PERINDOPRIL International Drug Development

Information principale

  • Nom commercial:
  • PERINDOPRIL International Drug Development 4 mg, comprimé
  • Dosage:
  • 3,338 mg
  • forme pharmaceutique:
  • comprimé
  • Composition:
  • composition pour un comprimé > périndopril : 3,338 mg . Sous forme de : tert-butylamine de périndopril 4 mg
  • Mode d'administration:
  • orale
  • Unités en paquet:
  • plaquette(s) thermoformée(s) aluminium PVC acétate de polyvinyle de 4 comprimé(s)
  • Type d'ordonnance:
  • liste I
  • Utiliser pour:
  • Humains
  • Type medicin:
  • médicament allopathique

Documents

Localisation

  • Disponible en:
  • PERINDOPRIL International Drug Development 4 mg, comprimé
    France
  • Langue:
  • français

Information thérapeutique

  • Domaine thérapeutique:
  • INHIBITEURS DE L'ENZYME DE CONVERSION DE L'ANGIOTENSINE
  • Descriptif du produit:
  • 376 970-6 ou 4009 376 970 6 4 - plaquette(s) thermoformée(s) aluminium PVC acétate de polyvinyle de 4 comprimé(s) - Déclaration de commercialisation non communiquée:;376 979-3 ou 4009 376 979 3 4 - plaquette(s) thermoformée(s) aluminium PVC acétate de polyvinyle de 90 comprimé(s) - Déclaration de commercialisation non communiquée:;570 024-5 ou 4009 570 024 5 9 - plaquette(s) thermoformée(s) aluminium PVC acétate de polyvinyle de 100 comprimé(s) - Déclaration de commercialisation non communiquée:;570 025-1 ou 4009 570 025 1 0 - plaquette(s) thermoformée(s) aluminium PVC acétate de polyvinyle de 112 comprimé(s) - Déclaration de commercialisation non communiquée:;570 026-8 ou 4009 570 026 8 8 - plaquette(s) thermoformée(s) aluminium PVC acétate de polyvinyle de 120 comprimé(s) - Déclaration de commercialisation non communiquée:;570 027-4 ou 4009 570 027 4 9 - plaquette(s) thermoformée(s) aluminium PVC acétate de polyvinyle de 500 comprimé(s) - Déclaration de commercialisation non communiquée:;376 971-2 ou 4009 376 971 2 5 - plaquette(s) thermoformée(s) aluminium PVC acétate de polyvinyle de 7 comprimé(s) - Déclaration de commercialisation non communiquée:;376 972-9 ou 4009 376 972 9 3 - plaquette(s) thermoformée(s) aluminium PVC acétate de polyvinyle de 14 comprimé(s) - Déclaration de commercialisation non communiquée:;376 973-5 ou 4009 376 973 5 4 - plaquette(s) thermoformée(s) aluminium PVC acétate de polyvinyle de 15 comprimé(s) - Déclaration de commercialisation non communiquée:;376 974-1 ou 4009 376 974 1 5 - plaquette(s) thermoformée(s) aluminium PVC acétate de polyvinyle de 28 comprimé(s) - Déclaration de commercialisation non communiquée:;376 975-8 ou 4009 376 975 8 3 - plaquette(s) thermoformée(s) aluminium PVC acétate de polyvinyle de 30 comprimé(s) - Déclaration de commercialisation non communiquée:;376 976-4 ou 4009 376 976 4 4 - plaquette(s) thermoformée(s) aluminium PVC acétate de polyvinyle de 50 comprimé(s) - Déclaration de commercialisation non communiquée:;376 977-0 ou 4009 376 977 0 5 - plaquette(s) thermoformée(s) aluminium PVC acétate de polyvinyle de 56 comprimé(s) - Déclaration de commercialisation non communiquée:;376 978-7 ou 4009 376 978 7 3 - plaquette(s) thermoformée(s) aluminium PVC acétate de polyvinyle de 60 comprimé(s) - Déclaration de commercialisation non communiquée:;

