TRIFLUOPERAZINA-

Información principal

  • Denominación comercial:
  • TRIFLUOPERAZINA-1
  • Dosis:
  • 1,20 mg
  • formulario farmacéutico:
  • Tableta
  • 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:
  • TRIFLUOPERAZINA-1
    Cuba
  • Idioma:
  • español

Otros datos

Estado

  • Fuente:
  • CECMED - Autoridad Reguladora de Medicamentos, Equipos y Dispositivos Médicos - Cuba
  • Número de autorización:
  • m14152n05
  • última actualización:
  • 10-05-2018

Ficha Técnica: dosis, interacciones, efectos secundarios

RESUMEN DE LAS CARACTERISTICAS DEL PRODUCTO

Nombre del producto:

TRIFLUOPERAZINA-1

Forma farmacéutica:

Tableta

Fortaleza:

1,20 mg

Presentación:

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

con 10 ó 20 tabletas cada uno.

Titular del Registro Sanitario, país:

Grupo Empresarial Farmacéutico

(QUIMEFA), Cuba.

Fabricante, país:

Empresa Laboratorios MedSol, Cuba.

Número de Registro Sanitario:

M-14-152-N05

Fecha de Inscripción:

16 de septiembre de 2014

Composición:

Cada tableta contiene:

Clorhidrato de trifluoperazina

(eq. a 1,0 mg de trifluoperazina)

1,20 mg

Lactosa monohidratada 83,80 mg

Plazo de validez:

36 meses

Condiciones de almacenamiento:

Almacenar por debajo de 30° C.

Protéjase de la luz.

Indicaciones terapéuticas.

Esquizofrenia y otras psicosis. Coadyuvante en el tratamiento a corto plazo de la ansiedad

severa, agitación psicomotora, excitación, comportamiento impulsivo, violento o peligroso.

Contraindicaciones:

Hipersensibilidad a la trifluoperazina. Estados comatosos. Depresión del sistema nervioso

central severa. Depresión de médula ósea. Daño hepático. Contiene lactosa, no administrar

en pacientes con intolerancia a la lactosa.

Feocromocitoma o tumores dependientes de prolactina.

Precauciones:

Niños: Más propensos (sobre todo en caso de infecciones eruptivas, Sistema Nervioso Central,

gastroenteritis y deshidratación) a desarrollar reacciones neuromusculares o extrapiramidales,

especialmente distonías.

Adulto mayor: Más susceptibles a los efectos antimuscarínicos, efectos extrapiramidales

(discinesia tardía), hipotensión ortostática, hipo e hipertermia. Riesgo de fractura de caderas.

Retención

urinaria.

Depresión.

Miastenia

grave.

Hipertrofia

prostática,

enfermedad

Parkinson (agrava efectos extrapiramidales).

Enfermedad cardiovascular, cerebrovascular, y/o depresión respiratoria severa.

Antecedentes de íctero. Discrasias sanguíneas (realizar conteo hematológico si aparece

fiebre o infección inexplicables).

Diabetes mellitus. Hipotiroidismo. Íleo paralítico.

Daño

renal:

ajuste

dosis.

Epilepsia:

puede

agravarse

(disminuye

umbral

convulsivo). Glaucoma de ángulo cerrado.

Realizar exámenes de forma regular en pacientes que estén bajo tratamientos prolongados

con fenotiazinas.

Advertencias especiales y precauciones de uso.

Evitar exposición directa a la luz solar.

Efectos indeseables:

Menos frecuentes: sedación, hipotensión ortostática, hipotermia y efectos antimuscarínicos

pero la trifluoperazina está asociada con una alta incidencia de efectos extrapiramidales

(acatisia, discinesia y distonía aguda), particularmente cuando la dosis diaria excede los 6

mg/día; pancitopenia, trombocitopenia, hiperpirexia, anorexia, visión borrosa, congestión

nasal, sequedad de la boca, cefalea, insomnio, mareos, vértigo, convulsiones.

Ocasionales: retención urinaria, fotosensibilidad, erupciones, amenorrea, alteraciones de la

líbido,

galactorrea,

ginecomastia,

aumento

peso,

hiperglucemia,

reacciones

hipersensibilidad, agranulocitosis, eosinofilia, leucopenia, leucocitosis, anemia aplástica, anemia

hemolítica y púrpuras.

