Dormicum 15 mg

Informazioni principali

  • Nome commerciale:
  • Dormicum 15 mg Filmtabletten
  • Forma farmaceutica:
  • Filmtabletten
  • Composizione:
  • midazolamum 15 mg ut midazolami malea, colore.: E 132, excipiens pro compresso obducto.
  • 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:
  • Dormicum 15 mg Filmtabletten
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Hypnoticum

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 45163
  • Data dell'autorizzazione:
  • 17-05-1983
  • Ultimo aggiornamento:
  • 19-10-2018

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

Patienteninformation

Dormicum® Compresse rivestite con film

Roche Pharma (Schweiz) AG

Che cos'è Dormicum e quando si usa?

Dormicum è un sonnifero ad azione rapida e potente. Dormicum è indicato per la terapia a breve

termine di gravi disturbi del sonno. Dormicum si somministra nei casi in cui il ritmo naturale del

sonno è alterato, soprattutto nei casi in cui riesce difficile prendere sonno. Di solito il sonno

sopraggiunge già dopo pochi minuti dalla somministrazione, al più tardi dopo 20 minuti circa.

Dormicum va somministrato soltanto in caso di seri disturbi del sonno e per un breve periodo di

tempo (non più di 2 settimane). Se il Suo medico intende prescriverLe in via eccezionale una terapia

con Dormicum per un periodo di tempo più lungo, dovrà chiarire con Lei, se il trattamento deve

essere continuato; questa verifica dovrà essere fatta regolarmente.

Dormicum contiene come principio attivo la benzodiazepina midazolam.

Dormicum può essere assunto soltanto su prescrizione medica.

Di che cosa occorre inoltre tener conto durante il trattamento?

Spesso basta modificare le abitudini di vita per ritrovare un sonno salutare. Se non ci si riesce, i

sonniferi possono essere d'aiuto. Eviti però assolutamente di assumere i sonniferi per un lungo

periodo di tempo e senza aver chiesto consiglio al Suo medico.

Dormicum non deve essere assunto se è sufficiente cambiare le proprie abitudini di vita per

ripristinare il sonno naturale.

Quando non si può assumere Dormicum?

Dormicum non è indicato in caso di ipersensibilità a uno o più componenti o in caso di apnea del

sonno (breve arresto della respirazione durante il sonno notturno). Avvisi il Suo medico se soffre di

disturbi respiratori. Informi, inoltre, il Suo medico se soffre di miastenia grave, una particolare

malattia dei muscoli. In questi casi la somministrazione di Dormicum non è indicata.

Dormicum è controindicato nei pazienti con disfunzione epatica grave.

Dormicum non deve essere somministrato né ai bambini né agli adolescenti per il trattamento dei

disturbi del sonno.

Quando è richiesta prudenza nella somministrazione di Dormicum?

Avverta il medico se il Suo stato generale di salute non è buono. Dormicum è un sonnifero ad azione

rapida e potente. Non appena terminato il processo di assorbimento del principio attivo, la cui

velocità varia da individuo a individuo, Dormicum inizia ad esplicare il suo effetto sedativo potente.

Ciò può avvenire già pochi minuti dopo la somministrazione. Pertanto, Dormicum deve essere

assunto quando si è già a letto o immediatamente prima di coricarsi. Una volta assunto Dormicum, si

deve poter dormire indisturbati per almeno 6 ore.

Le bevande alcoliche potenziano l'effetto di Dormicum, pregiudicando così la Sua capacità di

reazione. Per questo motivo si raccomanda di rinunciare alle bevande alcoliche durante la terapia con

Dormicum oppure di non bere alcolici per alcune ore prima della somministrazione del farmaco.

Dormicum compresse rivestite con film contiene lattosio. Non deve assumere il medicamento nel

caso in cui soffra di determinati disturbi ereditari del metabolismo degli zuccheri.

Più farmaci somministrati in concomitanza possono interagire tra loro. Avvisi quindi il Suo medico

se prende altri farmaci oltre a Dormicum.

Durante il trattamento con Dormicum può assumere altri farmaci soltanto con il consenso del

medico, perché i calmanti e altri farmaci che agiscono a livello del sistema nervoso centrale, come

gli analgesici, i sonniferi, gli antidepressivi o gli anticonvulsivanti (antiepilettici) nonché determinati

antibiotici e preparati anti-HIV possono potenziare l'effetto di Dormicum.

