Dermovate Scalp Application

Informazioni principali

  • Nome commerciale:
  • Dermovate Scalp Application Lösung
  • Forma farmaceutica:
  • Lösung
  • Composizione:
  • clobetasoli-17 propionas di 0,5 mg alcol isopropylicus, 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:
  • Dermovate Scalp Application Lösung
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Nicht infizierte, entzündliche Dermatosen der Kopfhaut

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 41823
  • Data dell'autorizzazione:
  • 23-02-1979
  • Ultimo aggiornamento:
  • 19-10-2018

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

Patienteninformation

Dermovate®

GlaxoSmithKline AG

Che cos'è Dermovate e quando si usa?

Dermovate contiene come principio attivo un corticosteroide ad effetto terapeutico molto forte per

uso topico. Il preparato si usa per il trattamento di dermopatie ostinate non infette quali psoriasi ed

eczemi di diversa origine, specie se tali affezioni non rispondono a corticosteroidi ad azione più

debole.

L'impiego di Dermovate porta ad un rapido alleviamento dei sintomi concomitanti della malattia

cutanea, in particolare prurito, bruciore ed arrossamento.

Il medicamento deve essere usato solo su prescrizione medica.

Quando non si può usare Dermovate?

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

genitale, dermatiti periorali e malattie della pelle causate da virus (p.es. infezioni erpetiche quali

herpes labiale, varicella, ecc.), da batteri o da funghi.

Inoltre, Dermovate non deve essere applicato su ferite aperte o su infezioni purulente quali foruncoli

od ascessi.

Dermovate non deve essere usato per bambini di età inferiore a 1 anno.

Dermovate scalp application non deve essere applicato in prossimità degli occhi.

Quando è richiesta prudenza nell’uso di Dermovate?

Dermovate è un medicamento molto potente. Non si deve superare la durata della terapia prescritta

dal medico, solitamente pari a 2-3 settimane, poiché altrimenti possono insorgere danni alla pelle.

Qualora sia necessario un trattamento di maggiore durata, non si deve applicare ininterrottamente il

preparato senza controllo medico per più di 4 settimane. Un'applicazione ininterrotta e di lunga

durata nonché un uso ripetuto e su estese superfici cutanee vanno effettuati solo su esplicita

prescrizione medica.

Se una dermopatia non risponde al trattamento entro pochi giorni o addirittura peggiora, occorre

consultare il medico. Bisogna segnalare al medico anche l'eventuale comparsa di prurito ed

arrossamento, vescicole, un forte assottigliamento della pelle o lesioni.

Informi il suo medico, se è allergico al clobetasolo o a uno degli altri componenti del medicamento.

Si deve evitare l'uso del prodotto su superfici estese (più del 10% della superficie corporea) nonché

su regioni cutanee in cui il principio attivo possa facilmente riversarsi nel circolo sanguigno (ferite

aperte, pelle lesa, pieghe della pelle, incavo di articolazioni, spazi tra le dita delle mani o dei piedi,

punti di transizione tra pelle e mucosa e zona perioculare).

Utilizzi bendaggi occlusivi sopra questo medicamento solo dietro indicazione del medico. Se utilizza

Dermovate sotto un bendaggio occlusivo, presti attenzione alla pulizia della pelle prima

dell'applicazione di un nuovo bendaggio, al fine di evitare infezioni.

In presenza di eczema nell'area di un'ulcera della gamba, 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, si sconsiglia l'applicazione prolungata sulla pelle particolarmente

sensibile del viso e nei pressi degli organi genitali.

Dermovate non deve entrare in contatto con gli occhi o essere applicato in prossimità degli occhi.

Durante l'impiego di Dermovate scalp application (prodotto infiammabile) non è consentito fumare e

sostare in prossimità di fiamme aperte e fonti di calore, incluso l'asciugacapelli.

Per quanto riguarda l'uso in pediatria, si raccomanda di applicare Dermovate con prudenza, non per

lungo tempo e non su grandi superfici.

Usi Dermovate solo per l'attuale malattia della pelle, per cui le è stato prescritto dal medico, e non

più tardi per altre affezioni cutanee. Non dia Dermovate ad altre persone.

Informi il suo medico o il suo farmacista nel caso in cui

·soffra di altre malattie,

·soffra di allergie o

·assuma o applichi esternamente altri medicamenti (anche se acquistati di sua iniziativa).

Si può usare Dermovate durante la gravidanza o l'allattamento?

Se è incinta o desidera una gravidanza, dovrebbe usare Dermovate solo dopo averne parlato col suo

medico. La stessa avvertenza vale se allatta il suo bambino.

