SILDENAFIL

Información principal

  • Denominación comercial:
  • SILDENAFIL 100 mg TABLETAS RECUBIERTAS
  • Dosis:
  • 100 mg(A4-c )
  • formulario farmacéutico:
  • TABLETA RECUBIERTA
  • Usar para:
  • Humanos
  • Tipo de medicina:
  • medicamento alopático
  • Fabricado por:
  • GENFAR, S.A.

Documentos

Localización

  • Disponible en:
  • SILDENAFIL 100 mg TABLETAS RECUBIERTAS
    Venezuela
  • Idioma:
  • español

Otros datos

Estado

  • Fuente:
  • Instituto Nacional de Higiene - República Bolivariana de Venezuela
  • Estado de Autorización:
  • VIGENTE
  • Número de autorización:
  • E.F.G.34.333
  • Fecha de autorización:
  • 27-07-2005
  • última actualización:
  • 03-09-2018

Prospecto

Republica

Bolivariana

·de

Venezuela

Ministerio de Salud y Desarrollo Social

Instituto Nacional de Higiene

"Rafael Rangel"

REGISTRO

NACIONAL

DE

PRODUCTOS

JR.-

052884

FARMACEUTICOS

Caracas,

0 9

AGO

2005

Ciudadano

(a)

Dr.

(a).

MARTHA

VILLALBA.

UNIBRAIN

REPRESENTACIONES,

C.A.

Presente.-

acuerdo

dictamen

Junta

Revisora

Productos

Farmaceuticos,

ses1on

Acta

8845

fecha

27/07/05,

aprueba

producto

SILDENAFIL

100

mg

TABLETAS

RECUBIERTAS

SR:

03-0684.

No.

DE

REGISTRO

E.F.G.

34.333.

Igualmente

informa

dispone

quince

(15)

dias

habiles,

para

solicitar

Junta

Revisora

Productos

Farmaceuticos,

reconsideraci6n

exigencias

senaladas

continuaci6n:

asigna

producto

periodo

validez

comprobado

tres

(03)

anos,

envasado

BLISTER

PVC/

TRANSPARENTE/

FOIL

ALUMINIO,

almacenado

bajo

condiciones

climaticas

Venezuela

(30°C±2°C/70%±5%HR).

especificaciones

material

empaque

blister

transparente

I

foil

aluminio

remitidas,

consideran

conformes.

reitera

debe

remitir

textos

empaque

prospecto

interno

corregidos

segun

modelos

anexos.

fines

estricto

cumplimiento

Articulo

Reglamento

del.

ercicio

Farmacia

vigente,

publicado

Gaceta

Oficial

4.582

Extraordinario

fecha

mayo

1993,

informa

estan

obligados

participar

Junta

Revisora

Productos

Farmaceuticos,

fecha

cual

inicie

comercializaci6n

primer

lote

elaborado,

manera

funcionarios

acredi

tados

Insti

tuto

Nacional

Higiene

"Rafael

Rangel",

puedan

proceder

captar

muestras

correspondientes

propio

sitio

fabricaci6n,

distribuci6n

caso

productos

importados.

incumplimiento

mencionado

compromiso

sera

sancionado

prohibici6n

producto.

"Prevenir

el

Dengue es tarea de todas y todos"

Republica

Bolivariana

de

Venezuela

Ministerio de Salud

y

Desarrollo Social

Instituto N acional de Higiene

"Rafael Rangel"

REGISTRO

NACIONAL

DE

PRODUCTOS

FARMACEUTICOS

Transcurrido

dicho

lapso

queda

usted

obligaci6n

cumplir

condiciones

bajo

cuales

aprobado

producto.

POR

LA

JUNTA

PRODUCTOS

FARMACEUTICOS

"Prevenir

el

Dengue es tarea de todas

y

todos"

15-11-2018

Drug Safety Update , Noviembre 2018

MHRA , 14 de noviembre de 2018 Hidroclorotiazida: riesgo de cáncer de piel no melanoma Sildenafil: hipertensión pulmonar persistente del recién nacido Fluoroquinolonas: aneurisma y disección aórtica

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

11-7-2018

MyNicNaxs, LLC Issues Voluntary Nationwide Recall of Various Dietary Supplements Due to Undeclared Active Pharmaceutical Ingredient (API)

MyNicNaxs, LLC Issues Voluntary Nationwide Recall of Various Dietary Supplements Due to Undeclared Active Pharmaceutical Ingredient (API)

MyNicNaxs, LLC, Deltona, FL is voluntarily recalling all lots of dietary supplements distributed nationwide to the consumer level. The products have been found to contain undeclared active pharmaceutical ingredients (API). The presence of Sildenafil, Sibutramine, Diclofenac and/or Phenolphthalein in the dietary supplements renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. These products were distributed from January 2013, to December ...