Pericolo di farmacodipendenza

La somministrazione di Dormicum - come quella di tutti i farmaci a base di benzodiazepine - può

portare a farmacodipendenza. La farmacodipendenza può comparire soprattutto in caso di

somministrazione ininterrotta per un lungo periodo di tempo (in certi casi già dopo alcune settimane)

e, se il trattamento viene interrotto bruscamente, può dare sintomi da astinenza, come agitazione,

stati ansiosi, insonnia, difficoltà di concentrazione, cefalea, spasmi muscolari, convulsioni e

sudorazione. Di solito questi fenomeni scompaiono entro 2-3 settimane.

Per ridurre al minimo il rischio di farmacodipendenza, Le raccomandiamo di osservare le seguenti

avvertenze:

·Prenda Dormicum soltanto su prescrizione del medico.

·Non aumenti in nessun caso la dose prescritta dal medico.

·Informi il medico se vuole interrompere il trattamento.

·Il medico valuterà periodicamente se la terapia deve essere continuata.

La somministrazione per un lungo periodo di tempo (di regola più di quattro settimane) può avvenire

soltanto sotto accurato controllo medico.

Questo farmaco può ridurre la capacità di reazione, la capacità di condurre un veicolo e la capacità di

utilizzare attrezzi o macchine!

Dopo avere assunto Dormicum non si metta alla guida e non usi macchine pericolose per circa 7–8

ore, perché in questo periodo la Sua capacità di reazione potrebbe essere ridotta.

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

·soffre di altre malattie,

·soffre di allergie o

·assume o applica altri medicamenti (anche acquistati di Sua iniziativa!)

Si può assumere Dormicum durante la gravidanza o l'allattamento?

Se è incinta o ha in programma una gravidanza, può assumere Dormicum soltanto su esplicita

prescrizione del medico che è informato della Sua condizione. Dormicum potrebbe causare danni al

feto.

Non somministrare Dormicum durante l'allattamento.

Come usare Dormicum?

Si attenga alle indicazioni del Suo medico in merito alla somministrazione del farmaco. Adulti:

deglutisca la compressa, senza masticarla, con abbondante acqua o succo di frutta. Quindi si corichi.

Il medico Le dirà se deve prendere ½-1 compressa da 7,5 mg o 1 compressa da 15 mg. Dopo

l'assunzione della compressa deve essere garantita la possibilità di un sonno ininterrotto della durata

di almeno 6 ore.

Durata del trattamento

Dormicum può essere assunto solo in caso di forti disturbi del sonno e per un breve periodo di tempo

(in generale per non più di 2 settimane).

Non modifichi di propria iniziativa la posologia prescritta. Se ritiene che l'azione del farmaco sia

troppo debole o troppo forte, ne parli al Suo medico o al Suo farmacista.

Quali effetti collaterali può avere Dormicum?

Con l'assunzione di Dormicum possono manifestarsi i seguenti effetti collaterali:

·reazioni di ipersensibilità, gonfiori (cosiddetti angioedemi).

·Stati di eccitazione, aggressività, comportamento anomalo, depressione, confusione mentale,

allucinazioni, nervosismo, incubi, apatia, scatti d'ira, calo della libido.

·Stanchezza e sonnolenza durante la giornata, spasmi muscolari, debolezza muscolare, cefalea,

vertigini, disturbi motori, nei pazienti anziani aumento del rischio di cadute e fratture, amnesia.

·Diplopia (visione doppia).

·Arresto cardiaco, tachicardia, ipotensione arteriosa.

·Dispnea fino all'arresto respiratorio.

·Nausea, vomito, costipazione intestinale, secchezza delle fauci, singhiozzo.

·Rash cutaneo, prurito.

Se compaiono effetti indesiderati che ritiene correlati alla somministrazione di Dormicum (per

esempio eccitazione, debolezza muscolare, confusione mentale, vertigini), interrompa la

somministrazione di Dormicum e si rivolga subito al Suo medico.

Se durante il giorno avverte stanchezza o sonnolenza, informi il Suo medico che provvederà

eventualmente ad aggiustare la posologia.

