Hyzaar 100 mg 12 5

Glavna informacija

  • Trgovački naziv:
  • Hyzaar 100 mg/12,5 mg filmom obložene tablete
  • Doziranje:
  • 100 mg + 12,5 mg
  • Farmaceutski oblik:
  • filmom obložena tableta
  • Sastav:
  • Urbroj: jedna filmom obložena tableta sadrži 100 mg losartankalija i 12,5 mg hidroklorotiazida (HCTZ)
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Merck Sharp & Dohme Ltd., Carmlington, Northumberland, Ujedinjeno Kraljevstvo; Merck Sharp & Dohme B.V., Haarlem, Nizoz

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Hyzaar 100 mg/12,5 mg filmom obložene tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 28 tableta u blisteru, u kutiji [HR-H-883944358-01] Urbroj: 381-12-01/70-16-04

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-883944358
  • Datum autorizacije:
  • 09-11-2016
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za bolesnika

Hyzaar 100 mg/12,5 mg filmom obložene tablete

losartankalij/hidroklorotiazid

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, ljekarniku ili medicinskoj sestri.

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 Vašeg liječnika, ljekarnika ili

medicinsku sestru. To uključuje i svaku moguću nuspojavu koja nije navedena u ovoj

uputi. Pogledajte dio 4.

Što se nalazi u ovoj uputi:

Što je Hyzaar i za što se koristi?

Što morate znati prije nego počnete uzimati Hyzaar?

Kako uzimati Hyzaar?

Moguće nuspojave

Kako čuvati Hyzaar?

Sadržaj pakiranja i druge informacije

1.

Što je Hyzaar i za što se koristi?

Hyzaar je kombinacija antagonista receptora angiotenzina II (losartan) i diuretika

(hidroklorotiazid). Angiotenzin II je tvar koja se proizvodi u tijelu i veže za receptore u krvnim

žilama, izazivajući njihovo stezanje. To dovodi do povišenja krvnog tlaka. Losartan sprječava

vezivanje angiotenzina II za te receptore, zbog čega se krvne žile opuštaju, što snižava krvni tlak.

Hidroklorotiazid djeluje na bubrege tako da propuštaju više vode i soli. To također pomaže

smanjenju krvnog tlaka.

Hyzaar se koristi za liječenje esencijalne hipertenzije (povišenog krvnog tlaka).

2.

Što morate znati prije nego počnete uzimati Hyzaar?

Nemojte uzimati Hyzaar

ako ste alergični na losartan, hidroklorotiazid ili neki drugi sastojak ovog lijeka (naveden u

dijelu 6.),

ako ste alergični na druge tvari sulfonamidskog porijekla (npr., druge tiazide ili neke

antibakterijske lijekove kao što su kotrimoksazol; obratite se svom liječniku ako niste

sigurni),

ako imate teško oštećenje funkcije jetre,

ako imate nisku razinu kalija, nisku razinu natrija ili visoku razinu kalcija koje se ne mogu

ispraviti lijekovima,

ako imate giht.

H A L M E D

09-11-2016

O D O B R E N O

ako ste trudni više od 3 mjeseca (također je bolje izbjegavati Hyzaar u ranoj trudnoći –

vidjeti dio Trudnoća),

ako imate teško oštećenje funkcije bubrega ili Vaši bubrezi uopće ne proizvode mokraću,

ako imate šećernu bolest ili oštećenu bubrežnu funkciju i liječite se lijekom za snižavanje

krvnog tlaka koji sadrži aliskiren.

Upozorenja i mjere opreza

Obratite se Vašem liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Hyzaar.

Morate obavijestiti Vašeg liječnika ako mislite da ste trudni (ili biste mogli zatrudniti

). Hyzaar se

ne preporučuje u ranoj trudnoći i ne smije se uzimati nakon 3. mjeseca trudnoće jer može

prouzročiti ozbiljna oštećenja djeteta ako se uzima u tom razdoblju trudnoće (vidjeti dio

Trudnoća).

