Co-Perineva

Glavna informacija

  • Trgovački naziv:
  • Co-Perineva 2 mg/0,625 mg tablete
  • Doziranje:
  • 2 mg + 0,625 mg
  • Farmaceutski oblik:
  • tableta
  • Sastav:
  • Urbroj: jedna tableta sadrži 2 mg perindopril-tert-butilamina i 0,625 mg indapamida
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Krka d.d., Novo mesto, Slovenija; Krka - farma d.o.o., Zagreb, Republika Hrvatska

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Co-Perineva 2 mg/0,625 mg tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 30 tableta u blisteru, u kutiji [HR-H-718684996-01]; 60 tableta u blisteru, u kutiji [HR-H-718684996-02] Urbroj: 381-12-01/70-16-06

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-718684996
  • Datum autorizacije:
  • 18-04-2016
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za korisnika

Co-Perineva 2 mg/0,625 mg tablete

perindopril-tert-butilamin/indapamid

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

podatke.

-

Sačuvajte ovu uputu. Možda ćete je trebati ponovo pročitati.

-

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

-

Ovaj je lijek propisan samo Vama. Nemojte ga davati drugima. Može im štetiti, 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, vidjeti dio 4.

Što se nalazi u ovoj uputi:

Što je Co-Perineva i za što se koristi?

Što morate znati prije nego počnete uzimati Co-Perinevu?

Kako uzimati Co-Perinevu?

Moguće nuspojave

Kako čuvati Co-Perinevu?

Sadržaj pakiranja i druge informacije

1.

Što je Co-Perineva i za što se koristi?

Co-Perineva je fiksna kombinacija dviju djelatnih tvari; perindopril-tert-butilamin i indapamid.

On je

antihipertenziv i koristi se za liječenje povišenog krvnog tlaka (hipertenzija).

Perindopril pripada skupini lijekova koji se nazivaju inhibitori angiotenzin-konvertirajućeg enzima

(ACE inhibitori). Djeluju tako da proširuju krvne žile, što Vašem srcu olakšava pumpanje krvi kroz

njih.

Indapamid je diuretik. Diuretici povećavaju količinu mokraće koju proizvode bubrezi. Međutim,

indapamid se razlikuje od drugih diuretika jer uzrokuje samo malo povećanje količine proizvedene

mokraće.

Svaka od djelatnih tvari snižava krvni tlak, a djelujući zajedno kontroliraju Vaš krvni tlak.

2.

Što morate znati prije nego počnete uzimati Co-Perinevu?

Nemojte uzimati Co-Perinevu

ako ste alergični na perindopril ili bilo koji drugi ACE inhibitor, na indapamid ili bilo koji drugi

sulfonamid ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6.);

ako ste imali simptome poput piskanja pri disanju, oticanja lica ili jezika, intenzivan svrbež ili

jak kožni osip uz prethodno liječenje ACE inhibitorima ili ako ste Vi ili član Vaše obitelji imali

ove simptome u bilo kojim drugim okolnostima (stanje koje se naziva angioedem);

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

krvnog tlaka koji sadrži aliskiren;

imate tešku

bolest jetre ili

bolujete od stanja

koje se

zove hepatička encefalopatija

(degenerativna bolest mozga);

ako imate tešku bolest bubrega ili ste na dijalizi;

ako imate nisku ili visoku razinu kalija u krvi;

ako postoji sumnja da imate neliječeno dekompenzirano zatajenje srca (jako zadržavanje vode,

otežano disanje);

ako ste trudni više od 3 mjeseca (također je bolje je izbjegavati Co-Perinevu u ranoj trudnoći,

vidjeti dio „Trudnoća i dojenje“);

H A L M E D

18-04-2016

O D O B R E N O

ako dojite.

