SUBSTAN

Información principal

  • Denominación comercial:
  • SUBSTAN 25 000
  • formulario farmacéutico:
  • Solución para inyección
  • Usar para:
  • Humanos
  • Tipo de medicina:
  • medicamento alopático

Documentos

  • para el público en general:
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Localización

  • Disponible en:
  • SUBSTAN  25 000
    Cuba
  • Idioma:
  • español

Otros datos

Estado

  • Fuente:
  • CECMED - Autoridad Reguladora de Medicamentos, Equipos y Dispositivos Médicos - Cuba
  • Número de autorización:
  • 04-086-15m
  • última actualización:
  • 10-05-2018

Ficha Técnica

RESUMEN DE LAS CARACTERÍSTICAS DEL PRODUCTO

Nombre del producto:

SUBSTAN® 25,000

Forma farmacéutica:

Solución para inyección

Fortaleza:

-

Presentación:

Estuche por una ampolleta de vidrio ámbar con 2

mL, jeringa descartable y toallita impregnada en

alcohol.

Titular del Registro Sanitario, país:

ESTABLECIMIENTOS ANCALMO S.A. DE C.V.,

SAN SALVADOR, EL SALVADOR.

Fabricante, país:

1- LABORATORIOS ANCALMO, S.A. DE C.V.,

SAN SALVADOR, EL SALVADOR.

2- LABORATORIOS PAILL, S.A. DE C.V., SAN

SALVADOR, EL SALVADOR.

Número de Registro Sanitario:

087-15D3

Fecha de Inscripción:

22 de diciembre de 2015

Composición:

Cada ampolleta contiene:

Vitamina B1 (Clorhidrato de tiamina)

Vitamina B6 (Clorhidrato de piridoxina)

Vitamina B12 (Cianocobalamina)

Hidroxocobalamnina

150,0 mg

100,0 mg

5000,0 mcg

20000,0 mcg

Alcohol bencílico

0,02 g

Plazo de validez:

36 meses

Condiciones de almacenamiento:

Almacenar por debajo de 30 °C.

Indicaciones terapéuticas:

SUBSTAN 25,000 INYECTABLE se recomienda para el tratamiento de afecciones en el

sistema nervioso periférico (neuritis, neuralgias), y sistema nervioso central, así también en

estados de deficiencia de vitamina B1 (Clorhidrato de Tiamina), Vitamina B6 (Clorhidrato de

Piridoxina) Vitamina B12 (Cianocobalamina), Hidroxicobalamina causados por alcoholismo,

uso de anticonceptivos y estrés.

Contraindicaciones:

Hipersensibilidad a cualquiera de los componentes de la fórmula.

Precauciones:

Tiamina (vitamina B

Antecedentes de alergia a las preparaciones que contiene tiamina.

Piridoxina (vitamina B

Convulsiones neonatales, tratamiento simultáneo con levodopa.

Cianocobalamina (vitamina B

El tratamiento con cianocobalamina puede enmascarar la deficiencia de ácido fólico, el ácido

fólico en grandes dosis puede corregir la megaloblastosis causada por la deficiencia de

vitamina B

, pero no previene las complicaciones neurológicas las cuales pueden ser

irreversibles. Los pacientes con anemia perniciosa o deficiencia de vitamina B

secundaria

a un defecto irreversible de la absorción requieren terapia con cianocobalamina de por vida.

Puede presentarse una respuesta clínica inadecuada a la cianocobalamina en presencia de

infección, enfermedad renal, tumores o deficiencia concomitante de ácido fólico o hierro.

Advertencias especiales y precauciones de uso:

Usar exclusivamente en adultos.

Efectos indeseables:

Incidencia rara: Reacciones Anafiláctica

Posología y método de administración:

1 ampolleta diaria, por vía intramuscular profunda o según criterio médico.

Interacción con otros productos medicinales y otras formas de interacción:

Con Medicación simultanea en preparaciones que contienen L-DOPA.

Uso en Embarazo y lactancia:

Debido a la concentración de vitaminas B

, B

y B

no se recomienda su administración

durante el embarazo y la lactancia, a menos que el médico así lo indique.

