Concor AM 10 mg 10 mg tablete

Glavna informacija

  • Trgovački naziv:
  • Concor AM 10 mg/10 mg tablete
  • Doziranje:
  • 10 mg + 10 mg
  • Farmaceutski oblik:
  • tableta
  • Sastav:
  • Urbroj: jedna tableta sadrži 10 mg bisoprololfumarata i 10 mg amlodipina (u obliku besilata)
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Merck KGaA, Darmstadt, Njemačka; Egis Pharmaceuticals Private Limited Company (PLC), Budimpešta, Mađarska; Egis Pharmaceutical

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Concor AM 10 mg/10 mg tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 28 tableta u blisteru, u kutiji [HR-H-473812739-01]; 30 tableta u blisteru, u kutiji [HR-H-473812739-02]; 56 tableta u blisteru, u kutiji [HR-H-473812739-03]; 90 tableta u blisteru, u kutiji [HR-H-473812739-04] Urbroj: 381-12-01/30-17-06

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-473812739
  • Datum autorizacije:
  • 09-02-2017
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za korisnika

Concor AM 5 mg/5 mg tablete

Concor AM 5 mg/10 mg tablete

Concor AM 10 mg/5 mg tablete

Concor AM 10 mg/10 mg tablete

bisoprololfumarat, amlodipin

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 svom liječniku ili ljekarniku.

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

njihovi znakovi bolesti jednaki Vašima.

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

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

Što se nalazi u ovoj uputi:

Što je Concor AM i za što se koristi

Što morate znati prije nego počnete uzimati Concor AM

Kako uzimati Concor AM

Moguće nuspojave

Kako čuvati Concor AM

Sadržaj pakiranja i druge informacije

1.

Što je Concor AM i za što se koristi

Concor AM se primjenjuje kao zamjenska terapija za liječenje povišenog krvnog tlaka kod bolesnika čija

je bolest dobro kontrolirana pojedinačnim lijekovima koji se daju istovremeno i u istim dozama kao u

kombinaciji, ali u odvojenim tabletama.

2.

Što morate znati prije nego počnete uzimati Concor AM

Nemojte uzimati Concor AM:

ako ste alergični (preosjetljivi) na amlodipin, bisoprolol, (djelatne tvari), derivate dihidropiridina ili

neki drugi sastojak ovog lijeka (naveden u dijelu 6.)

ako imate teško suženje izlaznog dijela lijeve srčane klijetke koje otežava rad srca (npr. aortna stenoza

visokog stupnja)

ako patite od akutnog zatajenja srca, nestablinog zatajenja srca nakon akutnog infarkta miokarda ili

zatajenja srca koje zahtjeva intravensko liječenje lijekovima koji pojačavaju kontraktilnost srca

ako ste u stanju šoka radi poremećene funkcije srca (u ovim slučajevima krvni tlak je izuzetno nizak i

cirkulacija blizu zatajenja)

ako patite od odreĎenih srčanih stanja pri kojima dolazi do vrlo usporenog pulsa ili nepravilnog ritma

srca (AV blok drugog ili trećeg stupnja, sino-atrijski blok, sindrom bolesnog sinusnog čvora, tzv.„sick

sinus sindrom“)

u slučaju izuzetno niskog krvnog tlaka

u slučaju sporih otkucaja srca

u slučaju teške bronhalne astme

u slučaju teške bolesti perifernih arterija

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u slučaju Raynaudovog sindroma, stanje koje može uzrokovati da Vaši prsti ruku i nogu trnu ili

postanu blijedi ili poplave pri izlaganju hladnoći

u slučaju neliječenog feokromocitoma koji je rijedak tumor nadbubrežne žlijezde

kod metaboličkih stanja u kojima pH krvi postaje prenizak (kiseo).

Ako mislite da patite od spomenutih bolesti, razgovarajte sa svojim liječnikom možete li uzimati ovaj lijek.

Upozorenja i mjere opreza

Obratite se svom liječniku ili ljekarniku prije nego uzmete Concor AM.

