Ursochol

Información principal

  • Denominación comercial:
  • Ursochol 150 mg
  • Dosis:
  • 150 mg
  • formulario farmacéutico:
  • Comprimido
  • Usar para:
  • Humanos
  • Tipo de medicina:
  • medicamento alopático

Documentos

  • 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.


    Solicitar el prospecto de información al público.

Localización

  • Disponible en:
  • Ursochol   150 mg
    Cuba
  • Idioma:
  • español

Otros datos

Estado

  • Fuente:
  • CECMED - Autoridad Reguladora de Medicamentos, Equipos y Dispositivos Médicos - Cuba
  • Número de autorización:
  • 007-15d2
  • última actualización:
  • 09-05-2018

Ficha Técnica

RESUMEN DE LAS CARACTERÍSTICAS DEL PRODUCTO

Nombre del producto:

Ursochol ® 150 mg

(Ácido ursodeoxicólico)

Forma farmacéutica:

Comprimido

Fortaleza:

150 mg

Presentación:

Estuche por 6 blísteres de PVC/AL

con 10 comprimidos cada uno.

Titular del Registro Sanitario, país:

Ibadesa Canarias, S.L., Gran Canaria,

España.

Fabricante, país:

Zambon S.p.A., Vicenza, Italia.

Número de Registro Sanitario:

007-15D2

Fecha de Inscripción:

12 de febrero de 2015

Composición:

Cada comprimido contiene:

Ácido ursodeoxicólico

150,00 mg

Lactosa

Plazo de validez:

36 meses

Condiciones de almacenamiento:

No requiere condiciones especiales de

almacenamiento.

Indicaciones terapéuticas:

Disolución de los cálculos de colesterol, siempre y cuando concurran las condiciones

siguientes: Cálculos radiotransparentes y vesícula biliar funcional.

Tratamiento de la cirrosis biliar primaria

Contraindicaciones:

Hipersensibilidad al principio activo o a cualquiera de los excipientes.

Contraindicado en pacientes con vesícula biliar no funcionante.

Ulcera gástrica o duodenal.

Alteraciones hepáticas o intestinales que interfieran con la circulación enterohepática de las

sales biliares.

Lactancia.

Precauciones:

recomienda

evitar

aquellos

medicamentos

produzcan

acumulación

biliar

colesterol, como estrógenos y anticonceptivos hormonales. Por tanto, se deberá aconsejar a

las mujeres en edad fértil que utilicen métodos alternativos de contracepción (Ver apartado

Interacción con otros medicamentos y otras formas de interacción).

Aunque no se ha evidenciado aumento de transaminasas durante el tratamiento con

URSOCHOL, se recomienda no asociarlo a medicamentos potencialmente hepatotóxicos.

Advertencias especiales y precauciones de uso:

Se procurará mantener una dieta moderada en calorías y colesterol.

Aunque

cantidad

lactosa

presente

cada

comprimido

probablemente,

suficiente para desencadenar los síntomas de intolerancia, en caso de que aparecieran

diarreas deberá consultarse al médico.

Efectos indeseables:

Reacciones adversas informadas como raras (<1/1.000): Gastrointestinales: náuseas y

vómitos,

dispepsia,

alteraciones

gusto,

dolor

biliar,

dolor

abdominal,

flatulencia,

estreñimiento.

Reacciones adversas informadas como muy raras (<1/10.000): Se ha descrito la aparición

de diarrea en relación con la administración de ácido ursodeoxicólico

Posología y método de administración:

Ancianos:

No se han realizado estudios adecuados en la población geriátrica. No obstante, no se

prevén problemas geriátricos que limiten la utilidad de este medicamento en ancianos.

Insuficiencia renal:

No es necesario ajuste de dosis.

Insuficiencia hepática:

No se han realizado estudios adecuados en pacientes con insuficiencia hepática. No

obstante, aunque en ciertos procesos degenerativos de origen hepático se puede producir

un incremento de la concentración sanguínea a nivel de la vena porta y una reducción de la

clearance hepática, la absorción intestinal de URSOCHOL no se ve afectada, por lo que no

se requiere ajuste de dosis en estos casos.

