Betnovate Scalp Application

Informazioni principali

  • Nome commerciale:
  • Betnovate Scalp Application Lösung
  • Forma farmaceutica:
  • Lösung
  • Composizione:
  • betamethasonum 1 mg ut betamethasoni valeras, excipiens annuncio solutionem pro 1 g.
  • Utilizzare per:
  • Esseri umani
  • Tipo di medicina:
  • Farmaco biologico

Documenti

  • per i professionisti:
  • Il foglio illustrativo per questo prodotto non è al momento disponibile, é possibile inviare una richiesta al nostro Servizio Clienti ed essere avvisati nel momento in cui è disponibile sulla nostra piattaforma.


    Richiedi il foglio illustrativo per i professionisti.

Localizzazione

  • Disponibile in:
  • Betnovate Scalp Application Lösung
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Entzündliche, nicht infizierte Dermatosen der Kopfhaut

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 33311
  • Data dell'autorizzazione:
  • 12-09-1967
  • Ultimo aggiornamento:
  • 19-10-2018

Foglio illustrativo: composizione, posologia, indicazioni, interazioni, gravidanza, allattamento, effetti indesiderati, controindicazioni

Patienteninformation

Betnovate®

GlaxoSmithKline AG

Che cos’è Betnovate e quando si usa?

Betnovate contiene come principio attivo un corticosteroide a forte azione per uso esterno. Esso

viene impiegato per il trattamento di eczemi di origini diverse, psoriasi, reazioni alle punture di

insetti e altre malattie della pelle di tipo infiammatorio o allergico.

L'uso di Betnovate porta un rapido alleviamento delle manifestazioni che accompagnano la malattia

della pelle, quali prurito, bruciore e arrossamento.

Betnovate va utilizzato solo su prescrizione del medico.

Quando non si può usare il Betnovate?

In presenza di rosacea, acne, prurito della cute senza infiammazione, prurito anale o della zona

genitale, reazioni infiammatorie della pelle in prossimità della bocca e con malattie della pelle

causate in prima linea da virus (ad esempio herpes, come nel caso di vescicole di febbre, varicella,

ecc.), da batteri o da funghi.

Betnovate non va usato nei bambini di età inferiore a un anno.

Betnovate scalp application non va applicato nelle vicinanze degli occhi.

Quando è richiesta prudenza nell’uso di Betnovate?

Betnovate è un farmaco dall'azione intensa. Non usare per periodi maggiori della durata di

trattamento prescritta dal medico, solitamente pari a 2-4 settimane, per evitare che insorgano danni

alla pelle.

Se la malattia della pelle non risponde alla terapia entro alcuni giorni o se addirittura peggiora,

consultare il medico. Può darsi che si tratti di un'allergia o di un'infezione. Inoltre informi il suo

medico in caso di comparsa di prurito e arrossamento, vescicole, forte assottigliamento della pelle o

ferite.

Informi il suo medico se è allergico al betametasone o a uno dei componenti del medicamento.

Questo medicamento non va utilizzato ininterrottamente ogni giorno per più di quattro settimane.

L'eventuale uso ininterrotto per lunghi periodi è possibile solo dietro istruzione esplicita da parte del

medico.

L'uso del prodotto su grandi superfici (più del 10% della superficie corporea) va evitato, così come

l'uso su zone della pelle da cui il principio attivo può penetrare nel sangue con maggiore facilità

(ferite aperte, pelle danneggiata, pieghe della pelle, parti interne delle articolazioni, tra le dita della

mano o del piede, in corrispondenza del confine tra pelle e mucosa e intorno agli occhi).

Utilizzare fasciature ermetiche sopra questo medicamento solo dietro indicazione del medico. Se si

utilizza Betnovate sotto a una fasciatura ermetica, prestare attenzione a pulire la pelle prima

dell'applicazione di una nuova fasciatura, al fine di evitare infezioni.

In presenza di un eczema nell'area di un'ulcera delle gambe, l'impiego di un corticosteroide topico

può aumentare il rischio di reazione allergica o di infezione nell'area dell'ulcera.

Si rivolga al suo medico nel caso in cui sviluppi un'infezione.

Come per tutti i corticosteroidi, è bene evitare l'applicazione di lungo termine (più di una settimana)

sulla pelle particolarmente sensibile del viso e vicino agli organi genitali. Se in casi eccezionali il

medico dovesse ordinarne l'applicazione sulle palpebre, occorre evitare con attenzione che il prodotto

entri negli occhi.

