acción prolongada y

corticosteroides inhalados administrados en inhaladores separados.

Pacientes

continúan

sintomáticos

pesar

estar

recibiendo

corticosteroides

inhalados.

Pacientes

tratados

regularmente

broncodilatadores

requieren

adicionar

corticosteroide

Contraindicaciones:

Hipersensibilidad a cualquier componente de la fórmula.

Niños menores de 4 años.

Precauciones:

El manejo de la enfermedad obstructiva reversible de las vías aéreas deberá normalmente

llevar

programa

escalonado

respuesta

paciente

deberá

monitoreada

clínicamente y mediante pruebas de función pulmonar.

Este producto no debe utilizarse para el alivio de los síntomas agudos; para ello, se requiere

de un broncodilatador de acción rápida y corta (ejemplo: salbutamol). Debe advertirse a los

pacientes que en todo momento tengan a mano su medicamento de alivio de un ataque de

asma agudo.

El incremento en el uso de broncodilatadores de corta acción para aliviar los síntomas del

asma, indica deterioro de la enfermedad, y los pacientes deben ser examinados por un

médico. Un deterioro repentino y progresivo del asma puede amenazar la vida del paciente,

por tanto, deberá ser evaluado por un médico y considerarse la posibilidad de incrementar la

terapia con corticosteroides. Deberá considerarse la posibilidad de administrar terapia

corticosteroide adicional e incluso antibióticos en caso de haber un proceso infeccioso

presente.

En los pacientes con asma, el tratamiento no debe suspenderse en forma abrupta, debido al

riesgo de exacerbación.

pacientes

EPOC,

suspensión

tratamiento

puede

asociarse

descompensación sintomática y debe ser supervisada por un médico.

Como

sucede

con todos los fármacos

inhalados

que contienen

corticosteroides,

este

producto debe administrarse con precaución en pacientes con tuberculosis pulmonar activa

latente.

Además,

debe

administrarse

precaución

pacientes

problemas

cardiovasculares graves, incluyendo anormalidades en el ritmo cardiaco, diabetes mellitus,

hipopotasemia no tratada o tirotoxicosis.

Diversos

efectos

sistémicos

pueden

llegar

presentarse

cualquier

costicosteroide administrado por vía inhalada, particularmente cuando se manejan dosis

altas durante periodos prolongados; estos efectos tienen una frecuencia mucho menor

comparada con el uso de los corticosteroides manejados por vía oral. Los posibles efectos

incluyen: supresión adrenal, retardo en el crecimiento en niños y adolescentes, disminución

de la densidad mineral ósea, cataratas y glaucoma. Es importante, por tanto, que la dosis de

los corticosteroides inhalados sea titulada a la dosis más baja, con la cual se obtenga un

control sostenido del asma.

Se recomienda que en niños que reciban tratamiento prolongado con corticosteroides

inhalados, la estatura sea monitoreada regularmente. Algunos individuos pueden exhibir una

susceptibilidad mayor a los efectos de los corticosteroides inhalados que la mayoría de los

pacientes. Debido a la posibilidad de presentarse una respuesta adrenal alterada, deberá

tenerse especial precaución con los pacientes que sean transferidos de la terapia esteroidea

oral a terapia con fluticasona inhalada, y la función adrenocortical debe ser monitoreada

regularmente. Posterior a la introducción de la fluticasona inhalada, la suspensión de la

terapia sistémica deberá ser gradual.

Advertencias especiales y precauciones de uso:

Uso en niños: No hay datos sobre el uso de este producto en niños menores de 4 años de

edad.

Uso en ancianos: Estudios apropiados desarrollados hasta la fecha no han demostrado

problemas geriátricos específicos que puedan limitar la utilidad de fluticasona y salmeterol

en los adultos mayores. Sin embargo, los pacientes adultos mayores son más propensos a

tener problemas médicos relacionados a la edad como enfermedades cardiovasculares, que

pueden requerir ajustar la dosis y usar con cuidado la combinación de fluticasona y

salmeterol en este tipo de pacientes.

Efectos indeseables:

reacciones

secundarias

pueden

presentarse

este

producto,

dependerán de cualquiera de los dos principios activos: salmeterol y fluticasona

propionato. No existe evidencia de que se presenten reacciones secundarias adicionales al

administrar ambos fármacos en forma concomitante.

Salmeterol:

Existen

reportes

irritación

orofaríngea.

reportado

temblor,

palpitaciones y cefalea, los cuales fueron transitorios y disminuyeron con la terapia regular.

Pueden llegar a presentarse arritmias cardiacas (incluyendo fibrilación auricular, taquicardia

supraventricular

extrasístoles),

especialmente

pacientes

susceptibles.

habido

reportes

artralgias

reacciones

hipersensibilidad

incluyen

rash,

edema

angioedema. Raros reportes de parestesias.

Propionato de fluticasona: En algunos pacientes puede ocurrir ronquera y candidiasis (aftas)

boca

garganta.

producido

reportes

poco

comunes

reacciones

hipersensibilidad cutánea. También se han comunicado reacciones de hipersensibilidad que

se manifiestan como angioedema (principalmente edema facial y bucofaríngeo), síntomas

respiratorios (disnea o broncoespasmo, o ambas cosas) y, muy raramente, reacciones

anafilácticas. Tanto la ronquera como la incidencia de candidiasis pueden aliviarse con

gárgaras

agua

después

usar

salmeterol/fluticasona

propionato

inhalador.

candidiasis

sintomática

puede

tratarse

terapia

antimicótica

tópica

durante

continuo

salmeterol/fluticasona

propionato

inhalador.

Entre

posibles

efectos

sistémicos se incluyen el síndrome de Cushing, rasgos cushingoides, supresión adrenal,

retardo del crecimiento en niños y adolescentes, disminución de la densidad mineral ósea,

cataratas y glaucoma. En raras ocasiones se han reportado casos de hiperglicemia,

ansiedad, trastornos del sueño y alteraciones del comportamiento, tales como hiperactividad

e irritabilidad (predominantemente en niños).