Autres informations

Statut

  • Source:
  • ANSM - Agence Nationale de Sécurité du Médicament et des Produits de Santé
  • Statut de autorisation:
  • Archivée
  • Numéro d'autorisation:
  • 69642587
  • Date de l'autorisation:
  • 14-08-2006
  • Dernière mise à jour:
  • 25-11-2017

Notice: composition, indications thérapeutiques, interactions, posologie, effets indésirable, grossesse, allaitement

NOTICE

ANSM - Mis à jour le : 09/02/2012

Dénomination du médicament

PERINDOPRIL INTERNATIONAL DRUG DEVELOPMENT 4 mg, comprimé

Tert-butylamine de périndopril

Encadré

Veuillez lire attentivement l'intégralité de cette notice avant de prendre ce médicament.

Gardez cette notice, vous pourriez avoir besoin de la relire.

Si vous avez toute autre question, si vous avez un doute, demandez plus d'informations à votre médecin ou à votre

pharmacien.

Ce médicament vous a été personnellement prescrit. Ne le donnez jamais à quelqu'un d'autre, même en cas de symptômes

identiques, cela pourrait lui être nocif.

Si l'un des effets indésirables devient grave ou si vous remarquez un effet indésirable non mentionné dans cette notice,

parlez-en à votre médecin ou à votre pharmacien.

Sommaire notice

Dans cette notice :

1. QU'EST-CE QUE PERINDOPRIL INTERNATIONAL DRUG DEVELOPMENT 4 mg, comprimé ET DANS QUELS CAS

EST-IL UTILISE ?

2. QUELLES SONT LES INFORMATIONS A CONNAITRE AVANT DE PRENDRE PERINDOPRIL INTERNATIONAL

DRUG DEVELOPMENT 4 mg, comprimé ?

3. COMMENT PRENDRE PERINDOPRIL INTERNATIONAL DRUG DEVELOPMENT 4 mg, comprimé ?

4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?

5. COMMENT CONSERVER PERINDOPRIL INTERNATIONAL DRUG DEVELOPMENT 4 mg, comprimé ?

6. INFORMATIONS SUPPLEMENTAIRES

1. QU'EST-CE QUE PERINDOPRIL INTERNATIONAL DRUG DEVELOPMENT 4 mg, comprimé ET DANS QUELS CAS

EST-IL UTILISE ?

Classe pharmacothérapeutique

Ce médicament appartient à la classe des inhibiteurs de l'enzyme de conversion de l'angiotensine (IEC).

Indications thérapeutiques

Ce médicament est préconisé dans les indications suivantes:

traitement de l'hypertension artérielle,

traitement de l'insuffisance cardiaque symptomatique,

maladie coronaire stable: le périndopril diminue le risque de survenue d'un nouvel accident cardiaque chez les patients

ayant déjà souffert d'un infarctus et/ou ayant subi un pontage ou une dilatation des artères coronaires.

2. QUELLES SONT LES INFORMATIONS A CONNAITRE AVANT DE PRENDRE PERINDOPRIL INTERNATIONAL

DRUG DEVELOPMENT 4 mg, comprimé ?

Liste des informations nécessaires avant la prise du médicament

Si votre médecin vous a informé(e) d'une intolérance à certains sucres, contactez-le avant de prendre ce médicament.

Contre-indications

Ne prenez jamais PERINDOPRIL INTERNATIONAL DRUG DEVELOPMENT 4 mg, comprimé dans les cas suivants:

si vous avez une allergie connue au périndopril ou à l'un des autres composants de ce médicament (voir Que contient

PERINDOPRIL INTERNATIONAL DRUG DEVELOPMENT 4 mg, comprimé ?),

si vous avez une allergie connue à d'autres médicaments de la même classe: les inhibiteurs de l'enzyme de conversion

(IEC),

si vous avez des antécédents d'œdème de Quincke (réaction allergique avec brusque gonflement du visage et du cou) lié à

la prise d'un IEC,

si vous avez des antécédents d'œdème de Quincke familial ou sans cause connue,

si vous êtes enceinte depuis plus de 3 mois (il est également préférable d'éviter de prendre PERINDOPRIL

INTERNATIONAL DRUG DEVELOPMENT en début de grossesse, voir rubrique Grossesse et Allaitement).