Tiamina (Vitamina B

Clasificado como tipo C. Para mujeres en lactancia o embarazadas se recomienda una dosis

de 1.4 mg diarios oralmente. No hay suficiente información sobre la seguridad de utilizar

dosis mayores durante el embarazo o lactancia.

Piridoxina (Vitamina B

La vitamina B

es segura cuando no se excede la dosis diaria recomendada de 1.9 mg

diarios orales. Para alivio de la nausea severa se han utilizado dosis de 30- 75 mg diarios.

No debe ser utilizado a largo plazo sin vigilancia medica. Existe cierta preocupación que

altas dosis maternas de piridoxina pueden ocasionar convulsiones en el neonato. Durante la

lactancia es seguro administrarla oralmente siempre que no se exceda la dosis diaria

recomendada. No hay suficiente información sobre el uso de altas dosis de piridoxina en

mujeres en lactancia.

Cianocobalamina (Vitamina B

La vitamina B

es segura cuando se administra oralmente en cantidades que no excedan la

dosis diaria recomendada. La dosis diaria recomendada es de 2.6 μg durante la gestación y

2.8 μg durante la lactancia.

Efectos sobre la conducciòn de vehìculos/maquinarias:

No procede.

Sobredosis:

Las vitaminas del "complejo B" están desprovistas de acciones farmacodinámicas cuando se

administra en la dosis terapéuticas habituales, por ser hidrosolubles son rápidamente

eliminadas por la orina.

Propiedades farmacodinámicas:

Las vitaminas B

participan en el metabolismo de todas las células del organismo,

pero su actividad predominante se ejerce sobre las células del sistema nervioso, por lo que

se les ha denominado vitaminas neurotropas.

Tiamina (vitamina B

La absorción gastrointestinal de la tiamina que se ingiere con los alimentos sucede mediante

un mecanismo de transporte activo; cuando se administra en grandes dosis, se absorbe por

difusión pasiva. El límite de absorción máxima es de ocho a 15 mg al día, pero esta cantidad

puede superarse fácilmente cuando se ingiere en dosis fraccionadas con los alimentos.

Los tejidos realizan la degradación total de aproximadamente un mg de tiamina al día.

Cuando la ingestión es inferior a esa cantidad, la tiamina no se excreta por la orina; pero

cuando la ingestión excede dicha cantidad, primeramente se saturan los depósitos tisulares

y, posteriormente, aparece sin modificación o como su catabolito: la pirimidina.

La forma funcionalmente activa de la tiamina es el pirofosfato de tiamina, que interviene en

el metabolismo de los carbohidratos como cofactor de las deshidrogenasas (deshidrogenasa

cetoácida de cadena ramificada, complejo piruvato deshidrogenasa y alfa-cetoglutarato

deshidrogenasa) y transcetolasas.

Entre los procesos metabólicos que resultan afectados durante la deficiencia de tiamina está

el aporte energético neuronal al inhibirse la degradación de los carbohidratos, lo que impide

la regeneración de la membrana axónica. Además de participar en el proceso de síntesis de

la acetilcolina, el pirofosfato de tiamina interviene en la liberación de este neurotransmisor

de la membrana presináptica, pues se han encontrado altas concentraciones de tiamina

fosforilada en las terminaciones nerviosas colinérgicas.

Piridoxina (vitamina B

piridoxina,

piridoxal

la piridoxamina

se absorben rápidamente

aparato

gastrointestinal después que son hidrolizadas a sus productos fosforilados. Por lo menos,

60% de la vitamina B

circulante corresponde al fosfato de piridoxal. Se considera que el

piridoxal es la forma primaria que atraviesa membranas celulares. El principal producto de

excreción es el ácido 4-piridóxico, formado por la acción de la aldehído oxidasa hepática

sobre el piridoxal libre.

El fosfato de piridoxal actúa como coenzima en varias transformaciones metabólicas de los

aminoácidos. La vitamina B

interviene en la síntesis de los siguientes neurotransmisores:

ácido

gamma-aminobutírico,

dopamina,

serotonina,

así

como

síntesis

esfingolípidos que constituyen la vaina de mielina.