Upozorenja i mjere opreza

Obratite se svom liječniku ili ljekarniku prije nego uzmete Co-Perinevu:

imate

stenozu

aorte (suženje

glavne

krvne

žile

koja izlazi

srca) ili

hipertrofičnu

kardiomiopatiju (bolest srčanog mišića) ili stenozu bubrežne arterije (suženje arterije koja

opskrbljuje bubreg krvlju);

ako imate bilo koje druge probleme sa srcem ili bubrezima;

ako imate probleme s jetrom;

imate

kolagensku

bolest

(kožna

bolest)

što

sistemski

lupus

eritematosus

sklerodermiju;

ako imate aterosklerozu (otvrdnjavanje arterija);

ako imate hiperparatiroidizam (previše aktivne paratireoidne žlijezde);

ako imate ulog (giht);

ako imate šećernu bolest (dijebetes);

ako ste na dijeti s ograničenim unosom soli ili koristite nadomjeske soli koje sadrže kalij;

ako uzimate litij ili diuretike koji štede kalij (spironolakton, triamteren), jer se njihova primjena

s lijekom Co-Perineva treba izbjegavati (vidjeti dio „Drugi lijekovi i Co-Perineva“)

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

krvnog tlaka:

- blokator angiotenzin II receptora (ARB) (nazivaju se i sartanima – primjerice valsartan,

telmisartan, irbesartan), 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 Co-Perinevu“.

Obavezno recite svom liječniku ako mislite da ste trudni ili biste mogli zatrudnjeti. Co-Perineva se ne

preporučuje u ranoj trudnoći i ne smije se uzimati ako ste trudni više od 3 mjeseca, jer može ozbiljno

naštetiti Vašem djetetu ako se primjenjuje u tom stadiju (vidjeti dio „Trudnoća i dojenje“).

Kada uzimate ovaj lijek, obavezno obavijestite svog liječnika ili medicinsko osoblje:

ako ćete biti podvrgnuti anesteziji i/ili kirurškom zahvatu,

ako ste nedavno imali proljev ili povraćali ili ste dehidrirani,

ako ćete biti podvrgnuti dijalizi ili LDL aferezi (uklanjanje kolesterola iz Vašeg organizma

pomoću uređaja),

ako ćete biti podvrgnuti desenzibilizacijskom tretmanu radi smanjivanja učinaka alergije na

ubod pčele ili ose,

ako ćete biti podvrgnuti medicinskoj pretrazi koja zahtijeva primjenu injekcije kontrastnog

sredstva koje sadrži jod (tvar koja omogućava da organi poput bubrega ili želuca budu vidljivi

na rendgenu).

Sportaši trebaju imati na umu da ovaj lijek sadrži djelatnu tvar (indapamid) koja može dati pozitivnu

reakciju na doping testu.

Djeca i adolescenti

Co-Perineva se ne smije davati djeci i adolescentima.

Drugi lijekovi i Co-Perineva

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

druge lijekove.

Trebate izbjegavati primjenu lijeka Co-Perineva s:

litijem (koristi se za liječenje depresije),

H A L M E D

18-04-2016

O D O B R E N O

diureticima koji štede kalij (spironolakton, triamteren), kalijevim solima.

Na liječenje Co-Perinevom mogu utjecati drugi lijekovi. Liječnik će Vam možda morati promijeniti

dozu i/ili poduzeti druge mjere opreza. Obavezno obavijestite svog liječnika ako uzimate bilo koji od

sljedećih lijekova, jer to može zahtijevati posebnu skrb:

drugi lijekovi za liječenje povišenog krvnog tlaka,

neki blokator angiotenzin II receptora (ARB) ili aliskiren (vidjeti također informacije pod

naslovima „Nemojte uzimati Co-Perinevu“ i „Upozorenja i mjere opreza“).