Concor AM može se primijeniti kod sljedećih stanja uz poseban oprez. Stoga, ukoliko se neko od sljedećih

stanja odnosi na Vas, obratite se svom liječniku prije nego uzmete Concor AM:

starija dob

zatajenje srca

šećerna bolest kod koje postoje izrazite varijacije u razini glukoze u krvi

strogo gladovanje

za vrijeme liječenja antialergijskim lijekom (desenzibilizacija) (npr. za sprječavanje alergijskog

rinitisa)

blage smetnje provoĎenja srčanog impulsa (AV blok prvog stupnja)

poremećaj protoka krvi u koronarnim krvnim žilama (Prizmentalova angina)

krvožilne bolesti ekstremiteta karakterizirane smanjenom prokrvljenošću

psorijaza

hipertireoza

bolest jetre ili bubrega

kod bolesnika s tumorom nadbubrežne žlijezde (feokromocitomom)

kod bronhalne astme ili drugih opstruktivnih bolesti pluća

ukoliko idete na operaciju, recite svojem anesteziologu da uzimate Concor AM.

U slučaju navedenih stanja, Vaš liječnik će možda odrediti dodatne mjere (npr. uvesti dodatnu terapiju).

Djeca i adolescenti

Ne preporučuje se primjena Concora AM u djece mlaĎe od 18 godina zbog nedostatnih podataka o

sigurnosti primjene i djelotvornosti ovoga lijeka u toj populaciji.

Drugi lijekovi i Concor AM

Terapijske nuspojave lijeka mogu biti povezane s istodobnim uzimanjem drugog lijeka.

Interakcije se mogu pojaviti i kada se drugi lijek uzme unutar kratkog vremenskog razdoblja.

Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili ćete možda uzeti bilo koje druge

lijekove.

Uzimanje sljedećih lijekova uz Concor AM se ne preporučuje:

Blokatori kalcijskih kanala tipa verapamil i diltiazem. Ovi lijekovi koriste se za liječenje visokog krvnog

tlaka i kronične stabilne angine pektoris.

Lijekovi za snižavanje krvnog tlaka koji djeluju centralno (npr. klonidin, metildopa, moksonidin,

rilmenidin): nemojte prestati uzimati ove lijekove bez prethodnog savjetovanja sa svojim liječnikom.

Sljedeći lijekovi mogu se uzimati uz Concor AM samo u odreĎenim okolnostima, uz naročiti oprez i

liječnički nadzor:

OdreĎeni lijekovi za regulaciju srčanog ritma (npr. kinidin, disopiramid, lidokain, fenitoin, flekainid,

propafenon, amiodaron). Ovi lijekovi primjenjuju se pri liječenju nepravilnog ritma rada srca.

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Beta-blokatori za vanjsku primjenu (npr. kapi za oči kod liječenja glaukoma).

Parasimpatomimetici. Ovi lijekovi primjenjuju se za stimulaciju funkcije glatkih mišića kod bolesti želuca,

crijeva ili mjehura te kod glaukoma.

Inzulin i oralni antidijabetici.

Hipnotici, anestetici.

Srčani glikozidi (digitalis), lijekovi koji se primjenjuje pri liječenju zatajenja srca.

Nesteroidni protuupalni lijekovi (NSAIDs). Ovi lijekovi primjenjuju se pri liječenju upale zglobova, boli ili

artritisa.

Simpatomimetici (npr. izoprenalin, dobutamin, noradrenalin, adrenalin). Ovi lijekovi primjenjuju se

za liječenje teških cirkulatornih stanja ili u hitnim slučajevima.

Drugi lijekovi koji mogu sniziti krvni tlak kao željeni ili neželjeni učinak (npr. antihipertenzivi, triciklički

antidepresivi, barbiturati, fenotiazini).

Takrolimus, lijek koji se koristi za potiskivanje imunološkog odgovora.

Ciklosporin, imunosupresiv.

Dantrolen, infuzija koja se koristi kod velikih odstupanja tjelesne temperature.

Simvastatin, lijek za sniženje kolesterola.

Vaš liječnik treba obratiti pažnju na moguće učinke prilikom istodobne primjene sljedećih lijekova uz

Concor AM:

Meflokin, lijek koji se primjenjuje za profilaksu ili liječenje malarije.

Inhibitori monoaminoksidaze (osim MAO-B inhibitori) koji se primjenjuju za liječenje depresije.

Lijekovi koji utječu na metabolizam amlodipina npr:

ketonazol, itrakonazol (lijekovi za liječenje gljivičnih infekcija )

ritonavir, indinavir, nelfinavir (tzv. inhibitori proteaze koji se koriste u liječenju HIV-a)

rifampicin, eritromicin, klaritromicin (antibiotici)

gospina trava (Hypericum Perforatum).

