Caduet 10 mg 10 mg filmom obložene

Glavna informacija

  • Trgovački naziv:
  • Caduet 10 mg/10 mg filmom obložene tablete
  • Doziranje:
  • 10 mg + 10 mg
  • Farmaceutski oblik:
  • filmom obložena tableta
  • Sastav:
  • Urbroj: jedna filmom obložena tableta sadrži 10 mg amlodipina u obliku amlodipinbesilata i 10 mg atorvastatina u obliku atorvastatinkalcij trihidrata
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Pfizer Manufacturing Deutschland GmbH, Freiburg, Njemačka

Dokument

Lokalizacija

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

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 30 tableta u blisteru, u kutiji [HR-H-732959683-01]; 100 tableta u blisteru, u kutiji [HR-H-732959683-02] Urbroj: 381-12-01/70-17-03

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-732959683
  • Datum autorizacije:
  • 29-09-2017
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za bolesnika

Caduet 5 mg/10 mg filmom obložene tablete

Caduet 10 mg/10 mg filmom obložene tablete

amlodipin / atorvastatin

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

podatke.

Sačuvajte ovu uputu. Moţda ćete je trebati ponovo pročitati.

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

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

su njihovi znakovi bolesti jednaki Vašima.

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

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

Što se nalazi u ovoj uputi:

Što je Caduet i za što se koristi?

Što morate znati prije nego počnete uzimati Caduet?

Kako uzimati Caduet?

Moguće nuspojave

Kako čuvati Caduet?

Sadrţaj pakiranja i druge informacije

1.

Što je Caduet i za što se koristi?

Caduet se primjenjuje za sprječavanje kardiovaskularnih događaja (npr. angine, srčanih udara) u

bolesnika s povišenim krvnim tlakom koji imaju i dodatne čimbenike rizika za srčano-krvoţilne

bolesti, poput pušenja, prekomjerne teţine, povećane razine kolesterola u krvi, obiteljske povijesti

srčanih bolesti ili dijabetesa. Postojanje navedenih čimbenika rizika, udruţenih s povišenim krvnim

tlakom, uzrokom je povećanog rizika za nastanak srčano-krvoţilnih događaja u tih bolesnika.

Caduet je lijek koji se sadrţi dvije djelatne tvari, amlodipin (antagonist kalcijevih kanala) i atorvastatin

(statin), a primjenjuje se kada Vaš liječnik procijeni da je prikladna primjena oba lijeka. Amlodipin se

primjenjuje za liječenje povišenog krvnog tlaka (hipertenzije), dok atorvastatin smanjuje kolesterol.

Povišeni krvni tlak (hipertenzija) je stanje kod kojeg postoji trajno povišenje krvnog tlaka te

predstavlja jedan od čimbenika rizika za nastanak srčano-krvoţilnih događaja (npr. angine, srčanog

udara, moţdanog udara).

Kolesterol je tvar koja se prirodno pojavljuje u organizmu, neophodna za normalan rast. Međutim, ako

ima previše kolesterola u krvi, on se moţe taloţiti na stijenke krvnih ţila, povećavajući opasnost od

nastanka krvnih ugrušaka i srčano-krvoţilnih događaja. To je jedan od najčešćih uzroka bolesti srca.

2.

Što morate znati prije nego počnete uzimati Caduet?

Nemojte uzimati Caduet

ako ste alergični na amlodipin ili atorvastatin ili na neki drugi lijek iz skupine blokatora

kalcijevih kanala ili na bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6.)

ako bolujete od neke bolesti jetre (ako ste od bolesti jetre bolovali u prošlosti, pogledajte dio