Raramente può accadere che, se si viene svegliati nelle prime ore dopo aver assunto Dormicum, in

un secondo momento non si sia più in grado di ricordare le attività svolte subito dopo essere stati

svegliati. Questi vuoti di memoria si manifestano con maggior frequenza se si è sottoposti a stress

psichici particolari. In questo caso si raccomanda di non prendere Dormicum.

Se osserva effetti collaterali qui non descritti, dovrebbe informare il Suo medico o il Suo farmacista.

Di che altro occorre tener conto?

Il farmaco deve essere conservato fuori della portata dei bambini e non deve essere utilizzato oltre la

data indicata con «EXP» sulla confezione.

Non conservare le compresse rivestite con film da 7,5 mg a temperature superiori a 30 °C.

Le compresse rivestite con film da 15 mg devono essere conservate al riparo dalla luce e a

temperature non superiori a 30 °C.

Dopo la conclusione della terapia o dopo il termine di scadenza, i medicamenti non utilizzati vanno

riconsegnati, nella loro confezione originale, alla sede di raccolta (medico o farmacista) per lo

smaltimento secondo le direttive stabilite.

Il medico o il farmacista, che sono in possesso di documentazione professionale dettagliata, possono

darLe ulteriori informazioni.

Cosa contiene Dormicum?

La compressa rivestita con film bianca contiene come principio attivo 7,5 mg di midazolam, la

compressa rivestita con film blu contiene 15 mg di midazolam. Le compresse si possono dividere.

Eccipienti: colorante: carminio d'indaco (E 132) solo nelle compresse rivestite con film da 15 mg;

lattosio e altre sostanze ausiliarie.

Numero dell’omologazione

45163 (Swissmedic).

Dove è ottenibile Dormicum? Quali confezioni sono disponibili?

In farmacia, dietro presentazione della prescrizione medica.

Compresse rivestite con film divisibili da 7,5 mg: confezioni da 10 e 30 compresse rivestite con film.

Compresse rivestite con film divisibili da 15 mg: confezioni da 10 e 30 compresse rivestite con film.

Titolare dell’omologazione

Roche Pharma (Svizzera) SA, 4153 Reinach.

Questo foglietto illustrativo è stato controllato l'ultima volta nel febbraio 2015 dall'autorità

competente in materia di medicamenti (Swissmedic).

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Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Published on: Mon, 15 Oct 2018 00:00:00 +0200 A rapid qualitative assessment has been done by performing a theoretical analysis on the transmission of low pathogenic avian influenza (LPAI) via fresh meat from poultry reared or kept in captivity for the production of meat (raw poultry meat) or raw table eggs. A predetermined transmission pathway followed a number of steps from a commercial or non‐commercial poultry establishment within the EU exposed to LPAI virus (LPAIV) to the onward virus transmission...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Melampsora farlowii

Pest categorisation of Melampsora farlowii

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Melampsora farlowii, a well‐defined and distinguishable fungus of the family Melampsoraceae. M. farlowii is the causal agent of a leaf and twig rust of hemlocks (Tsuga spp.) in eastern North America. The pathogen is regulated in Council Directive 2000/29/EC (Annex IAI) as a harmful organism whose introduction into the EU is banned. M. farlowii ...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Published on: Mon, 15 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in United Kingdom to evaluate the confirmatory data that were identified for teflubenzuron in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new metabolism study on leafy crops, a study investigating the nature of residues under standard hydrolytic conditions and a validated ...

Europe - EFSA - European Food Safety Authority Publications

3-10-2018

Sportminister Bruno Bruins brengt verrassingsbezoek aan Talent TeamNL in Buenos Aires

Sportminister Bruno Bruins brengt verrassingsbezoek aan Talent TeamNL in Buenos Aires

Van 6 tot 18 oktober wordt in Buenos Aires, Argentinië, de derde editie van de Jeugd Olympische Spelen gehouden. Toptalenten uit 206 landen tussen de 15 en 18 jaar oud doen hieraan mee. Talent TeamNL bestaat uit 41 sporters die uitkomen in  19 disciplines. Minister voor Sport Bruno Bruins bracht vandaag een verrassingsbezoek aan de Nederlandse ploeg. Hij bezocht het Olympisch Dorp waar de talenten onder leiding van Chef de Mission Mark Huizinga zich voorbereiden op de Spelen die zaterdag beginnen. 

