Co-Dafalgan

Informazioni principali

  • Nome commerciale:
  • Co-Dafalgan Brausetabletten
  • Forma farmaceutica:
  • Brausetabletten
  • Composizione:
  • paracetamolum 500 mg, codeini phosphas hemihydricus 30 mg, aromatica, aspartamum, mantenuto.: E 211, excipiens pro compresso.
  • 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:
  • Co-Dafalgan Brausetabletten
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Analgetikum

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 47353
  • Data dell'autorizzazione:
  • 03-12-1986
  • Ultimo aggiornamento:
  • 19-10-2018

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

Patienteninformation

Informazione destinata ai pazienti

Legga attentamente il foglietto illustrativo prima di far uso del medicamento. Questo medicamento le

è stato prescritto personalmente e quindi non deve essere consegnato ad altre persone, anche se i

sintomi sono gli stessi. Il medicamento potrebbe nuocere alla loro salute. Conservi il foglietto

illustrativo per poterlo rileggere all’occorrenza.

Co-Dafalgan® Compresse effervescenti dimezzabili

Che cos’è Co-Dafalgan e quando si usa?

Co-Dafalgan contiene i principi attivi paracetamolo e codeina, che hanno un'azione antidolorifica.

Co-Dafalgan viene prescritto dal medico per il trattamento a breve termine dei seguenti tipi di dolore

di intensità moderata: mal di testa, mal di denti, dolori in corrispondenza delle articolazioni e dei

legamenti, mal di schiena e dolori conseguenti a traumi nei casi in cui altri antidolorifici quali

paracetamolo o ibuprofene da soli non siano sufficientemente efficaci.

Le compresse effervescenti di Co-Dafalgan sono indicate per il trattamento di adulti e ragazzi (a

partire da 12 anni di età) con peso superiore a 33 kg.

Di che cosa occorre inoltre tener conto durante il trattamento?

Co-Dafalgan non deve essere assunto per un periodo superiore a 3 giorni. Qualora in questo periodo

non abbia riscontrato un evidente alleviamento del dolore si rivolga al suo medico.

Per evitare il rischio di una posologia eccessiva è necessario accertare che gli altri medicamenti

somministrati non contengano paracetamolo.

Non si deve superare la posologia indicata o prescritta dal medico.

Bisogna anche tener presente che l'uso prolungato di analgesici può di per sé contribuire a far sì che

il mal di testa persista.

L'uso prolungato di analgesici, specialmente in caso di associazione di diversi principi attivi

antidolorifici, può provocare lesioni permanenti ai reni con rischio di insufficienza renale.

Quando non si può assumere Co-Dafalgan?

Le compresse effervescenti di Co-Dafalgan non devono essere assunte nei seguenti casi:

-Ipersensibilità a paracetamolo, codeina o sostanze correlate rispettivamente a uno degli eccipienti

(vedasi «Cosa contiene Co-Dafalgan?»). Un'ipersensibilità di questo genere si manifesta per esempio

sotto forma di asma, difficoltà di respirazione, disturbi circolatori, gonfiori a livello della pelle e

delle mucose o eruzioni cutanee (orticaria);

-Gravi malattie del fegato;

-Consumo eccessivo d'alcool;

-Disfunzione ereditaria del fegato (la cosiddetta malattia di Meulengracht);

-Difficoltà respiratorie (vedasi «Quando è richiesta prudenza nella somministrazione di Co-

Dafalgan?»);

-Su bambini e ragazzi con peso corporeo inferiore a 33 kg (al di sotto di 12 anni di età);

-Su ragazzi con peso inferiore a 50 kg dopo un intervento per la rimozione delle tonsille, ad esempio

dovuto ad apnea notturna (brevi pause di respirazione durante il sonno);

-Durante l'allattamento;

-Se si è a conoscenza che il proprio organismo metabolizza rapidamente la codeina in morfina.

Quando è richiesta prudenza nella somministrazione di Co-Dafalgan?

Consultare il medico prima dell'uso in caso di malattie dei reni o del fegato o in presenza della

cosiddetta «carenza di glucosio-6 deidrogenasi» (rara malattia ereditaria dei globuli rossi).

Informare inoltre il medico in caso di colica biliare, pancreatite, stitichezza, epilessia, asma, tosse

con espettorato e altre malattie delle vie respiratorie, pressione bassa, ingrossamento della prostata o

restringimento uretrale.

Co-Dafalgan non va impiegato in soggetti a rischio di dipendenza né in soggetti con dipendenza da

sostanze stupefacenti attuale o pregressa.