„Upozorenja i mjere opreza”)

ako imate poremećene bilo koje testove jetrene funkcije nerazjašnjenog uzroka

ako ste trudni, nastojite zatrudnjeti ili dojite

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ako uzimate neki od sljedećih lijekova: ketokonazol, itrakonazol (lijekovi za liječenje gljivičnih

bolesti), telitromicin (antibiotik)

ako su vam vrijednosti krvnog tlaka izrazito niske (hipotenzija)

ako imate suţenje aortnih srčanih zalistaka (aortna stenoza) ili kardiogeni šok (stanje u kojem

vaše srce ne moţe tijelu dostaviti dovoljno krvi)

ako je nakon srčanog udara, nastupilo zatajenje srca

Upozorenja i mjere opreza

Obratite se Vašem liječniku ili ljekarniku prije nego uzmete Caduet:

ako bolujete od teškog zatajenja disanja.

ako uzimate ili ste uzeli u zadnjih 7 dana lijek koji se zove fusidatna kiselina (lijek za

bakterjisku infekciju) kroz usta ili kao injekciju. Kombinacija fusidatne kiseline i Cadueta

moţe dovesti do ozbiljnih problema s mišićima (rabdomiolize).

ako imate problema s bubrezima.

ako imate smanjenu aktivnost štitnjače (hipotireoidizam).

ako ste imali ponovljene grčeve ili bolove u mišićima ili su bili nerazjašnjenog uzroka,

odnosno ako imate osobnu ili obiteljsku povijest nasljedne bolesti mišića.

ako ste imali problema s mišićima prilikom ranijeg uzimanja nekog od lijekova za sniţavanje

razine kolesterola (lipida) (tj. nekog drugog lijeka iz skupine statina, odnosno fibrata).

ako redovito konzumirate veliku količinu alkohola.

ako ste u prošlosti imali neku bolest jetre.

ako ste stariji od 70 godina.

ako ste već imali moţdani udar s krvarenjem ili imate prostore u mozgu ispunjene tekućinom

kao posljedicu prijašnjih moţdanih udara.

Ako se bilo što od navedenog odnosi na Vas, Vaš će Vam liječnik trebati napraviti krvne pretrage prije

te moţda tijekom liječenja Caduetom, kako bi predvidio rizik nastanka nuspojava povezanih s

mišićima. Poznato je kako se rizik nuspojava povezanih s mišićima, npr. rabdomiolize, povećava kada

se neki lijekovi primjenjuju istodobno (vidjeti dio „Drugi lijekovi i Caduet“).

Također obavijestite svog liječnika ili ljekarnika ako imate konstantnu mišićnu slabost. Moţda će biti

potrebni dodatni testovi i lijekovi kako bi se to dijagnosticiralo i liječilo.

Vaš liječnik će vas paţljivo nadzirati tijekom uzimanja ovog lijeka, ako imate dijabetes ili imate rizik

za nastanak dijabetesa. Mogućnost nastanka dijabetesa postoji ako imate povišenu razinu šećera i

masnoća u krvi, ako ste pretili i imate povišeni krvni tlak.

Djeca i adolescenti

Ne preporuča se primjena ovog lijeka kod djece i adolescenata.

Drugi lijekovi i Caduet

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

druge lijekove.

Postoje određeni lijekovi koji mogu stupati u interakcije s Caduetom. Te interakcije mogu smanjiti

učinkovitost jednog ili obaju lijekova. S druge strane, to moţe povećati rizik ili teţinu nuspojava,

uključujući vaţno stanje razgradnje mišića koje se naziva rabdomioliza i miopatiju (opisane u dijelu

Neki antibiotici npr. rifampicin ili makrolidni antibiotici npr. eritromicin, klaritromicin,

telitromicin; fusidatna kiselina, odnosno neki lijekovi koji se primjenjuju u liječenju

gljivičnih oboljenja, npr. ketokonazol, itrakonazol, posakonazol.

Lijekovi koji kontroliraju razinu lipida (masnoća) u krvi: fibrati (npr. gemfibrozil) ili

kolestipol.

Lijekovi koji reguliraju srčani ritam, npr. amiodaron, diltiazem i verapamil.

Lijekovi za sprječavanje konvulzija, npr. karbamazepin, fenobarbital, fenitoin, fosfenitoin,

primidon.