Raras:

alteraciones

electroencefalográficas

(prolongación

intervalo

Torsades

Pointes), íctero obstructivo, delirio, agitación, estados catatónicos, retinopatía pigmentaria,

síndrome neuroléptico maligno y priapismo. Síndrome de abstinencia. Debido al riesgo por

sensibilización con el fármaco, se debe evitar la trituración manual de las tabletas.

Posología y modo de administración.

Esquizofrenia y otras psicosis, coadyuvantes en el tratamiento a corto plazo de la agitación

psicomotora, la excitación y el comportamiento impulsivo violento o peligroso:

Adultos:

Dosis inicial:

2 a 5 mg cada 12 hrs, aumentando la dosificación gradualmente en 5 mg después de 1

semana, y posteriormente cada 3 días según respuesta (dosis usual 15 – 20 mg/día).

Adulto mayor:

La mitad de la dosis del adulto.

Niños:

6 – 12 años hospitalizados o bajo estrecha vigilancia:

Dosis inicial:

1mg, 1 ó 2 veces/día; ajustar según respuesta, edad y peso corporal; no exceder 15 mg/día.

Tratamiento a corto plazo de ansiedad severa:

Adultos:

Dosis inicial:

2 – 4 mg/día, en dosis divididas, incrementar si fuera necesario hasta 6 mg/día.

Niños:

3 a 5 años: dosis 1 mg/día.

6 a 12 años: dosis 4 mg/día.

Interacción con otros productos medicinales y otras formas de interacción:

Alcohol o depresores del SNC: riesgo de depresión del SNC, respiratoria e hipotensión.

Antiarrítmicos que prolongan el intervalo QT: incrementan el riesgo de arritmias ventriculares

(evitar el uso de amiodarona y disopiramida).

Terfenadina, moxifloxacina, pimozida: incrementan el riesgo de arritmias ventriculares.

Apomorfina, levodopa, lisurida, pergolida: se antagonizan sus efectos.

Epinefrina: no debe ser empleada para tratar la hipotensión inducida por trifluoperazina, ya

que pueden bloquearse sus efectos alfaadrenérgicos, dando lugar a hipotensión y taquicardia.

Antitiroideos: puede aumentar el riesgo de agranulocitosis.

Bloqueadores de las neuronas adrenérgicas: altas dosis de trifluoperazina antagonizan el

efecto hipotensor de estos fármacos.

Antidepresivos tricíclicos, maprotilina, inhibidores de la MAO, furazolidona, procarbazina,

selegilina: pueden prolongar efectos sedantes y antimuscarínicos. Pueden aumentar las

concentraciones séricas de antidepresivos tricíclicos (riesgo de arritmias ventriculares).

Barbitúricos, carbamazepina, etosuximida, fenitoína, primidona y valproato: se antagonizan

sus efectos anticonvulsivantes por disminución del umbral convulsivo.

Antiácidos,

antidiarreicos

adsorbentes,

litio,

cimetidina:

disminuyen

absorción

trifluoperazina.

Anticolinérgicos y antihistamínicos: efectos aditivos antimuscarínicos, potencia efecto de

hiperpirexia.

Trihexifenidilo disminuye las concentraciones plasmáticas de la trifluoperazina.

Betabloqueadores: aumento de sus efectos hipotensores.

Propranolol: aumento de concentraciones séricas de ambos fármacos.

Dopamina: antagoniza la vasoconstricción periférica producida por dosis altas de dopamina

debido a la acción bloqueadora alfa de las fenotiacinas.

Anestésicos generales, alfa bloqueadores, metildopa, bloqueadores de canales de calcio,

clonidina, diazóxido, diuréticos, hidralazina, nitroprusiato, minoxidil, inhibidores de la enzima

convertidora de angiotensina, antagonistas de los receptores de la angiotensina II y nitratos:

se incrementan sus efectos hipotensores cuando se administran con antipsicóticos.

Simpaticomiméticos: se antagonizan sus efectos hipertensores.

Opiáceos: aumenta su efecto hipotensor y sedante.

Tramadol: incrementa el riesgo de convulsiones.

Sulfonilureas: antagonismo de sus efectos hipoglucemiantes.

Medicamentos que producen efectos extrapiramidales (metoclopramida, metildopa, entre

otros): pueden aumentar la frecuencia y severidad de los efectos extrapiramidales.

