Yasnal 10 mg filmom obložene

Glavna informacija

  • Trgovački naziv:
  • Yasnal 10 mg filmom obložene tablete
  • Doziranje:
  • 10 mg
  • Farmaceutski oblik:
  • filmom obložena tableta
  • Sastav:
  • Urbroj: svaka filmom obložena tableta sadrži 10 mg donepezilklorida
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Krka d.d., Novo mesto, Slovenija

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Yasnal 10 mg filmom obložene tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 28 tableta u blisteru, u kutiji [HR-H-370462092-01] Urbroj: 381-12-01/30-17-03

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-370462092
  • Datum autorizacije:
  • 23-05-2017
  • Zadnje ažuriranje:
  • 05-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za bolesnika

Yasnal 5 mg filmom obložene tablete

Yasnal 10 mg filmom obložene tablete

donepezilklorid

Pažljivo pročitajte cijelu uputu prije nego počnete uzimati ovaj lijek jer sadrži Vama važne

podatke.

Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.

Ako imate dodatnih pitanja, obratite se Vašem liječniku ili ljekarniku.

Ovaj je lijek propisan samo Vama. Nemojte ga davati drugima. Može im naškoditi, čak i ako su

njihovi znakovi bolesti jednaki Vašima.

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika. To uključuje

i svaku moguću nuspojavu koja nije navedena u ovoj uputi. Pogledajte dio 4.

Što se nalazi u ovoj uputi:

Što je Yasnal i za što se koristi?

Što morate znati prije nego počnete uzimati Yasnal?

Kako uzimati Yasnal?

Moguće nuspojave

Kako čuvati Yasnal?

Sadržaj pakiranja i druge informacije

1.

Što je Yasnal i za što se koristi?

Yasnal filmom obložena tableta sadrži djelatnu tvar donepezilklorid koji pripada skupini lijekova pod

nazivom inhibitori acetilkolinesteraze. Donepezil povisuje razinu acetilkolina, tvari u mozgu koja je

povezana uz funkciju pamćenja tako da usporava pad razine acetilkolina.

Yasnal je namijenjen liječenju simptoma demencije u bolesnika koji boluju od blage do umjereno

teške Alzheimerove bolesti.

Simptomi uključuju porast gubitka pamćenja, konfuziju i promjene u ponašanju što dovodi do toga da

se oboljeli od Alzheimerove bolesti sve teže i teže nose sa svakodnevnim aktivnostima.

Yasnal se smije primjenjivati samo u odraslih.

2.

Što morate znati prije nego počnete uzimati Yasnal?

Nemojte uzimati Yasnal

ako ste alergični na donepezilklorid, na derivate piperidina ili neki drugi sastojak ovog lijeka

(naveden u dijelu 6.).

Upozorenja i mjere opreza

Obratite se Vašem liječniku ili ljekarniku prije nego uzmete Yasnal.

Obavijestite svog liječnika ili ljekarnika prije nego počnete uzimati Yasnal ako imate ili ste imali:

čireve na želucu ili dvanaesniku

napadaje ili konvulzije

problem sa srcem (osobito nepravilan ili vrlo usporen rad srca)

astmu ili drugu dugotrajnu plućnu bolest

probleme s jetrom ili hepatitis

poteškoće s mokrenjem ili blagu bolest bubrega.

Recite Vašem liječniku ako ste trudni ili mislite da biste mogli biti trudni.

H A L M E D

23 - 05 - 2017

O D O B R E N O

Drugi lijekovi i Yasnal

Obavijestite Vašeg liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje

druge lijekove, uključujući i one koje ste nabavili bez liječničkog recepta. To se odnosi i na lijekove

koje biste mogli uzimati istodobno u ubuduće ako nastavite uzimati Yasnal. Nekolicina lijekova može

promijeniti djelovanje lijeka Yasnal, odnosno i Yasnal može utjecati na djelovanje drugog lijeka.