En cas de doute parlez-en à votre médecin.

Ce médicament ne doit généralement pas être utilisé:

chez l'enfant de moins de 15 ans.

Ce médicament est généralement déconseillé en cas d'associations avec les diurétiques épargneurs de potassium, les sels

de potassium, et le lithium (voir Prise ou utilisation d'autres médicaments).

Précautions d'emploi ; mises en garde spéciales

Faites attention avec PERINDOPRIL INTERNATIONAL DRUG DEVELOPMENT 4 mg, comprimé:

Une toux sèche peut se produire, il est impératif dans ce cas de consulter à nouveau le médecin qui jugera de l'opportunité

de poursuivre le traitement.

Risque de réactions allergiques, d'œdème de la face, de la glotte et/ou du larynx.

Risque de réactions allergiques chez les patients recevant un traitement de désensibilisation (par exemple avec du venin

d'hyménoptère: abeille, guêpe).

Risque de réactions allergiques chez les patients sous hémodialyse: prévenir votre médecin si vous devez être

hémodialysé.

Prévenir votre médecin traitant en cas de:

hypotension (chute de la pression artérielle) pouvant se traduire par des étourdissements ou des vertiges;

régime restrictif en sel ou de traitement diurétique prolongé;

insuffisance rénale, cardiaque ou hépatique;

rétrécissement de l'artère rénale ou des valves cardiaques;

athérosclérose (rétrécissement des artères);

diabète.

En cas d'intervention chirurgicale, prévenir l'anesthésiste de la prise de ce médicament.

Vous devez informer votre médecin si vous pensez être (ou susceptible de devenir) enceinte.

PERINDOPRIL INTERNATIONAL DRUG DEVELOPMENT est déconseillé en début de grossesse, et ne doit pas être pris si

vous êtes enceinte de plus de 3 mois, car cela pourrait nuire gravement à votre enfant en cas d'utilisation à partir de ce stade

de la grossesse (voir rubrique Grossesse).

L'utilisation de ce médicament est déconseillée chez les patients présentant une intolérance au galactose, un déficit en

lactase de Lapp ou un syndrome de malabsorption du glucose ou du galactose (maladies héréditaires rares).

Interactions avec d'autres médicaments

Prise ou utilisation d'autres médicaments

Veuillez indiquer à votre médecin ou à votre pharmacien si vous prenez ou avez pris récemment un autre médicament,

notamment certains diurétiques épargneurs de potassium, les sels de potassium, et le lithium, même s'il s'agit d'un

médicament obtenu sans ordonnance.

Interactions avec les aliments et les boissons

Sans objet.

Interactions avec les produits de phytothérapie ou thérapies alternatives

Sans objet.

Utilisation pendant la grossesse et l'allaitement

Grossesse et Allaitement

Grossesse

Vous devez informer votre médecin si vous pensez être (ou susceptible de devenir) enceinte. Votre médecin vous

recommandera normalement d'arrêter de prendre PERINDOPRIL INTERNATIONAL DRUG DEVELOPMENT avant d'être

enceinte ou dès que vous apprenez que vous êtes enceinte. Il vous recommandera de prendre un autre médicament à la

place de PERINDOPRIL INTERNATIONAL DRUG DEVELOPMENT.

PERINDOPRIL INTERNATIONAL DRUG DEVELOPMENT est déconseillé en début de grossesse et ne doit pas être pris si

vous êtes enceinte de plus de 3 mois, car cela pourrait nuire gravement à votre enfant.

Allaitement

Informez votre médecin si vous allaitez ou êtes sur le point de commencer à allaiter. PERINDOPRIL INTERNATIONAL

DRUG DEVELOPMENT est déconseillé aux femmes qui allaitent et votre médecin pourrait choisir un autre traitement si

vous souhaitez allaiter, surtout si votre enfant est un nouveau-né ou un prématuré.

Sportifs

Sans objet.

Effets sur l'aptitude à conduire des véhicules ou à utiliser des machines

Conduite de véhicules et utilisation de machines

Une prudence particulière devra être observée chez les conducteurs de véhicules automobiles et les utilisateurs de

machines, en raison du risque de sensations de vertiges ou de fatigue.