Posología y método de administración:

Fluticasona-Salmeterol se administrará solamente por vía inhalatoria.

Se hará saber a los pacientes que deben usar diariamente Fluticasona-Salmeterol, a fin de

obtener un beneficio óptimo, aun cuando no tengan síntomas.

Los pacientes deben ser reevaluados regularmente por un médico, de manera que la

concentración de Fluticasona-Salmeterol que reciban siga siendo la óptima y sólo se

modifique por consejo médico. Debe ajustarse la dosis a fin de que se administre la más

baja con la que se mantenga un control eficaz de los síntomas. Cuando el control de los

síntomas se mantenga con la concentración más baja de la combinación administrada dos

veces

día,

entonces

siguiente

paso

podría

consistir

probar

tratamiento

exclusivamente con un corticoesteroide por vía inhalatoria. Como alternativa, aquellos

pacientes que precisaran de un agonista b2 de acción prolongada podrían recibir

Fluticasona-Salmeterol una vez al día si, a criterio de su médico, éste fuera el tratamiento

adecuado para mantener el control de la enfermedad. En caso que la pauta posológica de

una vez al día se administre a un paciente con antecedentes de síntomas nocturnos, la

dosis debe ser administrada por la noche, mientras que si el paciente presenta un historial

de síntomas principalmente diurnos, la dosis debe administrarse por la mañana.

Los pacientes deben recibir la dosis de Fluticasona-Salmeterol que contenga la cantidad

apropiada de propionato de fluticasona adecuada a la gravedad de su enfermedad. Los

médicos deben conocer que, en pacientes con asma, el propionato de fluticasona es tan

eficaz como otros esteroides inhalados a la mitad aproximadamente de la dosis diaria en

microgramos.

ejemplo,

microgramos

propionato

fluticasona

equivalen

aproximadamente a 200 microgramos de dipropionato de beclometasona (conteniendo CFC)

o budesonida. Si un paciente individual necesitara una posología no incluida en el régimen

recomendado,

deberán

prescribir

dosis

apropiadas

beta-agonista

corticosteroide.

Dosis recomendadas:

Asma

Adultos y adolescentes de 12 años en adelante:

Una inhalación de 50 microgramos de salmeterol y 100 microgramos de propionato de

fluticasona dos veces al día o bien:

Una inhalación de 50 microgramos de salmeterol y 250 microgramos de propionato de

fluticasona dos veces al día o bien:

Una inhalación de 50 microgramos de salmeterol y 500 microgramos de propionato de

fluticasona dos veces al día.

Se puede probar, durante un periodo de tiempo limitado, la utilización de Fluticasona-

Salmeterol como terapia inicial de mantenimiento en adultos y adolescentes con asma

persistente

moderada

(definidos

como

pacientes

síntomas

diarios,

utilización

medicación de rescate diaria y obstrucción de las vías respiratorias de moderada a grave)

para los que es esencial un control rápido del asma.

En estos casos, la dosis inicial recomendada es una inhalación de 50 microgramos de

salmeterol y 100 microgramos de propionato de fluticasona dos veces al día. Una vez que

se ha alcanzado el control del asma, se debe revisar el tratamiento y considerar si los

pacientes deben ser tratados con corticosteroides inhalados únicamente. Es importante

controlar de forma regular a los pacientes a los que se les esté disminuyendo el tratamiento.

No se ha observado un beneficio claro al compararlo con propionato de fluticasona inhalado

solo, usado como terapia inicial de mantenimiento, cuando no se cumplen uno o dos de los

criterios de gravedad. En general los corticosteroides inhalados continúan como primera

línea de tratamiento para la mayoría de los pacientes. Fluticasona-Salmeterol no está

destinado al tratamiento inicial del asma leve. Fluticasona-Salmeterol en dosis de 50

microgramos/100 microgramos, no es apropiado en adultos y niños con asma grave; se

recomienda establecer la dosis apropiada de corticosteroides inhalados antes de utilizar

cualquier combinación fija en pacientes con asma grave.

Niños de 4 años en adelante:

Una inhalación de 50 microgramos de salmeterol y 100 microgramos de propionato de

fluticasona dos veces al día.

La dosis máxima permitida en niños es de 100 microgramos de propionato de fluticasona

dos veces al día.

No se dispone de datos acerca del uso de Fluticasona-Salmeterol en niños menores de 4

años.

EPOC

Adultos:

Una inhalación de 50 microgramos de salmeterol y 500 microgramos de propionato de

fluticasona dos veces al día.

Grupos especiales de pacientes:

No es necesario ajustar la dosis en pacientes ancianos o en aquéllos con insuficiencia renal.

No se dispone de datos para usar Fluticasona-Salmeterol en pacientes con insuficiencia

hepática.

Interacción con otros productos medicinales y otras formas de interacción:

Del Salmeterol: Deben evitarse los ß-bloqueadores tanto selectivos como no selectivos, a

menos que haya razones imperiosas para su uso.

De la fluticasona propionato: En circunstancias normales, después de la administración de

dosis

inhaladas

obtienen

bajas

concentraciones

plasmáticas

propionato

fluticasona, debido al extenso metabolismo de primer paso y a la alta eliminación sistémica

mediada por la isoenzima 3 A 4 del citocromo P450 en el intestino y el hígado. En

consecuencia, es improbable que se presenten interacciones fármaco-fármaco, clínicamente

significativas, mediadas por el propionato de fluticasona. Un estudio de interacción fármaco-

fármaco en sujetos sanos ha demostrado que el ritonavir (un inhibidor sumamente potente

isoenzima

citocromo

P450)

puede

aumentar

considerablemente

concentraciones plasmáticas de fluticasona propionato, lo cual resulta en una disminución

notable de las concentraciones séricas de cortisol. Existen reportes de interacción entre la

fluticasona

ritonavir

postcomercializacion

clínicamente

significativos,

produciendo

efectos sistémicos del corticosteroide significativos, tales como, síndrome de Cushing y

supresión adrenal. Por lo tanto, se debe evitar la combinación salvo que los beneficios

superen

riesgos

aumentados

efectos

adversos

glucocorticoides

sistémicos.