Nei bambini piccoli, a partire da un anno di età, e nei bambini più grandi, Betnovate va applicato con

particolare attenzione, per periodi brevi e solo su superfici ridotte.

Per il trattamento dell'eczema dovuto ai pannolini, i pannolini stretti e le mutandine per pannolini in

plastica facilitano l'assorbimento del principio attivo nella circolazione sanguigna. Per questo motivo,

se possibile, è opportuno utilizzare pannolini in stoffa senza mutandine in plastica.

Durante l'impiego di Betnovate scalp application e lozione non è consentito fumare e bisogna evitare

di sostare in prossimità di fiamme scoperte e fonti di calore, incluso l'asciugacapelli (pericolo

d'infiammabilità).

Betnovate va impiegato solo per la malattia per cui esso è stato prescritto dal medico e non va

conservato per eventuali malattie future. Betnovate non va dato ad altre persone.

Informi il suo medico o il farmacista se

·soffre di altre malattie,

·soffre di allergie o

·assume o applica esternamente altri medicamenti (anche se acquistati di sua iniziativa!).

Si può usare Betnovate durante la gravidanza o l’allattamento?

Durante la gravidanza, o se si intende iniziare una gravidanza, Betnovate va impiegato

esclusivamente su indicazione del medico. Lo stesso vale durante l'allattamento. Se dovesse

utilizzare comunque Betnovate durante l'allattamento, non può applicarlo nella zona del seno, al fine

di evitare che il bambino lo ingerisca inavvertitamente.

Come usare Betnovate?

A meno che il medico non abbia fornito istruzioni diverse, Betnovate va applicato con parsimonia 1

– 2 volte al giorno sulle zone di pelle ammalate, fino alla comparsa di un miglioramento.

Successivamente il processo di guarigione va mantenuto, secondo l'istruzione del medico,

proseguendo il trattamento con applicazioni di frequenza giornaliera o minore. Lavarsi le mani dopo

l'applicazione, a meno che il trattamento non riguardi le mani.

Se si impiega anche un prodotto di cura (crema idratante), attendere l'assorbimento completo di

Betnovate prima di applicare il prodotto di cura.

Il flacone di Betnovate scalp application ha un beccuccio prolungato che ne facilita l'applicazione

direttamente sulle zone interessate del cuoio capelluto. I capelli lavati devono essere asciutti prima di

applicare il liquido. Betnovate scalp application si distribuisce subito dopo l'applicazione, formando

una sottile pellicola sulle zone interessate; non incolla i capelli e, una volta asciutto, non lascia alcun

residuo visibile. Fino a che il liquido non si è asciugato, sul cuoio cappelluto permane una sensazione

di fresco.

Se ha dimenticato un'applicazione di Betnovate, la esegua non appena se ne ricorda e poi prosegua il

trattamento come di consueto. Non applichi una quantità maggiore di medicamento se ha dimenticato

la precedente applicazione.

Non modifichi di sua iniziativa la posologia del medicamento che le è stata prescritta. Se ritiene che

il farmaco agisca troppo o troppo poco, ne parli al suo medico o al suo farmacista.

Quali effetti collaterali può avere Betnovate?

I seguenti effetti collaterali possono comparire durante l'utilizzazione di Betnovate: effetti

indesiderati di carattere locale, come irritazione della pelle, bruciore, prurito e secchezza, come pure

reazioni di ipersensibilità.

Se si manifestassero segni di ipersensibilità, interrompere subito il trattamento e informare il medico.

Sono stati osservati anche casi di peggioramento o di ricaduta della malattia della pelle per cui viene

effettuato il trattamento.

Un trattamento intenso e di lunga durata con corticosteroidi a forte azione, particolarmente se

l'applicazione avviene sotto una fasciatura o nelle pieghe del corpo, possono comportare

assottigliamento della pelle, formazione di striature, pieghe cutanee, allargamento di piccoli vasi

superficiali della pelle, alterazioni della pigmentazione, aumento di peso/sovrappeso, “faccia di

luna”, secchezza cutanea, perdita di capelli e incremento della peluria corporea. Nel caso in cui soffra

di psoriasi, in casi molto rari, durante o dopo il trattamento è possibile la formazione di piccoli noduli

purulenti sottocutanei.

