PRAVASTATINE International Drug Development

Information principale

  • Nom commercial:
  • PRAVASTATINE International Drug Development 10 mg, comprimé
  • Dosage:
  • 10 mg
  • forme pharmaceutique:
  • comprimé
  • Composition:
  • composition pour un comprimé > pravastatine sodique : 10 mg
  • Mode d'administration:
  • orale
  • Unités en paquet:
  • plaquette(s) thermoformée(s) aluminium PVC de 28 comprimé(s)
  • Type d'ordonnance:
  • liste I
  • Utiliser pour:
  • Humains
  • Type medicin:
  • médicament allopathique

Documents

Localisation

  • Disponible en:
  • PRAVASTATINE International Drug Development 10 mg, comprimé
    France
  • Langue:
  • français

Information thérapeutique

  • Domaine thérapeutique:
  • HYPOLIPIDEMIANTS / HYPOCHOLESTEROLEMIANTS ET HYPOTRIGLYCERIDEMIANTS / INHIBITEURS DE LA HMG-COA REDUCTASE
  • Descriptif du produit:
  • 376 694-9 ou 4009 376 694 9 8 - plaquette(s) thermoformée(s) aluminium PVC de 28 comprimé(s) - Déclaration de commercialisation non communiquée:;376 695-5 ou 4009 376 695 5 9 - plaquette(s) thermoformée(s) aluminium PVC de 50 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:
  • 63392301
  • Date de l'autorisation:
  • 17-07-2006
  • Dernière mise à jour:
  • 11-08-2017

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

NOTICE

ANSM - Mis à jour le : 30/10/2014

Dénomination du médicament

PRAVASTATINE INTERNATIONAL DRUG DEVELOPMENT 10 mg, comprimé

Pravastatine sodique

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 PRAVASTATINE INTERNATIONAL DRUG DEVELOPMENT 10 mg, comprimé ET DANS QUELS

CAS EST-IL UTILISE ?

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

DRUG DEVELOPMENT 10 mg, comprimé ?

3. COMMENT PRENDRE PRAVASTATINE INTERNATIONAL DRUG DEVELOPMENT 10 mg, comprimé ?

4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?

5. COMMENT CONSERVER PRAVASTATINE INTERNATIONAL DRUG DEVELOPMENT 10 mg, comprimé ?

6. INFORMATIONS SUPPLEMENTAIRES

1. QU'EST-CE QUE PRAVASTATINE INTERNATIONAL DRUG DEVELOPMENT 10 mg, comprimé ET DANS QUELS

CAS EST-IL UTILISE ?

Classe pharmacothérapeutique

Sans objet.

Indications thérapeutiques

Il est indiqué dans le traitement de certaines hypercholestérolémies, lorsqu'un régime adapté et assidu s'est avéré

insuffisant.

Ce médicament diminue le risque de survenue d'accident cardiovasculaire (infarctus du myocarde, angine de poitrine,

accident vasculaire cérébral) et le risque de décès lié à cette maladie chez les personnes:

ayant déjà eu un accident cardiaque (infarctus du myocarde ou angor instable) et présentant un taux de cholestérol normal

ou élevé;

n'ayant pas eu d'accident cardiaque mais présentant une augmentation du cholestérol modérée ou importante, associée à

des facteurs de risque cardiovasculaire.

Le traitement par ce médicament doit être associé au suivi des conseils hygiéno-diététiques préconisés par votre médecin.

Ce médicament est également indiqué chez les personnes ayant eu une transplantation d'organe, en association à des

médicaments immunosuppresseurs, pour diminuer le taux de cholestérol dans le sang.

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

DRUG DEVELOPMENT 10 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 PRAVASTATINE INTERNATIONAL DRUG DEVELOPMENT 10 mg, comprimé

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

PRAVASTATINE INTERNATIONAL DRUG DEVELOPMENT 10 mg, comprimé ?)

si vous êtes enceinte ou si vous êtes susceptible de l'être

si vous allaitez

si vous avez une affection hépatique évolutive ou une augmentation du taux des enzymes hépatiques dans le sang.

Précautions d'emploi ; mises en garde spéciales

Faites attention avec PRAVASTATINE INTERNATIONAL DRUG DEVELOPMENT 10 mg, comprimé:

Avant de prendre ce médicament, indiquez à votre médecin si vous avez ou si vous avez eu dans le passé une maladie

hépatique, une maladie rénale, une hypothyroïdie, une maladie musculaire héréditaire, des effets secondaires affectant les

muscles ayant été provoqués par un autre médicament hypocholestérolémiant du groupe des statines ou du groupe des

fibrates, une consommation d'importantes quantités d'alcool.

Si vous avez été concerné par l'un de ces problèmes ou si vous avez plus de 70 ans, votre médecin vous demandera de

réaliser des contrôles sanguins des enzymes hépatiques (transaminases) ou des enzymes musculaires (CPK), avant et

parfois pendant toute la durée du traitement par ce médicament.

Au cours du traitement, si vous ressentez de façon inexpliquée des crampes ou des douleurs musculaires, prévenez

rapidement votre médecin.