Estudios han demostrado que otros inhibidores de la isoenzima 3 A 4 del citocromo P450

producen aumentos insignificantes (eritromicina) y leves (ketoconazol) de la exposición

sistémica de la fluticasona propionato sin reducciones notables de las concentraciones

séricas

cortisol.

embargo

recomienda

proceder

cuidado

cuando

coadministren inhibidores potentes de la isoenzima 3 A 4 del citocromo P450 (por ejemplo,

el ketoconazol) pues existe la posibilidad de que aumente la exposición sistémica a la

fluticasona.

Uso en Embarazo y lactancia:

Existe poca experiencia en relación con el uso de salmeterol y fluticasona durante el

embarazo y la lactancia en humanos. La extensa experiencia clínica con fármacos de esta

clase no ha mostrado evidencia de efectos a nivel fetal cuando se administran a dosis

terapéuticas.

administración

este

producto

durante

embarazo

sólo

deberá

contemplarse, si el beneficio esperado para la madre supera cualquier posible riesgo para el

feto.

concentraciones

plasmáticas

salmeterol

fluticasona

después

dosis

terapéuticas administradas por vía inhalada son muy bajas y, por tanto, las concentraciones

en leche materna son en consecuencia bajas (observado en estudios en animales en

periodo

lactancia).

existe

experiencia

humanos.

administración

este

producto durante el embarazo y la lactancia queda bajo la responsabilidad del médico

tratante

Efectos sobre la conducción de vehículos/maquinarias:

No se han realizado estudios específicos del efecto de salbutamol/fluticasona inhalador en

las actividades indicadas anteriormente, pero la farmacología de ambos principios activos

indica que no tendrán ningún efecto.

Sobredosis:

No existen datos disponibles de estudios clínicos en relación con la sobredosis de la

combinación Salmeterol/fluticasona inhalador. No obstante, a continuación se presentan

datos respecto a la sobredosis con cada principio activo:

signos

síntomas de

sobredosificación

salmeterol

temblores,

cefalea

taquicardia. Los antídotos preferidos son los agentes ß-bloqueadores cardioselectivos, los

cuales deben usarse con precaución en los pacientes con una historia de broncoespasmo.

Si el tratamiento con salmeterol/fluticasona requiere ser suspendido debido a la sobredosis

componente

ß-agonista,

deberá

considerarse

posibilidad

proporcionar

tratamiento sustitutivo apropiado con esteroides. La inhalación de dosis de fluticasona

propionato por arriba de las dosis recomendadas puede causar supresión temporal del eje

hipotalámico-hipofisiario-suprarrenal. Esto generalmente no requiere ninguna acción de

urgencia, pues la función adrenal normal típicamente se restablece en cuestión de días. Sin

embargo, si dosis mayores a las recomendadas continúan tomándose durante periodos

prolongados, puede haber algún grado de supresión suprarrenal significativa. En muy raras

ocasiones

habido

reportes

crisis

adrenal

aguda,

cual

presentado

principalmente en niños expuestos a dosis más altas que las aprobadas durante períodos

prolongados (varios meses o años); entre las características observadas han figurado

hipoglucemia asociada con deterioro del estado de conciencia y/o convulsiones. Entre las

situaciones que posiblemente podrían desencadenar la crisis adrenal aguda figuran la

exposición a traumatismo, cirugía, e infecciones. No se recomienda que los pacientes

reciban dosis de Salmeterol/fluticasona más altas que las aprobadas. Es importante revisar

la terapia regularmente y ajustar la dosis a la más baja aprobada con la que se mantenga el

control eficaz de la enfermedad.

Propiedades farmacodinámicas:

Este

producto

contiene

salmeterol

propionato

fluticasona,

principios

activos

diferentes mecanismos de acción:

Salmeterol: El salmeterol es un ß2-agonista selectivo de acción prolongada (12 horas), que

posee

larga

cadena

exo-sitio

receptor.

Estas

propiedades

farmacológicas del salmeterol ofrecen una mayor protección contra la broncoconstricción

inducida por la histamina y producen una broncodilatación de mayor duración, por lo menos

de 12 horas, que las dosis recomendadas de ß2-agonistas de acción corta convencionales.

Diversas pruebas in vitro han demostrado que salmeterol es un inhibidor potente y de larga

duración, de mediadores químicos liberados de los mastocitos como son la histamina, los

leucotrienos y prostaglandina D2. En el ser humano, salmeterol inhibe las fases temprana y

tardía de la respuesta a un alergeno inhalado. Dosis únicas de salmeterol atenúan la

hiperreactividad

bronquial.

Estas

propiedades

indican

salmeterol

tiene

efecto

adicional no broncodilatador, pero el significado clínico completo aún no es claro.

Propionato

fluticasona:

propionato

fluticasona

tiene

potente

acción

antiinflamatoria

glucocorticoide

nivel

pulmonar,

resultando

reducción

síntomas y exacerbaciones del asma, sin los efectos secundarios de los corticosteroides

administrados por vía sistémica.

Propiedades

farmacocinéticas

(Absorción,

distribución,

biotransformación,

eliminación):

La administración concomitante por vía inhalada de salmeterol y fluticasona no afecta la

farmacocinética de cada componente en comparación con su administración por separado.

Salmeterol: El salmeterol actúa localmente a nivel pulmonar, por tanto, las concentraciones

plasmáticas no son una indicación de sus efectos terapéuticos. Existe información limitada

de la farmacocinética de salmeterol debido a la dificultad técnica para analizar el fármaco en

el plasma a sus bajas concentraciones después de la administración de dosis terapéuticas

administradas por vía inhalada (aproximadamente 200 pg/ml o menores). Después de la

dosificación regular de salmeterol, puede detectarse ácido hidroxinaftoico en la circulación

sistémica, el cual alcanza concentraciones de estado regular de aproximadamente 100

ng/ml. Estas concentraciones son hasta 1.000 veces más bajas que los niveles de estado

regular que se observan en los estudios de toxicidad. No se han observado efectos

perjudiciales después de la administración regular de salmeterol a largo plazo (más de 12

meses) en pacientes con obstrucción de las vías aéreas.