Nei bambini, particolarmente lattanti e bambini piccoli, va ricordato che l'assunzione del principio

attivo nel flusso sanguigno è maggiore, e che in caso di utilizzo per periodi prolungati possono

pertanto verificarsi tra l'altro anche disturbi della crescita. Inoltre i pannolini possono avere l'effetto

di una fasciatura.

Nel caso lei noti effetti collaterali che non sono stati descritti qui, informi il suo medico o farmacista.

Di che altro occorre tener conto?

Betnovate va conservato a temperatura ambiente (15-25 °C) e fuori dalla portata dei bambini. Il

prodotto non va usato oltre la data indicata con «EXP» sulla confezione.

Betnovate scalp application/lozione non va impiegato in prossimità di fiamme scoperte o fonti di

calore (pericolo d'infiammabilità). Proteggere dall'irradiazione solare diretta.

Il suo medico o il suo farmacista, che possiedono una documentazione professionale dettagliata, le

possono fornire ulteriori informazioni.

Cosa contiene Betnovate?

1 g di Betnovate crema contiene come principio attivo 1 mg di betametasone sotto forma di

betametasone valerato, clorocresolo come conservante e altre sostanze ausiliarie (base lavabile non

oleosa).

1 g di Betnovate unguento contiene come principio attivo 1 mg di betametasone sotto forma di

betametasone valerato e sostanze ausiliarie (base oleosa non lavabile).

1 g di Betnovate lozione contiene come principio attivo 1 mg di betametasone sotto forma di

betametasone valerato, metil-p-idrossibenzoato (E 218) come conservante e altre sostanze ausiliarie

(base di pronta applicazione non oleosa).

1 g di Betnovate scalp application contiene come principio attivo 1 mg di betametasone sotto forma

di betametasone valerato e altre sostanze ausiliarie (soluzione alcolica per l'uso sul cuoio capelluto).

Numero dell’omologazione

Betnovate crema: 30968 (Swissmedic).

Betnovate unguento: 30970 (Swissmedic).

Betnovate lozione: 30969 (Swissmedic).

Betnovate scalp application: 33311 (Swissmedic).

Dov’è ottenibile il Betnovate? Quali confezioni sono disponibili?

Betnovate può essere ottenuto in farmacia, solo dietro presentazione della ricetta medica.

Crema e unguento in confezioni da 15 g e 30 g; lozione in confezione da 20 ml; scalp application in

confezioni da 30 ml e 100 ml.

Titolare dell’omologazione

GlaxoSmithKline AG, 3053 Münchenbuchsee.

Questo foglietto illustrativo è stato controllato l'ultima volta nel febbraio 2014 dall'autorità

competente in materia di medicamenti (Swissmedic).

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Safety and efficacy of Monteban® G100 (narasin) for ducks for fattening

Safety and efficacy of Monteban® G100 (narasin) for ducks for fattening

Published on: Wed, 21 Nov 2018 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Monteban® G100 for ducks. Monteban® G100, containing narasin, is intended for the prevention of coccidiosis in ducks for fattening at a dose range of 60–70 mg/kg of complete feed. Narasin from Monteban® G100 is safe for ducks for fattening at a level of 70 mg/kg complete feed...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐011)

Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐011)

Published on: Fri, 16 Nov 2018 Following the submission of application EFSA‐GMO‐RX‐011 under Regulation (EC) No 1829/2003 from Monsanto Europe, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified soybean MON 89788, for food and feed uses, excluding cultivation within the European Union....

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Review of the existing maximum residue levels for tau‐fluvalinate according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for tau‐fluvalinate according to Article 12 of Regulation (EC) No 396/2005

Published on: Fri, 16 Nov 2018 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tau‐fluvalinate. To assess the occurrence of tau‐fluvalinate residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member St...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Recommendations on the use of the proportionality approach in the framework of risk assessment for pesticide residues

Recommendations on the use of the proportionality approach in the framework of risk assessment for pesticide residues

Published on: Wed, 14 Nov 2018 The technical report reflects the outcome of the discussions and agreements that were reached in the pesticides peer review meeting on residues and maximum residue levels regarding the principles and guidance for application of the proportionality concept in the risk assessment methodologies used at European level for the estimation of the maximum residue levels for pesticides. In addition, practical experiences on the use of the proportionality approach gained by EFSA hav...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Published on: Wed, 14 Nov 2018 Following the submission of application EFSA‐GMO‐RX‐010 under Regulation (EC) No 1829/2003 from Bayer, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified LLCotton25, for food and feed uses, import and processing, excluding cultivation within the EU. The d...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Published on: Wed, 14 Nov 2018 The scope of application EFSA‐GMO‐DE‐2016‐133 is for food and feed uses, import and processing of genetically modified (GM) maize MZHG0JG in the European Union. Maize MZHG0JG was developed to confer tolerance to the herbicidal active substances glyphosate and glufosinate‐ammonium. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and com...