Au cours de votre traitement avec ce médicament, si vous êtes diabétique ou si vous présentez un risque de survenue d’un

diabète, vous serez suivi attentivement par votre médecin. Vous pouvez débuter un diabète si vous avez un taux de sucre

(glycémie) et de graisses élevés dans le sang, si vous êtes en surpoids et si vous avez une pression artérielle (tension)

élevée.

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,

même s'il s'agit d'un médicament obtenu sans ordonnance.

Il est particulièrement important que vous informiez votre médecin dans le cas où vous seriez déjà traité par un fibrate en

raison du risque potentiel de survenue d'un problème musculaire. Informez également votre médecin de la prise de

ciclosporine, d'érythromycine ou de clarithromycine.

Si vous devez prendre un agent hypolipémiant de type résine comme la cholestyramine ou colestipol, ce médicament doit

être pris 1 heure avant ou 4 heures après la prise de la résine. Cette précaution doit être prise car la résine peut affecter

l'absorption de pravastatine si les deux médicaments sont pris de manière trop rapprochée dans le temps.

Interactions avec les aliments et les boissons

Aliments et boissons

Ce médicament peut être pris pendant ou en dehors des repas.

Il ne doit pas être pris par des patients qui consomment régulièrement de grandes quantités d'alcool.

Interactions avec les produits de phytothérapie ou thérapies alternatives

Sans objet.

Utilisation pendant la grossesse et l'allaitement

Grossesse et allaitement

Grossesse

Ce médicament est contre-indiqué en cas de grossesse.

Si vous découvrez que vous êtes enceinte pendant le traitement, consultez rapidement votre médecin.

En cas de désir de grossesse, prévenez votre médecin.

Demandez conseil à votre médecin ou à votre pharmacien avant de prendre tout médicament.

Allaitement

Ce médicament est contre-indiqué si vous allaitez votre enfant car il passe dans le lait maternel.

Demandez conseil à votre médecin ou à votre pharmacien avant de prendre tout médicament.

Sportifs

Sans objet.

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

Conduite de véhicules et utilisation de machines

Ce médicament n'a pas ou peu d'influence sur l'aptitude à conduire des véhicules ou à utiliser des machines. Toutefois, lors

de la conduite de véhicules ou l'utilisation de machines, il devra être pris en compte la possible survenue de vertiges

pendant le traitement.

Liste des excipients à effet notoire

Liste des excipients à effet notoire: lactose.

3. COMMENT PRENDRE PRAVASTATINE INTERNATIONAL DRUG DEVELOPMENT 10 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

Respectez toujours la posologie indiquée par votre médecin. En cas d'incertitude, consultez votre médecin ou votre

pharmacien.

La dose habituelle est de 10 à 40 mg par jour, chez l'adulte.

Chez les enfants et les adolescents ayant une hypercholestérolémie familiale (maladie héréditaire) la dose habituelle est de

10 à 20 mg par jour entre 8 et 13 ans et de 10 à 40 mg par jour entre 14 et 18 ans.

Les comprimés peuvent être pris pendant ou en dehors des repas, de préférence le soir, en une prise.

Si vous avez l'impression que l'effet de PRAVASTATINE INTERNATIONAL DRUG DEVELOPMENT 10 mg, comprimé

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

Mode d'administration

Voie orale.

Les comprimés sont à avaler à l'aide d'un verre d'eau.

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

Symptômes et instructions en cas de surdosage

Si vous avez pris plus de PRAVASTATINE INTERNATIONAL DRUG DEVELOPMENT 10 mg, comprimé que vous

n'auriez dû: si vous avez pris trop de comprimés, ou si une autre personne en a avalé accidentellement, contactez votre

médecin ou l'hôpital le plus proche afin de recevoir des conseils.

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

Si vous oubliez de prendre PRAVASTATINE INTERNATIONAL DRUG DEVELOPMENT 10 mg, comprimé: si vous

oubliez une dose, prenez normalement la prochaine dose prévue.

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, PRAVASTATINE INTERNATIONAL DRUG DEVELOPMENT 10 mg, comprimé est

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

La plupart des effets indésirables rapportés sont peu fréquents: étourdissements, maux de tête, troubles du sommeil, troubles

de la vision, troubles gastro-intestinaux (diarrhée, nausées, vomissements, douleurs abdominales...), démangeaisons,

éruptions cutanées, urticaire, problème touchant les cheveux et le cuir chevelu, troubles urinaires, troubles sexuels, fatigue,

douleurs et crampes musculaires (accompagnées parfois d'une augmentation des enzymes musculaires, les CPK), douleurs

articulaires, augmentation de certains enzymes du foie (les transaminases).

Très rarement ont été rapportés: troubles du système nerveux (polyneuropathies et paresthésies), réactions allergiques

sévères (incluant un gonflement localisé de la face, des lèvres et/ou de la langue), éruptions cutanées pseudo-lupiques,

inflammations du foie ou du pancréas, jaunisse, problèmes musculaires appelés rhabdomyolyse, pouvant être graves.

Des cas exceptionnels d'atteinte des tendons ont également été observés.