Prije nego što počnete uzimati Hyzaar, važno je da obavijestite liječnika o sljedećem

:

ako ste nekada imali oticanja lica, usana, grla ili jezika,

ako uzimate diuretike (tablete za mokrenje),

ako ste na dijeti s ograničenim unosom soli,

ako jako povraćate ili ste povraćali i/ili imate ili ste imali proljev,

ako bolujete od zatajenja srca,

ako imate oštećenu funkciju jetre (vidjeti dio 2. Nemojte uzimati Hyzaar)

ako imate sužene arterije bubrega (stenozu bubrežne arterije) ili imate samo jedan bubreg

koji funkcionira ili ako Vam je nedavno presađen bubreg,

ako imate suženje arterija (ateroskleroza), anginu pektoris (bol u prsištu zbog oslabljenog

rada srca),

ako imate ‘aortalnu ili mitralnu stenozu’ (suženje srčanih zalistaka) ili ‘hipertrofičnu

kardiomiopatiju’ (bolest koja uzrokuje zadebljanje srčanog mišića),

ako bolujete od šećerne bolesti,

ako imate giht,

ako imate ili ste imali alergiju, astmu ili bolest koja uzrokuje bol u zglobovima, kožne

osipe i vrućicu (sistemski lupus eritematosus),

ako imate visoku razinu kalcija ili nisku razinu kalija ili ste na dijeti s niskim unosom

kalija,

ako trebate primiti anestetik (čak i kod zubara), spremate se na operaciju ili ćete raditi

pretrage funkcije paratireoidnih žlijezda, morate obavijestiti liječnika ili drugo zdravstveno

osoblje da uzimate tablete koje sadrže losartankalij i hidroklorotiazid,

ako bolujete od primarnog hiperaldosteronizma (sindrom povezan s pojačanim lučenjem

hormona aldosterona iz nadbubrežne žlijezde, zbog poremećaja te žlijezde)

ako uzimate bilo koji od lijekova navedenih u nastavku, koji se koriste za liječenje visokog

krvnog tlaka:

ACE inhibitor (primjerice enalapril, lisinopril, ramipril), osobito ako imate

bubrežne tegobe povezane sa šećernom bolešću),

Aliskiren.

Liječnik Vam može provjeravati bubrežnu funkciju, krvni tlak i količinu elektrolita (npr. kalija) u

krvi u redovitim intervalima.

Vidjeti također informacije pod naslovom „Nemojte uzimati Hyzaar“.

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Djeca i adolescenti

Ne postoji iskustvo s primjenom lijeka Hyzaar u djece. Stoga se Hyzaar ne smije primjenjivati u

djece.

Drugi lijekovi i Hyzaar

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

koje druge lijekove..

Diuretici poput hidroklorotiazida koji se nalazi u lijeku Hyzaar

mogu imati interakcije s drugim

lijekovima.

Lijekovi koji sadrže litij ne smiju se uzimati s lijekom Hyzaar bez strogog liječničkog nadzora.

Mogu biti potrebne posebne mjere opreza (npr. krvne pretrage) ako uzimate nadomjeske kalija,

zamjenske soli koje sadrže kalij ili lijekove koji štede kalij, druge diuretike (tablete za mokrenje),

neke laksative, lijekove za liječenje gihta ili lijekove za kontrolu srčanog ritma ili šećerne bolesti

(oralne lijekove ili inzuline).

Također je važno da obavijestite svog liječnika ako uzimate sljedeće lijekove:

druge lijekove za snižavanje krvnog tlaka,

steroide,

lijekove za liječenje raka,

lijekove protiv bolova,

lijekove za liječenje gljivičnih infekcija,

lijekove za liječenje artritisa,

smole za snižavanje povišenog kolesterola, kao što je kolestiramin,

lijekove za opuštanje mišića,

tablete za spavanje,

lijekove koji sadrže opijate kao što je morfij,

‘presorske amine’ kao što je adrenalin ili drugi lijekovi iz te skupine,

oralne lijekove ili inzuline za liječenje šećerne bolesti

Liječnik će Vam možda morati promijeniti dozu i/ili poduzeti druge mjere opreza:

Ako uzimate ACE inhibitor ili aliskiren (vidjeti također informacije pod naslovima „Nemojte

uzimati Hyzaar“ i „Upozorenja i mjere opreza“).

Molimo Vas da također obavijestite Vašeg liječnika o tome da uzimate Hyzaar ako planirate

radiološke pretrage zbog kojih ćete primiti kontrastno sredstvo koje sadrži jod.