Posebno naglasite svom liječniku ako uzimate bilo koji od sljedećih vrsta lijekova:

druge lijekove za liječenje Alzheimerove bolesti, npr. galantamin,

lijekove protiv boli ili artritisa npr. acetilsalicilatnu kiselinu, nesteroidne protuupalne lijekove

(NSAIL) poput ibuprofena ili diklofenaka,

antikolinergičke lijekove, npr. tolterodin,

antibiotike, npr. eritromicin, rifampicin,

lijekove protiv gljivičnih infekcija, npr. itrakonazol ili ketokonazol,

antidepresive npr. fluoksetin,

antikonvulzive (antiepileptike, protiv napadaja, grčeva), npr. fenitoin, karbamazepin,

lijekove za liječenje poteškoća sa srcem, npr. kinidin, beta-blokatore (propranolol i atenolol),

mišićne relaksanse, npr. diazepam, sukcinilkolin,

lijekove koji se mogu nabaviti bez recepta npr. biljne lijekove.

Ako idete na operaciju koja zahtijeva opću anesteziju, recite svom liječniku ili anesteziologu da

uzimate Yasnal. Razlog je što Vaš lijek može utjecati na količinu anestetika koja će biti potrebna.

Yasnal mogu koristiti bolesnici s bolešću bubrega ili blagom do umjerenom bolešću jetre. Ako imate

bolest bubrega ili jetre o tome prvo obavijestite svog liječnika. Bolesnici s teškom bolesti jetre ne bi

trebali uzimati Yasnal.

Recite liječniku ili ljekarniku ime svog njegovatelja. Njegovatelj će vam pomoći da pravilno uzimate

lijek.

Yasnal s hranom, pićem i alkoholom

Hrana neće utjecati na učinak Yasnala.

Nemojte piti alkohol tijekom uzimanja Yasnala jer alkohol može smanjiti njegovu učinkovitost.

Trudnoća i dojenje

Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate trudnoću, obratite se Vašem

liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.

Yasnal se ne smije primjenjivati tijekom trudnoće osim ako nije neophodno.

Yasnal se ne smije koristiti tijekom dojenja.

Upravljanje vozilima i strojevima

Alzheimerova bolest može smanjiti Vašu sposobnost upravljanja vozilima ili strojevima te ne smijete

izvoditi ove aktivnosti ako Vam liječnik nije rekao da su za Vas sigurne.

TakoĎer, Vaš lijek može uzrokovati umor, omaglicu i grč mišića. Ako Vam se pojavi nešto od

navedenoga, ne smijete upravljati vozilima ili strojevima.

Yasnal sadrži laktozu

Ako Vam je liječnik rekao da imate bolest nepodnošenja nekih šećera, prije nego što počnete uzimati

ovaj lijek posavjetujete se sa svojim liječnikom.

3.

Kako uzimati Yasnal?

Uvijek uzmite ovaj lijek točno onako kako Vam je rekao Vaš liječnik ili ljekarnik. Provjerite s Vašim

liječnikom ili ljekarnikom ako niste sigurni.

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23 - 05 - 2017

O D O B R E N O

Uobičajena početna doza je jedna tableta od 5 mg, uzeta s čašom vode svaku večer prije spavanja.

Nakon mjesec dana liječnik može povećati dozu na jednu tabletu od 10 mg koja se mora uzeti svaku

večer prije spavanja.

Jačina tableta koju ćete uzimati može se mijenjati ovisno o tome koliko dugo uzimate ovaj lijek te o

preporukama Vašeg liječnika. Najveća preporučena dnevna doza iznosi 10 mg.

Uvijek se pridržavajte uputa svog liječnika ili ljekarnika o načinu i vremenu uzimanja lijeka.

Nemojte sami mijenjati dozu bez savjetovanja sa svojim liječnikom.

Vaš će Vas liječnik ili ljekarnik savjetovati o tome koliko dugo trebate nastaviti uzimati tablete. Trebat

ćete s vremena na vrijeme posjetiti svog liječnika kako bi nadgledao Vaše liječenje i procijenio Vaše

simptome.

Primjena u djece i adolescenata

Yasnal se ne preporučuje za primjenu u djece i adolescenata (mlaĎih od 18 godina).

Ako uzmete više Yasnala nego što ste trebali

NEMOJTE uzimati više od jedne tablete dnevno. Odmah obavijestite svog liječnika ako uzmete više

nego što biste trebali. Ako ne možete kontaktirati svog liječnika, javite se hitnoj medicinskoj službi.

Uvijek ponesite sa sobom tablete i povijest bolesti kako bi liječnik mogao vidjeti što ste uzimali.