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Lijekovi koji se koriste za potiskivanje imunološkog odgovora npr. ciklosporin, takrolimus,

sirolimus, temsirolimus, everolimus.

Lijekovi kao što su ritonavir, lopinavir, atazanavir, indinavir, darunavir, kombinacija

tipranavira/ritonavira i ostali, nelfinavir koji se primjenjuju u liječenju HIV-a.

Neki lijekovi koji se koriste u liječenju hepatitisa C kao na primjer telaprevir.

Lijekovi koji se primjenjuju za liječenje depresije npr. nefazodon i imipramin.

Lijekovi koji se primjenjuju za liječenje duševnih poremećaja npr. neuroleptici.

Lijekovi koji se primjenjuju za liječenje zatajenja srca npr. beta-blokatori.

Lijekovi koji se primjenjuju za liječenje povišenog krvnog tlaka (npr. antagonisti

angiotenzina II, ACE-inhibitori, verapamil i diuretici).

Alfa blokatori koji se koriste u liječenju povišenog krvnog tlaka i problema s prostatom.

Ostali lijekovi za koje se zna da imaju interakciju s Caduetom uključuju ezetimib (koji

sniţava kolesterol), varfarin (koji smanjuje zgrušavanje krvi), oralne kontraceptive,

stiripentol (antikonvulziv za liječenje epilepsije), cimetidin (za liječenje ţgaravice i čira na

ţelucu), fenazon (lijek protiv bolova) kolhicin (koji se koriti u liječenju gihta), antacide

(lijekovi za lošu probavu koji sadrţe aluminij ili magnezij) i boceprevir (koristi se za

liječenje bolesti jetre, kao što je hepatitis C).

amifostin (koji se koristi u liječenju raka)

sildenafil (za erektilnu disfunkciju)

dantrolen i baklofen (za opuštanje mišića)

steroidi

Gospina trava, lijek koji se nabavlja bez liječničkog recepta.

Ako liječite bakterijsku infekciju uzimanjem fusidatne kiseline kroz usta, morat ćete

privremeno prestati uzimati ovaj lijek. Liječnik će Vam reći kad je sigurno da ponovno

počnete uzimati Caduet. Uzimanjem Cadueta sa fusidatnom kiselinom moţe rijetko doći do

slabosti u mišićima, pojačane osjetljivosti ili boli (rabdomioliza). Za više informacija o

rabdomiolizi pogledajte dio 4.

Caduet Vam moţe još jače sniziti krvni tlak, ako već uzimate lijekove koji sniţavaju krvni tlak.

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

druge lijekove.

Caduet s hranom, pićem i alkoholom

Caduet tablete mogu se uzimati u bilo koje doba dana, s hranom ili bez nje.

Sok od grejpa

Nemojte piti više od 1 do 2 čaše soka od grejpa na dan dok primjenjujete Caduet, zbog toga što velike

količine tog soka mogu izmijeniti učinke Cadueta.

Alkohol

Za vrijeme primjene Cadueta izbjegavajte prekomjerno konzumiranje alkohola. Vidjeti dio

„Upozorenja i mjere opreza“ za više informacija.

Trudnoća, dojenje i plodnost

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.

Ţene u generativnoj dobi moraju primjenjivati odgovarajuću kontracepciju tijekom primjene Cadueta.

Obratite se liječniku ili ljekarniku za savjet prije nego uzmete bilo koji lijek.

Amlodipin se izlučuje u majčino mlijeko.

Upravljanje vozilima i strojevima

Nemojte upravljati vozilom ili strojevima ako osjećate omaglicu nakon primjene Cadueta.

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3.

Kako uzimati Caduet?

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

ili ljekarnikom ako niste sigurni.

Odrasli

Uobičajena početna doza Cadueta je jedna tableta od 5mg/10mg na dan. Ako je potrebno, Vaš Vam

liječnik moţe povećati dozu na jednu Caduet 10mg/10mg tabletu na dan.

Caduet tablete progutajte čitave, s vodom. Tablete se mogu uzimati na usta u bilo koje doba dana, s

hranom ili bez nje. Ipak, nastojte uzimati tablete svakoga dana u isto vrijeme.