Liste des excipients à effet notoire

Liste des excipients à effet notoire:lactose.

3. COMMENT PRENDRE PERINDOPRIL INTERNATIONAL DRUG DEVELOPMENT 4 mg, comprimé ?

Instructions pour un bon usage

Sans objet.

Posologie, Mode et/ou voie(s) d'administration, Fréquence d'administration et Durée du traitement

Posologie

Réservé à l'adulte.

La posologie varie de 2 à 8 mg par jour.

Elle est adaptée à chaque patient; il est important de respecter les doses prescrites par votre médecin. La posologie au

début de traitement et au cours du traitement dépendent de votre état et des autres médicaments que vous prenez.

DANS TOUS LES CAS, SE CONFORMER STRICTEMENT A L'ORDONNANCE DE VOTRE MEDECIN.

Si vous avez l'impression que l'effet de PERINDOPRIL INTERNAT IONAL DRUG DEVELOPMENT 4 mg, comprimé est

trop fort ou trop faible, consultez votre médecin ou votre pharmacien.

Mode d'administration

Voie orale.

Avaler le comprimé avec un verre d'eau, en une prise quotidienne, le matin, avant le repas.

Symptômes et instructions en cas de surdosage

Si vous avez pris plus de PERINDOPRIL INTERNAT IONAL DRUG DEVELOPMENT 4 mg, comprimé que vous

n'auriez dû:

L'événement le plus probable, en cas de surdosage, est l'hypotension (chute de la pression artérielle) qui peut être associée

à des vertiges ou étourdissements.

Si une hypotension importante se produit, elle peut être combattue en allongeant le patient, jambes relevées. Si le malaise

se poursuit, alertez immédiatement votre médecin.

Instructions en cas d'omission d'une ou de plusieurs doses

Si vous oubliez de prendre PERINDOPRIL INTERNAT IONAL DRUG DEVELOPMENT 4 mg, comprimé:

Ne prenez pas de dose double pour compenser la dose que vous avez oublié de prendre.

Risque de syndrome de sevrage

Sans objet.

4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?

Description des effets indésirables

Comme tous les médicaments, PERINDOPRIL INTERNATIONAL DRUG DEVELOPMENT 4 mg, comprimé est susceptible

d'avoir des effets indésirables, bien que tout le monde n'y soit pas sujet:

maux de tête, étourdissements, vertiges, sensation de picotements et de fourmillements, troubles visuels, sifflements et

bourdonnements d'oreille, hypotension, toux sèche, difficulté respiratoire, troubles gastro-intestinaux (nausées, douleurs

abdominales), troubles du goût, fatigue, éruption cutanée, démangeaisons, crampes musculaires.

diverses modifications des examens biologiques:

rarement: diminution de l'hémoglobine, augmentation du taux de potassium dans le sang; augmentation des enzymes

hépatiques et de la bilirubinémie,

augmentation de l'urée et de la créatinine dans le sang.

En cas de troubles persistants, avertir votre médecin.

Arrêtez de prendre ce médicament et contactez immédiatement votre médecin dans les situations suivantes: gonflement de

la face, des lèvres, de la langue et/ou du larynx entraînant une difficulté à respirer ou à avaler.

Si vous remarquez des effets indésirables non mentionnés dans cette notice, ou si certains effets indésirables deviennent

graves, veuillez en informer votre médecin ou votre pharmacien.

5. COMMENT CONSERVER PERINDOPRIL INTERNATIONAL DRUG DEVELOPMENT 4 mg, comprimé ?

Tenir hors de la portée et de la vue des enfants.

Date de péremption

Ne pas utiliser PERINDOPRIL INTERNATIONAL DRUG DEVELOPMENT 4 mg, comprimé après la date de péremption

mentionnée sur la boîte.

Conditions de conservation

A conserver à une température ne dépassant pas +30°C.

Si nécessaire, mises en garde contre certains signes visibles de détérioration

Les médicaments ne doivent pas être jetés au tout à l'égout ou avec les ordures ménagères. Demandez à votre pharmacien

ce qu'il faut faire des médicaments inutilisés. Ces mesures permettront de protéger l'environnement.