Hyzaar s hranom i pićem

Savjetujemo Vam da ne pijete alkohol dok uzimate ove tablete: alkohol i Hyzaar

mogu pojačati

učinke jedan drugog.

Prehrana s pretjeranim unosom soli može poništiti učinak Hyzaar

tableta.

Hyzaar

tablete mogu se uzimati s hranom ili bez nje.

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Trudnoća i dojenje

Trudnoća

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

liječniku za savjet prije nego uzmete ovaj lijek. Liječnik će Vam u pravilu savjetovati da

prestanete uzimati Hyzaar prije početka trudnoće ili čim saznate da ste trudni i savjetovat će Vam

da umjesto lijeka Hyzaar uzimate drugi lijek. Hyzaar se ne preporučuje u ranoj trudnoći i ne smije

se uzimati nakon 3. mjeseca trudnoće jer može prouzročiti ozbiljna oštećenja djeteta ako se

koristi nakon trećeg mjeseca trudnoće.

Dojenje

Obavijestite Vašeg liječnika ako dojite ili planirate dojiti. Hyzaar se ne preporučuje majkama koje

doje. Želite li dojiti, Vaš liječnik može odabrati drugačiju vrstu liječenja

Primjena u starijih bolesnika

Hyzaar djeluje jednako dobro i jednako ga dobro podnosi većina starijih i mlađih odraslih

bolesnika. Većini starijih bolesnika potrebna je jednaka doza kao i mlađim bolesnicima.

Upravljanje vozilima i strojevima

Nakon što počnete uzimati ovaj lijek, ne smijete obavljati poslove koji zahtijevaju posebnu

pozornost (na primjer, upravljanje automobilom ili rad na opasnim strojevima) sve dok ne budete

sigurni da dobro podnosite lijek.

Hyzaar sadrži laktozu

Ako Vam je liječnik rekao da ne podnosite neke šećere, posavjetujte se s Vašim liječnikom prije

uzimanja ovog lijeka.

3.

Kako uzimati Hyzaar?

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

Vašim liječnikom ili ljekarnikom ako niste sigurni. Vaš liječnik će odlučiti koja Vam doza lijeka

Hyzaar odgovara ovisno o Vašem zdravstvenom stanju i drugim lijekovima koje uzimate. Važno

je da nastavite s uzimanjem lijeka Hyzaar onoliko dugo koliko je to propisao liječnik kako biste

bez poteškoća kontrolirali Vaš krvni tlak.

Povišen krvni tlak

Uobičajena doza lijeka Hyzaar za većinu bolesnika s povišenim krvnim tlakom je

1 losartan/hidroklorotiazid 50 mg/12,5 mg tableta jedanput na dan da bi krvni tlak bio pod

kontrolom tijekom 24 sata. Ta se doza može povećati na 2 losartan/hidroklorotiazid 50

mg/12,5 mg filmom obložene tablete jedanput na dan ili zamijeniti 1 losartan/hidroklorotiazid

100 mg/25 mg filmom obloženom tabletom jedanput na dan (jača doza). Maksimalna dnevna

doza iznosi 2 losartan/hidroklorotiazid 50 mg/12,5 mg filmom obložene tablete jedanput na dan

ili 1 losartan / hidroklorotiazid 100 mg/25 mg filmom obložena tableta jedanput na dan.

Ako uzmete više lijeka Hyzaar nego što ste trebali

U slučaju predoziranja odmah se javite svom liječniku tako da možete dobiti hitnu medicinsku

pomoć. Predoziranje može izazvati prejako sniženje krvnog tlaka, lupanje srca, usporen puls,

promjene u sastavu krvi i dehidraciju.

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Ako ste zaboravili uzeti Hyzaar

Uzimajte Hyzaar svaki dan kako je propisano. Međutim, ako propustite dozu, nemojte uzeti

dvostruku dozu kako biste nadoknadili zaboravljenu dozu. Samo nastavite uzimati lijek prema

uobičajenom rasporedu.

4.

Moguće nuspojave

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

Ako osjetite sljedeće znakove i simptome, prestanite uzimati Hyzaar tablete i odmah se javite

liječniku ili otiđite na hitnu službu u najbližu bolnicu:

Teška alergijska reakcija (osip, svrbež, oticanje lica, usana, usta ili grla što može

prouzročiti poteškoće pri gutanju ili disanju).

