CO-TRIMOXAZOL

Información principal

  • Denominación comercial:
  • CO-TRIMOXAZOL
  • Dosis:
  • 400/80 mg
  • formulario farmacéutico:
  • Tableta
  • Usar para:
  • Humanos
  • Tipo de medicina:
  • medicamento alopático

Documentos

  • para el público en general:
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Localización

  • Disponible en:
  • CO-TRIMOXAZOL
    Cuba
  • Idioma:
  • español

Otros datos

Estado

  • Fuente:
  • CECMED - Autoridad Reguladora de Medicamentos, Equipos y Dispositivos Médicos - Cuba
  • Número de autorización:
  • m15054j01
  • última actualización:
  • 10-05-2018

Ficha Técnica

RESUMEN DE LAS CARACTERÍSTICAS DEL PRODUCTO

Nombre del producto:

CO-TRIMOXAZOL

Forma farmacéutica:

Tableta

Fortaleza:

Presentación:

Estuche por 1, 2 ó 3 blísteres de PVC/AL

con 10 tabletas cada uno.

Estuche por 1, 2 ó 3 blísteres de PVC ámbar/AL

con 10 tabletas.

Titular del Registro Sanitario, país:

EMPRESA LABORATORIOS MEDSOL,

La Habana, Cuba.

Fabricante, país:

EMPRESA LABORATORIOS MEDSOL,

La Habana, Cuba.

UNIDAD EMPRESARIAL DE BASE (UEB) SOLMED,

PLANTA 1 Y PLANTA 2.

Número de Registro Sanitario:

M-15-054-J01

Fecha de Inscripción:

3 de marzo de 2015

Composición:

cada tableta contiene:

Sulfametoxazol

Trimetoprima

400,0 mg

80,0 mg

Lactosa monohidratada

73,17 mg

Plazo de validez:

36 meses

Condiciones de almacenamiento:

Almacenar por debajo de 30ºC.

Protéjase de la luz.

Indicaciones terapéuticas:

Infecciones urinarias por E. coli, Klebsiella, Enterobacter, Proteus mirabilis y P. vulgaris.

Infecciones respiratorias bacterianas: otitis media aguda (niños susceptibles a gérmenes

como Streptococcus pneumoniae y Haemophilus influenzae), sinusitis aguda, exacerbación

aguda de bronquitis crónica.

Enfermedad diarreica aguda bacteriana moderada a severa: Shigella spp., Escherichia coli

enterotoxigénica, Vibrio cholerae.

Neumonía por Pneumocystis carinii o en la profilaxis de esta neumonía en pacientes

inmunodeprimidos.

Profilaxis primaria para la toxoplasmosis cerebral en SIDA.

Infección

Stenotrophomona

(Xanthomona,

Pseudomonas

maltophilia),

Burkholderia

(Pseudomona cepacia). Granuloma inguinal. Nocardiosis.

Alternativa en: brucelosis (terapia combinada). Tosferina.

Infecciones

susceptibles

por:

Estafilococo

oxacilino

resistente,

Enterobacter

spp.,

Providencia spp., Aeromonas spp., Acinetobacter spp., Yersinia enterocolítica y Listeria

monocytogenes.

No está indicado en: faringitis por estreptococo grupo A (puede no erradicarlo y no prevenir

posibilidad de fiebre reumática).

Tampoco en bronquitis aguda no complicada (casi siempre tiene una causa viral).

Contraindicaciones:

Hipersensibilidad

sulfonamida

trimetoprima.

Embarazo

término.

Lactancia.

Lactantes menores de 2 meses de edad (excepto en la infección por p. Carinii). Deficiencia

de G6PD. Porfiria.

Contiene lactosa, no administrar a pacientes con intolerancia a la lactosa.

Precauciones:

Embarazo: debido a interferencia con el metabolismo del ácido fólico, debe ser usado

únicamente si el beneficio justifica el riesgo potencial para el feto; posibilidad de kernícterus

al final del embarazo. Categoría de riesgo: C.

Adulto mayor: incrementa la susceptibilidad a reacciones adversas. Insuficiencia renal:

mayor riesgo de toxicidad, puede causar necrosis tubular y nefritis intersticial; no es

recomendable en la forma severa, el ajuste de la dosis puede ser necesario, se debe

asegurar una adecuada hidratación. Insuficiencia hepática: mayor riesgo de toxicidad; puede

causar necrosis hepática fulminante; evitar el uso concomitante con fármacos hepatotóxicos.