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

28-9-2018

EpiPen and EpiPen Jr auto-injectors may stick in their carrier tube

EpiPen and EpiPen Jr auto-injectors may stick in their carrier tube

Pfizer Canada has advised Health Canada that, in a very small number of cases, some EpiPen (0.3 mg) and EpiPen Jr (0.15 mg) auto-injector devices may not slide out of their carrier tube easily, or at all. This could delay or prevent emergency treatment, possibly leading to patient disability or death.

Health Canada

28-9-2018

Avian influenza overview May – August 2018

Avian influenza overview May – August 2018

Published on: Thu, 27 Sep 2018 00:00:00 +0200 Between 16 May and 15 August 2018, three highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments and three HPAI A(H5N6) outbreaks in wild birds were reported in Europe. Three low pathogenic avian influenza (LPAI) outbreaks were reported in three Member States. Few HPAI and LPAI bird cases have been detected in this period of the year, in accordance with the seasonal expected pattern of LPAI and HPAI. There is no evidence to date ...

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

29-8-2018

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Published on: Thu, 16 Aug 2018 00:00:00 +0200 4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the avai...

Europe - EFSA - European Food Safety Authority Publications

16-8-2018

August 15, 2018: Florida Man Pleads Guilty to Scheme to Market Dietary Supplements

August 15, 2018: Florida Man Pleads Guilty to Scheme to Market Dietary Supplements

August 15, 2018: Florida Man Pleads Guilty to Scheme to Market Dietary Supplements

FDA - U.S. Food and Drug Administration

15-1-2019

Macimorelin Aeterna Zentaris (Aterna Zentaris GmbH)

Macimorelin Aeterna Zentaris (Aterna Zentaris GmbH)

Macimorelin Aeterna Zentaris (Active substance: macimorelin) - New authorisation - Commission Decision (2019)203 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4660

Europe -DG Health and Food Safety

15-1-2019

Topotecan Actavis (Actavis Group PTC ehf.)

Topotecan Actavis (Actavis Group PTC ehf.)

Topotecan Actavis (Active substance: topotecan) - Withdrawal - Commission Decision (2019)207 of Tue, 15 Jan 2019

Europe -DG Health and Food Safety

4-1-2019


Orphan designation: Glibenclamide for the treatment of neonatal diabetes, Treatment of neonatal diabetes, 15/01/2016, Positive

Orphan designation: Glibenclamide for the treatment of neonatal diabetes, Treatment of neonatal diabetes, 15/01/2016, Positive

Orphan designation: Glibenclamide for the treatment of neonatal diabetes, Treatment of neonatal diabetes, 15/01/2016, 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

29-11-2018

Inflacam (Chanelle Pharmaceuticals Manufacturing Limited)

Inflacam (Chanelle Pharmaceuticals Manufacturing Limited)

Inflacam (Active substance: Meloxicam) - Centralised - Variation - Commission Decision (2018)8036 of Thu, 29 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2497/X/15

Europe -DG Health and Food Safety

23-11-2018

Presentations have been posted for the November 15, 2018 Patient Engagement Advisory Committee meeting. #PEAC2018 Read more:  https://go.usa.gov/xPHxf   #FDA #MedicalDevice

Presentations have been posted for the November 15, 2018 Patient Engagement Advisory Committee meeting. #PEAC2018 Read more: https://go.usa.gov/xPHxf  #FDA #MedicalDevice

Presentations have been posted for the November 15, 2018 Patient Engagement Advisory Committee meeting. #PEAC2018 Read more: https://go.usa.gov/xPHxf  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

21-11-2018

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (Active substance: Recombinant human interleukin-3 truncated diphtheria toxin fusion protein) - Transfer of orphan designation - Commission Decision (2018)7816 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/064/15/T/02

Europe -DG Health and Food Safety

15-11-2018

Flixabi (Samsung Bioepis NL B.V.)

Flixabi (Samsung Bioepis NL B.V.)