6. INFORMATIONS SUPPLEMENTAIRES

Liste complète des substances actives et des excipients

Que contient PERINDOPRIL INTERNATIONAL DRUG DEVELOPMENT 4 mg, comprimé ?

La substance active est:

Tert-butylamine de périndopril ............................................................................................................... 4 mg

Pour un comprimé.

Les autres composants sont:

Lactose anhydre, stéarate de magnésium.

Forme pharmaceutique et contenu

Qu'est-ce que PERINDOPRIL INTERNATIONAL DRUG DEVELOPMENT 4 mg, comprimé et contenu de l'emballage

extérieur ?

Ce médicament se présente sous forme de comprimé. Boîte de 4, 7, 14, 15, 28, 30, 50, 56, 60, 90, 100, 112, 120 ou 500

comprimés.

Nom et adresse du titulaire de l'autorisation de mise sur le marché et du titulaire de l'autorisation de fabrication responsable

de la libération des lots, si différent

Titulaire

INTERNATIONAL DRUG DEVELOPMENT

5, rue Simonet

75013 Paris

Exploitant

KATWIJK FARMA BV

ARCHIMEDESWEG 2

P.O BOX 408

2300 AK LEIDEN

PAYS BAS

Fabricant

KATWIJK FARMA BV

BIO SCIENCE PARK

ARCHIMEDESWEG 2

2333 CN LEIDEN

PAYS BAS

Noms du médicament dans les Etats membres de l'Espace Economique Européen

Sans objet.

Date d’approbation de la notice

La dernière date à laquelle cette notice a été approuvée est le {date}.

AMM sous circonstances exceptionnelles

Sans objet.

Informations Internet

Des informations détaillées sur ce médicament sont disponibles sur le site Internet de l’Afssaps (France).

Informations réservées aux professionnels de santé

Sans objet.

Autres

Sans objet.

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Public Notification: Leopard Secret Miracle Honey contains hidden drug ingredient

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1-10-2018

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26-9-2018

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Public Notification: PremierZen Gold 4000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use PremierZen Gold 4000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

31-8-2018

Public Notification: Easy 2 Slim contains hidden drug ingredient

Public Notification: Easy 2 Slim contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Easy 2 Slim, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

31-8-2018

Public Notification: Slimming Capsule contains hidden drug ingredients

Public Notification: Slimming Capsule contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Slimming Capsule, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

31-8-2018

Public Notification: Extenze Nutritional Supplement contains hidden drug ingredient

Public Notification: Extenze Nutritional Supplement contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Extenze Nutritional Supplement, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

31-8-2018

Public Notification: Extenze Plus contains hidden drug ingredient

Public Notification: Extenze Plus contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Extenze Plus, a product promoted for sexual enhancement. This product was identified by FDA during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

31-8-2018

Public Notification: BodySlim Herbal contains hidden drug ingredient

Public Notification: BodySlim Herbal contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use BodySlim Herbal, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

6-8-2018

FDA takes new steps to encourage the development of novel medicines for the treatment of opioid use disorder

FDA takes new steps to encourage the development of novel medicines for the treatment of opioid use disorder

FDA issued new scientific recommendations aimed at encouraging more widespread innovation and development of novel medication-assisted treatment drugs to treat opioid use disorder.

FDA - U.S. Food and Drug Administration

3-8-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps the agency is taking to support the development of novel nicotine replacement drug therapies to help smokers quit cigarettes

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps the agency is taking to support the development of novel nicotine replacement drug therapies to help smokers quit cigarettes

FDA releases the first of two draft guidances aimed at supporting the development of novel, inhaled nicotine replacement therapies that could be submitted for approval as new drugs.