La dosis recomendada para la disolución de los cálculos biliares es 3 ó 4 comprimidos al día

(8-10 mg/kg/día de ácido ursodeoxicólico) por vía oral y repartidos en dos tomas. La dosis

mínima eficaz es de 2 comprimidos al día (4 mg/kg/día de ácido ursodeoxicólico), y como

norma general el tratamiento se comenzará con 3 comprimidos al día (10 mg/kg/día de ácido

ursodeoxicólico)

pacientes

obesos.

caso

necesitar

número

impar

comprimidos, la dosis más alta se tomará por la tarde.

Duración del tratamiento

En el caso de que URSOCHOL se administre para el tratamiento de litiasis biliar, la duración

del tratamiento está en función del tamaño de los cálculos. No suele ser inferior a los 3 – 4

meses. Los cálculos de diámetro superior a los 10 mm pueden necesitar más de un año de

tratamiento.

recomienda

superar

años

tratamiento

continuado

controlar

periódicamente los resultados mediante colecistografía.

En cualquier caso, la administración del medicamento se prolongará 3 – 4 meses tras la

disolución de los cálculos.

En la cirrosis biliar primaria la duración del tratamiento está en función de la evolución de la

enfermedad. Suele mantenerse el tratamiento con URSOCHOL hasta que el paciente se

somete a trasplante hepático.

La suspensión del tratamiento con URSOCHOL durante más de 3 – 4 semanas puede

originar la reversión del proceso y alargar la duración del mismo, originando además

reaparición de la sintomatología y alteraciones analíticas.

Interacción con otros productos medicinales y otras formas de interacción:

Interacciones farmacológicas:

No se recomienda la administración concomitante de URSOCHOL con: antiácidos que

contengan aluminio, colestiramina, colestipol, antihiperlipémicos, neomicina, estrógenos y

progestágenos (Ver apartado Advertencias y precauciones especiales de empleo).

URSOCHOL interacciona negativamente con los contraceptivos orales, por lo que un

método alternativo efectivo y seguro de contracepción deberá utilizarse con el tratamiento.

Interacciones analíticas:

Es importante tener en cuenta que URSOCHOL puede producir interferencias en las

determinaciones

niveles

transaminasas,

principalmente

alanina

aminotransferasa sérica.

Uso en Embarazo y lactancia:

Embarazo:

Los estudios en animales son insuficientes para confirmar los posibles efectos en el

embarazo, y/o desarrollo embrional y fetal, y/o alumbramiento y/o desarrollo postnatal (Ver

apartado

Datos

preclínicos

seguridad).

riesgo

potencial

humanos

desconocido.

Debe ser administrado con precaución durante el embarazo.

Lactancia:

Se desconoce si el ácido ursodeoxicólico se excreta en la leche materna, por lo que debe

advertirse a las madres lactantes que interrumpan la lactancia durante el tratamiento con

URSOCHOL.

Efectos sobre la conducción de vehículos/maquinarias:

No procede.

Sobredosis:

Se carece de experiencia clínica en caso de sobredosificación. En caso de sospecha, las

resinas de intercambio iónico pueden ser útiles para retener las sales biliares en el intestino

y evitar la absorción de las mismas.

Propiedades farmacodinámicas:

Disolución de los cálculos de colesterol:

El principio activo de URSOCHOL es el ácido ursodeoxicólico, el cual ha mostrado su

capacidad en desaturar la bilis litógena con la consiguiente lisis de los cálculos de colesterol.

Cirrosis biliar primaria:

En cirrosis biliar primaria, el ácido ursodeoxicólico mejora parámetros bioquímicos hepáticos

e histológicos. Respecto a las manifestaciones clínicas se objetivó una disminución del

prurito al final del tratamiento, sobre el resto de manifestaciones clínicas no se objetivaron

diferencias.

Propiedades

farmacocinéticas

(Absorción,

distribución,

biotransformación,

eliminación):

Absorción y distribución

El ácido ursodeoxicólico se absorbe a través del yeyuno y el íleon por difusión pasiva, y en

el íleon también por transporte activo. Hasta un 20 % de la dosis inicial puede absorberse a

nivel del colon, por lo que pueden alcanzarse concentraciones altas en la bilis de los

pacientes que han sufrido una resección ileal, efecto que depende de la dosis oral del

fármaco administrada.