Informi il suo medico anche se deve assumere contemporaneamente anticoagulanti o alcuni

medicamenti per il trattamento di tubercolosi (rifampicina, isoniazide), epilessia (fenitoina,

carbamazepina), gotta (probenecid), livelli elevati di lipidi nel sangue (colestiramina), infezioni da

HIV (zidovudina), dolori forti (oppiacei, celecoxib), tosse secca, ansia, depressione e altri disturbi

psichici e del sonno. Prestare particolare attenzione anche in caso di uso concomitante dei cosiddetti

anticolinergici o di medicamenti contenenti i principi attivi cloramfenicolo, salicilamide, fenobarbital

e desametasone.

Si sconsiglia l'uso concomitante di Co-Dafalgan e bevande alcoliche. Specialmente se assieme al

medicamento non si assume cibo aumenta il rischio di lesione del fegato dovuto al paracetamolo. Il

contemporaneo consumo di alcol e/o l'uso di medicamenti con azione depressiva sul sistema nervoso

centrale (ad es. sonniferi, ansiolitici, determinati antidolorifici, determinati antipsicotici) può ridurre

la capacità di reazione, la capacità di condurre un veicolo e la capacità di utilizzare attrezzi o

macchine.

Prestare particolare attenzione nella somministrazione di Co-Dafalgan in caso di disturbi

dell'alimentazione quali anoressia, bulimia, eccessivo dimagrimento e in caso di malnutrizione

cronica.

Particolare cautela nella somministrazione di Co-Dafalgan è richiesta in caso di disidratazione e in

presenza di una diminuita quantità di sangue. Anche in caso di grave infezione (ad esempio un

avvelenamento del sangue) Co-Dafalgan dev’essere somministrato con cautela.

La codeina viene convertita in morfina nel fegato per mezzo di un enzima. La morfina è la sostanza

che consente di alleviare il dolore. Alcuni individui presentano variazioni di questo enzima che

possono avere effetti diversi. Alcune persone non eseguono la conversione in morfina oppure ciò

avviene in quantità minime, non sufficienti per alleviare il dolore. In altre persone possono

presentarsi effetti collaterali importanti, dovuti alla formazione di elevate quantità di morfina. Se

viene rilevato uno degli effetti collaterali di seguito, interrompere subito il consumo di questo

medicamento e richiedere immediatamente il parere del medico: respirazione rallentata o

superficiale, confusione, sonnolenza, restringimento pupillare, nausea o vomito, stitichezza, perdita

dell'appetito.

Non assumere Co-Dafalgan compresse effervescenti in caso di intolleranza al fruttosio, poiché

contengono sorbitolo. Non assumere Co-Dafalgan compresse effervescenti in caso di fenilchetonuria,

malattia metabolica rara e congenita, poiché contengono l'edulcorante aspartame.

Questo medicamento contiene sodio. Se segue una dieta povera di sale o senza sale si chieda

consiglio al medico.

Singoli soggetti ipersensibili agli analgesici o agli antireumatici possono avere una reazione di

ipersensibilità anche al paracetamolo (vedasi «Quali effetti collaterali può avere Co-Dafalgan?»).

Informi il suo medico o il suo farmacista nel caso in cui soffre di altre malattie, soffre di allergie o

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

Si può somministrare Co-Dafalgan durante la gravidanza o l’allattamento?

Se è incinta o desidera una gravidanza, dovrà assumere Co-Dafalgan solo dopo aver consultato il

medico.

Il paracetamolo e la codeina passano in minima quantità nel latte materno. Pertanto, Co-Dafalgan

non deve essere usato durante l'allattamento.

Come usare Co-Dafalgan?

Non assumere le dosi singole di compresse effervescenti più spesso di quanto specificato. Non

superare la dose massima giornaliera indicata. Non somministrare in bambini e ragazzi con peso

corporeo inferiore a 33 kg (al di sotto di 12 anni).

Compresse effervescenti divisibili:

Adulti e ragazzi a partire da 12 anni di età e con peso superiore a 50 kg: fino a 4 volte al giorno 1-2

compresse effervescenti (dose massima: 8 compresse effervescenti al giorno).

Ragazzi con peso corporeo compreso tra 33 e 50 kg (a partire da 12 anni di età): fino a 4 volte al

giorno ½-1 compressa effervescente (dose massima: 4 compresse effervescenti al giorno).

Sciogliere le compresse effervescenti in un grande bicchiere d'acqua. Non masticare o ingerire le

compresse intere. Le singole dosi devono essere assunte ad almeno 6 ore di distanza l'una dall'altra.