Hipersensibilidad

cruzada:

furosemida,

tiacidas,

sulfonilureas,

inhibidores

anhidrasa carbónica.

Evitar la exposición a la luz ultravioleta o solar debido a la fotosensibilización.

Estados que predisponen a la deficiencia de folatos: alcoholismo, terapia anticonvulsiva,

síndrome de malaabsorción y malnutrición.

Discrasias sanguíneas: riesgo de agravarlas. La trimetoprima puede ocasionar hipercaliemia,

por lo que debe vigilarse el potasio sérico principalmente en pacientes con compromiso de la

función renal, con afecciones del metabolismo del potasio y con fármacos ahorradores de

Potasio.

Pacientes con diabetes mellitus.

Advertencias especiales y precauciones de uso:

Ingerir con abundantes líquidos para evitar la cristaluria y la formación de cálculos.

Evitar excesiva exposición al sol o a la luz ultravioleta.

Efectos indeseables:

Frecuentes: náuseas, vómitos, mareo, diarrea, dolor abdominal e hipersensibilidad (fiebre,

erupción cutánea).

Ocasionales: eritema multiforme, reacciones de tipo anafilácticas en ocasiones fatales

(síndrome de Stevens-Johnson y necrólisis tóxica epidérmica), necrosis hepática fulminante,

agranulocitosis,

discrasias

sanguíneas,

hepatitis

colestática,

kernícterus

neonatos),

oliguria, hematuria y cristaluria.

Raras: nefritis intersticial, necrosis tubular renal, colitis pseudomembranosa, meningitis

aséptica, bocio y alteraciones de la función tiroidea.

Posología y método de administración:

Adultos:

Infecciones por gérmenes susceptibles: dosis usual: sulfametoxazol 800 mg y trimetoprima

160 mg vía oral c/12 h por 10 a 14 d. Infecciones urinarias: bajas con períodos cortos de

tratamiento por 3 d; alta no complicada: por 10 a 14 d.

Insuficiencia renal: por encima de una depuración de creatinina de 30 mL/min dosis usual;

entre

mL/min,

reducir

dosis

usual;

menos

mL/min

recomendado, excepto si está en hemodiálisis.

Otitis, sinusitis aguda: por 10 d.

Exacerbación aguda bacteriana de bronquitis crónica: por 10 a 14 d.

Diarrea bacteriana: por 3 a 5 d.

Neumonía por P. Carinii: tratamiento: 75 a 100 mg/kg/d de sulfametoxazol y 15 a 20 mg/kg/d

de trimetoprima por vía oral c/6 h durante 14 a 21 d.

Profilaxis o terapia supresiva en SIDA: 800 mg de sulfametoxazol y 160 mg de trimetoprima

por vía oral c/24 h o 3 veces/semana.

Toxoplasmosis cerebral en SIDA: profilaxis primaria: 800 mg de sulfametoxazol y 160 mg de

trimetoprima por vía oral c/24 h o 3 veces/semana.

Granuloma inguinal: 800 mg de sulfametoxazol y 160 mg de trimetoprima por vía oral c/12 h

hasta que las lesiones cicatricen completamente (mínimo 3 semanas).

Niños mayores de 2 meses de edad y hasta con 40 kg de peso susceptibles a las

infecciones por gérmenes: dosis usual: sulfametoxazol 40 a 60 mg/kg/d y trimetoprima 8 a

12 mg/kg/d por vía oral c/12 h.

Duración de los tratamientos de acuerdo con la localización de la infección (ver adultos).

Neumonía por P. carinii: tratamiento: 75 a 100 mg/kg/d de sulfametoxazol y 15 a 20 mg/kg/d

de trimetoprima por vía oral c/6 h por 14 a 21 d:

Profilaxis en niños con 4 semanas o más edad: 750 mg/m

sc de sulfametoxazol y 150

mg/m

sc de trimetoprima por vía oral c/ 12-24 h o 3 veces/semana.

Toxoplasmosis cerebral en SIDA: profilaxis primaria: 750 mg/m

sc de sulfametoxazol y 150

mg/m

sc de trimetoprima por vía oral c/12-24 h o 3 veces/semana.

Interacción con otros productos medicinales y otras formas de interacción:

Fenitoína: incremento de las concentraciones séricas y efecto antifolato de la fenitoína.

Tolbutamida, clorpropamida: incremento del riesgo de hipoglicemia. Tiacidas: riesgo de

trombocitopenia y púrpura.