Flixabi (Active substance: infliximab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7549 of Thu, 15 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4020/T/30

Europe -DG Health and Food Safety

15-11-2018

alitretinoin

alitretinoin

alitretinoin (Active substance: alitretinoin) - Centralised - Art 28 - (PSUR - Commission Decision (2018)7675 of Thu, 15 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/90/201801

Europe -DG Health and Food Safety

15-11-2018

Benepali (Samsung Bioepis NL B.V.)

Benepali (Samsung Bioepis NL B.V.)

Benepali (Active substance: etanercept) - Centralised - Yearly update - Commission Decision (2018) 7557 of Thu, 15 Nov 2018

Europe -DG Health and Food Safety

8-11-2018

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries.pic.twitter.com/WkDNnXqm

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries.pic.twitter.com/WkDNnXqm

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries. pic.twitter.com/WkDNnXqmbw

FDA - U.S. Food and Drug Administration

31-10-2018

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Active substance: adalimumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7344 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4279/T/15

Europe -DG Health and Food Safety

22-10-2018

EU/3/16/1640 (Celgene Europe B.V.)

EU/3/16/1640 (Celgene Europe B.V.)

EU/3/16/1640 (Active substance: 2-methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol methanesulfonate) - Transfer of orphan designation - Commission Decision (2018)6989 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/253/15/T/01

Europe -DG Health and Food Safety

22-10-2018

EU/3/15/1495 (Ultragenyx Netherlands B.V.)

EU/3/15/1495 (Ultragenyx Netherlands B.V.)

EU/3/15/1495 (Active substance: Triheptanoin) - Transfer of orphan designation - Commission Decision (2018)6992 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/007/15/T/02

Europe -DG Health and Food Safety

22-10-2018

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Active substance: Insulin human) - Transfer of orphan designation - Commission Decision (2018)6985 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

17-10-2018

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review.

Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD.  https:

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review. Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD. https:

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review. Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD. https://go.usa.gov/xPqku  pic.twitter.com/EYNZANlgr9

FDA - U.S. Food and Drug Administration

15-10-2018

Riximyo (Sandoz GmbH)

Riximyo (Sandoz GmbH)

Riximyo (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)6811 of Mon, 15 Oct 2018

Europe -DG Health and Food Safety

1-10-2018

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Active substance: Synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker) - Transfer of orphan designation - Commission Decision (2018)6399 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/16/T/01

Europe -DG Health and Food Safety

25-9-2018

Conducting clinical trials & preparing a submission for #FDA review?

Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more!  https://go.

Conducting clinical trials & preparing a submission for #FDA review? Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more! https://go.

Conducting clinical trials & preparing a submission for #FDA review? Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more! https://go.usa.gov/xPqku . pic.twitter.com/Ktqq9Slx0y

FDA - U.S. Food and Drug Administration

24-9-2018

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

FDA - U.S. Food and Drug Administration

18-8-2018

EU/3/16/1645 (Salzman Group Ltd)

EU/3/16/1645 (Salzman Group Ltd)

EU/3/16/1645 (Active substance: Cannabidiol) - Transfer of orphan designation - Commission Decision (2018)4806 of Sat, 18 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/248/15/T/01

Europe -DG Health and Food Safety

15-8-2018

EU/3/18/1994 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/1994 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/1994 (Active substance: Ivosidenib) - Transfer of orphan designation - Commission Decision (2018)5555 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/172/17/T/01

Europe -DG Health and Food Safety

15-8-2018

Orbactiv (Rempex London Ltd)

Orbactiv (Rempex London Ltd)

Orbactiv (Active substance: oritavancin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5556 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3785/T/20

Europe -DG Health and Food Safety

15-8-2018

Komboglyze (AstraZeneca AB)

Komboglyze (AstraZeneca AB)

Komboglyze (Active substance: saxagliptin / metformin) - Centralised - 2-Monthly update - Commission Decision (2018)5559 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2059/WS/1289

Europe -DG Health and Food Safety

15-8-2018

Ivabradine Zentiva (Zentiva, k.s.)

Ivabradine Zentiva (Zentiva, k.s.)

Ivabradine Zentiva (Active substance: ivabradine) - Centralised - Yearly update - Commission Decision (2018)5558 of Wed, 15 Aug 2018

Europe -DG Health and Food Safety