Concor AM tablete s hranom, pićem i alkoholom

Alkohol može pojačati učinak sniženja krvnog tlaka ovog lijeka.

Bolesnici koji uzimaju Concor AM ne smiju konzumirati sok od grejpa ili grejp. Sok od grejpa i grejp

mogu uzrokovati porast vrijednosti djelatne tvari amlodipina u krvi, što može izazvati pojačano

djelovanje Concora AM na snižavanje krvnog tlaka.

Trudnoća i dojenje

Trudnoća

Budući da nema dovoljno kliničkih podataka o primjeni ovoga lijeka u trudnica, može se primijeniti samo

nakon pažljive individualne procjene omjera koristi i rizika od strane liječnika, stoga, nemojte propustiti

reći svom liječniku ako ste trudni ili planirate imati dijete.

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U slučaju primjene ovog lijeka u trudnoći, može biti potrebno pažljivo praćenje fetusa i novoroĎenčeta.

Dojenje

Pokazalo se da amlodipin prelazi u majčino mlijeko u malim količinama. Ne preporučuje se primjena

Concora AM tijekom dojenja.

Upravljanje vozilima i strojevima

Concor AM može narušiti sposobnost upravljanja vozilima i rada na strojevima uzrokujući omaglicu,

glavobolju, umor ili mučninu, osobito na početku liječenja ili kod promjene terapije te nakon konzumacije

alkohola. Stoga će Vaš liječnik individualno ocijeniti kod koje doze ovog lijeka možete upravljati vozilima

ili strojevima.

3.

Kako uzimati Concor AM

Uvijek uzmite ovaj lijek točno onako kako Vam je rekao liječnik. Provjerite sa svojim liječnikom ili

ljekarnikom ako niste sigurni.

Preporučena doza: jedna tableta propisane jačine lijeka.

Kod bolesnika s poremećajima rada jetre ili bubrega blage do umjerene jakosti, prilagoĎavanje doze u

pravilu nije potrebno. Kod bolesnika s teškom bolesti jetre ili bubrega, doza se može prilagoditi.

Starije osobe

Kod starijih osoba nije potrebno prilagoĎavanje doze. MeĎutim, kod povećanja doze preporučuje se oprez.

Primjena

Concor AM treba uzeti ujutro, uz obrok ili neovisno o obroku s malo tekućine. Tabletu se ne smije žvakati

Razdjelni urez služi samo kako bi se olakšalo lomljenje radi lakšeg gutanja.

Ako osjećate da Vam je učinak lijeka Concor AM previše jak ili previše slab, posavjetujte se sa svojim

liječnikom ili ljekarnikom.

Ako uzmete više Concora AM nego što ste trebali

Ako ste uzeli više lijeka Concor AM nego što ste trebali, odmah se posavjetujte s liječnikom.

Ako ste zaboravili uzeti Concor AM

Propuštenu dozu pokušajte nadoknaditi što je prije moguće. MeĎutim, ako je već vrijeme da uzmete

sljedeću dozu, nemojte uzeti dvostruku dozu kako biste nadoknadili propuštenu dozu. Na taj način ne biste

mogli nadoknaditi propuštenu količinu lijeka nego biste se izložili opasnosti od predoziranja.

Ako prestanete uzimati Concor AM

Nemojte naglo prestati s uzimanjem lijeka Concor AM ili mijenjati preporučenu dozu bez savjetovanja sa

svojim liječnikom. U suprotnom, Vaše zdravstveno stanje bi se moglo privremeno pogoršati. Naročito kod

bolesnika s ishemijskom bolesti srca, liječenje se ne smije naglo prekidati. Ako je prekid liječenja

potreban, liječnik će Vas uputiti kako postepeno smanjivati dozu.

U slučaju bilo kakvih 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 javiti kod svakoga.

Odmah posjetite svog liječnika ako dobijete bilo koju od sljedećih nuspojava nakon što ste uzeli ovaj

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lijek.

Teške kožne reakcije uključujući intenzivni kožni osip, koprivnjaču, crvenilo kože cijelog tijela,

jak svrbež, pojavu mjehurića na koži, ljuštenje i oticanje kože, upalu sluznica (Stevens-Johnsonov

sindrom, toksičnu epidermalnu nekrolizu) ili druge alergijske reakcije.