drugi diuretici (tablete za izmokravanje),

prokainamid (za liječenje nepravilnosti otkucaja srca),

alopurinol (za liječenje uloga (gihta)),

terfenadin, astemizol ili mizolastin (antihistaminici koji se primjenjuju u liječenju peludne

groznicu ili alergije),

kortikosteroidi

koji

primjenjuju

liječenju

različitih

stanja

uključujući

tešku

astmu

reumatoidni artritis,

imunosupresivi koji se primjenjuju u liječenju autoimunih poremećaja ili nakon transplantacije

kako bi se spriječilo odbacivanja organa (npr. ciklosporin),

lijekovi koji se koriste u liječenju raka,

eritromicin koji se daje u obliku injekcije (antibiotik),

halofantrin (koristi se za liječenje određenih vrsta malarije),

cisaprid ili difemanil (koriste se za liječenje probavnih smetnji),

sparfloksacin, moksifloksacin (antibiotici koji se koriste za liječenje infekcija),

metadon (koristi se u liječenju ovisnosti),

pentamidin (koristi se za liječenje upale pluća),

zlato koje se daje u obliku injekcije, poznato kao natrijev aurotiomalat (koristi se u liječenju

reumatoidnog poliartritisa),

vinkamin (koristi se u liječenju kongenitivnih poremećaja u starijih osoba, uključujući gubitak

pamćenja u starijih),

bepridil (koristi se za liječenje angine pektoris),

lijekovi

liječenje

poremećaja

srčanog

ritma

(npr.

kinidin,

hidrokinidin,

disopiramid,

amiodaron, sotalol, dofetilid, ibutilid, bretilij),

digoksin ili drugi srčani glikozidi (za liječenje srčanih problema),

baklofen (za liječenje ukočenosti mišića koja se javlja u bolestima poput multiple skleroze),

lijekovi koji se koriste za liječenje šećerne bolesti (dijabetesa) kao što su inzulin ili metformin,

kalcij, uključujući dodatke kalcija,

stimulirajuće laksative (npr. sena),

nesteroidni protuupalni lijekovi (npr. ibuprofen) ili visoke doze salicilata (npr. acetilsalicilatna

kiselina),

amfotericin B koji se daje injekcijom (za liječenje teških gljivičnih bolesti),

lijekovi

liječenje

mentalnih

poremećaja

poput

depresije,

tjeskobe,

shizofrenije

(npr.

triciklički

antidepresivi

neuroleptici

(kao

što

amisulprid,

sulpirid,

sultoprid,

tiaprid,

haloperidol, droperidol),

tetrakozaktid (za liječenje Crohnove bolesti),

jodirana kontrastna sredstva koja se daju u venu prije posebnih rendgenskih pretraga.

Co-Perineva s hranom, pićem i alkoholom

Preporučuje se uzeti lijek prije obroka.

Trudnoća i dojenje

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

liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.

Trudnoća

Liječnik će Vam u pravilu savjetovati da prestanete uzimati Co-Perinevu prije nego što zatrudnite ili

čim saznate da ste trudni te će Vam savjetovati da uzmete drugi lijek umjesto Co-Perineve.

H A L M E D

18-04-2016

O D O B R E N O

Ovaj lijek se ne preporučuje u ranoj trudnoći i ne smije se uzimati ako ste trudni više od 3 mjeseca, jer

može prouzročiti ozbiljna oštećenja u Vašeg djeteta ako se primjenjuje nakon trećeg mjeseca trudnoće.

Dojenje

Ne smijete uzimati ovaj lijek ako dojite. Odmah obavijestite svog liječnika ukoliko dojite ili planirate

dojiti.

Upravljanje vozilima i strojevima

Co-Perineva obično ne utječu na budnost, međutim različite reakcije poput omaglice ili slabosti,

povezane sa sniženjem krvnog tlaka mogu se javiti u određenih bolesnika. Ako do toga dođe, Vaša

sposobnost upravljanja vozilima i strojevima može biti oslabljena.

Co-Perineva sadrži laktozu

Ako Vam je liječnik rekao da ne podnosite neke šećere, savjetujte se s liječnikom prije uzimanja ovog

lijeka.

3.

Kako uzimati Co-Perinevu?