To je ozbiljna, ali rijetka nuspojava, koja se može javiti u manje od 1 na 1000 osoba. Postoji

mogućnost da će Vam biti potrebna hitna medicinska pomoć ili bolničko liječenje.

Zabilježene su sljedeće nuspojave:

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

kašalj, infekcija gornjih dišnih putova, začepljenost nosa, upala sinusa, smetnje sa sinusima

proljev, bol u trbuhu, mučnina, probavne smetnje

bol ili grčevi u mišićima, bol u nogama, bol u leđima,

nesanica, glavobolja, omaglica,

slabost, umor, bol u prsištu,

povišena razina kalija (koja može prouzročiti poremećaj srčanog ritma), snižena razina

hemoglobina

promjene funkcije bubrega uključujući zatajenje bubrega

jako snižene razine šećera u krvi (hipoglikemija).

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

Anemija (slabokrvnost), crvene ili smećkaste mrlje na koži (ponekad osobito na stopalima,

nogama, rukama i stražnjici, uz bol u zglobovima, oticanje šaka i stopala i bol u želucu),

modrice, smanjen broj bijelih krvnih stanica, problemi sa zgrušavanjem krvi i smanjen broj

krvnih pločica,

gubitak apetita, povišena razina mokraćne kiseline ili znakovi gihta, povišena razina šećera

u krvi, poremećaj razine elektrolita u krvi,

tjeskoba, nervoza, panični poremećaj (ponavljajući napadi panike), smetenost, depresija,

nenormalni snovi, poremećaj spavanja, pospanost, narušeno pamćenje,

trnci i žmarci ili slični osjeti, bol u udovima, drhtanje, migrena, nesvjestica,

zamagljen vid, peckanje ili bockanje u očima, konjunktivitis, pogoršanje vida, promjena

vida pri čemu se sve vidi žuto,

zvonjenje, zujanje, brujanje ili pucketanje u ušima,vrtoglavica

nizak krvni tlak, koji može biti povezan s promjenama u držanju tijela (osjećaj nadolazeće

nesvjestice ili slabosti prilikom ustajanja, angina pektoris (bol u prsištu), poremećen ritam

srca, prolazni napadaj nalik moždanom udaru (TIA, “mali moždani udar”), srčani udar,

lupanje srca,

upala krvnih žila, što je često povezano s kožnim osipom ili modricama,

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grlobolja, nedostatak zraka, bronhitis, pneumonija, voda u plućima (što otežava disanje),

krvarenje iz nosa, curenje iz nosa, začepljenost nosa,

zatvor, vjetrovi, nelagoda u želucu,

grčevi želuca, povraćanje, suha usta, upala žlijezda

slinovnica, zubobolja,

žutica (žuta boja bjeloočnica i kože), upala gušterače,

koprivnjača, svrbež, upala kože, osip, crvenilo kože, osjetljivost na svjetlo, suha koža,

navale crvenila, znojenje, gubitak kose,

bol u rukama, ramenima, kukovima, koljenima ili drugim zglobovima, oticanje zglobova,

ukočenost, mišićna slabost,

učestalo mokrenje uključujući mokrenje noću, poremećena funkcija bubrega uključujući

upalu bubrega, mokraćne infekcije, šećer u mokraći,

smanjen seksualni apetit, impotencija,

oticanje lica,lokalizirano oticanje (edem), vrućica.

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

Hepatitis (upala jetre), poremećeni nalazi funkcije jetre

Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka):

simptomi nalik gripi

bolovi u mišićima nepoznatog uzroka s tamno obojenom (boje čaja)mokraćom

(rabdomioliza)

niske razina natrija u krvi (hiponatremija)

opće loše osjećanje (malaksalost)

poremećaj okusa (disgeuzija)

Prijavljivanje nuspojava

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

medicinsku sestru. 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 Hyzaar?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju iza oznake

„EXP“. Rok valjanosti odnosi se na zadnji dan navedenog mjeseca.

Hyzaar čuvajte u originalnom pakiranju radi zaštite od svjetlosti i vlage. Čuvajte pri temperaturi

do 30

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

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

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6.

Sadržaj pakiranja i druge informacije

Što Hyzaar sadrži?

Djelatne tvari su losartankalij i hidroklorotiazid.