El promedio de absorción varía entre el 30 % y el 60 % de la dosis administrada, llegando la

concentración biliar máxima a una fase de meseta cuando la dosis oral oscila entre 10 y 12

mg/kg. La distribución tisular se limita a los órganos enterohepáticos y al plasma.

El ácido ursodeoxicólico se une entre un 96 – 99 % a proteínas séricas.

Metabolismo

El 60 % de la cantidad de ácido ursodeoxicólico absorbido se aclara a nivel hepático, donde

se conjuga completamente con glicina ó taurina, dando lugar a los correspondientes

derivados (UDC-gli / UDC-tau) que, tras diversos procesos metabólicos dan lugar al ácido

litocólico, que se considera el principal metabolito del ácido ursodeoxicólico.

Eliminación

La excreción del ácido ursodeoxicólico y sus metabolitos se produce principalmente por vía

fecal. Una pequeña proporción se elimina, asimismo, por vía renal.

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

producto:

No procede.

Fecha de aprobación/ revisión del texto: 12 de febrero de 2015.

  • 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.



  • Los documentos en otros idiomas están disponibles aquí

15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)

Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐a‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐OC 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 microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels recommended, dietary exposure to the food enzyme–...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)

Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐SO 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 microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme–total organi...

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

9-11-2018

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of polyacrylic acid, sodium salt, cross‐linked, FCM substance No 1015, which is intended to be used as a liquid absorber in the packaging of fresh or frozen foods such as meat, poultry and seafood as well as fresh fruits and vegetables. Specific migration tests were not performed due to the high absorption of liquids by the substance. The Panel noted that if polya...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Published on: Wed, 07 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4‐benzene dicarboxylate complexes, used as a taggant in plastics for authentication and ...

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

1-11-2018

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucan 1,4‐α‐glucosidase (EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM‐BW 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. The glucan 1,4‐α‐glucosidase food enzyme is intended to be used in distilled alcohol production and starch processing for the production of glucose syrups. Residu...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucoamylase (glucan 1,4‐α‐glucosidase; EC 3.2.1.3) is produced with the genetically modified strain of Aspergillus niger 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 glucoamylase is intended to be used in brewing processes and in starch processing for glucose syrups production. Residual amounts of total organic s...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified strain of Aspergillus niger 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 α‐amylase is intended to be used in starch processing for glucose syrups production, beverage alcohol (distilling) processes and baking proces...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA 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 a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

26-10-2018

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Published on: Thu, 25 Oct 2018 00:00:00 +0200 The product subject of this assessment is l‐threonine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 7.232). It is intended to be used in feed and water for drinking for all animal species and categories. The production strain and its recombinant DNA were not detected in the additive. The product l‐threonine, manufactured by fermentation with E. coli CGMCC 7.232, does not raise any safety concern with regard to the gen...

Europe - EFSA - European Food Safety Authority Publications

15-10-2018

Toy Land Company recalls Boom Boom ChemsSlime andPutty

Toy Land Company recalls Boom Boom ChemsSlime andPutty

Health Canada has determined that the slime and putty products do not meet the Canadian toy safety requirements related to boric acid content.

Health Canada

15-10-2018

Dollar Novelty (Karapelle Inc) recalls Barrel-O-Slime Toy

Dollar Novelty (Karapelle Inc) recalls Barrel-O-Slime Toy

Health Canada's sampling and evaluation program has determined the Barrel-O-Slime toy does not meet the Canadian toy safety requirements related to boric acid content.

Health Canada

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

3-10-2018

Inhibidores de la bomba de protones: evite el uso a largo plazo

  Prescrire, 1 de octubre de 2018 Los inhibidores de la bomba de protones (IBP), como el omeprazol, se utilizan en la esofagitis, los síntomas relacionados con el reflujo gastroesofágico y las úlceras pépticas. Tienen pocos efectos secundarios graves en el corto plazo. Pero este no es el caso a largo plazo: infecciones, fracturas, hiponatremia, etc. Pero la suspensión de un inhibidor de la bomba de protones se ve dificultado por un rebote de acidez, que a menudo conduce a una mayor ingesta de estos medi...