Simptomi predoziranja uključuju slabost i mučninu, slinjenje, znojenje, usporen rad srca, niski krvni

tlak (ošamućenost ili omaglicu prilikom ustajanja), probleme s disanjem, gubitak svijesti i napadaje

(trzanje) ili konvulzije.

Ako ste zaboravili uzeti Yasnal

Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.

Nastavite s primjenom lijeka tako da pravodobno uzmete sljedeću dozu.

Ako zaboravite uzimati lijek dulje od tjedan dana, obratite se liječniku prije nastavka uzimanja tableta.

Ako prestanete uzimati Yasnal

Veoma je važno da uzimate Yasnal toliko dugo koliko Vam je liječnik preporučio. Nemojte prestati s

uzimanjem tableta, osim ako vam to kaže Vaš liječnik.

Ako imate bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se Vašem liječniku ili

ljekarniku.

4.

Moguće nuspojave

Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće pojaviti u svakoga.

Morate odmah obavijestiti svog liječnika ako primijetite ovdje navedene ozbiljne nuspojave. Možda će

Vam trebati hitno liječenje.

vrućica praćena ukočenošću mišića, znojenjem ili sniženom razinom svijesti (poremećaj koji se

naziva “neuroleptički maligni sindrom”) (može se javiti u manje od 1 na 10 000 osoba).

mišićna slabost, osjetljivost ili bol, a posebice ako se istovremeno ne osjećate dobro, imate

visoku temperaturu ili tamnu mokraću. To može biti uzrokovano abnormalnom razgradnjom

mišića koja može biti opasna po život i dovesti do problema s bubrezima (stanje koje se zove

rabdomioliza) (može se javiti u manje od 1 na 10 000 osoba).

oštećenje jetre npr. hepatitis. Simptomi hepatitisa su osjećaj mučnine ili slabosti, gubitak

apetita, loše opće stanje, vrućica, svrbež, žutilo kože i očiju te tamno obojena mokraća (može se

javiti u manje od 1 na 1000 osoba).

čir na želucu i dvanaesniku. Simptomi pojave čireva su bol i nelagoda u želucu (loša probava)

koja se osjeća izmeĎu pupka i prsne kosti (može se javiti u manje od 1 na 100 osoba).

H A L M E D

23 - 05 - 2017

O D O B R E N O

krvarenje u želucu ili crijevima. To može dovesti do pojave stolice crne poput katrana ili

vidljivih tragova krvi iz rektuma (završnog dijela debelog crijeva) (može se javiti u manje od 1

na 100 osoba).

napadaji ili konvulzije (mogu se javiti u manje od 1 na 100 osoba).

Vrlo česte (mogu se javiti u više od 1 na 10 osoba):

proljev

mučnina

glavobolja

Česte (mogu se javiti u manje od 1 na 10 osoba):

prehlada

gubitak apetita

halucinacije (pričinjavanje da vidite ili čujete stvari kojih zapravo nema)

neobični snovi uključujući noćne more

uznemirenost

agresivno ponašanje

nesvjestica

omaglica

problemi sa spavanjem (nesanica)

povraćanje

nelagoda u želucu

kožni osip

svrbež

grč mišića

nekontrolirano mokrenje (inkontinencija)

umor

bolovi

sklonost padovima i ozljedama

Manje česte (mogu se javiti u manje od 1 na 100 osoba):

usporeni rad srca

Rijetke (mogu se javiti u manje od 1 na 1000 osoba):

ukočenost, drhtanje ili nekontrolirani pokreti, osobito lica i jezika, ali i udova (ekstrapiramidalni

simptomi)

poremećaji srčanog sustava za provoĎenje električnih impulsa (sinus- atrijski blok,

atrioventrikularni blok)

Prijavljivanje nuspojava

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti Vašeg liječnika ili ljekarnika. To

uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi. Nuspojave možete prijaviti

izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.

Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.

5.

Kako čuvati Yasnal?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju. Rok valjanosti

odnosi se na zadnji dan navedenog mjeseca.

Lijek ne zahtijeva posebne uvjete čuvanja.

H A L M E D

23 - 05 - 2017

O D O B R E N O

Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad. Pitajte svog ljekarnika kako

baciti lijekove koje više ne koristite. Ove će mjere pomoći u očuvanju okoliša.

6.

Sadržaj pakiranja i druge informacije

Što Yasnal sadrži?