Europe - EFSA - European Food Safety Authority Publications

10-11-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Published on: Fri, 09 Nov 2018 00:00:00 +0100 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for propolis extract are presented. The context of the evaluation ...

Europe - EFSA - European Food Safety Authority Publications

8-11-2018

Hazard analysis approaches for certain small retail establishments and food donations: second scientific opinion

Hazard analysis approaches for certain small retail establishments and food donations: second scientific opinion

Published on: Wed, 07 Nov 2018 00:00:00 +0100 In 2017, EFSA published a ‘simplified’ food safety management system (FSMS) for certain small retail establishments (butcher, grocer, baker, fish and ice cream shop) based on the application of prerequisite programme (PRP) criteria. The aim of this opinion was to develop similar FSMSs for other small retail enterprises including retail distribution centres, supermarkets, restaurants (including pubs and other catering activities) and food donation. The latter...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Published on: Tue, 30 Oct 2018 00:00:00 +0100 In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide an update of the reasoned opinion on the review of existing maximum residue levels (MRLs) for imazalil published on 5 September 2017, taking into account the additional information provided on the toxicity of the metabolites R014821, FK‐772 and FK‐284. EFSA did not derive MRL proposals from the post‐harvest uses reported on citrus fru...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Guidance on the scientific requirements for health claims related to muscle function and physical performance

Guidance on the scientific requirements for health claims related to muscle function and physical performance

Published on: Tue, 30 Oct 2018 00:00:00 +0100 EFSA has asked the Panel on Nutrition, Novel Foods and Food Allergens (NDA) to update the guidance on the scientific requirements for health claims related to physical performance published in 2012. The update takes into account the experience gained by the NDA Panel with the evaluation of additional health claim applications, changes introduced to the general scientific guidance for stakeholders for health claims applications and information collected from ...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of a strain of Lactobacillus hilgardii and of Lactobacillus buchneri when used as a technological additive intended to improve ensiling at a proposed application rate of 3.0 x 108 colony forming units (CFU)/kg fresh material. The two bacterial species are considered by EFS...

Europe - EFSA - European Food Safety Authority Publications

22-10-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s ongoing commitment to improving efficiency, transparency of tobacco product application review process as part of FDA’s comprehensive framework to reduce tobacco-related disease and death

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s ongoing commitment to improving efficiency, transparency of tobacco product application review process as part of FDA’s comprehensive framework to reduce tobacco-related disease and death

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s ongoing commitment to improving efficiency, transparency of tobacco product application review process as part of FDA’s comprehensive framework to reduce tobacco-related disease and death.

FDA - U.S. Food and Drug Administration

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant, Nichino Europe Co. Ltd., submitted application request to the competent national authority in the Netherlands to evaluate confirmatory data that were identified for pyraflufen‐ethyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted data were sufficient to confirm the MRLs for citrus fruits, tree nuts, pome fruits, stone fruits, table and wine grapes, curra...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Stagonosporopsis andigena

Pest categorisation of Stagonosporopsis andigena

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of Stagonosporopsis andigena, the causal agent of black blight of potato, for the EU. The pest is a well‐defined fungal species and reliable methods exist for its detection and identification. S. andigena is present in Bolivia and Peru. The pest is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC as Phoma andina, meaning its introduction into the EU is prohibited. The ma...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Thecaphora solani

Pest categorisation of Thecaphora solani

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of the fungus Thecaphora solani, the causal agent of smut of potato, for the EU. The identity of the pest is well established and reliable methods exist for its detection and identification. T. solaniis present in Bolivia, Chile, Colombia, Ecuador, Mexico, Panama, Peru and Venezuela. The pathogen is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC, meaning its introducti...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Published on: Mon, 15 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant, BASF SE, submitted an application to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance mepiquat in cotton seeds. The data submitted in support of the application were found to be sufficient to derive a MRL proposal for cotton seeds and the previously derived MRL proposals for animal commodities were found to be stil...