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 Co-Dafalgan?

Con l'assunzione di Co-Dafalgan possono manifestarsi i seguenti effetti collaterali:

In rari casi possono verificarsi reazioni di sensibilità come prurito, gonfiore della pelle e delle

mucose o eruzioni cutanee con reazioni cutanee anche gravi (molto rare) e nausea. Inoltre possono

manifestarsi affanno e asma, soprattutto se questi effetti collaterali sono già stati osservati in

precedenza con l'uso di acido acetilsalicilico o altri farmaci antinfiammatori non steroidei (FANS).

Se si manifestano segni di una reazione di ipersensibilità o formazione di lividi/sanguinamenti,

interrompere l'uso del medicamento e consultare il medico. Molto raramente sono state osservate

alterazioni della conta ematica, come una riduzione del numero di piastrine (trombocitopenia) o una

forte riduzione di certi tipi di globuli bianchi (agranulocitosi).

Spesso compaiono stitichezza, lieve mal di testa, sonnolenza e, soprattutto all'inizio del trattamento,

nausea e vomito. Talora insorgono confusione, capogiri, raramente ronzii auricolari, secchezza della

bocca, disturbi del sonno e rallentamento della respirazione (depressione respiratoria). Possono

verificarsi disturbi della minzione, disturbi della vista, restringimento pupillare ed euforia.

I farmaci che contengono codeina possono causare dipendenza.

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

Di che altro occorre tener conto?

Conservare a temperatura ambiente (15-25°C), al riparo dall'umidità e fuori dalla portata dei

bambini.

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

In caso di uso incontrollato (sovradosaggio) bisogna consultare immediatamente un medico. Nausea,

vomito, dolori addominali, inappetenza, sensazione generale di malessere, diminuzione della

respirazione, sonnolenza e/o letargia possono essere indizi di iperdosaggio, ma si manifestano

solamente da alcune ore a 1 giorno dopo aver preso il medicamento.

Un sovradosaggio può causare danni molto gravi al fegato. Il sovradosaggio inoltre può causare una

paralisi respiratoria.

I medicamenti contenenti paracetamolo e codeina non possono essere somministrati a bambini che

per errore hanno assunto alcol.

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

darle ulteriori informazioni.

Cosa contiene Co-Dafalgan?

1 compressa effervescente contiene:

Principi attivi: 500 mg di paracetamolo e 30 mg di codeina fosfato.

Eccipienti: aspartame, aromi; conservante: benzoato di sodio (E211); Excipiens q.s. ad compr.

Numero dell’omologazione

47353 (Swissmedic)

Dove è ottenibile Co-Dafalgan? Quali confezioni sono disponibili?

In farmacia dietro presentazione della prescrizione medica.

Confezioni da 16 compresse effervescenti divisibili.

Titolare dell’omologazione

Bristol-Myers Squibb SA, Steinhausen

Questo foglietto illustrativo è stato controllato l'ultima volta nel gennaio 2017 dall'autorità

competente in materia di medicamenti (Swissmedic).

20-12-2018

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17-10-2018

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Europe - EFSA - European Food Safety Authority Publications

4-10-2018

Peer review of the pesticide risk assessment of the active substance ethoprophos

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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

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Europe - EFSA - European Food Safety Authority Publications

21-9-2018

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Europe - EFSA - European Food Safety Authority Publications

18-9-2018

Peer review of the pesticide risk assessment of the active substance beta‐cyfluthrin

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11-9-2018

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

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31-8-2018

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Europe - EFSA - European Food Safety Authority Publications

30-8-2018

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29-8-2018

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29-8-2018

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Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Peer review of the pesticide risk assessment of the active substance carvone (substance evaluated d‐carvone)

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Europe - EFSA - European Food Safety Authority Publications

10-8-2018

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

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FDA - U.S. Food and Drug Administration

18-7-2018

Sodium glucose co-transporter 2 inhibitors

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Therapeutic Goods Administration - Australia

13-7-2018

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

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Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. -- that is used in the manufacture of the subject product ...