Cianocobalamina (vitamina B

La vitamina B

que se ingiere con los alimentos se une al factor intrínseco (glucoproteína

masa

molecular

59,000

Da),

presencia

ácido

gástrico

proteasas

pancreáticas. El complejo vitamina B

-factor intrínseco llega al íleon distal, donde interactúa

con un receptor específico situado sobre las células de la mucosa ileal y desde ahí es

transportado a la circulación. Además del factor intrínseco, se requieren la presencia de bilis

y bicarbonato de sodio (a pH adecuado) para el transporte de la vitamina B

a través del

íleon. El desarrollo de la deficiencia de vitamina B

, comúnmente, no proviene de una

carencia en la dieta sino de un defecto en la absorción gastrointestinal. Una vez absorbida,

la vitamina B

se une a una betaglobu-lina plasmática llamada transcobalamina II, para

transportarla a los tejidos. La vitamina B

unida a la transcobalamina II es rápidamente

extraída del plasma y almacenada en las células hepáticas, de tal manera que hasta 90% de

los depósitos corporales de vitamina B

en el adulto normal, o sea, 1 a 10 mg están en el

hígado. La vitamina B

se almacena como coenzima activa, con una tasa de recambio de

0.5 a 0.8 mcg por día, dependiendo de la capacidad de los depósitos corporales. El

requerimiento mínimo al día de la vitamina es de un mcg.

Aproximadamente, tres mcg de vitamina B

son secretados cada día a través de la bilis y 50

a 60% de esa cantidad no está destinada a la reabsorción. Este ciclo enterohepático impide

que, durante una enfermedad intestinal, se interfiera con la reabsorción, lo que puede

resultar en un vaciamiento continuo de los almacenes hepáticos de la vitamina.

Las formas metabólicamente activas de la vitamina B

son la metilcobalamina y la 5-

desoxiadenosilcobalamina, las cuales son esenciales para el crecimiento y la replicación

celular. La metilcobalamina participa en la transformación de la homocisteína en metionina y

su derivado, la S-adenosilmetionina, así como en la conversión del N5-metiltetrahidrofolato a

tretrahidrofolato. La 5-desoxiadenosilcobalamina interviene en la isomerización de la L-

metilmalonil coenzima A a succinil coenzima A, la que favorece la síntesis de ácidos grasos.

Estas acciones metabólicas, en el seno del sistema nervioso, conducen a la generación de

ATP que es necesario para: a) la síntesis de ADN mitocondrial de las neuronas, b) para la

formación de la vaina de mielina axónica, c) para proporcionar los componentes bioquímicos

de la neurotransmisión y d) para mantener la constancia del medio interno neuronal,

necesaria para generar los potenciales de acción y permitir la transmisión en la sinapsis.

La combinación de las vitaminas B

posee actividad antinociceptiva, de acuerdo a

observaciones clínicas recientes, lo que se traduce en efectos analgésicos sustanciales.

Propiedades

farmacocinéticas

(Absorción,

distribución,

biotransformación,

eliminación):

Ver Farmacodinamia.

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

producto:

No procede.

Fecha de aprobación/ revisión del texto: 22 de diciembre 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.

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29-10-2018

Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Aurobindo Pharma Limited is voluntarily recalling 22 Batches of the drug substance Irbesartan due to the presence of an impurity, N-nitrosodiethylamine (NDEA). The impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC).

FDA - U.S. Food and Drug Administration

16-11-2018

Daptomycin Hospira (Hospira UK Limited)

Daptomycin Hospira (Hospira UK Limited)

Daptomycin Hospira (Active substance: daptomycin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7678 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004310/T/0008

Europe -DG Health and Food Safety

14-11-2018

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Active substance: tolvaptan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7604 of Wed, 14 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2788/T/20

Europe -DG Health and Food Safety

14-11-2018

Clopidogrel ratiopharm (Teva B.V.)

Clopidogrel ratiopharm (Teva B.V.)