Europe - EFSA - European Food Safety Authority Publications

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

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

Published on: Tue, 25 Sep 2018 00:00:00 +0200 Abstract Following a notification from Sorghum Zrt., submitted to the European Commission under Article 14 of Regulation (EU) 2015/2283 to place on the market syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country (TF), and in line with Article 15(2) of that Regulation, EFSA was asked by the European Commission whether there are duly reasoned safety objections to the placing on the market of the TF within the European Union. The ap...

Europe - EFSA - European Food Safety Authority Publications

24-9-2018

FDA Announces Availability of Resources for Animal Drug Sponsors

FDA Announces Availability of Resources for Animal Drug Sponsors

The FDA is making available two pre-recorded webinars and a slide presentation to help drug sponsors understand recent changes to the submission process for new animal drug applications and related submissions. The changes take effect 10/1/2018.

FDA - U.S. Food and Drug Administration

21-9-2018

Scientific guideline:  Guideline on determination of withdrawal periods for edible tissues - Revision 1, adopted

Scientific guideline: Guideline on determination of withdrawal periods for edible tissues - Revision 1, adopted

This document provides a standard approach to be used across the European Union in the analysis of residue depletion data for the purpose of establishing withdrawal periods for edible tissues. Emphasis has been put on a statistical approach. As the method of first choice, a linear regression technique is recommended. A computerised version of the method described is available: Updated application software: withdrawal time calculation for tissues. Read together with the explanatory note on updated applica...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-1-2019


European Medicines Agency practical guidance on the application form for centralised type IA and IB variations for veterinary medicinal products

European Medicines Agency practical guidance on the application form for centralised type IA and IB variations for veterinary medicinal products

European Medicines Agency practical guidance on the application form for centralised type IA and IB variations for veterinary medicinal products

Europe - EMA - European Medicines Agency

16-1-2019

TGA vs Industry time for GMP clearance applications

TGA vs Industry time for GMP clearance applications

We have started to accurately capture the processing times of CV applications by consistently applying our stop clock process throughout the entire application

Therapeutic Goods Administration - Australia

14-1-2019


Applications for new human medicines under evaluation by the CHMP: January 2019

Applications for new human medicines under evaluation by the CHMP: January 2019

Applications for new human medicines under evaluation by the CHMP: January 2019

Europe - EMA - European Medicines Agency

14-12-2018


Withdrawn application: Fyzoclad, adalimumab, Date of withdrawal: 05/12/2018, Initial authorisation

Withdrawn application: Fyzoclad, adalimumab, Date of withdrawal: 05/12/2018, Initial authorisation

Withdrawn application: Fyzoclad, adalimumab, Date of withdrawal: 05/12/2018, Initial authorisation

Europe - EMA - European Medicines Agency

14-12-2018


Withdrawn application: Canakinumab Novartis, canakinumab, Date of withdrawal: 04/12/2018, Initial authorisation

Withdrawn application: Canakinumab Novartis, canakinumab, Date of withdrawal: 04/12/2018, Initial authorisation

Withdrawn application: Canakinumab Novartis, canakinumab, Date of withdrawal: 04/12/2018, Initial authorisation

Europe - EMA - European Medicines Agency

11-12-2018


Withdrawn application: Opdivo, nivolumab, Date of withdrawal: 27/06/2018, Post-authorisation

Withdrawn application: Opdivo, nivolumab, Date of withdrawal: 27/06/2018, Post-authorisation

Withdrawn application: Opdivo, nivolumab, Date of withdrawal: 27/06/2018, Post-authorisation

Europe - EMA - European Medicines Agency

4-12-2018

TGA presentation: Advertising therapeutic goods in 2019: The Code basics, 13 and 15 November 2018

TGA presentation: Advertising therapeutic goods in 2019: The Code basics, 13 and 15 November 2018

A detailed walkthrough of the Code with examples to illustrate the application of the key sections.