Nastavite slijediti upute liječnika glede prehrane, što se posebno odnosi na dijetu sa smanjenim

unosom masnoća, izbjegavajte pušenje te redovito vjeţbajte.

Ako vam se učini da je učinak Cadueta prejak ili preslab, obavijestite o tome Vašeg liječnika ili

ljekarnika.

Primjena u djece i adolescenata

Ne preporučuje se primjena lijeka u djece i adolescenata.

Ako uzmete više Cadueta nego što ste trebali

Ako ste slučajno uzeli previše tableta Caduet (više od Vaše uobičajene dnevne doze), odmah se javite

svom liječniku ili u najbliţu bolnicu. Ponesite sa sobom preostale tablete, u originalnom pakiranju,

kako bi bolničko osoblje lakše vidjelo koji ste lijek uzeli.

Ako ste zaboravili uzeti Caduet

Ako ste zaboravili uzeti tabletu Cadueta, uzmite sljedeću dozu u uobičajeno vrijeme.

Nemojte uzeti dvostruku dozu kako biste nadomjestili zaboravljenu dozu.

Ako prestanete uzimati Caduet

Nemojte prestati primjenjivati Caduet sve dok Vam to ne kaţe liječnik.

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

ljekarniku.

4.

Moguće nuspojave

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

Ako se dogodi nešto od sljedećeg, prestanite uzimati Caduet i odmah se obratite svom liječniku:

Oticanje lica, jezika i dušnika, što moţe uzrokovati velike poteškoće u disanju.

Ako osjetite neobjašnjivu slabost u mišićima, osjetljivost ili bol u mišićima, te ako se

istodobno ne osjećate dobro ili imate povišenu temperaturu. (Vrlo rijetko, kombinacija ovih

učinaka moţe prerasti u ozbiljno, po ţivot opasno stanje koje se naziva rabdomioliza).

Prijavljene su i sljedeće nuspojave:

Vrlo često: mogu se javiti u više od 1 na 10 osoba

oticanje (edem)

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

alergijska reakcija

prehlada

glavobolja (pogotovo na početku liječenja), omaglica, osjećaj umora, pospanost

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nepravilni otkucaji srca; crvenilo praćeno osjećajem vrućine

palpitacije (abnormalni srčani ritam), kratkoća daha

bol u grlu, krvarenje u nosu

mučnina, bol u trbuhu, loša probava, promjene u uobičajenom radu crijeva (uključujući

proljev, zatvor i vjetrove)

oticanje zglobova (uključujući oticanje gleţnjeva)

bol u mišićima i zglobovima, grčevi u mišićima, bol u leđima, bolovi u udovima

porast razine šećera u krvi (ako imate šećernu bolest, trebali biste nastaviti paţljivo pratiti

razinu šećera u krvi), porast kreatin fosfokinaze u krvi, krvne pretrage koje ukazuju na

funkciju Vaše jetre mogu postati abnormalne

problemi s vidom (uključujući dvoslike), zamagljen vid

zvonjenje ili zujanje u ušima

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

hepatitis (upala jetre)

curenje nosa, gubitak apetita, smanjenje nivoa šećera u krvi (ako imate dijabetes trebate

nastaviti paţljivo nadzirati šećer u krvi), dobivanje na teţini ili gubljenje teţine,

nesanica, pojava noćnih mora, promjene raspoloţenja (uključujući tjeskobu), depresija,

nevoljno drhtanje, gubitak pamćenja

nesvjestica, pojačano znojenje, sniţeni krvni tlak

suhoća usta, promjene osjeta okusa, povraćanje, podrigivanje

gubitak kose, modrice ili sitne točkice na koţi, promjene boje koţe, smanjenje osjeta koţe

za dodir ili bol, utrnulost ili trnci u prstima ruku i stopala, koţni osip, urtikarija ili svrbeţ

