Ecomucyl Sandoz 100

Informazioni principali

  • Nome commerciale:
  • Ecomucyl Sandoz 100 Di aggregazione mit Arance-Aroma
  • Forma farmaceutica:
  • Di aggregazione mit Arance-Aroma
  • Composizione:
  • acetylcysteinum 100 mg, arom.: saccharinum natricum et alia, antiox.: E 320, excipiens annuncio granulatum, pro charta.
  • 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:
  • Ecomucyl Sandoz 100 Di aggregazione mit Arance-Aroma
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Mukolytikum

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 47920
  • Data dell'autorizzazione:
  • 08-01-1987
  • 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, che contiene importanti informazioni.

Questo medicamento le è stato prescritto dal suo medico o le è stato consegnato senza prescrizione

medica in farmacia o in drogheria. Per ottenere il maggior beneficio, usi il medicamento

conformemente al foglietto illustrativo o segua le indicazioni del suo medico, del suo farmacista o

del suo droghiere.

Conservi il foglietto illustrativo per poterlo rileggere all’occorrenza.

Ecomucyl® Sandoz granulato

Che cos’è Ecomucyl® Sandoz e quando si usa?

Ecomucyl Sandoz contiene il principio attivo acetilcisteina. Questo principio attivo fluidifica e

scioglie le dense secrezioni che ristagnano nelle vie respiratorie e ne favorisce l’espettorazione.

Il muco che ricopre la mucosa delle vie respiratorie svolge un importante ruolo nella protezione

dell’organismo da sostanze nocive presenti nell’aria come batteri, polvere e impurità chimiche.

Queste sostanze irritanti vengono catturate dal muco che le rende inoffensive e poi eliminate con

l’espettorato.

In caso di infezioni batteriche o virali (raffreddore, influenza, bronchite) e di irritazioni croniche

indotte da sostanze nocive, si ha un aumento della produzione di muco. Se il muco diventa più denso

e viscoso, può portare a un’ostruzione delle vie respiratorie con difficoltà di respirazione e di

espettorazione.

Grazie all’effetto mucolitico, Ecomucyl Sandoz fluidifica le secrezioni dense che possono quindi

essere eliminate meglio con l’espettorato. In questo modo il rischio di un’eventuale infezione

diminuisce. Liberando le vie respiratorie, la tosse si calma e la respirazione diventa più facile.

Ecomucyl Sandoz è indicato per il trattamento di tutte le malattie delle vie respiratorie che provocano

un’eccessiva produzione di muco quale per es. raffreddore o influenza, associati a tosse e catarro,

come pure bronchite acuta e cronica, in caso di sinusite, laringite, faringite, asma bronchiale e (come

terapia complementare) nella mucoviscidosi (fibrosi cistica).

Di che cosa occorre inoltre tener conto durante il trattamento?

Bere molto può incrementare l’effetto dell’Ecomucyl Sandoz. Il fumo contribuisce all’eccessiva

formazione di muco bronchiale. Rinunciando al fumo può rafforzare l’effetto dell’Ecomucyl Sandoz.

Quando non si può assumere Ecomucyl® Sandoz?

Ecomucyl Sandoz non deve essere preso in caso di ipersensibilità conosciuta al principio attivo

acetilcisteina o di ulcera gastrica e intestinale. Il granulate non deve altresì essere assunto in presenza

di un’altra rara malattia congenita del metabolismo glucidico (intolleranza al fruttosio).

Ecomucyl Sandoz non dovrebbe inoltre essere assunto assieme ad antitussivi in quanto questi

sopprimono lo stimolo della tosse ed il naturale meccanismo di autopulizia delle vie respiratorie

impedendo quindi l’espettorazione del muco fluidificato. Ne può conseguire un ristagno di muco nei

bronchi con il pericolo di causare crampi bronchiali e infezioni delle vie respiratorie.

Per via dell'alto contenuto in principio attivo, le bustine di granulato da 600 mg non devono essere

somministrate a bambini di età inferiore a 12 anni (in caso di mucoviscidosi (fibrosi cistica) bambini

di età inferiore a 6 anni).