Therapeutic Goods Administration - Australia

3-12-2018


Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Europe - EMA - European Medicines Agency

30-11-2018

Selected participants will work directly with the FDA to accelerate the development of and eventual review of marketing applications for these innovative products. Read more:  https://go.usa.gov/xPMPk pic.twitter.com/6rRnfSyLy4

Selected participants will work directly with the FDA to accelerate the development of and eventual review of marketing applications for these innovative products. Read more: https://go.usa.gov/xPMPk pic.twitter.com/6rRnfSyLy4

Selected participants will work directly with the FDA to accelerate the development of and eventual review of marketing applications for these innovative products. Read more: https://go.usa.gov/xPMPk  pic.twitter.com/6rRnfSyLy4

FDA - U.S. Food and Drug Administration

26-11-2018


Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation

Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation

Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation

Europe - EMA - European Medicines Agency

26-11-2018

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient https://go.usa.gov/xPHdE 

FDA - U.S. Food and Drug Administration

31-10-2018

Advertising to the public

Advertising to the public

This guidance is designed to provide further information about the understanding, interpretation and application of the Code provisions

Therapeutic Goods Administration - Australia

30-9-2018

Today is the last day to submit applications to the #FDAInnovationChallenge. Thanks to all who have applied.  Selected applications will be announced in November. For more information about the challenge, click the link:   https://go.usa.gov/xP4Nk pic.twi

Today is the last day to submit applications to the #FDAInnovationChallenge. Thanks to all who have applied. Selected applications will be announced in November. For more information about the challenge, click the link: https://go.usa.gov/xP4Nk pic.twi

Today is the last day to submit applications to the #FDAInnovationChallenge. Thanks to all who have applied. Selected applications will be announced in November. For more information about the challenge, click the link: https://go.usa.gov/xP4Nk  pic.twitter.com/pFJZ39oGJC

FDA - U.S. Food and Drug Administration

29-9-2018

Reminder: the last day to submit applications to the #FDAInnovationChallenge is tomorrow, September 30th. Click the link to find out more about the challenge and how to submit your application:  https://go.usa.gov/xP4Nk pic.twitter.com/lLYiMa0cLe

Reminder: the last day to submit applications to the #FDAInnovationChallenge is tomorrow, September 30th. Click the link to find out more about the challenge and how to submit your application: https://go.usa.gov/xP4Nk pic.twitter.com/lLYiMa0cLe

Reminder: the last day to submit applications to the #FDAInnovationChallenge is tomorrow, September 30th. Click the link to find out more about the challenge and how to submit your application: https://go.usa.gov/xP4Nk  pic.twitter.com/lLYiMa0cLe

FDA - U.S. Food and Drug Administration

26-9-2018

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application:   http://go.usa.g

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application: http://go.usa.g

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application: http://go.usa.gov/xPrum  #MedicalDevice pic.twitter.com/Zsmq00NCdd

FDA - U.S. Food and Drug Administration

25-9-2018

Withdrawn application:  Entolimod TMC, entolimod, Initial authorisation

Withdrawn application: Entolimod TMC, entolimod, Initial authorisation

Europe - EMA - European Medicines Agency

24-9-2018

For more information about the #FDA’s effort to address the epidemic of  #opioid addiction, click the link to find out more about the  #FDAInnovationChallenge:  https://go.usa.gov/xPja7  The last day to submit  applications is September 30th, 2018.https:/

For more information about the #FDA’s effort to address the epidemic of #opioid addiction, click the link to find out more about the #FDAInnovationChallenge: https://go.usa.gov/xPja7  The last day to submit applications is September 30th, 2018.https:/

For more information about the #FDA’s effort to address the epidemic of #opioid addiction, click the link to find out more about the #FDAInnovationChallenge: https://go.usa.gov/xPja7  The last day to submit applications is September 30th, 2018. https://twitter.com/NIDAnews/status/1032719474934382593 …

FDA - U.S. Food and Drug Administration

21-9-2018

Regulatory and procedural guideline:  Draft qualification opinion on stride velocity 95th centile as a secondary endpoint in Duchenne Muscular Dystrophy measured by a valid and suitable wearable device, draft: consultation open

Regulatory and procedural guideline: Draft qualification opinion on stride velocity 95th centile as a secondary endpoint in Duchenne Muscular Dystrophy measured by a valid and suitable wearable device, draft: consultation open

This report provides a final agreed draft Context of Use for public consultation describing where Stride Velocity measured at the ankle 95th Centile is deemed by CHMP as an appropriate endpoint in studies to support regulatory decision making on medicines for the treatment of Duchenne Muscular Dystrophy (DMD), together with CHMP’s scientific consideration of the submission leading to the draft opinion. The document also includes the questions posed by the applicant and also raised by CHMP to the Applic...

Europe - EMA - European Medicines Agency