poremećaji mokrenja (uključujući prekomjerno mokrenje noću i povećanu učestalost

mokrenja), impotencija, povećanje grudi kod muškaraca

osjećaj tjelesne nelagode, zamor mišića, malaksalost, pankreatitis (upala gušterače koja

dovodi do boli u trbuhu), bol, bol u vratu, bol u prsištu

testovi mokraće pozitivni na bijele krvne stanice

abnormalni srčani ritam

kašalj

oticanje ruku, šaka, nogu ili stopala

vrućica

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

oštećenje osjetilnih ţivaca (smanjenje osjetilnosti) ruku i nogu

teška upala mišića, vrlo jaka bol u mišićima ili grčevi koji u vrlo rijetkim slučajevima

vode do rabdomiolize (uništenja mišićnih stanica) i nenormalna razgradnja mišića.

Nenormalna razgradnja mišića ponekad se moţe nastaviti čak i nakon prestanka uzimanja

lijeka Caduet i moţe biti opasna po ţivot i dovesti do problema s bubrezima.

smanjenje broja krvnih pločica u krvi (trombocita) koje moţe dovesti do neočekivanog

krvarenja ili nastanka modrica

problemi s jetrom ( ţutilo koţe ili bjeloočnica)

teške koţne reakcije alergijske prirode, crvenilo koţe, osip u obliku mjehurića, ljuštenje

koţe koja se lako odvaja s cijelog tijela i moţe započeti sa simptomima sličnima gripi

udruţenima s visokom temperaturom

oteknuće u dubokim slojevima koţe- uključujući oteknuće usana, kapaka i jezika

upala ili oteknuće skeletnih mišića, osip s mjehurićima, iznenadno područno teško

oteknuće koţe

upala tetive, ozljede tetive

smetenost

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

teške alergijske reakcije – simptomi mogu uključivati iznenadno piskanje i bol u prsima ili

stezanje u prsima, naticanje kapaka, lica, usana, usta, jezika ili grla, poteškoće u disanju,

kolaps

smanjen broj bijelih krvnih stanica u krvi

ukočenost i napetost mišića

srčani udar, upala malih krvnih ţila, bol u ţelucu (gastritis)

bujanje desni

gubitak sluha, zatajenje jetre, ţutica

fotoosjetljivost (osjetljivost koţe na svjetlost), upala koţe

Druge moguće nuspojave:

problemi s disanjem, uključujući uporan kašalj i/ili nedostatak zraka

poremećaji koji uključuju ukočenost, nevoljno drhtanje i/ili poremećaje kretanja

dijabetes (šećerna bolest). Vjerojatniji je ako imate povišene razine šećera i masnoća u krvi,

ako ste pretili i imate povišen krvni tlak. Vaš liječnik će vas nadzirati dok uzimate ovaj lijek.

konstantna mišićna slabost

Prijavljivanje nuspojava

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

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

izravno putem nacionalnog sustava prijave nuspojava: navedenog u Dodatku V.

Prijavljivanjem nuspojava moţete pridonijeti u procjeni sigurnosti ovog lijeka.

5. Kako čuvati Caduet?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Ne čuvati na temperaturi iznad 30

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

odnosi se na zadnji dan navedenog mjeseca.

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.

6. Sadržaj pakiranja i druge informacije

Što Caduet sadrži?

Djelatne tvari su amlodipin i atrovastatin.

Caduet 5 mg/10 mg tablete sadrţe 5 mg amlodipina (u obliku amlodipinbesilata) i 10 mg atorvastatina

(u obliku atorvastatinkalcijevog trihidrata).

Caduet 10 mg/10 mg tablete sadrţe 10 mg amlodipina (u obliku amlodipinbesilata) i 10 mg

atorvastatina (u obliku atorvastatinkalcijevog trihidrata).

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Pomoćne tvari su: kalcijev karbonat, umreţena karmelozanatrij, mikrokristalična celuloza, prethodno

geliran kukuruzni škrob, polisorbat 80, hiproloza, koloidni bezvodni silicijev dioksid i magnezijev

stearat.