Il vostro medico saprà cosa fare in casi del genere.

Ecomucyl Sandoz non è indicato per i bambini di età inferiore ai 2 anni.

Quando è richiesta prudenza nella somministrazione di Ecomucyl® Sandoz?

L’utilizzo dell’Ecomucyl Sandoz può, soprattutto all’inizio del trattamento, comportare una

fluidificazione delle secrezioni bronchiali e favorire l’espettorazione. Se il paziente non è in grado di

espettorarle in maniera sufficiente, il medico potrà prendere delle misure di sostegno. Se in passato

ha avuto eruzioni cutanee o disturbi respiratori a seguito dell’assunzione di un medicamento

contenente lo stesso principio attivo dell’Ecomucyl Sandoz dovrebbe assolutamente informare il suo

medico, farmacista o droghiere prima di iniziare la cura.

La somministrazione simultanea di altri medicamenti può influenzare reciprocamente l’effetto.

Infatti, l’efficacia di certi medicamenti per il trattamento dell’insufficienza coronarica (ad es. la

nitroglicerina nell’angina pectoris) può essere aumentata.

La somministrazione simultanea di acetilcisteina e di carbamazepina può portare alla riduzione della

concentrazione di carbamazepina.

La somministrazione simultanea di antitussivi può pregiudicare l’effetto dell’Ecomucyl Sandoz (vedi

sopra: «Quando non si può assumere Ecomucyl Sandoz?»).

Inoltre, gli antibiotici non dovrebbero essere presi contemporaneamente a Ecomucyl Sandoz ma

soltanto dopo un intervallo di almeno 2 ore.

Informi il suo medico, farmacista o droghiere se soffre di altre malattie, soffre di allergie o assume o

applica altri medicamenti (anche se acquistati di propria iniziativa!).

Si può somministrare Ecomucyl® Sandoz durante la gravidanza o l’allattamento?

In base alle esperienze fatte finora, non sono noti rischi per il bambino se il medicamento è usato

correttamente. Tuttavia non sono state compiute indagini scientifiche sistematiche. Per precauzione

dovrebbe rinunciare, nella misura del possibile, ad assumere medicamenti durante la gravidanza o

chiedere consiglio al suo medico, farmacista o droghiere.

Non ci sono informazioni sull’escrezione di acetilcisteina nel latte materno. Pertanto, Ecomucyl

Sandoz dovrebbe essere usato durante l’allattamento soltanto se il medico curante lo ritiene

necessario.

Come usare Ecomucyl® Sandoz?

Salvo diversa prescrizione medica, il dosaggio abituale in caso di malattie acute è:

Bambini da 2 a 12 anni: 3 volte al giorno 1 bustina da 100 mg.

Ragazzi da 12 anni e adulti: 600 mg al giorno, ripartiti su una (1 bustina da 600 mg) o più

somministrazioni (ad es. 3 volte 200 mg).

Trattamento a lungo termine (solo su prescrizione medica):

400–600 mg al giorno, suddivisi su una o più somministrazioni, durata del trattamento 3–6 mesi al

massimo.

Se l’eccessiva produzione di muco e la tosse non dovessero diminuire dopo 2 settimane di

trattamento, dovrebbe consultare un medico in modo che questi possa stabilirne la causa ed escludere

un’eventuale malattia maligna delle vie respiratorie.

Mucoviscidosi: stesso dosaggio, tuttavia già per bambini dai 6 anni 1 bustina da 200 mg 3 volte al

giorno o 1 bustina di granulato da 600 mg 1 volta al giorno.

Sciogliere il contenuto di una bustina in un bicchiere di acqua fredda o calda e bere immediatamente.

Non sciogliere altri medicamenti insieme a Ecomucyl Sandoz in quanto sia l’effetto dell’Ecomucyl

Sandoz che quello dell’altro medicamento potrebbe essere influenzato o annullato.

All’apertura della bustina può percepire un leggero odore di zolfo. Questo è tipico del principio

attivo acetilcisteina e non ha alcuna influenza sulla sua efficacia.