Propionato

fluticasona:

biodisponibilidad

absoluta

propionato

fluticasona

administrado por vía inhalada en sujetos sanos, varía entre 10 a 30% aproximadamente de

la dosis nominal, dependiendo del dispositivo utilizado para la inhalación. En los pacientes

enfermedad

obstructiva

reversible

vías

respiratorias

EPOC,

observado

grado

menor

exposición

sistémica

propionato

fluticasona.

absorción ocurre principalmente a nivel pulmonar y es inicialmente rápida, haciéndose luego

más lenta. Una parte de la dosis inhalada puede ser tragada; sin embargo, su concentración

es mínima para que haya una exposición sistémica debido a su baja solubilidad acuosa y

metabolismo presistémico, resultando en una biodisponibilidad menor del 1%. Hay un

incremento lineal en la exposición sistémica con el incremento de la dosis inhalada.

Propionato de fluticasona tiene un alto aclaramiento plasmático (1,150 ml/min), un amplio

volumen de distribución en estado estable (aproximadamente de 300 L) y una vida media

terminal de aproximadamente 8 horas. La unión a proteínas es moderadamente alta (91%).

elimina

rápidamente

circulación

sistémica,

principalmente

metabolismo

(metabolito

inactivo:

ácido

carboxílico),

citocromo

P-450,

enzima

CYP3A4.

eliminación renal de propionato de fluticasona es insignificante (< 0.2%), y menos del 5%

como metabolito. Debe tenerse cuidado cuando se coadministren inhibidores CYP3A4

conocidos, ya que existe un potencial aumento a la exposición sistémica a propionato de

fluticasona.

Instrucciones de uso, manipulación y destrucción del remanente no utilizable del

producto:

No congelar.

Fecha de aprobación/ revisión del texto: 1 de marzo 2016.

  • El prospecto de información de este producto no está disponible actualmente, puede enviar una petición a nuestro servicio al cliente y le notificaremos tan pronto como nos sea posible para conseguirlo.

    Solicitar el prospecto de información al público.



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Recommendations on the use of the proportionality approach in the framework of risk assessment for pesticide residues

Recommendations on the use of the proportionality approach in the framework of risk assessment for pesticide residues

Published on: Wed, 14 Nov 2018 The technical report reflects the outcome of the discussions and agreements that were reached in the pesticides peer review meeting on residues and maximum residue levels regarding the principles and guidance for application of the proportionality concept in the risk assessment methodologies used at European level for the estimation of the maximum residue levels for pesticides. In addition, practical experiences on the use of the proportionality approach gained by EFSA hav...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Published on: Wed, 14 Nov 2018 The food enzyme acetolactate decarboxylase (α‐acetolactate decarboxylase; EC 4.1.1.5) is produced with a genetically modified Bacillus licheniformis strain NZYM‐JB by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This acetolactate decarboxylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organi...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

FDA Publishes Design Recommendations for Residue Studies in Honey

FDA Publishes Design Recommendations for Residue Studies in Honey

FDA published draft guidance for industry #243 “Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Study Design Recommendations for Residue Studies in Honey for Establishing MRLs and Withdrawal Periods.”

FDA - U.S. Food and Drug Administration

6-11-2018

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Published on: Fri, 02 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the Australian Government Department of Agriculture and Water Resources submitted two requests to the competent national authority in Denmark to set import tolerances for the active substance haloxyfop‐P in linseed and rapeseed. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for linseed and rapeseed. Adequate analytical metho...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with the genetically modified Bacillus subtilis strain LMG S‐24584 by Puratos N. V. The genetic modifications do not give rise to safety concerns. The Panel noted that, although the production strain was not detected in the food enzyme, recombinant DNA was present in all batches of the food enzyme tested. The food enzyme is intended to be used in baking processes. Based on the maximum use levels re...

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Published on: Tue, 23 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of HOSTAZYM® X as a feed additive for sows in order to have benefit in piglets. The additive HOSTAZYM® X contains endo‐1,4‐beta‐xylanase and is available in liquid and solid formulations. This product is authorised as a feed additive for chickens for fattening, tu...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

10-10-2018

Tanning booths: ANSES issues a reminder of the proven risk of skin cancer

Tanning booths: ANSES issues a reminder of the proven risk of skin cancer

The health risks associated with exposure to artificial UV radiation from tanning booths have been well established for many years now. ANSES points out that recent data on the subject support previous assessments: there is a proven cancer risk associated with UV radiation from artificial tanning equipment. The Agency therefore recommends that the public authorities take the necessary steps to prevent people from being exposed to artificial UV radiation from tanning booths used for cosmetic purposes.

France - Agence Nationale du Médicament Vétérinaire

9-10-2018

Europa: recomiendan restricciones al uso de las fluoroquinolonas y quinolonas

El Comité de Farmacovigilancia de la agencia europea propone nuevas restricciones luego de revisar los efectos secundarios discapacitantes y potencialmente duraderos. EMA, 5 de octubre de 2018

REDCIMLAC - Red de Centros de Información de Medicamentos de Latinoamérica y el Caribe

3-10-2018

Reconciliación de medicamentos en la atención primaria: evaluación de la calidad de la información relacionada con la medicación proporcionada al alta de la atención secundaria

Eur J Hosp Pharm, 26 de septiembre 2018. Esta evaluación reveló un buen cumplimiento general con los estándares de documentación de descarga de medicamentos, pero una serie de cambios en los medicamentos durante la hospitalización no se comunicaron por completo o se documentaron en el resumen de alta ni se aplicaron en la práctica general después del alta.