Djelatna tvar je donepezilklorid. Svaka filmom obložena tableta sadrži 5 mg ili 10 mg

donepezilklorida.

Drugi sastojci u jezgri tablete su: hidroksipropilceluloza; laktoza hidrat; mikrokristalična

celuloza; kukuruzni škrob i magnezijev stearat. Drugi sastojci u film ovojnici tablete su:

titanijev dioksid (E171); hipromeloza i makrogol. U film ovojnici tableta od 10 mg nalazi se i

žuti željezov oksid (E171).

Kako Yasnal izgleda i sadržaj pakiranja?

5 mg filmom obložene tablete su bijelo do gotovo bijele boje, okrugle, bikonvesne, promjera 5 mm.

10 mg filmom obložene tablete su žuto-smeĎe boje, okrugle, binkovesne, promjera 8,9-9,4 mm.

Yasnal je dostupan u blisterima po 7 filmom obloženih tableta, a svaka kutija sadrži ukupno

28 filmom obloženih tableta.

Nositelj odobrenja za stavljanje lijeka u promet i proizvođač

Nositelj odobrenja:

KRKA - FARMA d.o.o., Radnička cesta 48, 10000 Zagreb

Proizvođač:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u svibnju 2017.

H A L M E D

23 - 05 - 2017

O D O B R E N O

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Spodoptera frugiperda partial risk assessment

Spodoptera frugiperda partial risk assessment

Published on: Fri, 31 Aug 2018 00:00:00 +0200 EFSA was asked for a partial risk assessment of Spodoptera frugiperda for the territory of the EU focussing on the main pathways for entry, factors affecting establishment, risk reduction options and pest management. As a polyphagous pest, five commodity pathways were examined in detail. Aggregating across these and other pathways, we estimate that tens of thousands to over a million individual larvae could enter the EU annually on host commodities. Instigat...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on a draft protocol for the Scientific Opinion on free sugars from all dietary sources, prepared by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel), supported by the ad‐hoc Working Group on Sugars. The draft protocol was endorsed by the Panel for public consultation at its plenary meeti...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 10 Aug 2018 00:00:00 +0200 This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process General Plastic (EU register No RECYC153), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes orig...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 In June 2016, EFSA received a mandate from the national food competent authorities of five European countries (Denmark, Finland, Iceland, Norway and Sweden) to provide a dietary reference value (DRV) for sugars, with particular attention to added sugars. A draft protocol was developed with the aim of defining as much as possible beforehand the strategy that will be applied for collecting data, appraising the relevant evidence, and analysing and integrating t...

Europe - EFSA - European Food Safety Authority Publications

22-8-2018

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food, Inc. of Portland, OR is expanding its voluntary recall to include an additional quantity of Rad Cat Raw Diet across all varieties with Best By dates of 10/19/18 through 12/3/19 because it has the potential to be contaminated with Listeria monocytogenes. Radagast Pet Food is conducting this voluntary recall out of an abundance of caution because of its strong commitment to food safety and quality.

FDA - U.S. Food and Drug Administration

10-8-2018

Enforcement Report for the Week of July 25, 2018

Enforcement Report for the Week of July 25, 2018

Recently Updated Records for the Week of July 25, 2018 Last Modified Date: Friday, August 10, 2018

FDA - U.S. Food and Drug Administration

12-11-2018

Spinraza (Biogen Netherlands B.V.)

Spinraza (Biogen Netherlands B.V.)

Spinraza (Active substance: nusinersen) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7550 of Mon, 12 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4312/T/10

Europe -DG Health and Food Safety

23-10-2018

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Active substance: Pegylated recombinant human interleukin-10) - Transfer of orphan designation - Commission Decision (2018)6994 of Tue, 23 Oct 2018

Europe -DG Health and Food Safety

22-10-2018

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Active substance: Sildenafil citrate) - Transfer of orphan designation - Commission Decision (2018)6993 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/068/10/T/01

Europe -DG Health and Food Safety

19-10-2018

Recocam (Bimeda Animal Health Limited)

Recocam (Bimeda Animal Health Limited)

Recocam (Active substance: Meloxicam) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6954 of Fri, 19 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2247/T/10

Europe -DG Health and Food Safety

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety

19-9-2018

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Active substance: olaratumab) - Centralised - Annual renewal - Commission Decision (2018)6105 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4216/R/10