Hyzaar 100 mg/12,5 mg sadrži 100 mg losartankalija i 12,5 mg hidroklorotiazida kao djelatne

tvari.

Druge pomoćne tvari su:

mikrokristalična celuloza, laktoza hidrat, prethodno geliran škrob, magnezijev stearat,

hidroksipropilceluloza, hipromeloza, titanijev dioksid (E171) i karnauba vosak (E903).

Kako Hyzaar izgleda i sadržaj pakiranja?

Hyzaar 100 mg/12,5 mg dostupan je u obliku bijelih, ovalnih, filmom obloženih tableta veličine

13,335 mm x 7,55 mm koje imaju oznaku "745" na jednoj strani, a s druge su strane glatke.

Hyzaar 100 mg/12,5 mg - PVC/PE/PVDC//Al blister pakiranje sa 28 tableta, u kartonskoj kutiji.

Nositelj odobrenja za stavljanje lijeka u promet i proizvođač

Nositelj odobrenja

Merck Sharp & Dohme d.o.o.

Ivana Lučića 2a, 10 000 Zagreb

Proizvođač

Merck Sharp & Dohme B.V.

Waarderweg 39, Postbus 581, 2003 PC Haarlem

Nizozemska

Merck Sharp & Dohme Ltd.

Shotton Lane, Cramlington, Northumberland, NE23 3JU

Ujedinjeno Kraljevstvo

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je posljednji put revidirana u studenom 2016.

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09-11-2016

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

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

Published on: Thu, 15 Nov 2018 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for pyraclostrobin in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residues trials supporting the existing use of pyraclostrobin on table grapes authorised in southern EU Member States and an analytical method for analysing residues of pyraclostrobin in ...

Europe - EFSA - European Food Safety Authority Publications

14-11-2018

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

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

Published on: Tue, 13 Nov 2018 The applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in France to evaluate the confirmatory data that were identified in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. The data gap which was related to information on freezer storage conditions for the residue trials reported on potatoes, tomatoes and cucurbits with edible and inedible peel was considered satisfactorily addressed...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Peer review of the pesticide risk assessment of the active substance napropamide‐M

Peer review of the pesticide risk assessment of the active substance napropamide‐M

Published on: Mon, 12 Nov 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State the United Kingdom for the pesticide active substance napropamide‐M are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of napropamid...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Published on: Mon, 12 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Agro BV submitted a request to the competent national authority in the United Kingdom to set import tolerances for the active substance teflubenzuron in grapefruits and mandarins imported from Brazil and for broccoli imported from Paraguay. The data submitted were found to be sufficient to derive maximum residue level (MRL) proposals for grapefruits and broccoli. The MRL derived ...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

The importance of vector abundance and seasonality

The importance of vector abundance and seasonality

Published on: Mon, 12 Nov 2018 00:00:00 +0100 This joint ECDC‐EFSA report assesses whether vector count data (abundance) and the way these change throughout the year (seasonality) can provide useful information about vector‐borne diseases epidemiological processes of interest, and therefore, whether resources should be devoted to collecting such data. The document also summarises what measures of abundance and seasonality can be collected for each vector group (mosquitoes, sandflies, midges and ticks), ...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Alebrije Dist Wholesale Recalls Quesillo Queseria “La Milagrosa” and “Alebrije Cheese” Because of Possible Health Risk

Alebrije Dist Wholesale Recalls Quesillo Queseria “La Milagrosa” and “Alebrije Cheese” Because of Possible Health Risk

ALEBRIJE DIST WHOLESALE is collaborating with health officials due to a positive finding of Salmonella in a sample of Quesillo “Queseria La Milagrosa”. ALEBRIJE DIST WHOLESALE is voluntarily recalling the amount of 100 kilos of Quesillo “Queseria La Milagrosa”. While “Alebrije Cheese” has not been found positive for Salmonella, ALEBRIJE DIST WHOLESALE has decided to voluntarily recall the specific 498 “Alebrije Cheese” pieces that were imported during the same period out of an abundance of caution.

FDA - U.S. Food and Drug Administration

9-11-2018

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz Inc. Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. This impurity, which is a substance that occurs naturally in ...

FDA - U.S. Food and Drug Administration

9-11-2018

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

These vaping products do not meet requirements of the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) under the Canada Consumer Product Safety Act.