Warfarina: incremento de su efecto. Incrementa el riesgo de nefrotoxicidad con metotrexato,

ciclosporina,

hematotoxicidad

azatioprina,

mercaptopurina.

Incrementa

efecto

antifolato de pirimetamina, metotrexato y otras sulfonamidas.

Fármacos que acidifican la orina (ácido ascórbico, metenamina): provocan la precipitación

de sulfa en los túbulos renales provocando cristaluria. Disminuyen la eficacia de los

antidepresivos tricíclicos.

Amiodarona:

incrementa

riesgo

arritmia

ventricular.

Incremento

riesgo

agranulocitosis con la clozapina.

Etanol: posibilidad de reacción tipo disulfiram.

Uso en Embarazo y lactancia:

Embarazo: debido a interferencia con el metabolismo del ácido fólico, debe ser usado

únicamente si el beneficio justifica el riesgo potencial para el feto; posibilidad de kernícterus

al final del embarazo. Categoría de riesgo: C.

Efectos sobre la conducción de vehículos/maquinarias:

No procede.

Sobredosis:

Los síntomas por sobredosificación incluyen náuseas, vómitos, mareo y confusión; en casos

muy graves se ha descrito hematuria, anuria y cristaluria, ante lo cual deberá suspenderse el

tratamiento.

lavado

gástrico

puede

útil,

aunque

absorción

tracto

gastrointestinal normalmente es muy rápida, y después de aproximadamente dos horas, la

absorción del fármaco ha sido completa.

La acidificación de la orina aumenta la eliminación de la trimetoprima.

inducción

diuresis

alcalinización

orina,

aumenta

eliminación

sulfametoxazol.

Propiedades farmacodinámicas:

ATC: J01EC01 Sulfonamidas de Acción intermedia

La asociación de una sulfamida, el sulfametoxazol y una diaminopirimidina, la trimetoprima,

origina un compuesto antimicrobiano de amplio espectro, su efecto bactericida deriva del

bloqueo de dos enzimas que catalizan reacciones sucesivas en la biosíntesis del ácido

folínico en el microorganismo. Y es por este mecanismo de acción único que no se ha

presentado resistencia significativa a lo largo de 20 años.

Los dos principios activos ejercen una acción sinérgica bactericida que abarca el siguiente

espectro antibacteriano, tanto en organismos grampositivos como gramnegativos como:

estafilococos,

neumococos,

meningococos,

gonococos,

Salmonella,

Klebsiella,

Enterobacter, Shiguella sonnei, Shigella flexreri, Pneumocystis carinii, Morganella morganii y

Vibrio colérico, entre otros. Además tiene acción contra Haemophilus influenzae, Escherichia

coli, Proteus mirabilis, Proteus vulgaris, Neisseria gonorrhoeae, Streptococcus pneumoniae.

No es susceptible la Pseudomonas aeruginosa.

El grado de máximo de sinergismo se produce cuando los microorganismos son sensibles a

ambos componentes.

Mecanismo de acción:

El sulfametoxazol es un antimicrobiano bacteriostático de amplio espectro.

Es un análogo estructural del ácido aminobenzoico (PABA) e inhibe competitivamente a una

enzima bacteriana, la dihidropteroato sintetasa, que es la responsable de la incorporación

del PABA al ácido dihidrofólico. Esto bloquea la síntesis del ácido dihidrofólico y disminuye

la cantidad de ácido tetrahidrofólico que es el metabólicamente activo, un cofactor en la

síntesis de purinas, timidina y ADN. Las bacterias sensibles son aquellas que sintetizan

ácido fólico. La acción del sulfametoxazol es antagonizada por el PABA y sus derivados (por

ejemplo, procaína y tetracaína) y por la presencia de pus o productos de degradación tisular

los cuales proveen de los componentes necesarios para el crecimiento bacteriano. Por tanto

el sulfametoxazol compite con el ácido paraaminobenzoico, necesario para la bacteria

patógena en la formación del ácido fólico impidiendo así la reproducción bacteriana de

nucleoproteínas y aminoácidos. La trimetoprima es bacteriostática y es una base débil

lipofílica estructuralmente relacionada con la pirimetamina. Se une e inhibe a la enzima

bacteriana

dihidrofolato

reductasa,

bloqueando

selectivamente

conversión

ácido

dihidrofólico a su forma funcional, el ácido tetrahidrofólico. Esto depleta de folato a la

bacteria siendo un cofactor esencial en la biosíntesis de los ácidos nucléicos, lo que resulta

en interferir con el ácido nucléico bacteriano y con la producción de proteínas bacterianas.