REDCIMLAC - Red de Centros de Información de Medicamentos de Latinoamérica y el Caribe

21-9-2018

Scientific guideline:  Guideline on determination of withdrawal periods for edible tissues - Revision 1, adopted

Scientific guideline: Guideline on determination of withdrawal periods for edible tissues - Revision 1, adopted

This document provides a standard approach to be used across the European Union in the analysis of residue depletion data for the purpose of establishing withdrawal periods for edible tissues. Emphasis has been put on a statistical approach. As the method of first choice, a linear regression technique is recommended. A computerised version of the method described is available: Updated application software: withdrawal time calculation for tissues. Read together with the explanatory note on updated applica...

Europe - EFSA - European Food Safety Authority EFSA Journal

11-9-2018

Risk assessment of white willow (Salix alba) in food

Risk assessment of white willow (Salix alba) in food

Published on: Tue, 28 Aug 2018 00:00:00 +0200 This Technical Report contains a description of the activities within the work programme of the EU‐FORA Fellowship on the risk assessment of white willow in food. The bark of different varieties of willow has had a long history of medical use as a means to reduce fever and as a painkiller. Willow bark is also used in weight loss and sports performance food supplements. The labelling of these products usually does not mention any restrictions to the length of...

Europe - EFSA - European Food Safety Authority Publications

31-8-2018

Alcon Announces Voluntary Global Market Withdrawal of CyPass Micro-Stent for Surgical Glaucoma

Alcon Announces Voluntary Global Market Withdrawal of CyPass Micro-Stent for Surgical Glaucoma

Reflecting its uncompromising commitment to patient safety, Alcon today announced an immediate, voluntary market withdrawal of the CyPass Micro-Stent from the global market. In addition, Alcon advises surgeons to immediately cease further implantation with the CyPass Micro-Stent and to return any unused devices to Alcon. This decision and corresponding recommendation is based on an analysis of five-year post-surgery data from the COMPASS-XT long-term safety study. The US Food and Drug Administration (FD...

FDA - U.S. Food and Drug Administration

29-8-2018

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The EFSA Panel on Plant Protection Products and their Residues reviewed the guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessment. The inclusion of aged sorption is a higher tier in the groundwater leaching assessment. The Panel based its review on a test with three substances taken from a data set provided by the European Crop Protection Association. Particular points of attention were the quali...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Published on: Tue, 21 Aug 2018 00:00:00 +0200 Abstract In May 2018, EFSA and ECDC co‐facilitated a workshop on preparedness for a multi‐national food safety/public health incident. The workshop, hosted at AGES in Vienna, was conceived to closely align with EFSA's Strategy 2020 commitment to prepare for future risk assessment challenges. EFSA, ECDC, AGES and BfR worked together closely to develop a workshop and associated training materials to be delivered over a 2.5‐day agenda. The workshop was attended...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Strategic partnership with German data providing institutions on data quality (Pilot project) – Final report

Strategic partnership with German data providing institutions on data quality (Pilot project) – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 This report describes the framework of collection, management and transmission of food safety data in the Federal Republic of Germany. To adjust optimally the data governance processes to the requirements defined by the EFSA, measures had been agreed upon in order to improve the specified situation. Subsequent methodological system enhancements related to data quality are given as well as structural adjustments and the development and implementation of suppo...

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

New recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones

New recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones

The EU's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted new recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones (bone metastases). Xofigo should only be used in symptomatic patients who have had two previous treatments for prostate cancer and who cannot be treated with other medicines.

Danish Medicines Agency

23-8-2018

Third external evaluation of EFSA – progress made, recommendations for improvement

Third external evaluation of EFSA – progress made, recommendations for improvement

Third external evaluation of EFSA – progress made, recommendations for improvement

Europe - EFSA - European Food Safety Authority Press Releases & News Stories

7-8-2018

Seaweed consumption: remain vigilant to the risk of excess iodine intake

Seaweed consumption: remain vigilant to the risk of excess iodine intake

Over the last few years, seaweed has become increasingly common on our plates. Fresh, dried or as a food supplement, its iodine content varies and can sometimes be high. ANSES assessed the risk of excess iodine intake from the consumption of seaweed-based products. In view of the non-negligible risk of exceeding the upper limit of safe intake for iodine, the Agency advises against the consumption of seaweed and seaweed-based food supplements by certain at-risk populations, and recommends that regular con...

France - Agence Nationale du Médicament Vétérinaire

6-8-2018

FDA takes new steps to encourage the development of novel medicines for the treatment of opioid use disorder

FDA takes new steps to encourage the development of novel medicines for the treatment of opioid use disorder

FDA issued new scientific recommendations aimed at encouraging more widespread innovation and development of novel medication-assisted treatment drugs to treat opioid use disorder.

FDA - U.S. Food and Drug Administration

30-7-2018

ANSES recommends that certain populations avoid the consumption of food supplements containing melatonin

ANSES recommends that certain populations avoid the consumption of food supplements containing melatonin

Under the national nutrivigilance scheme, reports of adverse effects likely to be associated with the consumption of food supplements containing melatonin have been brought to the attention of ANSES. A retrospective analysis of these reports, combined with the considerable level of consumption of this type of supplement, led ANSES to conduct an assessment of the potential health risks. In its Opinion of February 2018, the Agency highlighted the existence of populations and situations at risk, for which t...

France - Agence Nationale du Médicament Vétérinaire

20-7-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to encourage the development of and broaden access to generic versions of opioid analgesics that are formulated to deter abuse

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to encourage the development of and broaden access to generic versions of opioid analgesics that are formulated to deter abuse

FDA posted a new batch of 43 product-specific guidances related to the development of generic drug products that includes three revised product-specific guidances for ADF opioid products. These guidances recommend specific in vivo studies and in vitro study considerations for abuse deterrence evaluations.

FDA - U.S. Food and Drug Administration

19-7-2018

Assessment of the safety of feminine hygiene products

Assessment of the safety of feminine hygiene products

Today ANSES is publishing its health risk assessment on the safety of feminine hygiene products. Chemicals have been identified in these products at very low concentrations not exceeding health thresholds. The expert appraisal did not reveal any risk associated with these substances. Nevertheless, the Agency recommends that manufacturers improve the quality of these products in order to eliminate or minimise the presence of chemicals. ANSES’s expert appraisal also examined the risk of menstrual toxic sho...