Health Canada

9-11-2018

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Published on: Wed, 07 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4‐benzene dicarboxylate complexes, used as a taggant in plastics for authentication and ...

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Published on: Fri, 02 Nov 2018 00:00:00 +0100 The applicant BASF SE submitted a request to the competent national authority in Belgium to evaluate the confirmatory data that were identified for kresoxim‐methyl 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 confirmatory data requirement, a new study on the storage stability of kresoxim‐methyl residues in animal matrices was submitted. The data gap was considered ...

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Published on: Fri, 02 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the Australian Government Department of Agriculture and Water Resources submitted two requests to the competent national authority in Denmark to set import tolerances for the active substance haloxyfop‐P in linseed and rapeseed. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for linseed and rapeseed. Adequate analytical metho...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Published on: Tue, 30 Oct 2018 00:00:00 +0100 In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide an update of the reasoned opinion on the review of existing maximum residue levels (MRLs) for imazalil published on 5 September 2017, taking into account the additional information provided on the toxicity of the metabolites R014821, FK‐772 and FK‐284. EFSA did not derive MRL proposals from the post‐harvest uses reported on citrus fru...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The product Bergazym® P100 contains a xylanase which is produced by a non‐genetically modified strain of Trichoderma reesei. The additive is available in a coated granular form and it is intended to be used as a zootechnical additive (functional group: digestibility enhancers) for chickens for fattening, and weaned piglets at the dose of 1,500 EPU/kg feed. The production strain and the additive were fully characterised in a previous assessment of the Panel o...

Europe - EFSA - European Food Safety Authority Publications

26-10-2018

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Published on: Thu, 25 Oct 2018 00:00:00 +0200 A multi-country outbreak of 12 listeriosis cases caused by Listeria monocytogenes sequence type (ST) 8 has been identified through whole genome sequencing (WGS) analysis in three EU/EEA countries: Denmark (6 cases), Germany (5) and France (1). Four of these cases have died due to or with the disease. It is likely that the extent of this outbreak has been underestimated since the outbreak was identified through sequencing and only a subset of the EU/EEA count...

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

FDA approves new drug to treat influenza

FDA approves new drug to treat influenza

FDA approved Xofluza (baloxavir marboxil) to treat acute uncomplicated flu in patients 12 years old and older who have been symptomatic for less than 48 hours.

FDA - U.S. Food and Drug Administration

24-10-2018

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Published on: Tue, 23 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of HOSTAZYM® X as a feed additive for sows in order to have benefit in piglets. The additive HOSTAZYM® X contains endo‐1,4‐beta‐xylanase and is available in liquid and solid formulations. This product is authorised as a feed additive for chickens for fattening, tu...

Europe - EFSA - European Food Safety Authority Publications

23-10-2018

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

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

Published on: Mon, 22 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified 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, residue trials on strawberries, onions, garlic, tomatoes, peppers, cucumbers, artichokes, leeks and rape seeds were submitted. The data gaps are considere...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for dimethomorph in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted residue data on raspberries were satisfactorily addressing the data gaps on raspberries and blackberries. Considering the new information provided, it is appropri...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant, Nichino Europe Co. Ltd., submitted application request to the competent national authority in the Netherlands to evaluate confirmatory data that were identified for pyraflufen‐ethyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted data were sufficient to confirm the MRLs for citrus fruits, tree nuts, pome fruits, stone fruits, table and wine grapes, curra...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2‐methylpent‐2‐enal [FL‐no: 05.090] and 2 methylcrotonaldehyde [FL‐no: 05.095], from subgroup 1.1.2 of FGE.19. In FGE.201Rev1, the Panel concluded that further data were required in order to clarify the genotoxic poten...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Clackamas Bakery Recalls Fred Meyer Bakery Angel Food Cake Bar Due to Undeclared Allergens

Clackamas Bakery Recalls Fred Meyer Bakery Angel Food Cake Bar Due to Undeclared Allergens

Clackamas Bakery has recalled Fred Meyer Bakery Angel Food Cake Bar (12 oz.) sold in its retail stores because the product may contain milk and soy not listed on the label. Clackamas Bakery initiated the recall when it was discovered that the Fred Meyer Bakery Angel Food Cake Bar label had been incorrectly applied to packages of cornbread.