Si attenga alla posologia indicata nel foglietto illustrativo o prescritta dal suo medico. Se ritiene che

l’azione del medicamento sia troppo debole o troppo forte ne parli con il suo medico, il suo

farmacista o il suo droghiere.

Quali effetti collaterali può avere Ecomucyl® Sandoz?

Con l’assunzione di Ecomucyl Sandoz possono manifestarsi i seguenti effetti collaterali:

occasionalmente disturbi gastrointestinali come vomito, diarrea, nausea, dolori addominali o

infiammazioni della mucosa orale come pure reazioni di ipersensibilità, orticaria, mal di testa e

febbre.

Inoltre è possibile che si manifestino occasionalmente casi di polso accelerato, ipotensione e ronzio

nelle orecchie, bruciori di stomaco, emorragie e ritenzione idrica in viso.

Possono anche comparire reazioni allergiche di tipo comune (come ad es. eruzioni cutanee o pruriti).

Qualora le reazioni di ipersensibilità dovessero provocare anche disturbi respiratori e crampi

bronchiali, cosa che può accadere in casi molto rari, dovrebbe interrompere immediatamente il

trattamento con Ecomucyl Sandoz e consultare un medico.

L’alito può temporaneamente avere un odore sgradevole.

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

suo droghiere.

Di che altro occorre tener conto?

Conservare nella confezione originale, a temperatura ambiente (15–25°C), al riparo

dalla luce e dall’umidità e fuori dalla portata dei bambini.

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

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

possono darle ulteriori informazioni.

Cosa contiene Ecomucyl® Sandoz?

1 bustina Ecomucyl Sandoz 100, granulato contiene: acetilcisteina 100 mg.

Eccipienti: sostanze aromatiche: saccarina di sodio e altri, sostanza conservante: E320 (butile-

idrossi-anisolo), nonché altri eccipienti.

1 bustina Ecomucyl Sandoz 200, granulato contiene: acetilcisteina 200 mg.

Eccipienti: sostanze aromatiche: saccarina di sodio e altri, sostanza conservante: E320 (butile-

idrossi-anisolo), nonché altri eccipienti.

1 bustina Ecomucyl Sandoz 600, granulato contiene: acetilcisteina 600 mg.

Eccipienti: sostanze aromatiche: saccarina di sodio e altri, sostanza conservante: E320 (butile-

idrossi-anisolo), nonché altri eccipienti.

Numero dell’omologazione

47920 (Swissmedic)

Dove è ottenibile Ecomucyl® Sandoz? Quali confezioni sono disponibili?

In farmacia e in drogheria senza prescrizione medica.

Sono disponibili le seguenti confezioni:

30 bustine di 100 mg

30 bustine di 200 mg

10 bustine di 600 mg

In farmacia dietro presentazione della prescrizione medica.

Sono disponibili le seguenti confezioni:

100 bustine di 200 mg

100 bustine di 600 mg

Titolare dell’omologazione

Sandoz Pharmaceuticals S.A., Risch; domicilio: Rotkreuz

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

competente in materia di medicamenti (Swissmedic).

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World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix LLC, is voluntarily recalling lot: 112710 of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa capsules, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend to the consumer level. These products have been tested by the U.S. Food and Drug Administration (“FDA”) and found to be contaminated with High Microbial Loads. Additionally, this serves as a update to a previous press release posted on June 30th 2018, concerning Blissful...

FDA - U.S. Food and Drug Administration

3-8-2018

Scientific guideline:  Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance, adopted

Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

22-6-2018

Metronidazole intravenous infusion 500 mg/100 mL bag

Metronidazole intravenous infusion 500 mg/100 mL bag

Shortage and althernative supply of Metronidazole intravenous infusion 500 mg/100 mL bag

Therapeutic Goods Administration - Australia

15-6-2018

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

At least 43 patient reported adverse event after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared i...