Se dovesse utilizzare ugualmente Dermovate durante l'allattamento, non deve applicarlo nella zona

del seno, al fine di evitare che il bambino lo ingerisca inavvertitamente.

Come usare Dermovate?

Salvo diversa prescrizione medica, applicare Dermovate crema o unguento con parsimonia 1-2 volte

al giorno sulle zone cutanee malate. Dermovate scalp application va applicato con parsimonia

mattina e sera sul cuoio capelluto, fino ad ottenere un miglioramento. In seguito il trattamento viene

solitamente proseguito utilizzando un corticosteroide meno potente.

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

Se impiega anche un prodotto per la cura della pelle (crema idratante), attenda l'assorbimento

completo di Dermovate prima di applicare il prodotto di cura.

Il flaconcino di Dermovate scalp application ha un beccuccio allungato che permette di applicare

facilmente il preparato direttamente sulle zone cutanee malate coperte da peli.

I capelli lavati devono essere asciutti prima di applicare il liquido. Dermovate scalp application si

spande da solo subito dopo l'applicazione e forma una pellicola sottile sulle zone malate; non incolla

i capelli e, una volta asciutto, non lascia residui visibili.

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

Se ha dimenticato un'applicazione di Dermovate, 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 propria iniziativa la posologia prescritta. Se ritiene che l'azione del medicamento

sia troppo debole o troppo forte, ne parli al suo medico o al suo farmacista.

Quali effetti collaterali può avere Dermovate?

Con l'applicazione di Dermovate possono manifestarsi i seguenti effetti collaterali: effetti indesiderati

locali quali irritazione della pelle, bruciore, prurito e secchezza, nonché reazioni di ipersensibilità.

Qualora si verificassero segni di ipersensibilità, si deve interrompere subito il trattamento ed

informarne il medico.

Si è osservato anche un peggioramento/riaccensione della dermopatia trattata con Dermovate. In casi

molto rari, è stata osservata la comparsa di acne.

Trattamenti protratti e intensi con corticosteroidi molto potenti, specialmente sotto bendaggi

occlusivi o applicati nelle pieghe del corpo, possono provocare i seguenti effetti: assottigliamento

della pelle, formazione di strie, pieghe cutanee, dilatazione di piccoli vasi sanguigni superficiali,

alterazioni della pigmentazione, aumento di peso/sovrappeso, faccia a forma di luna, secchezza

cutanea, perdita di capelli ed aumento della peluria corporea.

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

noduli purulenti sottocutanei.

Nei bambini, specialmente nei lattanti e nei bambini piccoli, bisogna tener presente che il principio

attivo viene assorbito nel circolo sanguigno in misura maggiore, per cui, in caso di uso prolungato,

possono insorgere, tra l'altro, disturbi della crescita. Inoltre, i pannolini possono avere l'effetto di un

bendaggio occlusivo.

Informi il suo medico se durante il trattamento osserva un peggioramento dell'affezione cutanea.

Se osserva effetti collaterali qui non descritti deve informare il suo medico o il suo farmacista.

Di che altro occorre tener conto?

Il medicamento non dev'essere utilizzato oltre la data indicata con «EXP» sul contenitore.

Dermovate va conservato nella confezione originale, a temperatura ambiente (15-25 °C) e fuori dalla

portata dei bambini. Dermovate scalp application non va impiegato in prossimità di fiamme aperte o

fonti di calore (è un prodotto infiammabile). Proteggere Dermovate scalp application

dall'irradiazione solare diretta.

Il suo medico o il suo farmacista, che sono in possesso di un'informazione professionale dettagliata,

possono darle ulteriori informazioni.

Cosa contiene Dermovate?

Unguento: 1 g di Dermovate unguento contiene come principio attivo 0,5 mg di clobetasolo-17-

propionato, nonché glicole propilenico e altre sostanze ausiliarie (base grassa non lavabile).

Crema: 1 g di Dermovate crema contiene come principio attivo 0,5 mg di clobetasolo-17-propionato,

il conservante clorocresolo nonché glicole propilenico ed altre sostanze ausiliarie (base lavabile).

Scalp Application: 1 g di Dermovate scalp application contiene come principio attivo 0,5 mg di

clobetasolo-17-propionato, nonché isopropanolo e altre sostanze ausiliarie (soluzione alcolica per

l'applicazione su pelle coperta da peli).

Numero dell'omologazione

39905, 39906, 41823 (Swissmedic).

Dov'è ottenibile Dermovate? Quali confezioni sono disponibili?