FDA - U.S. Food and Drug Administration

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

5-10-2018

Consumer Alert: Sprout Creek Farm “Margie” Cheese Batch Recalled

Consumer Alert: Sprout Creek Farm “Margie” Cheese Batch Recalled

Today the New York State Department of Agriculture and Markets alerted consumers to a pasteurization problem with one of Sprout Creek Farm's pasteurized cow's milk cheeses, "Margie," made on 8/28/2018. Sprout Creek Farm is located in Poughkeepsie, NY. The reason for the recall is the air temperature at the start and end of the pasteurization process is required to be above 150deg F per the Grade "A" Pasteurized Milk Ordinance; the batch in question did not meet that standard. The recall pertains only to...

FDA - U.S. Food and Drug Administration

2-10-2018

Review of the existing maximum residue levels for cyflufenamid according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for cyflufenamid according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 01 Oct 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance cyflufenamid. To assess the occurrence of cyflufenamid residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (in...

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo International plc (NASDAQ: ENDP) today announced that one of its operating companies, Endo Pharmaceuticals Inc., is voluntarily recalling two lots of Robaxin® (methocarbamol tablets, USP) 750mg Tablets 100 Count Bottle pack to the consumer level. The products have been found to have incorrect daily dosing information on the label due to a labeling error which misstates the daily dose as "two to four tablets four times daily" rather than the correct dosage of "two tablets three times daily." (see pic...

FDA - U.S. Food and Drug Administration

27-9-2018

Review of the existing maximum residue levels for tembotrione according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for tembotrione according to Article 12 of Regulation (EC) No 396/2005

Published on: Wed, 26 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tembotrione. To assess the occurrence of tembotrione residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011 as well as the import tolerances and European author...

Europe - EFSA - European Food Safety Authority Publications

24-9-2018

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

FDA has awarded 12 new clinical trial research grants to enhance the development of medical products for patients with rare diseases

FDA - U.S. Food and Drug Administration

20-9-2018

Vacant position at IMA's Quality Assessment Team

Vacant position at IMA's Quality Assessment Team

The Agency advertises vacancy for expert in Quality Assessment Team in Assessment Division. The Agency is looking for strong candidate who are willing to work on challenging and interesting tasks. The vacancy is a full position (100%).

IMA - Icelandic Medicines Agency

13-9-2018

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Published on: Wed, 12 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluquinconazole. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for fluquinconazole within the European Union. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue ...

Europe - EFSA - European Food Safety Authority Publications

12-9-2018

Enforcement Report for the Week of September 12, 2018

Enforcement Report for the Week of September 12, 2018

Recently Updated Records for the Week of September 12, 2018 Last Modified Date: Friday, September 07, 2018

FDA - U.S. Food and Drug Administration

12-9-2018

Kabinet investeert in eerste 1000 dagen kind

Kabinet investeert in eerste 1000 dagen kind

Van kinderwens tot 2-jarige peuter: de ontwikkeling die we in de eerste 1000 dagen als kind meemaken is cruciaal voor zowel een gezonde groei als de ontplooiing en kansen op latere leeftijd. Verreweg de meeste kinderen in Nederland groeien veilig en gezond op. Toch heeft ongeveer 14% van de kinderen in Nederland een ‘valse’ start door vroeggeboorte, een te laag geboortegewicht of een combinatie van beide. Minister Hugo de Jonge (VWS), gemeenten, partijen uit de geboortezorg en de jeugdgezondheidszorg (JG...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

7-9-2018

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

, SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.

FDA - U.S. Food and Drug Administration

7-9-2018

Orphan designation:  Recombinant human beta-glucuronidase (vestronidase alfa),  for the: Treatment of mucopolysaccharidosis type VII (Sly syndrome)

Orphan designation: Recombinant human beta-glucuronidase (vestronidase alfa), for the: Treatment of mucopolysaccharidosis type VII (Sly syndrome)

On 21 March 2012, orphan designation (EU/3/12/973) was granted by the European Commission to NDA Regulatory Science Ltd, United Kingdom, for recombinant human beta-glucuronidase for the treatment of mucopolysaccharidosis type VII (Sly syndrome).