FDA - U.S. Food and Drug Administration

12-6-2018

Blokhuis: harde feiten gif in sigaretten zeer zorgelijk

Blokhuis: harde feiten gif in sigaretten zeer zorgelijk

Teer, nicotine en koolmonoxide gehalten in sigaretten die gemeten worden volgens de Canadian Intense (CI) methode zijn minimaal twee keer zo hoog als de gehalten gemeten met de wettelijke voorgeschreven ISO methode waarmee de EU en dus ook Nederland werkt. In sommige gevallen liggen de gehaltes zelfs tot meer dan 20 keer hoger. Dat blijkt uit onderzoek van het RIVM, dat 100 sigaretten onder de loep nam. Staatssecretaris Paul Blokhuis (VWS) heeft als opdrachtgever het onderzoek vandaag in ontvangst genome...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

3-5-2018

CVM eSubmitter Webinar 1 Agenda

CVM eSubmitter Webinar 1 Agenda

CVM will host the first of a three-part webinar series to provide information on the use of CVM’s electronic submission tool, eSubmitter, in the new animal drug application approval process. These webinars will support the use of eSubmitter as we move to 100% electronic submission.

FDA - U.S. Food and Drug Administration

28-2-2018

Help 100% & Pure Natural & Body Slim capsules

Help 100% & Pure Natural & Body Slim capsules

Help 100% & Pure Natural & Body Slim Capsules pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

8-9-2017

The Icelandic Medicines Agency advertises a vacancy for an inspector in its Inspection Unit

The Icelandic Medicines Agency advertises a vacancy for an inspector in its Inspection Unit

The Icelandic Medicines Agency advertises a vacancy for an inspector. The Agency is looking for a candidate who is willing and able to work on demanding and interesting tasks, including travels in Iceland and abroad on behalf of the Agency. The vacancy is a full post (100%).

IMA - Icelandic Medicines Agency

3-7-2017

The Icelandic Medicines Agency wishes to recruit experts to its Licencing Unit

The Icelandic Medicines Agency wishes to recruit experts to its Licencing Unit

The Agency advertises two vacancies for experts in its Quality Assessment Team. The Agency is looking for strong candidates who are willing to work on challenging and interesting tasks. Each vacancy is a full position (100%). Application deadline is up to and including 16 July 2017.

IMA - Icelandic Medicines Agency

12-12-2018

Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018

Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018

TGO 100 has been registered on the Federal Register of Legislation. It commences on 8 December 2018, repealing and replacing TGO 98

Therapeutic Goods Administration - Australia

26-11-2018

Ziextenzo (Sandoz GmbH)

Ziextenzo (Sandoz GmbH)

Ziextenzo (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)7961 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4802

Europe -DG Health and Food Safety

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Bempedoic acid (ETC-1002), decision type: , therapeutic area: , PIP number: P/0185/2018

Opinion/decision on a Paediatric investigation plan (PIP): Bempedoic acid (ETC-1002), decision type: , therapeutic area: , PIP number: P/0185/2018

Opinion/decision on a Paediatric investigation plan (PIP): Bempedoic acid (ETC-1002), decision type: , therapeutic area: , PIP number: P/0185/2018

Europe - EMA - European Medicines Agency

21-11-2018

EU/3/18/2100 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/2100 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/2100 (Active substance: Propagermanium) - Orphan designation - Commission Decision (2018)7810 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/103/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

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

24-9-2018

Rixathon (Sandoz GmbH)

Rixathon (Sandoz GmbH)

Rixathon (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)6230 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

19-9-2018

Kadcyla (Roche Registration GmbH)

Kadcyla (Roche Registration GmbH)

Kadcyla (Active substance: Trastuzumab emtansine) - Centralised - Renewal - Commission Decision (2018)6100 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2389/R/39

Europe -DG Health and Food Safety

4-9-2018

Binocrit (Sandoz GmbH)

Binocrit (Sandoz GmbH)

Binocrit (Active substance: epoetin alfa) - Centralised - 2-Monthly update - Commission Decision (2018)5856 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/725/II/WS/1406

Europe -DG Health and Food Safety

29-8-2018

Zarzio (Sandoz GmbH)

Zarzio (Sandoz GmbH)