FDA - U.S. Food and Drug Administration

31-7-2018

Public Notification: Black Rhino 25000 contains hidden drug ingredient

Public Notification: Black Rhino 25000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Black Rhino 25000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

31-7-2018

Public Notification: Krazzy Rhino 25000 contains hidden drug ingredient

Public Notification: Krazzy Rhino 25000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Krazzy Rhino 25000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

31-7-2018

Public Notification: Boss Rhino 15000 contains hidden drug ingredient

Public Notification: Boss Rhino 15000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Boss Rhino 15000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

31-7-2018

Public Notification: Gold Rhino 25000 contains hidden drug ingredient

Public Notification: Gold Rhino 25000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Gold Rhino 25000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

31-7-2018

Public Notification: Platinum Rhino 25000 contains hidden drug ingredient

Public Notification: Platinum Rhino 25000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Platinum Rhino 25000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

24-7-2018

Statement from FDA Commissioner Scott Gottlieb, M.D. on voluntary recalls of Ritz, Goldfish and other products issued out of an abundance of caution

Statement from FDA Commissioner Scott Gottlieb, M.D. on voluntary recalls of Ritz, Goldfish and other products issued out of an abundance of caution

The U.S. Food and Drug Administration is working with Mondelēz International, Inc., Pepperidge Farm Inc. and Flowers Foods, Inc. to initiate voluntarily recalls of certain products due to a potential risk that one of the ingredients may have been contaminated with Salmonella.

FDA - U.S. Food and Drug Administration

20-7-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to encourage the development of and broaden access to generic versions of opioid analgesics that are formulated to deter abuse

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to encourage the development of and broaden access to generic versions of opioid analgesics that are formulated to deter abuse

FDA posted a new batch of 43 product-specific guidances related to the development of generic drug products that includes three revised product-specific guidances for ADF opioid products. These guidances recommend specific in vivo studies and in vitro study considerations for abuse deterrence evaluations.

FDA - U.S. Food and Drug Administration

18-7-2018

FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency

FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency

FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency

FDA - U.S. Food and Drug Administration

9-7-2018

Public Notification: Maximum Powerful contains hidden drug ingredient

Public Notification: Maximum Powerful contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Maximum Powerful, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

9-7-2018

Public Notification: Asunsa contains hidden drug ingredients

Public Notification: Asunsa contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Asunsa, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

9-7-2018

Public Notification: Dale Mas contains hidden drug ingredients

Public Notification: Dale Mas contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Dale Mas, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

9-7-2018

Public Notification: Lyn DTOX FS3 contains hidden drug ingredients

Public Notification: Lyn DTOX FS3 contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Lyn DTOX FS3, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

9-7-2018

Public Notification: C.U. Plus contains hidden drug ingredients

Public Notification: C.U. Plus contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use C.U. Plus, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

9-7-2018

Public Notification: Grakcu Capsule contains hidden drug ingredients

Public Notification: Grakcu Capsule contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Grakcu Capsule, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

3-7-2018

Public Notification: Maxidus contains hidden drug ingredient

Public Notification: Maxidus contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Maxidus, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments .

FDA - U.S. Food and Drug Administration

3-7-2018

Public Notification: Chong Cao Qiang Shen Wang contains hidden drug ingredient

Public Notification: Chong Cao Qiang Shen Wang contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Chong Cao Qiang Shen Wang, a product promoted for sexual enhancement. FDA identified this product during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

3-7-2018

Public Notification: Adipotrim XT contains hidden drug ingredient

Public Notification: Adipotrim XT contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Adipotrim XT, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

3-7-2018

Public Notification: Row of Antibody Pil contains hidden drug ingredients

Public Notification: Row of Antibody Pil contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Row of Antibody Pil, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

3-7-2018

Public Notification: Body Shape Weight Loss System contains hidden drug ingredient

Public Notification: Body Shape Weight Loss System contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Body Shape Weight Loss System, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

26-6-2018

Generic Drug Development

Generic Drug Development

News and Announcements updated

FDA - U.S. Food and Drug Administration

20-6-2018

Public Notification: Gold Viagra contains hidden drug ingredient

Public Notification: Gold Viagra contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Gold Viagra, a product promoted for sexual enhancement. This product was identified by FDA during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

20-6-2018

Public Notification: XXXPlosion contains hidden drug ingredient

Public Notification: XXXPlosion contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use XXXPlosion, a product promoted for sexual enhancement. This product was identified by FDA during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