Litio: incremento del riesgo de efectos extrapiramidales y posible neurotoxicidad.

Memantina: posible reducción del efecto de los antipsicóticos.

Medicamentos fotosensibilizantes: efectos aditivos.

Bromocriptina

carbegolina:

antagonizan

efectos

hipoprolactinémicos

antiparkinsonianos.

Ritonavir: posible incremento de concentraciones plasmáticas de antipsicóticos.

Sibutramina: incrementa el riesgo de toxicidad sobre el sistema nervioso central.

Uso en Embarazo y lactancia:

Embarazo: Categoría de riesgo C. Sólo se debe administrar si el posible beneficio deseado

justifica el riesgo potencial en el feto.

Lactancia materna: Evitar si es posible y vigilar posible somnolencia.

Efectos sobre la conducción de vehículos/maquinarias:

Puede producir mareo, debe ser usado con precaución si maneja vehículos u opera

maquinarias.

Sobredosis.

Medidas generales.

Propiedades farmacodinámicas.

trifluoperazina

fenotiazina

antipsicótica

propiedades

similares

clorpromazina.

Reduce la iniciativa y el interés por el ambiente; las emociones y el afecto. Al inicio lentitud

de respuesta a los estímulos y somnolencia.

Los pacientes psicóticos se vuelven menos agitados y los aislados o autistas más reactivos;

disminuye la conducta agresiva e impulsiva.

Desaparecen los síntomas psicóticos (alucinación, delirios, etc) por bloqueo de receptores

D2 mesolímbicos.

Efectos extrapiramidales por bloqueo de receptores D2 en ganglios basales.

Las fenotiazinas también producen un efecto del bloqueo alfa adrenérgico y deprimen la

liberación de hormonas hipotalámicas e hipofisarias.

Sin embargo, el bloqueo de los receptores dopaminérgicos D2 aumenta la liberación de

prolactina en la hipófisis anterior.

Ansiolítico; sedante: reducción de los reflejos vasomotores mediados por hipotálamo y tallo

encefálico lo que produce una disminución de la tensión arterial mediada por el Sistema

Nervioso Central.

Propiedades

farmacocinéticas

(Absorción,

distribución,

biotransformación,

eliminación):

Absorción:

rápidamente

absorbida

tracto

gastrointestinal,

aunque

veces

erráticamente;

puede

modificada

presencia

alimentos.

concentración

plasmática alcanza un pico máximo entre las 2 y las 4 horas después de la administración.

Metabolismo: Hepático. Tiene un considerable efecto de primer paso.

Biodisponibilidad: condicionada por variaciones interindividuales en su metabolismo de primer

paso; elevado grado de unión a proteínas plasmáticas.

Distribución: Las fenotiazinas se distribuyen ampliamente en los tejidos. Atraviesa la barrera

hematoencefálica y las concentraciones en el SNC exceden a las concentraciones plasmáticas.

Atraviesa también la placenta y se distribuyen en la lecha materna.

Eliminación: Principalmente, renal; biliar, como metabólitos activos e inactivos.

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

producto:

No se ha reportado hasta la fecha.

Fecha de aprobación/revisión del texto: 16 de septiembre de 2014.

  • 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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Opinion/decision on a Paediatric investigation plan (PIP): Ciprofloxacin (hydrochloride), decision type: , therapeutic area: , PIP number: P/0253/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ciprofloxacin (hydrochloride), decision type: , therapeutic area: , PIP number: P/0253/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ciprofloxacin (hydrochloride), decision type: , therapeutic area: , PIP number: P/0253/2018

Europe - EMA - European Medicines Agency

31-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Cariprazine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0301/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cariprazine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0301/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cariprazine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0301/2018

Europe - EMA - European Medicines Agency

29-1-2019


Chlorphenoxamine hydrochloride : List of nationally authorised medicinal products - PSUSA/00010361/201805

Chlorphenoxamine hydrochloride : List of nationally authorised medicinal products - PSUSA/00010361/201805

Chlorphenoxamine hydrochloride : List of nationally authorised medicinal products - PSUSA/00010361/201805

Europe - EMA - European Medicines Agency

28-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Sarizotan (hydrochloride), decision type: , therapeutic area: , PIP number: P/0287/2018