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

22-9-2018

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) carnation FLO‐40689‐6 and concluded that there is no scientific reason to consider that the import, distribution and retailing in the EU of carnation FLO‐40689‐6 cut flowers for ornamental use will cause any adverse effects on human health or the environment. On 27 October 2017, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for...

Europe - EFSA - European Food Safety Authority Publications

22-9-2018

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) soybean BPS‐CV127‐9. This soybean was found to be as safe and nutritious as its conventional counterpart and commercial soybean varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 16 February 2018, European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soy...

Europe - EFSA - European Food Safety Authority Publications

10-9-2018

Kangaroo Manufacturing Inc. recalls Kangaroo's Super Cool Slime

Kangaroo Manufacturing Inc. recalls Kangaroo's Super Cool Slime

Health Canada's sampling and evaluation program has determined the Super Cool Slime products donot meet the Canadian toy safety requirements related to boric acid content.

Health Canada

14-8-2018

Genius Premium Craft Boxes recalls Do-It-Yourself Slime Kits

Genius Premium Craft Boxes recalls Do-It-Yourself Slime Kits

Health Canada’s sampling and evaluation program has determined the Do-It-Yourself Slime Kits do not meet the Canadian toy safety requirements related to boric acid content.

Health Canada

10-8-2018

FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease

FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease

FDA approves new drug for treatment of polyneuropathy caused by hereditary transthyretin-mediated amyloidosis (hATTR). This is the first FDA-approved treatment for this rare, debilitating and often fatal genetic disease and the first FDA approval of a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.

FDA - U.S. Food and Drug Administration

3-8-2018

Scientific guideline:  Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

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

7-6-2018

Ovejoterapia: la nueva metodología que impacta física y cognitivamente en personas con discapacidad

Ovejoterapia: la nueva metodología que impacta física y cognitivamente en personas con discapacidad

“Las ovejas son una especie altamente social, superinteligentes, y son animales muy poco agresivos, por eso considerábamos que cumplían con requisitos mínimos para trabajar con niños en terapia, fue así como se nos ocurrió incluirlas en el trabajo terapéutico”, relata María José Ubilla, veterinaria, etóloga y coordinadora del Centro de Terapia Asistidas con Animales (CTAA) […]

Cuba - infomed - Red de Salud de Cuba

6-6-2018

NOTCH2NL, los genes detrás del gran tamaño del cerebro humano

NOTCH2NL, los genes detrás del gran tamaño del cerebro humano

La evolución del cerebro en los últimos 3 millones de años jugó un papel importante en nuestra capacidad como especie para pensar y desarrollar la cultura. Pero siempre ha sido complejo determinar los cambios genéticos detrás de la expansión cerebral que nos hizo humanos. En dos trabajos que se publican en Cell, sendos equipos de […]

Cuba - infomed - Red de Salud de Cuba

4-6-2018

Tabaco, déficit de vitamina D y dieta, posibles factores del aumento de esclerosis múltiple en España

Tabaco, déficit de vitamina D y dieta, posibles factores del aumento de esclerosis múltiple en España

Según datos de la Sociedad Española de Neurología (SEN), la esclerosis múltiple (EM) afecta a 47 000 personas en España y es, tras los accidentes de tráfico, la principal causa de discapacidad en jóvenes. Cada año se diagnostican 1800 nuevos casos en España de esta enfermedad, que afecta a 700 000 personas en Europa y […]

Cuba - infomed - Red de Salud de Cuba

5-11-2018

EU/3/18/2070 (Accelsiors CRO and Consultancy Services Ltd)

EU/3/18/2070 (Accelsiors CRO and Consultancy Services Ltd)

EU/3/18/2070 (Active substance: (6aR,10aR)-3-(1,1-dimethylheptyl)-delta8-tetrahydro-cannabinol-9-carboxylic acid) - Orphan designation - Commission Decision (2018)7271 of Mon, 05 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/114/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

29-10-2018

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Active substance: clopidogrel / acetylsalicylic acid) - Centralised - 2-Monthly update - Commission Decision (2018)7249 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1144/WS1433/0051

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Actavis (Actavis Group PTC ehf.)