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 )

Glavobolja, omaglica, izrazita pospanost (naročito na početku liječenja); osjećaj lupanja srca; crvenilo, bol

u trbuhu, oticanje zglobova, umor, osjećaj opće slabosti (astenija), osjećaj hladnoće i gubitak osjeta u

udovima; probavne tegobe kao što su mučnina, povraćanje, poremećaj u radu crijeva, proljev, zatvor,

probavne smetenje, poremećaji vida (uključujući pojavu dvoslika), grčevi u mišićima, otežano disanje.

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

Nesanica, promjene raspoloženja (uključujući tjeskobu), depresija, kratkotrajni gubitak svijesti (sinkopa),

smanjenje osjeta dodira, trnci, poremećaj osjeta okusa (disgeuzija), nevoljno drhtanje, šum u uhu, sniženi

krvni tlak, hunjavica (rinitis), kašalj, suha usta, gubitak kose, mala krvarenja u koži i sluznici (purpura),

promjena boje kože, prekomjerno znojenje, svrbež kože, osip, koprivnjača, bolovi u zglobovima, mišićima,

mišićna slabost, bol u leĎima, problemi s mokrenjem, buĎenje iz sna zbog mokrenja (nikturija), učestala

potreba za mokrenjem, smetnje potencije, povećanje tkiva dojki kod muškarca, bol u prsima, bol,

malaksalost, povećanje tjelesne težine, smanjenje tjelesne težine, poremećaji sna, smetnje provoĎenja

srčanog impulsa, pogoršanje postojećeg srčanog zatajenja, aritmija, usporenje rada srca (manje od 50

otkucaja u minuti), nizak krvni tlak, bronhospazam kod bolesnika s bronhalnom astmom ili opstruktivnom

plućnom bolesti u povijesti bolesti, slabost mišića.

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

Smetenost, povišena razina triglicerida, noćne more, poremećaji percepcije bez odgovarajuće objektivne

stimulacije, slično stvarnom osjetu i čini se stvarnim (halucinacije), smanjena sekrecija suza (uzeti u obzir

ukoliko

bolesnik

nosi

kontaktne

leće),

smetnje

sluha,

alergijska

hunjavica,

upala

jetre,

reakcije

preosjetljivosti kao što su svrbež, crvenilo, osip, povišeni jetreni enzimi.

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

Smanjeni broj bijelih krvnih stanica i trombocita, alergijske reakcije, povišena razina šećera u krvi,

povišeni krvni tlak, periferna neuropatija (oštećenje završetaka živaca), srčani udar, upala krvnih žila

(vaskulitis), upala sluznice želuca, povećanje desni, upala gušterače, žutica (žuta boja kože i očiju),

oteklina kože ili sluznice koja najčešće uključuje očne kapke, usne, zglobove, genitalije, glasnice, ždrijelo i

jezik (angioedem), ozbiljne upale kože ili sluznice s crvenim mjehurićima (multiformni eritem), crvenilo i

ljuštenje

kože

(eksofolijativni

dermatitis),

lezije

kože

sluznice

ustima,

genitalijama

analnim

područjima

praćeno

temperaturom,

grloboljom,

malaksalošću

(Stevens-Johnsonov

sindrom),

preosjetljivost

sunčevu

svjetlost

(fotosenzitivnost),

konjunktivitis,

lijekovi

sličnog

mehanizma

djelovanja kao bisoprolol (djelatna tvar lijeka) mogu izazvati ili pogoršati psorijazu (kronično kožno

oboljenje s ljuskavim crvenim plakovima koji svrbe) ili mogu izazvati poremećaje kože slične psorijazi,

poremećaj koji obuhvaća nevoljno drhtanje, ukočenost i poremećaj pokreta, tremor (ekstrapiramidalni

sindrom).

Prijavljivanje nuspojava

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

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5.

Kako čuvati Concor AM

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Ne čuvati na temperaturi iznad 30°C. Čuvati u originalnom pakiranju radi zaštite od svjetlosti.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji iza oznake „EXP“ . Rok

valjanosti odnosi se na zadnji dan navedenog mjeseca.

Concor AM se ne smije upotrijebiti ukoliko primijetite vidljive znakove kvarenja (promjena boje).

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 Concor AM sadrži

Djelatne tvari su:

Concor AM 5 mg/5 mg:

5 mg bisoprololfumarata i 5 mg amlodipina (u obliku besilata).