Ovojnica Caduet 5 mg/10 mg tableta sadrţi: boja Opadry II White 85F28751 (polivinilni alkohol,

titanijev dioksid (E171), makrogol 3000 i talk).

Ovojnica Caduet 10 mg/10 mg tableta sadrţi: boja Opadry II Blue 85F10919 (polivinilni alkohol,

titanijev dioksid (E171), indigo carmine aluminium lake (132), makrogol 3000 i talk).

Kako Caduet izgleda i sadržaj pakiranja?

Caduet 5 mg/10 mg tablete su bijele, ovalnog oblika s oznakom “Pfizer” na jednoj strani i “CDT 051”

na drugoj strani.

Caduet 10 mg/10 mg tablete su plave, ovalnog oblika s oznakom „Pfizer“ na jednoj strani i “CDT

101“ na drugoj strani.

Caduet tablete su dostupne u blister pakiranjima od 30 ili 100 tableta.

Nositelj odobrenja za stavljanje lijeka u promet i proizvoĎač

Nositelj odobrenja

Pfizer Croatia d.o.o.

Slavonska avenija 6

10000 Zagreb

Proizvođač

Pfizer Manufacturing Deutschland GmbH

Betriebsstätte Freiburg

Mooswaldallee 1

79090

Freiburg,

Njemačka

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je posljednji put revidirana u siječnju 2018.

H A L M E D

17 - 01 - 2018

O D O B R E N O

24-10-2018

Vita Health Products Recall (2018-10-24)

Vita Health Products Recall (2018-10-24)

Health Canada

18-10-2018

Mom Life Market recalls 10" & 16" Personalized Stuffed Plush Bunnies

Mom Life Market recalls 10" & 16" Personalized Stuffed Plush Bunnies

The recalled products may contain phthalate levels that exceed the allowable levels.

Health Canada

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

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

11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Published on: Wed, 10 Oct 2018 00:00:00 +0200 This report provides a review of existing models for predicting the spatial distribution and abundance of wild boar at various scales (global, continental, national and regional) in order to inform the development of a new model to produce estimates of wild boar abundance at European level. The review identifies and discusses a range of models based on a wide variety of data types, corresponding to those targeted by the data collection model set by ENETwild,...

Europe - EFSA - European Food Safety Authority Publications

10-10-2018

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Eight and Company LLC, d/b/a Sprayology is voluntarily recalling all lots within expiry from 10/18-7/22 of its aqueous-based homeopathic product line for human use. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.

FDA - U.S. Food and Drug Administration

10-10-2018

Enforcement Report for the Week of October 10, 2018

Enforcement Report for the Week of October 10, 2018

Recently Updated Records for the Week of October 10, 2018 Last Modified Date: Tuesday, October 09, 2018

FDA - U.S. Food and Drug Administration

24-9-2018

FDA Announces Availability of Resources for Animal Drug Sponsors

FDA Announces Availability of Resources for Animal Drug Sponsors

The FDA is making available two pre-recorded webinars and a slide presentation to help drug sponsors understand recent changes to the submission process for new animal drug applications and related submissions. The changes take effect 10/1/2018.

FDA - U.S. Food and Drug Administration

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement

FDA - U.S. Food and Drug Administration

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

11-9-2018

Update of the Xylella spp. host plant database

Update of the Xylella spp. host plant database

Published on: Mon, 10 Sep 2018 00:00:00 +0200 Following a request from the European Commission, EFSA periodically updates the database on the host plants of Xylella spp. While previous editions of the database (2015 and 2016) dealt with the species Xylella fastidiosa only, this database version addresses the whole genus Xylella, including therefore both species X. fastidiosa and Xylella taiwanensis. The database now includes information on host plants of Xylella spp. retrieved from scientific literature...

Europe - EFSA - European Food Safety Authority Publications

10-9-2018

USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry

USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry

WASHINGTON, Sept. 10, 2018 – U.S. Secretary of Agriculture Sonny Perdue, DVM and U.S. Food and Drug Administration Commissioner Scott Gottlieb, M.D. today announced a joint public meeting to be held on Oct. 23-24, 2018 to discuss the use of cell culture technology to develop products derived from livestock and poultry.