Europe -DG Health and Food Safety

19-9-2018

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 5971 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4078/T/10

Europe -DG Health and Food Safety

10-9-2018

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Active substance: netupitant / palonosetron) - Centralised - Yearly update - Commission Decision (2018)5947 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

10-9-2018

Alkindi (Diurnal Limited)

Alkindi (Diurnal Limited)

Alkindi (Active substance: hydrocortisone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5945 of Mon, 10 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4416/T/03

Europe -DG Health and Food Safety

10-9-2018

Retacrit (Hospira UK Limited)

Retacrit (Hospira UK Limited)

Retacrit (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5946 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

10-9-2018

Silapo (STADA Arzneimittel AG)

Silapo (STADA Arzneimittel AG)

Silapo (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5944 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

4-9-2018

ACM meeting statement, Meeting 10, 2 August 2018

ACM meeting statement, Meeting 10, 2 August 2018

The Advisory Committee on Medicines meeting statement is now available

Therapeutic Goods Administration - Australia

22-8-2018

BTVPUR (Merial)

BTVPUR (Merial)

BTVPUR (Active substance: Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 4)) - Centralised - 2-Monthly update - Commission Decision (2018)5630 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2231/II/10

Europe -DG Health and Food Safety

10-8-2018

Torisel (Pfizer Europe MA EEIG)

Torisel (Pfizer Europe MA EEIG)

Torisel (Active substance: Temsirolimus) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5521 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/799/T/71

Europe -DG Health and Food Safety

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

Brinavess (Active substance: vernakalant hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5523 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1215/T/31

Europe -DG Health and Food Safety

10-8-2018

Lymphoseek (Norgine B.V.)

Lymphoseek (Norgine B.V.)

Lymphoseek (Active substance: tilmanocept) - Centralised - Yearly update - Commission Decision (2018)5520 of Fri, 10 Aug 2018

Europe -DG Health and Food Safety

10-8-2018

Sivextro (Merck Sharp and Dohme B.V.)

Sivextro (Merck Sharp and Dohme B.V.)

Sivextro (Active substance: tedizolid phosphate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5522 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2846/T/28

Europe -DG Health and Food Safety

10-8-2018

Cubicin (Merck Sharp and Dohme B.V.)

Cubicin (Merck Sharp and Dohme B.V.)

Cubicin (Active substance: Daptomycin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5519 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/637/T/69

Europe -DG Health and Food Safety

10-8-2018

Thalidomide Celgene (Celgene Europe B.V.)

Thalidomide Celgene (Celgene Europe B.V.)

Thalidomide Celgene (Active substance: Thalidomide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5524 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/823/T/57

Europe -DG Health and Food Safety

10-8-2018

CANCIDAS (Merck Sharp and Dohme B.V.)

CANCIDAS (Merck Sharp and Dohme B.V.)

CANCIDAS (Active substance: caspofungin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5517 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/379/T/67

Europe -DG Health and Food Safety

10-8-2018

Tesavel (Merck Sharp and Dohme B.V.)

Tesavel (Merck Sharp and Dohme B.V.)

Tesavel (Active substance: sitagliptin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5518 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/910/T/65

Europe -DG Health and Food Safety

10-8-2018

Januvia (Merck Sharp and Dohme B.V.)

Januvia (Merck Sharp and Dohme B.V.)

Januvia (Active substance: sitagliptin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4511 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/722/T/65

Europe -DG Health and Food Safety

10-8-2018

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Active substance: bortezomib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5515 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4207/T/10

Europe -DG Health and Food Safety

7-8-2018

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

FDA - U.S. Food and Drug Administration

7-8-2018

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Active substance: memantine) - Centralised - Renewal - Commission Decision (2018)5421 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2766/R/10

Europe -DG Health and Food Safety

30-7-2018

Zalmoxis (MolMed S.p.A.)

Zalmoxis (MolMed S.p.A.)

Zalmoxis (Active substance: Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (?LNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2)) - Centralised - Renewal - Commission Decision (2018)5118 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2801/R/10

Europe -DG Health and Food Safety

27-7-2018

EU/3/11/868 (Celgene Europe B.V.)

EU/3/11/868 (Celgene Europe B.V.)

EU/3/11/868 (Active substance: Lenalidomide) - Transfer of orphan designation - Commission Decision (2018)5045 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/160/10/T/01

Europe -DG Health and Food Safety