Dermovate è ottenibile in farmacia, dietro presentazione della prescrizione medica.

Dermovate crema: 25 g, 30 g e 100 g.

Dermovate unguento: 25 g, 30 g e 100 g.

Dermovate scalp application: 25 ml e 100 ml.

Titolare dell’omologazione

GlaxoSmithKline AG, 3053 Münchenbuchsee.

Questo foglietto illustrativo è stato controllato l’ultima volta nel settembre 2016 dall’autorità

competente in materia di medicamenti (Swissmedic).

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FDA clears a mobile medical application (app) to help increase retention (the amount of time a patient participates) in an outpatient treatment program for individuals with opioid use disorder

FDA - U.S. Food and Drug Administration

6-12-2018

Application deadlines in 2018

Application deadlines in 2018

The Danish Medicines Agency will be closed between Christmas and New Year from 22 December 2018 to 1 January 2019, both days inclusive. This means that enquiries made to the Danish Medicines Agency, with a few exceptions, will not be read and replied during this period. On this page, you can find the deadlines that apply to applications in the Danish Medicines Agency's area in 2018.

Danish Medicines Agency

4-12-2018

Joint project on Benchmark Dose modelling with RIVM

Joint project on Benchmark Dose modelling with RIVM

Published on: Mon, 03 Dec 2018 A web application for PROAST, a software package for BMD modelling, was developed to make the use of the BMD approach significantly easier for toxicologists and risk assessors. In addition, model averaging was included in the software, for the most frequently occurring types of data in toxicological studies. The PROAST web application now allows for applying model averaging for the case of both quantal and continuous data, as well as for combined datasets (dose‐response da...

Europe - EFSA - European Food Safety Authority Publications

1-12-2018

Safety assessment of the process ‘RecyPET Hungária’, based on RecyPET Hungária technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘RecyPET Hungária’, based on RecyPET Hungária technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 30 Nov 2018 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process RecyPET Hungária (EU register number RECYC0146). The input is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers, containing no more than 5% of PET from non‐food applications. The flakes are dried and extruded. The output of the extrusion step is cut into pellets in an underwater...

Europe - EFSA - European Food Safety Authority Publications

29-11-2018

Glyphosate: ANSES launches a comparative assessment with the available alternatives

Glyphosate: ANSES launches a comparative assessment with the available alternatives

Following the five-year re-approval of this active substance at European level in December 2017, ANSES is reassessing marketing authorisations for products containing glyphosate. For products for which an application for authorisation or re-authorisation has been submitted, the Agency will carry out a comparative assessment with the available alternatives. For each glyphosate-based product, all uses for which there is an alternative that meets the substitution criteria will therefore be prohibited.

France - Agence Nationale du Médicament Vétérinaire

28-11-2018

EFSA Scientific Colloquium 24 – 'omics in risk assessment: state of the art and next steps

EFSA Scientific Colloquium 24 – 'omics in risk assessment: state of the art and next steps

Published on: Tue, 27 Nov 2018 In recent years, the development of innovative tools in genomics, transcriptomics, proteomics and metabolomics (designated collectively as 'omics technologies) has opened up new possibilities for applications in scientific research and led to the availability of vast amounts of analytical data. The interpretation and integration of 'omics data can provide valuable information on the functional status of an organism and on the effect of external factors such as stressors. T...

Europe - EFSA - European Food Safety Authority Publications

27-11-2018

Risk assessment of new sequencing information for genetically modified soybean A2704‐12

Risk assessment of new sequencing information for genetically modified soybean A2704‐12

Published on: Mon, 26 Nov 2018 The GMO Panel has previously assessed genetically modified (GM) soybean A2704‐12. This soybean was found to be as safe and nutritious as its conventional counterpart with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 5 June 2018, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soybean A2704‐12 and to indicate whether the previous c...

Europe - EFSA - European Food Safety Authority Publications

26-11-2018

FDA Welcomes Grant Applications for Animal Drugs for Minor Uses and Minor Species

FDA Welcomes Grant Applications for Animal Drugs for Minor Uses and Minor Species

The U.S. Food and Drug Administration today announced an open period for applications for grants to support the development of new animal drugs intended to treat uncommon diseases (minor uses) in major species (horses, dogs, cats, cattle, pigs, turkeys and chickens) or to treat minor species.