Opinion/decision on a Paediatric investigation plan (PIP): Sarizotan (hydrochloride), decision type: , therapeutic area: , PIP number: P/0287/2018

Opinion/decision on a Paediatric investigation plan (PIP): Sarizotan (hydrochloride), decision type: , therapeutic area: , PIP number: P/0287/2018

Europe - EMA - European Medicines Agency

28-1-2019

Clomicalm (Elanco GmbH)

Clomicalm (Elanco GmbH)

Clomicalm (Active substance: Clomipramine hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)720 of Mon, 28 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/000039/T/0030

Europe -DG Health and Food Safety

23-1-2019


Orphan designation: 3-(5-Amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride-, Treatment of diffuse large B-cell lymphoma, 27/06/2016, Positive

Orphan designation: 3-(5-Amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride-, Treatment of diffuse large B-cell lymphoma, 27/06/2016, Positive

Orphan designation: 3-(5-Amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride-, Treatment of diffuse large B-cell lymphoma, 27/06/2016, Positive

Europe - EMA - European Medicines Agency

22-1-2019


Orphan designation: Doxorubicin hydrochloride (in heat-sensitive liposomes), Treatment of hepatocellular carcinoma, 23/02/2011, Positive

Orphan designation: Doxorubicin hydrochloride (in heat-sensitive liposomes), Treatment of hepatocellular carcinoma, 23/02/2011, Positive

Orphan designation: Doxorubicin hydrochloride (in heat-sensitive liposomes), Treatment of hepatocellular carcinoma, 23/02/2011, Positive

Europe - EMA - European Medicines Agency

16-1-2019

EU/3/18/2125 (Isabelle Ramirez)

EU/3/18/2125 (Isabelle Ramirez)

EU/3/18/2125 (Active substance: Benserazide hydrochloride) - Orphan designation - Commission Decision (2019)221 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000001719

Europe -DG Health and Food Safety

16-1-2019

EU/3/10/833 (FGK Representative Service GmbH)

EU/3/10/833 (FGK Representative Service GmbH)

EU/3/10/833 (Active substance: Doxorubicin hydrochloride (in heat-sensitive liposomes)) - Transfer of orphan designation - Commission Decision (2019)237 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003113

Europe -DG Health and Food Safety

16-1-2019

EU/3/16/1672 (Celgene Europe B.V.)

EU/3/16/1672 (Celgene Europe B.V.)

EU/3/16/1672 (Active substance: 3-(5-amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride) - Transfer of orphan designation - Commission Decision (2019)236 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003283

Europe -DG Health and Food Safety

11-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Europe - EMA - European Medicines Agency

13-12-2018


Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Europe - EMA - European Medicines Agency

13-12-2018


Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

11-12-2018


Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Europe - EMA - European Medicines Agency

28-11-2018

Econor (Elanco GmbH)

Econor (Elanco GmbH)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8038 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/42/T/54

Europe -DG Health and Food Safety

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-gu

Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-gu

Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-guanidino-1-hexanone hexahydrochloride, decision type: , therapeutic area: , PIP number: P/0134/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Europe - EMA - European Medicines Agency

27-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Europe - EMA - European Medicines Agency

26-11-2018

Wakix (Bioprojet Pharma)

Wakix (Bioprojet Pharma)

Wakix (Active substance: Pitolisant hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7974 of Mon, 26 Nov 2018

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Active substance: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride) - Orphan designation - Commission Decision (2018)7791 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/040/18

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7576 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/233/16/T/01

Europe -DG Health and Food Safety

13-11-2018

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7575 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/140/13/T/01

Europe -DG Health and Food Safety

1-11-2018

Dexdomitor (Orion Corporation)

Dexdomitor (Orion Corporation)

Dexdomitor (Active substance: dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7380 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

31-10-2018

Evista (Daiichi Sankyo Europe GmbH)

Evista (Daiichi Sankyo Europe GmbH)

Evista (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7342 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

26-9-2018

Sileo (Orion Corporation)

Sileo (Orion Corporation)

Sileo (Active substance: Dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)6325 of Wed, 26 Sep 2018

Europe -DG Health and Food Safety

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

Brinavess (Active substance: vernakalant hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5523 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1215/T/31

Europe -DG Health and Food Safety

30-7-2018

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Active substance: ertugliflozin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5103 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4314/T/2

Europe -DG Health and Food Safety