FDA - U.S. Food and Drug Administration

18-5-2018

7K and Poseidon 4500 by Shoreside Enterprises: Voluntary Recall - Due to Presence of Undeclared Sildenafil and/or Tadalafil

7K and Poseidon 4500 by Shoreside Enterprises: Voluntary Recall - Due to Presence of Undeclared Sildenafil and/or Tadalafil

Use of products with the undeclared active ingredients, sildenafil and tadalafil, may pose a threat to consumers because the active ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. Among the adult male population who are most likely to use these products, adult males who use nitrates for cardiac conditions are the most at risk from these products. These products are considered ta...

FDA - U.S. Food and Drug Administration

17-5-2018

Shoreside Enterprises Issues Voluntary Nationwide Recall of 7K and Poseidon 4500 (Extreme 1000 Mg) Due to Presence of Undeclared Sildenafil and Tadalafil

Shoreside Enterprises Issues Voluntary Nationwide Recall of 7K and Poseidon 4500 (Extreme 1000 Mg) Due to Presence of Undeclared Sildenafil and Tadalafil

Shoreside Enterprises, Inc. is voluntarily recalling 7K (Lot specific: Lot #RO) and Poseidon 4500 (Extreme 1000 mg) (Lot specific: Lot #20117BL) to the consumer level. FDA analysis found the samples of these products to contain undeclared Sildenafil and/or Tadalafil. Sildenafil and Tadalafil are active ingredients in two FDA-approved prescription drugs used for the treatment of erectile dysfunction (ED).

FDA - U.S. Food and Drug Administration

17-4-2018

Epic Products, LLC, Issues Voluntary Nationwide Recall of All Lots of Euphoric Capsules Due to Presence of Undeclared Sildenafil and Tadalafil

Epic Products, LLC, Issues Voluntary Nationwide Recall of All Lots of Euphoric Capsules Due to Presence of Undeclared Sildenafil and Tadalafil

Overland Park, KS, Epic Products, LLC is voluntarily recalling all lots of Euphoric capsules, packaged in 1 count blister cards, 3 count bottles, and 12 count bottles to the consumer level. FDA analysis found samples of Euphoric to be tainted with undeclared sildenafil and tadalafil, active ingredients in two FDA-approved prescription drug products, also known as phosphodiesterase 5-inhibitors (PDE-5 inhibitors), used to treat male erectile dysfunction (ED). The presence of sildenafil and tadalafil in E...

FDA - U.S. Food and Drug Administration

14-3-2018

Sexual enhancement product "Leopard Miracle of Honey" may pose serious health risks

Sexual enhancement product "Leopard Miracle of Honey" may pose serious health risks

Health Canada is advising Canadians that two versions of the sexual enhancement product “Leopard Miracle of Honey” may pose serious health risks. Both versions are labelled as being approved by Health Canada, with NPN 80073650. Health Canada’s testing found that both versions of the product contain the undeclared prescription drug sildenafil. The product was not authorized to contain this prescription drug. Health Canada seized the products from two Ontario convenience stores located in Woodbridge, ON, a...

Health Canada

14-12-2017

Marmex Corp Issues Voluntary Nationwide Recall Of Blue Pearl All Natural Male Enhancement Supplement, Due To Undeclared Sildenafil

Marmex Corp Issues Voluntary Nationwide Recall Of Blue Pearl All Natural Male Enhancement Supplement, Due To Undeclared Sildenafil

Orange, CA, Marmex Corp is voluntarily recalling All lots of Blue Pearl All Natural Male Enhancement Supplement, 500mg to the consumer level. FDA analysis has found the products to contain sildenafil.

FDA - U.S. Food and Drug Administration

30-11-2017

Nutra Labs Inc. Issues Voluntary Nationwide Recall of Dietary Supplements Bull and Chao Jimengnan Tablets Due to Undeclared Active Pharmaceutical Ingredients

Nutra Labs Inc. Issues Voluntary Nationwide Recall of Dietary Supplements Bull and Chao Jimengnan Tablets Due to Undeclared Active Pharmaceutical Ingredients

Nutra Labs Inc. is voluntarily recalling lots sold by their firm of the male enhancement supplements Bull 1800 mg Capsules with the production date of 05/08/2016, and Chao Jimengnan 150 mg Tablets with Lot # 20151018 to the consumer level. FDA analysis found the products to be tainted with sildenafil, 0.026mg/capsule for Bull, and 70.46mg/tablet for Chao Jimengnan respectively. Sildenafil is the active pharmaceutical ingredient in an FDA approved product used for erectile dysfunction, making Bull capsule...

FDA - U.S. Food and Drug Administration

22-10-2018

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Active substance: Sildenafil citrate) - Transfer of orphan designation - Commission Decision (2018)6993 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/068/10/T/01

Europe -DG Health and Food Safety

1-8-2018

Viagra (Pfizer Europe MA EEIG)

Viagra (Pfizer Europe MA EEIG)

Viagra (Active substance: sildenafil) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5203 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/202/T/98

Europe -DG Health and Food Safety

1-8-2018

Revatio (Pfizer Europe MA EEIG)

Revatio (Pfizer Europe MA EEIG)

Revatio (Active substance: sildenafil) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5221 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/638/T/82

Europe -DG Health and Food Safety