FDA - U.S. Food and Drug Administration

17-5-2018

BLM Issues Allergy Alert On Undeclared Egg and Milk

BLM Issues Allergy Alert On Undeclared Egg and Milk

BLM Prod.-u. Vertriebsges. mbH & Co. KG, is voluntarily recalling Priano Rosso Pesto Sauce as it may contain undeclared milk and egg. People who have an allergy or severe sensitivity to milk and egg run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

16-5-2018

Mas Food Services Co. Issues Allergy Alert on Undeclared Sulfites in The Peruchef Dry Potato

Mas Food Services Co. Issues Allergy Alert on Undeclared Sulfites in The Peruchef Dry Potato

Mas Food Services Co. of Oakland Park, FL is recalling its 15 ounce packages of The Peruchef brand dry potato because it may contain undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

8-5-2018

Neurovascular Stents Used for Stent-Assisted Coiling (SAC): Letter to Health Care Providers - Recommendations Associated With the Use of These Devices in the Treatment of Unruptured Brain Aneurysms

Neurovascular Stents Used for Stent-Assisted Coiling (SAC): Letter to Health Care Providers - Recommendations Associated With the Use of These Devices in the Treatment of Unruptured Brain Aneurysms

The FDA has received reports associated with the use of these devices in the treatment of unruptured brain aneurysms that suggest some events of peri-procedural stroke and/or death may have been related to procedural risks or patient selection related factors. These factors include patients who had serious co-morbidities resulting in a reduced life expectancy, or who were intolerant to required anticoagulation or anti-platelet therapy.

FDA - U.S. Food and Drug Administration

18-12-2018

Alkyl nitrites - public meetings

Alkyl nitrites - public meetings

The TGA will be co-hosting two public meetings regarding appropriate access and safety controls of alkyl nitrites: Sydney 31 Jan 2019 and Melbourne 7 Feb 2019

Therapeutic Goods Administration - Australia

15-10-2018

We have created a rumor control page for Hurricane #Michael that will be updated regularly. Help us share this info and remember to always check with official sources like @FLSERT, @GeorgiaEMA and @femaregion4.

 http://fema.gov/hurricane-michael-rumor-co

We have created a rumor control page for Hurricane #Michael that will be updated regularly. Help us share this info and remember to always check with official sources like @FLSERT, @GeorgiaEMA and @femaregion4. http://fema.gov/hurricane-michael-rumor-co

We have created a rumor control page for Hurricane #Michael that will be updated regularly. Help us share this info and remember to always check with official sources like @FLSERT, @GeorgiaEMA and @femaregion4. http://fema.gov/hurricane-michael-rumor-control … pic.twitter.com/T3h7ZiFUrZ

FDA - U.S. Food and Drug Administration

15-10-2018

National Cybersecurity Awareness Month is in its 3rd week. This week's theme: “Strengthening the Cybersecurity Workforce Across All Sectors”. Go to  https://www.dhs.gov/stopthinkconnect … to see what #NCSAM is all about. #FDA #MedicalDevicespic.twitter.co

National Cybersecurity Awareness Month is in its 3rd week. This week's theme: “Strengthening the Cybersecurity Workforce Across All Sectors”. Go to https://www.dhs.gov/stopthinkconnect … to see what #NCSAM is all about. #FDA #MedicalDevicespic.twitter.co

National Cybersecurity Awareness Month is in its 3rd week. This week's theme: “Strengthening the Cybersecurity Workforce Across All Sectors”. Go to https://www.dhs.gov/stopthinkconnect … to see what #NCSAM is all about. #FDA #MedicalDevices pic.twitter.com/KBLIxo9CiV

FDA - U.S. Food and Drug Administration

18-9-2018

 Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018

Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018

This third meeting between regulators and representatives of industry stakeholder organisations addresses all areas of product-development support, including scientific advice, specifics for paediatric and orphan medicines and support for innovation. The meeting focuses on the implementation of the orphan notice, ‘histology-independent indications’ in the context of orphan designations, the upcoming rollout of a new tool for orphan designation applications, digital technology proposals in medicine develo...

Europe - EMA - European Medicines Agency

4-9-2018

Abseamed (Medice Arzneimittel PUtter GmbH and Co KG)

Abseamed (Medice Arzneimittel PUtter GmbH and Co KG)

Abseamed (Active substance: epoetin alfa) - Centralised - 2-Monthly update - Commission Decision (2018)5860 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/727/WS/1406

Europe -DG Health and Food Safety

2-7-2018

Verifica urgente - Officina Farmaceutica: Zhejiang Huahai Pharmaceutical (Cina) (02/07/2018)

Verifica urgente - Officina Farmaceutica: Zhejiang Huahai Pharmaceutical (Cina) (02/07/2018)

Richiesta alle Aziende Farmaceutiche detentrici dell’Autorizzazione all’Immissione in Commercio per il mercato italiano di medicinali ad uso umano e/o alle Aziende produttrici di medicinali destinati al mercato comunitario o all'esportazione in Paesi terzi contenenti VALSARTAN come materia prima farmacologicamente attiva e/o intermedio di produzione fornita dal produttore: ZHEJIANG HUAHAI PHARMACEUTICAL Co. Ltd (Cina).