La trimetoprima ejerce su efecto en la biosíntesis de folatos junto con el efecto del

sulfametoxazol. Cuando ambos son administrados juntos, hay un sinergismo en su acción,

el cual es atribuido a la inhibición de la producción del tetrahidrofolato en dos pasos

esenciales de su biosíntesis. El medicamento formado puede actuar como bactericida o

bacteriostático dependiendo del tejido, la concentración de la droga y el microorganismo

infectante.

Propiedades

farmacocinéticas

(Absorción,

distribución,

biotransformación,

eliminación):

Absorción: Oral - Sulfametoxazol y trimetoprima: Se absorbe rápida y casi completamente

(del 90 al 100 %) en el tracto gastrointestinal.

Unión a proteínas:

Sulfametoxazol: De moderada a elevada (60-70 %); sus metabolitos acetilados se unen más

a proteínas que la droga sola. Las sulfas compiten con la bilirrubina en su unión a albúmina.

Por lo tanto, en prematuros y neonatos puede presentar-se kernicterus. Su unión a proteínas

disminuye en la insuficiencia renal. Solamente la droga libre y no unida a proteínas tiene

acción antibacteriana.

Trimetoprima: De moderada a elevada (40-70 %).

Distribución: El sulfametoxazol se distribuye rápida y ampliamente en varios tejidos y

líquidos corporales, incluyendo la leche materna, líquido pleural, peritoneal, sinovial y ocular.

También atraviesa la placenta. La trimetoprima también es ampliamente distribuida en varios

tejidos y líquidos, incluyendo riñones, hígado, bazo, secreciones bronquiales, saliva y tejido

y líquido prostático.Se distribuye muy bien en bilis, humor acuoso, médula ósea y en hueso

esponjoso; mucosa intestinal y líquido seminal. Las concentraciones biliares exceden a las

séricas. Las concentraciones en líquido cefalorraquídeo (L.C.R.) varían de 30-50 % de las

concentraciones séricas. Las concentraciones en líquido vaginal llegan hasta tres veces más

altas que las del suero. Cruza la placenta y se excreta en la leche materna.

Biotransformación:

Sulfametoxazol: Por vía hepática; primariamente por acetilación a metabolitos inactivos que

conservan la toxicidad del compuesto primario. Puede ocurrir cierto grado de conjugación

con ácido glucurónico. Su metabolismo aumenta en la insuficiencia renal y disminuye en la

insuficiencia hepática.

La trimetoprima se metaboliza en el hígado, del 10 a 20 % se inactiva a metabolitos o-

desmetilación,

n-oxidación

alfa-hidroxilación.

metabolitos

pueden

libres

conjugados.

Vida media:

Sulfametoxazol:

Función renal normal: De 6 a 12 horas.

Estadío final de la insuficiencia renal: De 20 a 50 horas.

Trimetoprima:

Función renal normal: De 24 horas.

Pacientes anúricos: Hasta 20 a 50 horas.

Tiempo hasta la concentración sérica media máxima:

Sulfametoxazol: De 2 a 4 horas (oral).

Trimetoprima: De 1 a 4 horas (oral).

Tiempo hasta la concentración máxima en orina:

Sulfametoxazol: 0,5 horas.

Eliminación:

Sulfametoxazol:

El sulfametoxazol se elimina por vía renal a través de filtración glomerular con algo de

secreción y reabsorción tubular tanto su forma activa como sus metabolitos. Su excreción

aumenta con la orina alcalina; se excretan pequeñas cantidades en las heces, bilis, y otras

secreciones corporales y leche materna. Se elimina con hemodiálisis.

Trimetoprima:

La trimetoprima también se elimina por vía renal, eliminándose en las primeras 24 horas,

entre el 40-60 %, principalmente por filtración glomerular y secreción tubular; de esta

cantidad, el 80-90 % se elimina sin cambios y el resto por metabolitos inactivos. Su

excreción aumenta con la orina ácida y disminuye con la orina alcalina. Sólo pequeñas

cantidades se eliminan por las heces (4 %), leche materna y bilis. La trimetoprima se

elimina de la sangre por hemodiálisis en cantidades significativas, requiriéndose, una dosis

de mantenimiento máximo después del proceso de diálisis. El proceso de diálisis peritoneal

no es eficaz para eliminar la trimetoprima de la sangre en caso de sobredosis.

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

producto:

No procede.

Fecha de aprobación/ revisión del texto: 31 de enero de 2018.