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

liječnikom ili ljekarnikom ako niste sigurni

.

Preporučena doza je jedna tableta jednom dnevno. Vaš liječnik može odlučiti povisiti dozu ili

prilagoditi doziranje lijeka ako imate oštećenje bubrega.

Uzmite tabletu ujutro prije obroka. Progutajte tabletu uz čašu vode.

Ako uzmete više Co-Perineve nego što ste trebali

uzmete

previše

tableta,

odmah

se javite svom

liječniku

hitnoj

službi

najbliže

bolnice.

Najvjerojatniji učinak u slučaju predoziranja je nizak krvni tlak. Ako dođe do značajnog pada krvnog

tlaka (simptomi poput omaglice ili nesvjestice), može pomoći postavljenje ležeći položaj s podignutim

nogama.

Ako ste zaboravili uzeti Co-Perinevu

Važno je da svoj lijek uzimate svaki dan jer je redovito liječenje učinkovitije.

Međutim,

zaboravite uzeti jednu dozu Co-Perineve, uzmite sljedeću dozu u uobičajeno vrijeme. Nemojte uzeti

dvostruku dozu kako biste nadoknadili zaboravljenu dozu.

Ako prestanete uzimati Co-Perinevu

Budući da liječenje visokog krvnog tlaka obično traje cijeli život, obavezno se savjetujte sa svojim

liječnikom prije prestanka uzimanja ovog lijeka.

U slučaju bilo kakvih nejasnoća ili pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku

ili ljekarniku

.

4.

Moguće nuspojave

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

Ako se kod Vas javi neka od sljedećih nuspojava, odmah prestanite uzimati lijek i javite se svom

liječniku:

otok lica, usana, usta, jezika ili grla, otežano disanje

teška omaglica ili nesvjestica,

neuobičajeno ubrzani ili nepravilni otkucaji.

Prema padajućem redoslijedu učestalosti, nuspojave mogu uključivati:

H A L M E D

18-04-2016

O D O B R E N O

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

glavobolja, omaglica, vrtoglavica,

osećaj trnjenja, bockanja, mravinjanja, žarenja u nekom

dijelu tijela,

poremećaji vida,

zujanje u ušima (tinitus),

ošamućenost zbog niskog krvnog tlaka,

kašalj, nedostatak zraka,

poremećaji probavnog sustava (mučnina, bol u žličici (epigastriju), gubitak apetita, povraćanje,

bol u trbuhu, poremećaji okusa, suha usta, probavne tegobe, proljev, zatvor),

alergijske reakcije (poput kožnog osipa, svrbeža),

grčevi mišića,

opća slabost.

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

promjene raspoloženja, poremećaji spavanja,

stezanje u grudima, piskutavo disanje i nedostatak zraka (bronhospazam),

simptomi poput čujnog, piskutavog disanja, otok lica ili jezika (angioedem),

urtikarija

crvene točkice na koži (purpura),

zatajivanje bubrega,

impotencija,

znojenje.

Vrlo rijetko (mogu se javiti u manje od 1 na 10 000 osoba):

smetenost,

poremećaji krvožilnog sustava (nepravilni otkucaji srca, angina, srčani udar),

eozinofilna pneumonija (rijetka vrsta upale pluća), začepljenje ili curenje iz nosa (rinitis),

teške kožne reakcije, uključujući kožni osip s crvenim mrljama na licu, rukama ili nogama koji

jako svrbe (multiformni eritem),

upala gušterače (pankreatitis) koja može uzrokovati snažne bolove u trbuhu i u leđima praćenu s

jakom mučninom,

upala jetre (hepatitis).

bolujete

sistemskog

eritemskog

lupusa

(vrsta

kolagenske

bolesti),

moguće

njegovo

pogoršanje.

Prijavljeni su i slučajevi fotoosjetljivosti (promjene u izgledu kože) nakon izlaganja kože sunčevom

svjetlu ili umjetnom UV svjetlu.