20-6-2018

Public Notification: Black Stallion 35000 contains hidden drug ingredient

Public Notification: Black Stallion 35000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Black Stallion 35000, a product promoted for sexual enhancement. This product was identified by FDA during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

20-6-2018

Public Notification: Adriana Balance S contains hidden drug ingredient

Public Notification: Adriana Balance S contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Adriana Balance S, a product promoted for weight loss. This product was identified by FDA during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

20-6-2018

Public Notification: AB Slim contains hidden drug ingredients

Public Notification: AB Slim contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use AB Slim, a product promoted for weight loss. This product was identified by FDA during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

18-6-2018

The FDA Encourages New Treatments for Sickle Cell Disease

The FDA Encourages New Treatments for Sickle Cell Disease

The U.S. Food and Drug Administration is collaborating with patients, academics, and the pharmaceutical industry to encourage the development of new treatments for sickle cell disease (SCD).

FDA - U.S. Food and Drug Administration

12-6-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts to foster discovery and development of new tools to fight antimicrobial-resistant infections

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts to foster discovery and development of new tools to fight antimicrobial-resistant infections

The increase in serious antimicrobial drug resistant infections is a critical public health concern and a growing threat to patients. FDA is taking steps to combat antibiotic-resistant bacteria.

FDA - U.S. Food and Drug Administration

19-11-2018

By providing more clarity around how these prescription-drug-use-related software products will be regulated, #FDA hopes to promote development of these innovations. We believe these innovative products can help significantly improve patients’ health

By providing more clarity around how these prescription-drug-use-related software products will be regulated, #FDA hopes to promote development of these innovations. We believe these innovative products can help significantly improve patients’ health

By providing more clarity around how these prescription-drug-use-related software products will be regulated, #FDA hopes to promote development of these innovations. We believe these innovative products can help significantly improve patients’ health

FDA - U.S. Food and Drug Administration

19-11-2018

The #FDA wants to promote the development of #digitaltech that can also help guide the safe and effective use of prescription drugs, to help patients improve their health  https://go.usa.gov/xPAak pic.twitter.com/nRPaMkKini

The #FDA wants to promote the development of #digitaltech that can also help guide the safe and effective use of prescription drugs, to help patients improve their health https://go.usa.gov/xPAak pic.twitter.com/nRPaMkKini

The #FDA wants to promote the development of #digitaltech that can also help guide the safe and effective use of prescription drugs, to help patients improve their health https://go.usa.gov/xPAak  pic.twitter.com/nRPaMkKini

FDA - U.S. Food and Drug Administration

22-10-2018

EU/3/16/1704 (Drug Development and Regulation S.L.)

EU/3/16/1704 (Drug Development and Regulation S.L.)

EU/3/16/1704 (Active substance: Sirolimus) - Transfer of orphan designation - Commission Decision (2018)6988 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/045/16/T/01

Europe -DG Health and Food Safety

6-8-2018

Scientific guideline:  ICH M9 on biopharmaceutics classification system based biowaivers - Step 2b - First version, draft: consultation open

Scientific guideline: ICH M9 on biopharmaceutics classification system based biowaivers - Step 2b - First version, draft: consultation open

This new multidisciplinary guideline is proposed to address biopharmaceutics classification system (BCS)-based biowaivers. BCS-based biowaivers may be applicable to BCS Class I and III drugs, however BCS-based biowaivers for these two classes are not recognized worldwide. This means that pharmaceutical companies have to follow different approaches in the different regions. This guideline will provide recommendations to support the biopharmaceutics classification of medicinal products and will provide rec...

Europe - EMA - European Medicines Agency

1-8-2018

Scientific guideline:  Draft questions and answers on Data Monitoring Committees issues, draft: consultation open

Scientific guideline: Draft questions and answers on Data Monitoring Committees issues, draft: consultation open

The aim of this question-and-answer document is to supplement the CHMP Data Monitoring Committee Guideline (Doc Ref. EMEA/CHMP/EWP/5872/03) by providing clarification on the role and necessity for a Data Monitoring Committee (DMC) in different phases of drug development and throughout the product lifecycle as well as with regard to the responsibilities for implementing DMC decisions.

Europe - EMA - European Medicines Agency