Clopidogrel ratiopharm (Active substance: clopidogrel) - Centralised - Yearly update - Commission Decision (2018)7602 of Wed, 14 Nov 2018

Europe -DG Health and Food Safety

14-11-2018

Desloratadine ratiopharm (ratiopharm GmbH)

Desloratadine ratiopharm (ratiopharm GmbH)

Desloratadine ratiopharm (Active substance: desloratadine) - Centralised - Yearly update - Commission Decision (2018)7603 of Wed, 14 Nov 2018

Europe -DG Health and Food Safety

14-11-2018

Ebymect (AstraZeneca AB)

Ebymect (AstraZeneca AB)

Ebymect (Active substance: dapagliflozin / metformin) - Centralised - 2-Monthly update - Commission Decision (2018)7605 of Wed, 14 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4162/WS/1380

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1863 (Celgene Europe B.V.)

EU/3/17/1863 (Celgene Europe B.V.)

EU/3/17/1863 (Active substance: Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human B cell maturation antigen with 4-1BB and CD3-zeta intracellular signalling domains) - Transfer of orphan designation - Commission Decision (2018)7574 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/270/16/02

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

13-11-2018

EU/3/17/1964 (Incyte Biosciences Distribution B.V.)

EU/3/17/1964 (Incyte Biosciences Distribution B.V.)

EU/3/17/1964 (Active substance: Itacitinib) - Transfer of orphan designation - Commission Decision (2018)7573 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/169/17/T/01

Europe -DG Health and Food Safety

12-11-2018

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Zentiva, k.s.)

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Zentiva, k.s.)

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Active substance: efavirenz / emtricitabine / tenofovir disoproxil) - Centralised - Yearly update - Commission Decision (2018)7547 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

12-11-2018

Ruconest (Pharming Group N.V.)

Ruconest (Pharming Group N.V.)

Ruconest (Active substance: Conestat alfa) - Centralised - Yearly update - Commission Decision (2018)7548 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

12-11-2018

Spinraza (Biogen Netherlands B.V.)

Spinraza (Biogen Netherlands B.V.)

Spinraza (Active substance: nusinersen) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7550 of Mon, 12 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4312/T/10

Europe -DG Health and Food Safety

6-11-2018

Symkevi (Vertex Pharmaceuticals (Europe) Limited)

Symkevi (Vertex Pharmaceuticals (Europe) Limited)

Symkevi (Active substance: tezacaftor/ivacaftor) - Centralised - Authorisation - Commission Decision (2018)7415 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4682

Europe -DG Health and Food Safety

6-11-2018

Trelegy Ellipta (GlaxoSmithKline Trading Services Limited)

Trelegy Ellipta (GlaxoSmithKline Trading Services Limited)

Trelegy Ellipta (Active substance: fluticasone furoate/umeclidinium/vilanterol) - Centralised - 2-Monthly update - Commission Decision (2018)7416 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4363/WS/1369

Europe -DG Health and Food Safety

6-11-2018

Elebrato Ellipta (GlaxoSmithKline Trading Services Limited)

Elebrato Ellipta (GlaxoSmithKline Trading Services Limited)

Elebrato Ellipta (Active substance: fluticasone furoate/umeclidinium/vilanterol) - Centralised - 2-Monthly update - Commission Decision (2018)7417 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4781/WS/1369

Europe -DG Health and Food Safety

6-11-2018

Neulasta (Amgen Europe B.V.)

Neulasta (Amgen Europe B.V.)

Neulasta (Active substance: Pegfilgrastim) - Centralised - Yearly update - Commission Decision (2018)7420 of Tue, 06 Nov 2018

Europe -DG Health and Food Safety

6-11-2018

Samsca (Otsuka Pharmaceutical Netherlands B.V.)

Samsca (Otsuka Pharmaceutical Netherlands B.V.)

Samsca (Active substance: tolvaptan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7419 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/980/T/36

Europe -DG Health and Food Safety

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

5-11-2018

Improvac (Zoetis Belgium S.A.)

Improvac (Zoetis Belgium S.A.)