Zoledronic acid Actavis (Actavis Group PTC ehf.)

Zoledronic acid Actavis (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6488 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Active substance: Recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein) - Transfer of orphan designation - Commission Decision (2018)6427 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/183/16/T/02

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Mylan (Mylan S.A.S.)

Zoledronic acid Mylan (Mylan S.A.S.)

Zoledronic acid Mylan (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6486 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Teva (Teva B.V.)

Zoledronic acid Teva (Teva B.V.)

Zoledronic acid Teva (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6466 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

1-10-2018

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Active substance: Synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker) - Transfer of orphan designation - Commission Decision (2018)6399 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/16/T/01

Europe -DG Health and Food Safety

24-9-2018

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

Zoledronic acid Hospira (Active substance: zoledronic acid) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6243 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2365/T/33

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Active substance: (S)-(-)-3-(4-aminophenyl)-2-methoxypropanoic acid) - Orphan designation - Commission Decision (2018)5728 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/075/18

Europe -DG Health and Food Safety

6-8-2018

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)5386 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

1-8-2018

Ucedane (Lucane Pharma)

Ucedane (Lucane Pharma)

Ucedane (Active substance: carglumic acid) - Centralised - Yearly update - Commission Decision (2018)5230 of Wed, 01 Aug 2018

Europe -DG Health and Food Safety

27-7-2018

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Active substance: Synthetic cyclic 8 amino acid analogue of human unacylated ghrelin) - Transfer of orphan designation - Commission Decision (2018)5049 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/066/17/T/01

Europe -DG Health and Food Safety

11-7-2018

Vantavo (Merck Sharp and Dohme B.V.)

Vantavo (Merck Sharp and Dohme B.V.)

Vantavo (Active substance: alendronic acid / colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4511 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1180/T/30

Europe -DG Health and Food Safety

3-7-2018

Granupas (Eurocept International B.V.)

Granupas (Eurocept International B.V.)

Granupas (Active substance: Para-aminosalicylic acid) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4256 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2709/T/25

Europe -DG Health and Food Safety

27-6-2018

EU/3/11/849 (Merck Sharp and Dohme B.V.)

EU/3/11/849 (Merck Sharp and Dohme B.V.)

EU/3/11/849 (Active substance: (S)-{8-fluoro-2-2[4-(3-methoxyphenyl)-1-piperazinyl]-3-[2-methoxy-5-(trifluoromethyl)-phenyl]-3,4-dihydro-4-quinazolinyl} acetic acid) - Transfer of orphan designation - Commission Decision (2018)4102 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/090/10/T/02

Europe -DG Health and Food Safety

19-6-2018

Dany's BienenWohl (Dany Bienenwohl GmbH)

Dany's BienenWohl (Dany Bienenwohl GmbH)

Dany's BienenWohl (Active substance: oxalic acid dihydrate) - Centralised - Authorisation - Commission Decision (2018)3892 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4667

Europe -DG Health and Food Safety

4-6-2018

Chenodeoxycholic acid Leadiant (Leadiant GmbH)

Chenodeoxycholic acid Leadiant (Leadiant GmbH)

Chenodeoxycholic acid Leadiant (Active substance: chenodeoxycholic acid) - Centralised - Yearly update - Commission Decision (2018)3627 of Mon, 04 Jun 2018

Europe -DG Health and Food Safety

1-6-2018

Valproate

Valproate

Valproate (Active substance: medicinal products containing substances related to valproate (sodium valproate, valproic acid, valproate semisodium, valpromide, valproate magnesium)) - Community Referrals - Art 31 - Commission Decision (2018)3623 of Fri, 01 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1454

Europe -DG Health and Food Safety

29-5-2018

EU/3/14/1400 (Orphan Europe S.A.R.L.)

EU/3/14/1400 (Orphan Europe S.A.R.L.)

EU/3/14/1400 (Active substance: (1S,4R,5R,7S)-3,4-dibenzyl-2-oxo-6,8-dioxa-3-azabyciclo[3.2.1]octane-7-carboxylic acid-L-lysine) - Transfer of orphan designation - Commission Decision (2018)3402 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/185/14/T/01

Europe -DG Health and Food Safety