Zarzio (Active substance: Filgrastim) - Centralised - Yearly update - Commission Decision (2018)5764 of Wed, 29 Aug 2018

Europe -DG Health and Food Safety

23-8-2018

 Minutes of the 100th meeting of the Management Board: 6-7 June 2018

Minutes of the 100th meeting of the Management Board: 6-7 June 2018

Europe - EMA - European Medicines Agency

30-7-2018

Hyrimoz (Sandoz GmbH)

Hyrimoz (Sandoz GmbH)

Hyrimoz (Active substance: adalimumab) - Centralised - Authorisation - Commission Decision (2018)5097 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4320

Europe -DG Health and Food Safety

30-7-2018

Halimatoz (Sandoz GmbH)

Halimatoz (Sandoz GmbH)

Halimatoz (Active substance: adalimumab) - Centralised - Authorisation - Commission Decision (2018)5098 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4866

Europe -DG Health and Food Safety

30-7-2018

Hefiya (Sandoz GmbH)

Hefiya (Sandoz GmbH)

Hefiya (Active substance: adalimumab) - Centralised - Authorisation - Commission Decision (2018)5099 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4865

Europe -DG Health and Food Safety

13-7-2018

Erelzi (Sandoz GmbH)

Erelzi (Sandoz GmbH)

Erelzi (Active substance: etanercept) - Centralised - Yearly update - Commission Decision (2018)4712 of Fri, 13 Jul 2018

Europe -DG Health and Food Safety

10-7-2018

Temozolomide Sandoz (Sandoz GmbH)

Temozolomide Sandoz (Sandoz GmbH)

Temozolomide Sandoz (Active substance: temozolomide) - Centralised - Yearly update - Commission Decision (2018)4480 of Tue, 10 Jul 2018

Europe -DG Health and Food Safety

10-7-2018

Pemetrexed Sandoz (Sandoz GmbH)

Pemetrexed Sandoz (Sandoz GmbH)

Pemetrexed Sandoz (Active substance: pemetrexed) - Centralised - Yearly update - Commission Decision (2018)4485 of Tue, 10 Jul 2018

Europe -DG Health and Food Safety

27-6-2018

PANTOLOC Control (Takeda GmbH)

PANTOLOC Control (Takeda GmbH)

PANTOLOC Control (Active substance: pantoprazole) - PSUSA - Modification - Commission Decision (2018)4105 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1100/PSUSA/2285/201708

Europe -DG Health and Food Safety

6-6-2018

Agenda:  Agenda for the 100th meeting of the Management Board

Agenda: Agenda for the 100th meeting of the Management Board

Europe - EMA - European Medicines Agency

5-6-2018

Agenda:  Draft agenda for the 100th meeting of the Management Board

Agenda: Draft agenda for the 100th meeting of the Management Board

Europe - EMA - European Medicines Agency

24-5-2018

Tybost (Gilead Sciences International Limited)

Tybost (Gilead Sciences International Limited)

Tybost (Active substance: cobicistat) - PSUSA - Modification - Commission Decision (2018)3255 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10081/201708

Europe -DG Health and Food Safety

24-5-2018

Stribild (Gilead Sciences International Limited)

Stribild (Gilead Sciences International Limited)

Stribild (Active substance: elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil (as fumarate)) - PSUSA - Modification - Commission Decision (2018)3277 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2574/PSUSA/10082/201708

Europe -DG Health and Food Safety

23-5-2018

Zessly (Sandoz GmbH)

Zessly (Sandoz GmbH)

Zessly (Active substance: infliximab) - Centralised - Authorisation - Commission Decision (2018)3215 of Wed, 23 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4647

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Active substance: 4-{[(2R,3S,4R,5S)-4-(4-chloro-2-fluoro-phenyl)-3-(3-chloro-2-fluoro-phenyl)-4-cyano-5-(2,2-dimethyl-propyl)-pyrrolidine-2-carbonyl]-amino}-3-methoxy-benzoic acid) - Transfer of orphan designation - Commission Decision (2018)3149 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/14/T/01

Europe -DG Health and Food Safety