France - Agence Nationale du Médicament Vétérinaire

18-7-2018

&quot;Anti-pollution&quot; masks: not enough data to demonstrate a health benefit and justify recommending their use

&quot;Anti-pollution&quot; masks: not enough data to demonstrate a health benefit and justify recommending their use

In a context where prevention of ambient air pollution is a real public health issue, questions are regularly asked about the value of recommending that the population wear personal protective equipment. This led ANSES to assess the potential health benefits of wearing "anti-pollution" masks. Its expert appraisal revealed a lack of data demonstrating a health benefit. To reduce the health impacts associated with ambient air pollution, the Agency reiterates the importance of prioritising action at the sou...

France - Agence Nationale du Médicament Vétérinaire

13-7-2018

Scientific guideline:  Guideline on good pharmacogenomic practice - First version, adopted

Scientific guideline: Guideline on good pharmacogenomic practice - First version, adopted

This guideline provides recommendations for the conduct of genomic studies in relation to medical therapy in order to provide high quality information on the impact of genomic variability on drug response. Primary focus is on the analysis of genomic germline DNA. The analysis of somatic DNA and genomic biomarkers for cancer treatment is not being discussed and might be developed as an Annex or in separate guidance.

Europe - EFSA - European Food Safety Authority EFSA Journal

4-7-2018

Footwear and textile clothing: consumers need better protection from the risks of skin allergies and irritation

Footwear and textile clothing: consumers need better protection from the risks of skin allergies and irritation

Cases of skin allergies and irritation related to clothing or footwear are regularly reported to the health authorities. Today ANSES is publishing the results of the expert appraisal it conducted to identify the chemicals likely to be found in these articles and possibly responsible for these cases. Further to this expert appraisal, the Agency is issuing recommendations on how to better protect consumers from the risks of skin allergies and irritation caused by the presence of these substances.

France - Agence Nationale du Médicament Vétérinaire

28-6-2018

Ambient air quality: ANSES recommends the surveillance of 1,3-butadiene and the enhanced monitoring of ultrafine particles (UFPs) and carbon black

Ambient air quality: ANSES recommends the surveillance of 1,3-butadiene and the enhanced monitoring of ultrafine particles (UFPs) and carbon black

The European monitoring strategy for air quality relies heavily on quality standards for a number of pollutants. Advances in knowledge on the toxicity of substances and their emissions in the atmosphere have shown that certain pollutants that may have an impact on human health are not currently taken into account in regulatory monitoring. ANSES therefore received a formal request from the Ministries of Ecology and Health to propose a list of new priority pollutants for this air quality monitoring to supp...

France - Agence Nationale du Médicament Vétérinaire

8-5-2018

Neurovascular Stents Used for Stent-Assisted Coiling (SAC): Letter to Health Care Providers - Recommendations Associated With the Use of These Devices in the Treatment of Unruptured Brain Aneurysms

Neurovascular Stents Used for Stent-Assisted Coiling (SAC): Letter to Health Care Providers - Recommendations Associated With the Use of These Devices in the Treatment of Unruptured Brain Aneurysms

The FDA has received reports associated with the use of these devices in the treatment of unruptured brain aneurysms that suggest some events of peri-procedural stroke and/or death may have been related to procedural risks or patient selection related factors. These factors include patients who had serious co-morbidities resulting in a reduced life expectancy, or who were intolerant to required anticoagulation or anti-platelet therapy.

FDA - U.S. Food and Drug Administration

20-3-2018

Medicines Safety Update, Volume 9, Number 1, February-March 2018

Medicines Safety Update, Volume 9, Number 1, February-March 2018

First-generation oral sedating antihistamines – use in children, Suvorexant (Belsomra) – next day effects, Desvenlafaxine (Pristiq) recommended dose, Miconazole and potential interaction with warfarin

Therapeutic Goods Administration - Australia

15-2-2018

Be aware of rare but possible risk of liver injury in medical treatment of fibroids

Be aware of rare but possible risk of liver injury in medical treatment of fibroids

The Danish Medicines Agency recommends doctors not to start any new patients on the medicine Esmya (ulipristal) because of a rare, but possible, risk of developing serious liver injury.

Danish Medicines Agency

14-11-2017

The European Commission has published three recommendations for the clinical trials regulation

The European Commission has published three recommendations for the clinical trials regulation

In cooperation with the clinical trials expert group, the European Commission is updating and issuing new recommendations as a result of the regulation on clinical trials on medicinal products for human use.

Danish Medicines Agency

21-3-2017

New recommendation for phasing out zinc oxide for young pigs

New recommendation for phasing out zinc oxide for young pigs

The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) has confirmed a previous decision to phase out zinc oxide. Consequently, the CVMP has once more recommended to the European Commission that medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs should be withdrawn from the market.

Danish Medicines Agency

19-12-2016

Zinc oxide for young pigs to be phased out

Zinc oxide for young pigs to be phased out

The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) has recommended to the European Commission that medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs should be withdrawn from the market.

Danish Medicines Agency

20-7-2016

Marketing authorisation for medicine for cows suspended in the EU/EEA

Marketing authorisation for medicine for cows suspended in the EU/EEA

On 14 July 2016, the Committee for Medicinal Products for Veterinary Use (CVMP) recommended that the marketing authorisation for the centrally authorised medicinal product Velactis (cabergoline) be suspended temporarily. Velactis is used to reduce milk production in dairy cows at the time of drying off. The recommendation follows reports of serious adverse events after treatment with Velactis.

Danish Medicines Agency

17-10-2014

PRAC recommends strengthening the restrictions on the use of valproate in women and girls

PRAC recommends strengthening the restrictions on the use of valproate in women and girls

The EMA’s Pharmacovigilance and Risk Assessment Committee (PRAC) recommends strengthening the restrictions on the use of the antiepileptic valproate due to the risk of malformations and developmental problems in children exposed to valproate in the womb.