FDA - U.S. Food and Drug Administration

22-11-2018

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

13-11-2018

Oscor Inc. Issues Recall Product Expansion of TB – Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models)

Oscor Inc. Issues Recall Product Expansion of TB – Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models)

On September 26, 2018 Oscor notified customers of a recall for certain lots (Recall No. 1035166- 09/07/2018-01-R) of TB Unshrouded Bipolar Pacing Leads. As part of the recall correction activities, Oscor is retrieving any remaining inventory out in the field. The recall scope is being expanded to include expired inventory for devices distributed between December 21, 2011 to May 17, 2018. The recall expansion is to ensure proper disposition of expired units. The FDA has been notified and is aware Oscor In...

FDA - U.S. Food and Drug Administration

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

19-12-2018

Join us on January 17, 2019 from 1-2:30 PM EST for a webinar to help clarify the Breakthrough Devices Program final guidance for manufacturers. Find out more about the webinar:  https://go.usa.gov/xExHX  #MedicalDevice #FDApic.twitter.com/sHElqFFODy

Join us on January 17, 2019 from 1-2:30 PM EST for a webinar to help clarify the Breakthrough Devices Program final guidance for manufacturers. Find out more about the webinar: https://go.usa.gov/xExHX  #MedicalDevice #FDApic.twitter.com/sHElqFFODy

Join us on January 17, 2019 from 1-2:30 PM EST for a webinar to help clarify the Breakthrough Devices Program final guidance for manufacturers. Find out more about the webinar: https://go.usa.gov/xExHX  #MedicalDevice #FDA pic.twitter.com/sHElqFFODy

FDA - U.S. Food and Drug Administration

17-12-2018


Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Europe - EMA - European Medicines Agency

17-12-2018

OCALIVA (Intercept Pharma Ltd)

OCALIVA (Intercept Pharma Ltd)

OCALIVA (Active substance: obeticholic acid) - Centralised - Annual renewal - Commission Decision (2018)8909 of Mon, 17 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4093/R/9

Europe -DG Health and Food Safety

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

10-12-2018

EU/3/17/1906 (PTC Therapeutics International Limited)

EU/3/17/1906 (PTC Therapeutics International Limited)

EU/3/17/1906 (Active substance: Recombinant adeno-associated viral vector serotype 5 carrying the gene for the human frataxin protein) - Transfer of orphan designation - Commission Decision (2018)8634 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002509

Europe -DG Health and Food Safety

10-12-2018

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (Active substance: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1?3)-beta-D-galactopyranoside) - Transfer of orphan designation - Commission Decision (2018)8628 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/048/17/T/01

Europe -DG Health and Food Safety

5-12-2018


Orphan designation: Paclitaxel (micellar), Treatment of ovarian cancer, 17/12/2006, Positive

Orphan designation: Paclitaxel (micellar), Treatment of ovarian cancer, 17/12/2006, Positive

Orphan designation: Paclitaxel (micellar), Treatment of ovarian cancer, 17/12/2006, Positive

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

29-11-2018


Orphan designation: Humanised IgG4 monoclonal antibody against total complement component 1, subcomponent s, Treatment of autoimmune haemolytic anaemia, 17/02/2016, Positive

Orphan designation: Humanised IgG4 monoclonal antibody against total complement component 1, subcomponent s, Treatment of autoimmune haemolytic anaemia, 17/02/2016, Positive

Orphan designation: Humanised IgG4 monoclonal antibody against total complement component 1, subcomponent s, Treatment of autoimmune haemolytic anaemia, 17/02/2016, Positive

Europe - EMA - European Medicines Agency

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

22-11-2018

EU/3/17/1933 (Emerald Health Pharmaceuticals EspaNa, S.L.)

EU/3/17/1933 (Emerald Health Pharmaceuticals EspaNa, S.L.)

EU/3/17/1933 (Active substance: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione) - Transfer of orphan designation - Commission Decision (2018)7813 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000001966

Europe -DG Health and Food Safety

21-11-2018

EU/3/17/1962 (MWB Consulting S.A.R.L.)

EU/3/17/1962 (MWB Consulting S.A.R.L.)

EU/3/17/1962 (Active substance: Humanised Fc-engineered monoclonal antibody against CD19) - Transfer of orphan designation - Commission Decision (2018)7815 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/155/17/T/01

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2084 (Bayer AG)

EU/3/18/2084 (Bayer AG)

EU/3/18/2084 (Active substance: Anetumab ravtansine) - Orphan designation - Commission Decision (2018)7793 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/258/17

Europe -DG Health and Food Safety

13-11-2018

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

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

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

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7576 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/233/16/T/01

Europe -DG Health and Food Safety

13-11-2018

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

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

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

Europe -DG Health and Food Safety