Si vous ressentez des douleurs musculaires, une sensibilité musculaire douloureuse ou une fatigue musculaire,

spécialement si vous ressentez un malaise ou avez une température élevée, contactez votre médecin immédiatement car les

problèmes musculaires peuvent être graves dans de rares cas.

Autres effets indésirables éventuels :

cauchemars,

perte de mémoire,

dépression,

problèmes respiratoires, y compris toux persistante et/ou essoufflement et fièvre,

diabète : vous pouvez débuter un diabète si vous avez un taux de sucre (glycémie) et de graisses élevés dans le sang, si

vous êtes en surpoids et si vous avez une pression artérielle (tension) élevée. Vous serez suivi attentivement par votre

médecin au cours de votre traitement avec ce médicament.

Déclaration des effets secondaires :

Si vous ressentez un quelconque effet indésirable, parlez-en à votre médecin ou à votre pharmacien. Ceci s’applique aussi

à tout effet indésirable qui ne serait pas mentionné dans cette notice. Vous pouvez également déclarer les effets indésirables

directement via le système national de déclaration : Agence nationale de sécurité du médicament et des produits de santé

(Ansm) et réseau des Centres Régionaux de Pharmacovigilance - Site internet: www.ansm.sante.fr. En signalant les effets

indésirables, vous contribuez à fournir davantage d’informations sur la sécurité du médicament

5. COMMENT CONSERVER PRAVASTATINE INTERNATIONAL DRUG DEVELOPMENT 10 mg, comprimé ?

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

Date de péremption

Ne pas utiliser PRAVASTATINE INTERNATIONAL DRUG DEVELOPMENT 10 mg, comprimé après la date de péremption

mentionnée sur la boîte, les plaquettes.

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 PRAVASTATINE INTERNATIONAL DRUG DEVELOPMENT 10 mg, comprimé ?

La substance active est:

Pravastatine sodique ......................................................................................................................... 10 mg

Pour un comprimé.

Les autres composants sont:

Lactose monohydraté, cellulose microcristalline, croscarmellose sodique, stéarate de magnésium, oxyde de fer rouge

(E172).

Forme pharmaceutique et contenu

Qu'est-ce que PRAVASTATINE INTERNATIONAL DRUG DEVELOPMENT 10 mg, comprimé et contenu de

l'emballage extérieur ?

Ce médicament se présente sous forme de comprimé. Boîte de 28 ou 50 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

FRANCE

Exploitant

KATWIJK FARMA BV

Archimedesweg 2

P.O Box 408

2300 AK LEIDEN

PAYS BAS

Fabricant

CHANELLE MEDICAL LIMITED

IDA Industrial Estate,

Loughrea, Co. Galway

IRLANDE

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.

6-12-2018

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21-11-2018

Public Notification: Pink Granada contains hidden drug ingredients

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Published on: Tue, 20 Nov 2018 The feed additive Monteban® G100, containing the active substance narasin, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 60–70 mg/kg complete feed. Narasin is produced by fermentation. Limited data on the taxonomic identification of the production strain did not allow the proper identification of strain NRRL 8092 as Streptomyces aureofaciens. The FEEDAP Panel cannot conclude on the absence of genetic determinants for ...

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17-11-2018

Recall of Green Cedar Dairy Ackawi Cheese Bearing a Sell by Date of March 26, 2019 or Later

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Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

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Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

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8-11-2018

Public Notification: Best Leopard Miracle of Honey contains hidden drug ingredients

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Public Notification: Leopard Secret Miracle Honey contains hidden drug ingredient

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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)

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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).

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15-10-2018

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9-10-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance the development of generic copies of complex drugs to improve patient access to medicines

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1-10-2018

Public Notification: Shengan Natural Model contains hidden drug ingredient

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1-10-2018

Public Notification: USA for Women contains hidden drug ingredient

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1-10-2018

Public Notification: In Shape contains hidden drug ingredient

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1-10-2018

Public Notification: ProSolution contains hidden drug ingredient

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FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: FX75000 contains hidden drug ingredient

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1-10-2018

Public Notification: Baschi Quick Slimming Capsule contains hidden drug ingredients

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1-10-2018

Public Notification: V-Max contains hidden drug ingredient

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1-10-2018

Public Notification: Strong Horses contains hidden drug ingredient

Public Notification: Strong Horses contains hidden drug ingredient

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FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: Green Lean Body Capsule contains hidden drug ingredients

Public Notification: Green Lean Body Capsule contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Green Lean Body 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

1-10-2018

Public Notification: Like Slim Coffee contains hidden drug ingredient

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28-9-2018

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26-9-2018

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

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31-8-2018

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

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31-8-2018

Public Notification: PremierZen Gold 4000 contains hidden drug ingredient

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

29-8-2018

SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area

SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area

Requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide.

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

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

Europe -DG Health and Food Safety

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

10-7-2018

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Active substance: Sodium phenylbutyrate) - Centralised - Yearly update - Commission Decision (2018)4483 of Tue, 10 Jul 2018

Europe -DG Health and Food Safety