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

kratkotrajni gubitak svijesti,

nepravilan rad srca koji je životno ugrožavajući (

torsades de pointes

), promjene u nalazima

EKG-a, povišena razina jetrenih enzima.

Mogu se javiti poremećaji krvi, funkcije bubrega, jetre ili gušterače, a rezultati pretraga krvi mogu biti

promijenjeni. Vaš liječnik možda će Vas uputiti na ispitivanje krvi kako bi kontrolirao Vaše stanje.

U slučajevima zatajenja jetre (poteškoće s jetrom), postoji mogućnost razvoja hepatičke encefalopatije

(degenerativne bolesti mozga).

Prijavljivanje nuspojava

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

H A L M E D

18-04-2016

O D O B R E N O

5.

Kako čuvati Co-Perinevu?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Čuvati na temperaturi ispod 30

Čuvati u originalnom pakiranju radi zaštite od vlage.

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

odnosi se na zadnji dan navedenog mjeseca.

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 Co-Perineva sadrži?

Djelatne tvari su perindopril-tert-butilamin i indapamid.

Jedna Co-Perineva 2 mg/0,625 mg tableta sadrži 2 mg perindopril-tert-butilamina i 0,625 mg

indapamida.

Drugi sastojci su: kalcijev klorid heksahidrat, laktoza hidrat, krospovidon, mikrokristalična

celuloza, natrijev hidrogenkarbonat; koloidni, bezvodni silicijev dioksid; magnezijev stearat.

Kako Co-Perineva izgleda i sadržaj pakiranja?

2 mg/0,625 mg tablete su bijele do gotovo bijele boje, okrugle, blago bikonveksne, s ukošenim

rubovima i s urezanom kratkom crtom na jednoj strani.

Co-Perineva tablete su dostupne u blisterima po 10 ili 15 tableta, a svaka kutija sadrži ukupno 30 ili

60 tableta.

Nositelj odobrenja za stavljanje lijeka u promet i proizvođač

Nositelj odobrenja

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

Proizvođači

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

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

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u travnju 2016.

H A L M E D

18-04-2016

O D O B R E N O

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

31-10-2018

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

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

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Italy and co‐rapporteur Member State Bulgaria for the pesticide active substance dimethoate are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of dimetho...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State the United Kingdom and co‐rapporteur Member State Germany for the pesticide active substance methiocarb are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative use...

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

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

4-10-2018

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

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

Published on: Wed, 03 Oct 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Italy and co‐rapporteur Member State Ireland for the pesticide active substance ethoprophos are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of ethopro...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Published on: Tue, 25 Sep 2018 00:00:00 +0200 Abstract Following a notification from Sorghum Zrt., submitted to the European Commission under Article 14 of Regulation (EU) 2015/2283 to place on the market syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country (TF), and in line with Article 15(2) of that Regulation, EFSA was asked by the European Commission whether there are duly reasoned safety objections to the placing on the market of the TF within the European Union. The ap...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Published on: Thu, 20 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member State...

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

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

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

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Germany and co‐rapporteur Member State Hungary for the pesticide active substance beta‐cyfluthrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of b...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

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

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

Published on: Mon, 10 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Greece for the pesticide active substance alpha‐cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of...