Concor AM 5 mg/10 mg:

5 mg bisoprololfumarata i 10 mg amlodipina (u obliku besilata).

Concor AM 10 mg/5 mg:

10 mg bisoprololfumarata i 5 mg amlodipina (u obliku besilata).

Concor AM 10 mg/10 mg:

10 mg bisoprololfumarata i 10 mg amlodipina (u obliku besilata).

Drugi sastojci su: koloidni bezvodni silicijev dioksid, magnezijev stearat, natrijev škroboglikolat vrste A,

mikrokristalična celuloza.

Kako Concor AM izgleda i sadržaj pakiranja

Concor AM 5 mg/5 mg tablete: bijele ili gotovo bijele, duguljaste, blago konveksne tablete bez mirisa,

duljine 9,5 mm i širine 4,5 mm, s razdjelnim urezom na jednoj strani i

utisnutim MS na drugoj strani. Razdjelni urez služi samo kako bi se

olakšalo lomljenje radi lakšeg gutanja, a ne da bi se lijek podijelio u

jednake doze.

Concor AM 5 mg/10 mg tablete: bijele ili gotovo bijele, okrugle, ravne tablete bez mirisa, blago zakošenog

ruba, veličine 10 mm, s razdjelnim urezom na jednoj strani i utisnutim

MS na drugoj strani. Razdjelni urez služi samo kako bi se olakšalo

lomljenje radi lakšeg gutanja, a ne da bi se lijek podijelio u jednake doze.

Concor AM 10 mg/5 mg tablete: bijele ili gotovo bijele, ovalne, blago konveksne tablete bez mirisa,

duljine 13 mm i širine 7 mm, s razdjelnim urezom na jednoj strani i

utisnutim MS na drugoj strani. Razdjelni urez služi samo kako bi se

olakšalo lomljenje radi lakšeg gutanja, a ne da bi se lijek podijelio u

jednake doze.

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Concor AM 10 mg/10 mg tablete: bijele ili gotovo bijele, okrugle, blago konveksne tablete bez mirisa,

veličine 10 mm, s razdjelnim urezom na jednoj strani i utisnutim MS na

drugoj strani. Razdjelni urez služi samo kako bi se olakšalo lomljenje

radi lakšeg gutanja, a ne da bi se lijek podijelio u jednake doze.

Concor AM je dostupan u pakiranjima od 28, 30, 56 ili 90 tableta u OPA/Al/PVC//Al blisteru, u kutiji.

Na tržištu se ne moraju nalaziti sve veličine pakiranja.

Nositelja odobrenja za stavljanje lijeka u promet

Merck d.o.o., Ulica Andrije Hebranga 32-34, 10000 Zagreb, Hrvatska

Proizvođači

EGIS Pharmaceuticals PLC

H-1106 Budapest, Keresztúri út 30-38.

MaĎarska

EGIS Pharmaceuticals PLC

H-1165 Budapest, Bökényföldi út 118-120.

MaĎarska

Merck KGaA

Frankfurter Strasse 250

64293 Darmstadt

Njemačka

Ovaj lijek je odobren u državama članicama Europskog ekonomskog prostora (EEA) pod sljedećim

nazivima:

Austrija

Concor AMLO

Bugarska

Hrvatska

Concor

Concor AM

Češka Republika

Concor

Combi

MaĎarska

Concor

AMLO

Latvija

Concor

Poljska

Concoram

Rumunjska

Concor

Slovačka

Concor Combi

Način i mjesto izdavanja lijeka

Na recept, u ljekarni.

Ova uputa je zadnji put revidirana u siječnju 2018.

H A L M E D

05 - 03 - 2018

O D O B R E N O

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

18-7-2018

Orphan designation:  Recombinant humanised anti-human interleukin-1 beta monoclonal antibody,  for the: Treatment of Behçet’s disease

Orphan designation: Recombinant humanised anti-human interleukin-1 beta monoclonal antibody, for the: Treatment of Behçet’s disease

On 1 October 2010, orphan designation (EU/3/10/796) was granted by the European Commission to XOMA Ireland Ltd, Ireland, for recombinant humanised anti-human interleukin-1 beta monoclonal antibody for the treatment of Behçet’s disease.

Europe - EMA - European Medicines Agency

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

24-9-2018

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

FDA - U.S. Food and Drug Administration

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