Europe - EMA - European Medicines Agency

1-9-2018

Acknowledgement:EFSA  wishes  to  thank  the  rapporteur  Member  State  Denmark  for  thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Acknowledgement:EFSA wishes to thank the rapporteur Member State Denmark for thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Published on: Fri, 31 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance napropamide. To assess the occurrence of napropamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Review of the existing MRLs for fenbuconazole

Review of the existing MRLs for fenbuconazole

Published on: Fri, 31 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fenbuconazole. To assess the occurrence of fenbuconazole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

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

12-11-2018

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Zentiva, k.s.)

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Zentiva, k.s.)

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva (Active substance: efavirenz / emtricitabine / tenofovir disoproxil) - Centralised - Yearly update - Commission Decision (2018)7547 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

12-11-2018

Ruconest (Pharming Group N.V.)

Ruconest (Pharming Group N.V.)

Ruconest (Active substance: Conestat alfa) - Centralised - Yearly update - Commission Decision (2018)7548 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

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

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

12-10-2018

Irbesartan Zentiva (Zentiva k.s.)

Irbesartan Zentiva (Zentiva k.s.)

Irbesartan Zentiva (Active substance: Irbesartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6772 of Fri, 12 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/785T/79

Europe -DG Health and Food Safety

2-10-2018

NexoBrid (MediWound Germany GmbH)

NexoBrid (MediWound Germany GmbH)

NexoBrid (Active substance: Concentrate of proteolytic enzymes enriched in bromelain) - PSUSA - Modification - Commission Decision (2018)6460 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10028/201712

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6434 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/056/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03

Europe -DG Health and Food Safety

26-9-2018

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application:   http://go.usa.g

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application: http://go.usa.g

Today, Wednesday, September 26th 2018 at 12 pm EST is the last day that the #FDA will be soliciting site visit proposals for the 2018 Experiential Learning Program. Click the link to find more about the program & submit your application: http://go.usa.gov/xPrum  #MedicalDevice pic.twitter.com/Zsmq00NCdd

FDA - U.S. Food and Drug Administration

19-9-2018

Reminder: #FDA site visit proposal solicitation period for the 2018  Experiential Learning Program is currently OPEN through Wednesday,  9/26/18 @ 12 pm EST. Click the link to find more about the  program & to submit your application  https://go.usa.gov/x

Reminder: #FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, 9/26/18 @ 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/x

Reminder: #FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, 9/26/18 @ 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/xPrum  #MedicalDevice pic.twitter.com/FN1mNN65dD

FDA - U.S. Food and Drug Administration

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

19-9-2018

Memantine Mylan (Mylan S.A.S.)

Memantine Mylan (Mylan S.A.S.)

Memantine Mylan (Active substance: Memantine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5972 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2660/T/12

Europe -DG Health and Food Safety

14-9-2018

Agenda:  Agenda - CAT agenda of the 12-14 September 2018 meeting

Agenda: Agenda - CAT agenda of the 12-14 September 2018 meeting

Europe - EMA - European Medicines Agency

12-9-2018

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application  https://go.usa.gov/x

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/x

The FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/xPrum  #FDA #MedicalDevice pic.twitter.com/Kyo5z44Os4

FDA - U.S. Food and Drug Administration

12-9-2018

ADCETRIS (Takeda Pharma A/S)

ADCETRIS (Takeda Pharma A/S)

ADCETRIS (Active substance: Brentuximab vedotin) - Centralised - Annual renewal - Commission Decision (2018)5973 of Wed, 12 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2455/R/58

Europe -DG Health and Food Safety

11-9-2018

 Focus group meeting  on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

Focus group meeting on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

This meeting will allow a direct exchange of views between the Agency’s working party and stakeholders on its draft reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation (EMA/CVMP/849775/2017). It complements the public consultation on this reflection paper ending on 31 January 2019. The reflection paper follows considerations in the report on a pilot project that aimed to develop and test non-experimental appr...

Europe - EMA - European Medicines Agency

5-9-2018

The FDA's site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 at 12 pm EST. Click the link to find more about the program and to submit your application:  https://go.u

The FDA's site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 at 12 pm EST. Click the link to find more about the program and to submit your application: https://go.u

The FDA's site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, September 26th 2018 at 12 pm EST. Click the link to find more about the program and to submit your application: https://go.usa.gov/xPcpn  #MedicalDevice

FDA - U.S. Food and Drug Administration