Europe - EFSA - European Food Safety Authority Publications

31-8-2018

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

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

Published on: Thu, 30 Aug 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Germany for the pesticide active substance cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of cype...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Cyprus and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Cyprus and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Cyprus alongside with another 4 countries has participated successfully in the Grant Agreement GP/EFSA/DATA/2016/01‐GA 02, entitled: “Strategic Partnership with Cyprus on Data Quality”. The project was co‐financed by EFSA, aiming to help both EFSA and data providers from Member States to possess data of high quality in a quantitatively manageable way. The main objective of the grant agreement was the establishment of the data governance, coordination and imp...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Published on: Tue, 21 Aug 2018 00:00:00 +0200 Abstract In May 2018, EFSA and ECDC co‐facilitated a workshop on preparedness for a multi‐national food safety/public health incident. The workshop, hosted at AGES in Vienna, was conceived to closely align with EFSA's Strategy 2020 commitment to prepare for future risk assessment challenges. EFSA, ECDC, AGES and BfR worked together closely to develop a workshop and associated training materials to be delivered over a 2.5‐day agenda. The workshop was attended...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Tue, 07 Aug 2018 00:00:00 +0200 The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, the Netherlands and co‐rapporteur Member State, Sweden, for the pesticide active substance carvone are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative use...

Europe - EFSA - European Food Safety Authority Publications

10-8-2018

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

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

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Ma...

FDA - U.S. Food and Drug Administration

18-7-2018

Sodium glucose co-transporter 2 inhibitors

Sodium glucose co-transporter 2 inhibitors

Safety advisory - diabetic ketoacidosis and surgical procedures

Therapeutic Goods Administration - Australia

13-7-2018

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

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

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

FDA - U.S. Food and Drug Administration

17-5-2018

BLM Issues Allergy Alert On Undeclared Egg and Milk

BLM Issues Allergy Alert On Undeclared Egg and Milk

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

FDA - U.S. Food and Drug Administration

16-5-2018

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

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

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

FDA - U.S. Food and Drug Administration

8-5-2018

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

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

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

FDA - U.S. Food and Drug Administration

15-10-2018

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

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

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

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

FDA - U.S. Food and Drug Administration

15-10-2018

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

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

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

FDA - U.S. Food and Drug Administration

18-9-2018

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

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

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

Europe - EMA - European Medicines Agency

4-9-2018

Abseamed (Medice Arzneimittel PUtter GmbH and Co KG)

Abseamed (Medice Arzneimittel PUtter GmbH and Co KG)

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

Europe -DG Health and Food Safety

19-6-2018

Maviret (AbbVie Deutschland GmbH and Co. KG)

Maviret (AbbVie Deutschland GmbH and Co. KG)

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

Europe -DG Health and Food Safety

11-6-2018

Viekirax (AbbVie Deutschland GmbH and Co. KG)

Viekirax (AbbVie Deutschland GmbH and Co. KG)

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

Europe -DG Health and Food Safety

4-6-2018

Venclyxto (AbbVie Deutschland GmbH and Co. KG)

Venclyxto (AbbVie Deutschland GmbH and Co. KG)

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

Europe -DG Health and Food Safety

4-6-2018

Exviera (AbbVie Deutschland GmbH and Co. KG)

Exviera (AbbVie Deutschland GmbH and Co. KG)

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

Europe -DG Health and Food Safety

29-5-2018

Norvir (AbbVie Deutschland GmbH and Co. KG)

Norvir (AbbVie Deutschland GmbH and Co. KG)

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

Europe -DG Health and Food Safety

25-5-2018

Kaletra (AbbVie Deutschland GmbH and Co. KG)

Kaletra (AbbVie Deutschland GmbH and Co. KG)

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

Europe -DG Health and Food Safety

16-5-2018

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

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

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

Europe -DG Health and Food Safety

16-5-2018

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

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

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

Europe -DG Health and Food Safety

16-5-2018

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

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

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

Europe -DG Health and Food Safety

16-5-2018

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

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

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

Europe -DG Health and Food Safety

16-5-2018

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

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

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

Europe -DG Health and Food Safety

16-5-2018

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

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

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

Europe -DG Health and Food Safety

16-5-2018

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

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

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

Europe -DG Health and Food Safety

16-5-2018

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

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

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

Europe -DG Health and Food Safety

15-5-2018

Synagis (AbbVie Deutschland GmbH and Co. KG)

Synagis (AbbVie Deutschland GmbH and Co. KG)

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

Europe -DG Health and Food Safety

3-4-2018

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

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

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

Europe -DG Health and Food Safety