FDA - U.S. Food and Drug Administration

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

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

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

22-8-2018

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

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

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

FDA - U.S. Food and Drug Administration

10-8-2018

Enforcement Report for the Week of July 25, 2018

Enforcement Report for the Week of July 25, 2018

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

FDA - U.S. Food and Drug Administration

12-11-2018

Spinraza (Biogen Netherlands B.V.)

Spinraza (Biogen Netherlands B.V.)

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

Europe -DG Health and Food Safety

23-10-2018

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

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

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

Europe -DG Health and Food Safety

22-10-2018

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

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

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

Europe -DG Health and Food Safety

19-10-2018

Recocam (Bimeda Animal Health Limited)

Recocam (Bimeda Animal Health Limited)

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

Europe -DG Health and Food Safety

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

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

Europe -DG Health and Food Safety

19-9-2018

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Eli Lilly Nederland B.V.)

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

Europe -DG Health and Food Safety

19-9-2018

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Mylan S.A.S.)

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

Europe -DG Health and Food Safety

10-9-2018

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

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

Europe -DG Health and Food Safety

10-9-2018

Alkindi (Diurnal Limited)

Alkindi (Diurnal Limited)

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

Europe -DG Health and Food Safety

10-9-2018

Retacrit (Hospira UK Limited)

Retacrit (Hospira UK Limited)

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

Europe -DG Health and Food Safety

10-9-2018

Silapo (STADA Arzneimittel AG)

Silapo (STADA Arzneimittel AG)

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

Europe -DG Health and Food Safety

4-9-2018

ACM meeting statement, Meeting 10, 2 August 2018

ACM meeting statement, Meeting 10, 2 August 2018

The Advisory Committee on Medicines meeting statement is now available

Therapeutic Goods Administration - Australia

22-8-2018

BTVPUR (Merial)

BTVPUR (Merial)

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

Europe -DG Health and Food Safety

10-8-2018

Torisel (Pfizer Europe MA EEIG)

Torisel (Pfizer Europe MA EEIG)

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

Europe -DG Health and Food Safety

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

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

Europe -DG Health and Food Safety

10-8-2018

Lymphoseek (Norgine B.V.)

Lymphoseek (Norgine B.V.)

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

Europe -DG Health and Food Safety

10-8-2018

Sivextro (Merck Sharp and Dohme B.V.)

Sivextro (Merck Sharp and Dohme B.V.)

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

Europe -DG Health and Food Safety

10-8-2018

Cubicin (Merck Sharp and Dohme B.V.)

Cubicin (Merck Sharp and Dohme B.V.)

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

Europe -DG Health and Food Safety

10-8-2018

Thalidomide Celgene (Celgene Europe B.V.)

Thalidomide Celgene (Celgene Europe B.V.)

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

Europe -DG Health and Food Safety

10-8-2018

CANCIDAS (Merck Sharp and Dohme B.V.)

CANCIDAS (Merck Sharp and Dohme B.V.)

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

Europe -DG Health and Food Safety

10-8-2018

Tesavel (Merck Sharp and Dohme B.V.)

Tesavel (Merck Sharp and Dohme B.V.)

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

Europe -DG Health and Food Safety

10-8-2018

Januvia (Merck Sharp and Dohme B.V.)

Januvia (Merck Sharp and Dohme B.V.)

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

Europe -DG Health and Food Safety

10-8-2018

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Pfizer Europe MA EEIG)

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

Europe -DG Health and Food Safety

7-8-2018

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

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

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

FDA - U.S. Food and Drug Administration

7-8-2018

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

30-7-2018

Zalmoxis (MolMed S.p.A.)

Zalmoxis (MolMed S.p.A.)

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

Europe -DG Health and Food Safety

27-7-2018

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

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

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

Europe -DG Health and Food Safety