Danish Medicines Agency

3-10-2014

Consultation procedure about medicinal products and safety measure requirements not completed yet

Consultation procedure about medicinal products and safety measure requirements not completed yet

On 5 September 2014, the Danish Health and Medicines Authority submitted a draft list of the medicinal products comprised by the new safety measures rules (Directive 2001/83) for consultation. The consultation period expired on 17 September 2014, and on 3 October we were to inform the European Commission of the medicinal products we recommend including in the common EU lists. We have received 22 consultation responses. But on 24 September 2014 the European Commission amended the original guideline for...

Danish Medicines Agency

25-2-2014

EMA recommends further restrictions on the use of the osteoporosis medicine strontium ranelate (Protelos®)

EMA recommends further restrictions on the use of the osteoporosis medicine strontium ranelate (Protelos®)

The European Medicines Agency (EMA) recommends to restrict the use of the osteoporosis medicine strontium ranelate (Protelos®) to patients with severe osteoporosis who cannot be treated with other medicines approved for osteoporosis.

Danish Medicines Agency

5-1-2012

Consultation on the Reimbursement Committee's recommendation concerning the reimbursement status of strong painkillers (opioids)

Consultation on the Reimbursement Committee's recommendation concerning the reimbursement status of strong painkillers (opioids)

At the Danish Medicines Agency's request, the Reimbursement Committee has reassessed the reimbursement status of medicines in ATC group N02A, opioids, as well as certain medicines in ATC groups N07BC and R05DA.

Danish Medicines Agency

3-1-2012

Danish Pharmacovigilance Update, 15 December 2011

Danish Pharmacovigilance Update, 15 December 2011

Among the topics covered in this issue of Danish Pharmacovigilance Update are: Atomoxetine (Strattera®) and the risk of increased blood pressure and heart rate, increased suspicion of risk of congenital malformations with the antiepileptic topiramate (Topimax® and others), and new recommendations for the antidepressant escitalopram.

Danish Medicines Agency

1-12-2011

Danish Pharmacovigilance Update, 17 November 2011

Danish Pharmacovigilance Update, 17 November 2011

In this issue of Danish Pharmacovigilance Update, you can read about domperidone (Motilium® etc.) and potential risk of cardiac disorders, about the European Medicines Agency's recommendation on a lower dose of the antidepressant citalopram as well as about more interesting aspects of pharmacovigilance.

Danish Medicines Agency

4-11-2011

Comments received on the reassessment of reimbursement status of strong analgesics (opioids)

Comments received on the reassessment of reimbursement status of strong analgesics (opioids)

The Danish Medicines Agency has received a number of comments for the Reimbursement Committee's discussion of reimbursement status of strong analgesics (opioids). These comments were presented to the Reimbursement Committee at its meeting on 27 September 2011. The Reimbursement Committee is currently processing a recommendation.

Danish Medicines Agency

7-10-2011

Changed reimbursement for medicines for depression and anxiety as of 5 March 2012

Changed reimbursement for medicines for depression and anxiety as of 5 March 2012

With effect from 5 March 2012, the reimbursement is changed for certain medicinal products for treatment of depression and anxiety (antidepressants and anxiolytics). Based on the Reimbursement Committee's recommendation, the Danish Medicines Agency has decided that in future the general rule is that treatment with inexpensive medicines (e.g. sertraline and citalopram) must be attempted before reimbursement can be granted for more expensive medicines (e.g. escitalopram, duloxetine, pregabalin and agomelat...

Danish Medicines Agency

20-9-2011

Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of glucosamine-containing medicines

Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of glucosamine-containing medicines

The Reimbursement Committee’s recommendation on the future reimbursement status of glucosamine-containing medicines was open for consultation until 8 August 2011. The Danish Medicines Agency received 4 consultation responses.

Danish Medicines Agency

20-9-2011

Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicines for treatment of depression and anxiety (ACT group N06A, etc.)

Consultation responses on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicines for treatment of depression and anxiety (ACT group N06A, etc.)

The Reimbursement Committee’s recommendation on the future reimbursement status of medicines in ATC group N06A, antidepressants, as well as certain medicines in ATC groups N03A, N05A and N05B was open for consultation until 15 August 2011. The Danish Medicines Agency received 9 consultation responses.

Danish Medicines Agency

26-8-2011

Reassessment of reimbursement status of strong analgesics (opioids) – methadone and codeine

Reassessment of reimbursement status of strong analgesics (opioids) – methadone and codeine

On 15 August 2011, the Danish Medicines Agency announced that we would begin reassessing the reimbursement status of medicines in ATC group N02A, opioids. The Reimbursement Committee opened its preliminary discussions at its meeting on 23 August 2011 and recommended to include the opioids methadone (N07BC02) and codeine (R05DA04), also used in pain management, in the reassessment of reimbursement status of medicinal products in ATC group N02A.

Danish Medicines Agency

5-7-2011

Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicines in ATC group C01 (cardiac therapy)

Consultation on the Reimbursement Committee’s recommendation concerning the reimbursement status of medicines in ATC group C01 (cardiac therapy)

At the request of the Danish Medicines Agency, the Reimbursement Committee has reassessed the reimbursement status of medicines in ATC group C01 – cardiac therapy. These medicines are used for the treatment of cardiac arrhythmia (e.g. atrial fibrillation) and heart cramps (angina pectoris).

Danish Medicines Agency

21-10-2018

We’re now moving to update/modernize our oversight to capitalize on a # of important advances, including the increased use of digital imaging, revised screening recommendations from the @CDCgov and need for uniform nation-wide breast density reporting  ht

We’re now moving to update/modernize our oversight to capitalize on a # of important advances, including the increased use of digital imaging, revised screening recommendations from the @CDCgov and need for uniform nation-wide breast density reporting ht

We’re now moving to update/modernize our oversight to capitalize on a # of important advances, including the increased use of digital imaging, revised screening recommendations from the @CDCgov and need for uniform nation-wide breast density reporting https://go.usa.gov/xPnyd .