Improvac (Active substance: Not available) - Centralised - Yearly update - Commission Decision (2018)7381 of Mon, 05 Nov 2018

Europe -DG Health and Food Safety

1-11-2018

Zolvix (Elanco GmbH)

Zolvix (Elanco GmbH)

Zolvix (Active substance: monepantel) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7383 of Thu, 01 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/000154/T/0024

Europe -DG Health and Food Safety

1-11-2018

Protopic (Leo Pharma A/S)

Protopic (Leo Pharma A/S)

Protopic (Active substance: Tacrolimus) - Centralised - Yearly update - Commission Decision (2018)7343 of Thu, 01 Nov 2018

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

1-11-2018

Taxespira (Hospira UK Limited)

Taxespira (Hospira UK Limited)

Taxespira (Active substance: docetaxel) - Centralised - Withdrawal - Commission Decision (2018)7368 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

31-10-2018

Integrilin (GlaxoSmithKline (Ireland) Limited)

Integrilin (GlaxoSmithKline (Ireland) Limited)

Integrilin (Active substance: Eptifibatide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7340 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/230/T/79

Europe -DG Health and Food Safety

31-10-2018

Volibris (GlaxoSmithKline (Ireland) Limited)

Volibris (GlaxoSmithKline (Ireland) Limited)

Volibris (Active substance: Ambrisentan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7339 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/839/T/56

Europe -DG Health and Food Safety

31-10-2018

AMGEVITA (Amgen Europe B.V.)

AMGEVITA (Amgen Europe B.V.)

AMGEVITA (Active substance: adalimumab) - Centralised - Yearly update - Commission Decision (2018)7341 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

31-10-2018

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Active substance: adalimumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7344 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4279/T/15

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

30-10-2018

EU/3/14/1250 (Akcea Therapeutics UK Ltd)

EU/3/14/1250 (Akcea Therapeutics UK Ltd)

EU/3/14/1250 (Active substance: Phosphorothioate oligonucleotide targeted to transthyretin) - Transfer of orphan designation - Commission Decision (2018)7282 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/098/13/T/01

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Active substance: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant) - Orphan designation - Commission Decision (2018)7281 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/127/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Active substance: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII) - Orphan designation - Commission Decision (2018)7280 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/104/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2078 (Sellas Life Sciences Limited)

EU/3/18/2078 (Sellas Life Sciences Limited)

EU/3/18/2078 (Active substance: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG) - Orphan designation - Commission Decision (2018)7279 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/091/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2077 (Worphmed Srl)

EU/3/18/2077 (Worphmed Srl)

EU/3/18/2077 (Active substance: Melatonin) - Orphan designation - Commission Decision (2018)7278 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/077/18

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

30-10-2018

EU/3/18/2075 (Consorcio Centro de InvestigaciOn BiomEdica en Red M.P.)

EU/3/18/2075 (Consorcio Centro de InvestigaciOn BiomEdica en Red M.P.)

EU/3/18/2075 (Active substance: Gefitinib) - Orphan designation - Commission Decision (2018)7276 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/090/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2074 (PhaRA bvba)

EU/3/18/2074 (PhaRA bvba)

EU/3/18/2074 (Active substance: Avapritinib) - Orphan designation - Commission Decision (2018)7275 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/079/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2073 (Fondazione Telethon)

EU/3/18/2073 (Fondazione Telethon)

EU/3/18/2073 (Active substance: Autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA) - Orphan designation - Commission Decision (2018)7274 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/113/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Active substance: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile) - Orphan designation - Commission Decision (2018)7272 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/125/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (Active substance: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate) - Orphan designation - Commission Decision (2018)7273 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/102/18

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

29-10-2018

Replagal (Shire Human Genetic Therapies AB)

Replagal (Shire Human Genetic Therapies AB)

Replagal (Active substance: Agalsidase alfa) - Centralised - Yearly update - Commission Decision (2018)7250 of Mon, 29 Oct 2018

Europe -DG Health and Food Safety

29-10-2018

Synflorix (GlaxoSmithKline Biologicals S.A.)

Synflorix (GlaxoSmithKline Biologicals S.A.)

Synflorix (Active substance: Pneumococcal polysaccharide conjugate vaccine (adsorbed)) - Centralised - Yearly update - Commission Decision (2018)7257 of Mon, 29 Oct 2018

Europe -DG Health and Food Safety