  • 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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Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Cyprus and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Cyprus and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Cyprus alongside with another 4 countries has participated successfully in the Grant Agreement GP/EFSA/DATA/2016/01‐GA 02, entitled: “Strategic Partnership with Cyprus on Data Quality”. The project was co‐financed by EFSA, aiming to help both EFSA and data providers from Member States to possess data of high quality in a quantitatively manageable way. The main objective of the grant agreement was the establishment of the data governance, coordination and imp...

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

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Published on: Thu, 16 Aug 2018 00:00:00 +0200 4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the avai...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Peer review of the pesticide risk assessment of the active substance carvone (substance evaluated d‐carvone)

Peer review of the pesticide risk assessment of the active substance carvone (substance evaluated d‐carvone)

Published on: Tue, 07 Aug 2018 00:00:00 +0200 The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, the Netherlands and co‐rapporteur Member State, Sweden, for the pesticide active substance carvone are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative use...

Europe - EFSA - European Food Safety Authority Publications

10-8-2018

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Ma...

FDA - U.S. Food and Drug Administration

18-7-2018

Sodium glucose co-transporter 2 inhibitors

Sodium glucose co-transporter 2 inhibitors

Safety advisory - diabetic ketoacidosis and surgical procedures

Therapeutic Goods Administration - Australia

13-7-2018

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. -- that is used in the manufacture of the subject product ...

FDA - U.S. Food and Drug Administration

17-5-2018

BLM Issues Allergy Alert On Undeclared Egg and Milk

BLM Issues Allergy Alert On Undeclared Egg and Milk

BLM Prod.-u. Vertriebsges. mbH & Co. KG, is voluntarily recalling Priano Rosso Pesto Sauce as it may contain undeclared milk and egg. People who have an allergy or severe sensitivity to milk and egg run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

16-5-2018

Mas Food Services Co. Issues Allergy Alert on Undeclared Sulfites in The Peruchef Dry Potato

Mas Food Services Co. Issues Allergy Alert on Undeclared Sulfites in The Peruchef Dry Potato

Mas Food Services Co. of Oakland Park, FL is recalling its 15 ounce packages of The Peruchef brand dry potato because it may contain undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

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

15-10-2018

We have created a rumor control page for Hurricane #Michael that will be updated regularly. Help us share this info and remember to always check with official sources like @FLSERT, @GeorgiaEMA and @femaregion4.

 http://fema.gov/hurricane-michael-rumor-co

We have created a rumor control page for Hurricane #Michael that will be updated regularly. Help us share this info and remember to always check with official sources like @FLSERT, @GeorgiaEMA and @femaregion4. http://fema.gov/hurricane-michael-rumor-co

We have created a rumor control page for Hurricane #Michael that will be updated regularly. Help us share this info and remember to always check with official sources like @FLSERT, @GeorgiaEMA and @femaregion4. http://fema.gov/hurricane-michael-rumor-control … pic.twitter.com/T3h7ZiFUrZ

FDA - U.S. Food and Drug Administration

15-10-2018

National Cybersecurity Awareness Month is in its 3rd week. This week's theme: “Strengthening the Cybersecurity Workforce Across All Sectors”. Go to  https://www.dhs.gov/stopthinkconnect … to see what #NCSAM is all about. #FDA #MedicalDevicespic.twitter.co

National Cybersecurity Awareness Month is in its 3rd week. This week's theme: “Strengthening the Cybersecurity Workforce Across All Sectors”. Go to https://www.dhs.gov/stopthinkconnect … to see what #NCSAM is all about. #FDA #MedicalDevicespic.twitter.co

National Cybersecurity Awareness Month is in its 3rd week. This week's theme: “Strengthening the Cybersecurity Workforce Across All Sectors”. Go to https://www.dhs.gov/stopthinkconnect … to see what #NCSAM is all about. #FDA #MedicalDevices pic.twitter.com/KBLIxo9CiV

FDA - U.S. Food and Drug Administration

18-9-2018

 Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018

Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018

This third meeting between regulators and representatives of industry stakeholder organisations addresses all areas of product-development support, including scientific advice, specifics for paediatric and orphan medicines and support for innovation. The meeting focuses on the implementation of the orphan notice, ‘histology-independent indications’ in the context of orphan designations, the upcoming rollout of a new tool for orphan designation applications, digital technology proposals in medicine develo...