Italia - AIFA - Agenzia Italiana del Farmaco

19-6-2018

Maviret (AbbVie Deutschland GmbH and Co. KG)

Maviret (AbbVie Deutschland GmbH and Co. KG)

Maviret (Active substance: glecaprevir / pibrentasvir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3916 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4430/T/11

Europe -DG Health and Food Safety

11-6-2018

Viekirax (AbbVie Deutschland GmbH and Co. KG)

Viekirax (AbbVie Deutschland GmbH and Co. KG)

Viekirax (Active substance: ombitasvir / paritaprevir / ritonavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3766 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3839/T/45

Europe -DG Health and Food Safety

4-6-2018

Venclyxto (AbbVie Deutschland GmbH and Co. KG)

Venclyxto (AbbVie Deutschland GmbH and Co. KG)

Venclyxto (Active substance: venetoclax) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3633 of Mon, 04 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4106/T/12

Europe -DG Health and Food Safety

4-6-2018

Exviera (AbbVie Deutschland GmbH and Co. KG)

Exviera (AbbVie Deutschland GmbH and Co. KG)

Exviera (Active substance: dasabuvir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3628 of Mon, 04 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3837/T/38

Europe -DG Health and Food Safety

29-5-2018

Norvir (AbbVie Deutschland GmbH and Co. KG)

Norvir (AbbVie Deutschland GmbH and Co. KG)

Norvir (Active substance: Ritonavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3340 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/127/T/149

Europe -DG Health and Food Safety

25-5-2018

Kaletra (AbbVie Deutschland GmbH and Co. KG)

Kaletra (AbbVie Deutschland GmbH and Co. KG)

Kaletra (Active substance: lopinavir / Ritonavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3282 of Fri, 25 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/368/T/169

Europe -DG Health and Food Safety

16-5-2018

EU/3/14/1305 (AbbVie Deutschland GmbH and Co. KG)

EU/3/14/1305 (AbbVie Deutschland GmbH and Co. KG)

EU/3/14/1305 (Active substance: Humanised recombinant monoclonal antibody against epidermal growth factor receptor conjugated to maleimidocaproyl monomethylauristatin F) - Transfer of orphan designation - Commission Decision (2018)3022 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/065/14/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/17/1954 (AbbVie Deutschland GmbH and Co. KG)

EU/3/17/1954 (AbbVie Deutschland GmbH and Co. KG)

EU/3/17/1954 (Active substance: Venetoclax) - Transfer of orphan designation - Commission Decision (2018)3028 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/131/17/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1767 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1767 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1767 (Active substance: Venetoclax) - Transfer of orphan designation - Commission Decision (2018)3027 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/121/16/T01

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1766 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1766 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1766 (Active substance: Venetoclax) - Transfer of orphan designation - Commission Decision (2018)3026 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/122/16/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1667 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1667 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1667 (Active substance: Rovalpituzumab tesirine) - Transfer of orphan designation - Commission Decision (2018)3025 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/015/16/T02

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1649 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1649 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1649 (Active substance: Humanised recombinant IgG4 anti-human tau antibody) - Transfer of orphan designation - Commission Decision (2018)3024 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/239/15/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1617 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1617 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1617 (Active substance: Venetoclax) - Transfer of orphan designation - Commission Decision (2018)3023 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/205/15/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/10/830 (AbbVie Deutschland GmbH and Co. KG)

EU/3/10/830 (AbbVie Deutschland GmbH and Co. KG)

EU/3/10/830 (Active substance: Veliparib) - Transfer of orphan designation - Commission Decision (2018)3021 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/110/10/T/02

Europe -DG Health and Food Safety

15-5-2018

Synagis (AbbVie Deutschland GmbH and Co. KG)

Synagis (AbbVie Deutschland GmbH and Co. KG)

Synagis (Active substance: palivizumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3064 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/257/T/116

Europe -DG Health and Food Safety

3-4-2018

EU/3/12/1080 (AbbVie Deutschland GmbH and Co. KG)

EU/3/12/1080 (AbbVie Deutschland GmbH and Co. KG)

EU/3/12/1080 (Active substance: 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide) - Transfer of orphan designation - Commission Decision (2018)2056 of Tue, 03 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/124/12/T/01

Europe -DG Health and Food Safety