FDA - U.S. Food and Drug Administration

9-10-2018

#ICYMI - FDA issues recommendations to help prevent surgical fires and      related patient injury. Click the link to read the recommendations:  https://go.usa.gov/xQdwG   #FirePreventionWeek #MedicalDevice

#ICYMI - FDA issues recommendations to help prevent surgical fires and related patient injury. Click the link to read the recommendations: https://go.usa.gov/xQdwG  #FirePreventionWeek #MedicalDevice

#ICYMI - FDA issues recommendations to help prevent surgical fires and related patient injury. Click the link to read the recommendations: https://go.usa.gov/xQdwG  #FirePreventionWeek #MedicalDevice

FDA - U.S. Food and Drug Administration

21-9-2018

Click the link for a handy list of #FDA’s recommendations for using and  caring for your medical devices during a #hurricane.   https://go.usa.gov/xPbgc  #MedicalDevice

Click the link for a handy list of #FDA’s recommendations for using and caring for your medical devices during a #hurricane. https://go.usa.gov/xPbgc  #MedicalDevice

Click the link for a handy list of #FDA’s recommendations for using and caring for your medical devices during a #hurricane. https://go.usa.gov/xPbgc  #MedicalDevice

FDA - U.S. Food and Drug Administration

21-9-2018

Scientific guideline:  Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health, draft: consultation open

Scientific guideline: Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health, draft: consultation open

The objective of this document is to review available information on the use of aminopenicillins and their beta-lactamase inhibitor combinations in veterinary medicines in the EU, their effect on the emergence of antimicrobial resistance (AMR) and the potential impact of resistance on human and animal health. The document provides information for the risk profiling, as recommended by the Antimicrobial Advice ad hoc Expert Group (AMEG) of the EMA.

Europe - EMA - European Medicines Agency

19-9-2018

#FDA issues final guidance with recommendations for labeling and safety testing of #heparin  containing medical devices and device-led combination products to help  reduce the risk of patient injury. To read the guidance, click here:  https://go.usa.gov/x

#FDA issues final guidance with recommendations for labeling and safety testing of #heparin containing medical devices and device-led combination products to help reduce the risk of patient injury. To read the guidance, click here: https://go.usa.gov/x

#FDA issues final guidance with recommendations for labeling and safety testing of #heparin containing medical devices and device-led combination products to help reduce the risk of patient injury. To read the guidance, click here: https://go.usa.gov/xP2VB  #MedicalDevice pic.twitter.com/hsdX5ylKPu

FDA - U.S. Food and Drug Administration

21-8-2018

It’s #ContactLensHealthWeek! Remember to wear your contacts no longer than recommended and to replace your contact lens case once every 3 months!  https://go.usa.gov/xUskq 
#OnePairTakeCarepic.twitter.com/VRDkVPvMTR

It’s #ContactLensHealthWeek! Remember to wear your contacts no longer than recommended and to replace your contact lens case once every 3 months! https://go.usa.gov/xUskq  #OnePairTakeCarepic.twitter.com/VRDkVPvMTR

It’s #ContactLensHealthWeek! Remember to wear your contacts no longer than recommended and to replace your contact lens case once every 3 months! https://go.usa.gov/xUskq  #OnePairTakeCare pic.twitter.com/VRDkVPvMTR

FDA - U.S. Food and Drug Administration

6-8-2018

Scientific guideline:  ICH M9 on biopharmaceutics classification system based biowaivers - Step 2b - First version, draft: consultation open

Scientific guideline: ICH M9 on biopharmaceutics classification system based biowaivers - Step 2b - First version, draft: consultation open

This new multidisciplinary guideline is proposed to address biopharmaceutics classification system (BCS)-based biowaivers. BCS-based biowaivers may be applicable to BCS Class I and III drugs, however BCS-based biowaivers for these two classes are not recognized worldwide. This means that pharmaceutical companies have to follow different approaches in the different regions. This guideline will provide recommendations to support the biopharmaceutics classification of medicinal products and will provide rec...

Europe - EMA - European Medicines Agency

18-7-2018

THREAD: We’re proud to work with the public-private Healthcare Sector Coordinating Council’s Medical Technology & Health IT Task Group to address @HHSgov Cybersecurity Task Force Report recommendations related to medical device cybersecurity:  https://hea

THREAD: We’re proud to work with the public-private Healthcare Sector Coordinating Council’s Medical Technology & Health IT Task Group to address @HHSgov Cybersecurity Task Force Report recommendations related to medical device cybersecurity: https://hea

THREAD: We’re proud to work with the public-private Healthcare Sector Coordinating Council’s Medical Technology & Health IT Task Group to address @HHSgov Cybersecurity Task Force Report recommendations related to medical device cybersecurity: https://healthsectorcouncil.org/health-sector-mobilizes-against-cyber-threats/ …

FDA - U.S. Food and Drug Administration

16-7-2018

Reconcile (Nexcyon Pharmaceuticals Ltd)

Reconcile (Nexcyon Pharmaceuticals Ltd)

Reconcile (Active substance: Fluoxetine) - Centralised - Renewal - Commission Decision (2018)4770 of Mon, 16 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/133/R-18

Europe -DG Health and Food Safety

9-7-2018

Scientific guideline:  Concept paper on the need to develop a reflection paper on development of medicinal products to prevent and treat acute kidney injury, draft: consultation open

Scientific guideline: Concept paper on the need to develop a reflection paper on development of medicinal products to prevent and treat acute kidney injury, draft: consultation open

The concept paper will include discussion of and recommendations for the requirements for evaluation and development of medicinal products for the prevention and/or treatment of acute kidney injury (AKI) and its long-term complications. Relevant topics for discussion include patient populations, endpoints, study methodology, and study duration.

Europe - EMA - European Medicines Agency

29-5-2018

FDA issues recommendations to help prevent surgical fires and related patient injury-  https://go.usa.gov/xQdwG  #MedicalDevice #Safety

FDA issues recommendations to help prevent surgical fires and related patient injury- https://go.usa.gov/xQdwG  #MedicalDevice #Safety

FDA issues recommendations to help prevent surgical fires and related patient injury- https://go.usa.gov/xQdwG  #MedicalDevice #Safety

FDA - U.S. Food and Drug Administration