Europe - EMA - European Medicines Agency

4-9-2018

Abseamed (Medice Arzneimittel PUtter GmbH and Co KG)

Abseamed (Medice Arzneimittel PUtter GmbH and Co KG)

Abseamed (Active substance: epoetin alfa) - Centralised - 2-Monthly update - Commission Decision (2018)5860 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/727/WS/1406

Europe -DG Health and Food Safety

19-6-2018

Maviret (AbbVie Deutschland GmbH and Co. KG)

Maviret (AbbVie Deutschland GmbH and Co. KG)

Maviret (Active substance: glecaprevir / pibrentasvir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3916 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4430/T/11

Europe -DG Health and Food Safety

11-6-2018

Viekirax (AbbVie Deutschland GmbH and Co. KG)

Viekirax (AbbVie Deutschland GmbH and Co. KG)

Viekirax (Active substance: ombitasvir / paritaprevir / ritonavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3766 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3839/T/45

Europe -DG Health and Food Safety

4-6-2018

Venclyxto (AbbVie Deutschland GmbH and Co. KG)

Venclyxto (AbbVie Deutschland GmbH and Co. KG)

Venclyxto (Active substance: venetoclax) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3633 of Mon, 04 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4106/T/12

Europe -DG Health and Food Safety

4-6-2018

Exviera (AbbVie Deutschland GmbH and Co. KG)

Exviera (AbbVie Deutschland GmbH and Co. KG)

Exviera (Active substance: dasabuvir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3628 of Mon, 04 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3837/T/38

Europe -DG Health and Food Safety

29-5-2018

Norvir (AbbVie Deutschland GmbH and Co. KG)

Norvir (AbbVie Deutschland GmbH and Co. KG)

Norvir (Active substance: Ritonavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3340 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/127/T/149

Europe -DG Health and Food Safety

25-5-2018

Kaletra (AbbVie Deutschland GmbH and Co. KG)

Kaletra (AbbVie Deutschland GmbH and Co. KG)

Kaletra (Active substance: lopinavir / Ritonavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3282 of Fri, 25 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/368/T/169

Europe -DG Health and Food Safety

16-5-2018

EU/3/14/1305 (AbbVie Deutschland GmbH and Co. KG)

EU/3/14/1305 (AbbVie Deutschland GmbH and Co. KG)

EU/3/14/1305 (Active substance: Humanised recombinant monoclonal antibody against epidermal growth factor receptor conjugated to maleimidocaproyl monomethylauristatin F) - Transfer of orphan designation - Commission Decision (2018)3022 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/065/14/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/17/1954 (AbbVie Deutschland GmbH and Co. KG)

EU/3/17/1954 (AbbVie Deutschland GmbH and Co. KG)

EU/3/17/1954 (Active substance: Venetoclax) - Transfer of orphan designation - Commission Decision (2018)3028 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/131/17/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1767 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1767 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1767 (Active substance: Venetoclax) - Transfer of orphan designation - Commission Decision (2018)3027 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/121/16/T01

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1766 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1766 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1766 (Active substance: Venetoclax) - Transfer of orphan designation - Commission Decision (2018)3026 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/122/16/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1667 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1667 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1667 (Active substance: Rovalpituzumab tesirine) - Transfer of orphan designation - Commission Decision (2018)3025 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/015/16/T02

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1649 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1649 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1649 (Active substance: Humanised recombinant IgG4 anti-human tau antibody) - Transfer of orphan designation - Commission Decision (2018)3024 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/239/15/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1617 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1617 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1617 (Active substance: Venetoclax) - Transfer of orphan designation - Commission Decision (2018)3023 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/205/15/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/10/830 (AbbVie Deutschland GmbH and Co. KG)

EU/3/10/830 (AbbVie Deutschland GmbH and Co. KG)

EU/3/10/830 (Active substance: Veliparib) - Transfer of orphan designation - Commission Decision (2018)3021 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/110/10/T/02

Europe -DG Health and Food Safety

15-5-2018

Synagis (AbbVie Deutschland GmbH and Co. KG)

Synagis (AbbVie Deutschland GmbH and Co. KG)

Synagis (Active substance: palivizumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3064 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/257/T/116

Europe -DG Health and Food Safety

3-4-2018

EU/3/12/1080 (AbbVie Deutschland GmbH and Co. KG)

EU/3/12/1080 (AbbVie Deutschland GmbH and Co. KG)

EU/3/12/1080 (Active substance: 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide) - Transfer of orphan designation - Commission Decision (2018)2056 of Tue, 03 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/124/12/T/01

Europe -DG Health and Food Safety