Atimos 12 mikrograma

Glavna informacija

  • Trgovački naziv:
  • Atimos 12 mikrograma po potisku, stlačeni inhalat, otopina
  • Doziranje:
  • 12 mikrograma
  • Farmaceutski oblik:
  • stlačeni inhalat, otopina
  • Sastav:
  • Urbroj: jedna potiskom ispuštena doza sadrži 12 mikrograma formoterolfumarat dihidrata, što odgovara udahnutoj dozi od 10,1 mikrograma
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Chiesi Pharmaceuticals GmbH, Beč, Austrija; Chiesi Farmaceutici S.p.A., Parma, Italija

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Atimos 12 mikrograma po potisku, stlačeni inhalat, otopina
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 1 inhalator sa 100 doza, u kutiji [HR-H-206948118-01]; 1 inhalator sa 120 doza, u kutiji [HR-H-206948118-02] Urbroj: 381-12-01/70-17-05

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-206948118
  • Datum autorizacije:
  • 25-09-2017
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za bolesnika

Atimos 12 mikrograma po potisku, stlačeni inhalat, otopina

formoterolfumarat dihidrat

Paţljivo pročitajte cijelu uputu prije nego počnete primjenjivati ovaj lijek jer sadrţi Vama

vaţne podatke.

Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.

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

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

njihovi znakovi bolesti jednaki Vašima.

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti 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 Atimos i za što se koristi?

Što morate znati prije nego počnete primjenjivati Atimos?

Kako primjenjivati Atimos?

Moguće nuspojave

Kako čuvati Atimos?

Sadržaj pakiranja i druge informacije

1.

Što je Atimos i za što se koristi?

Atimos je lijek kojim se djelatna tvar udisanjem (inhalacijom) dostavlja izravno u pluća, gdje je i

potrebna. Djelatna tvar, formoterolfumarat, pripada skupini lijekova koji se nazivaju bronhodilatatori

odnosno oni olakšavaju disanje opuštanjem grčeva mišića u dišnim putovima pluća.

Koristi se za liječenje simptoma piskanja pri disanju i nedostatka zraka u bolesnika s umjerenom do

teškom astmom. Redovito uzimanje Atimosa zajedno sa steroidima (inhalacijom ili kroz usta)

pridonijet će dugoročnom sprječavanju tegoba s disanjem.

Atimos se takoĎer može koristiti za ublažavanje simptoma kao što su kašalj, piskanje pri disanju i

nedostatak zraka u bolesnika s kroničnom opstruktivnom plućnom bolešću (KOPB), kojima je

potrebna dugotrajna redovita terapija bronhodilatatorima.

2.

Što morate znati prije nego počnete primjenjivati Atimos?

Nemojte primjenjivati Atimos:

ako ste alergični na formoterol ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).

za liječenje iznenadnih napadaja nedostatka zraka. Atimos neće pomoći. Koristite „pumpicu“

za tu svrhu i nosite je uvijek sa sobom.

Upozorenja i mjere opreza

Obratite se Vašem liječniku ili ljekarniku prije nego primijenite Atimos.

Uvijek obavijestite liječnika ako:

bolujete od teške srčane bolesti, osobito ako ste nedavno doživjeli srčani udar, bolesti krvnih

žila srca ili teške slabosti srčanog mišića (kongestivno zatajenje srca)

bolujete od poremećaja srčanog ritma kao što je ubrzan rad srca, oštećenje srčanog zaliska, ili

imate neuredan EKG (elektrokardiografski) nalaz, ili bolujete od bilo koje druge srčane

bolesti

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imate suženje krvnih žila, osobito arterija, ili abnormalno proširenje stjenke krvnih žila

bolujete od povišenog krvnog tlaka

imate povišenu razinu šećera u krvi (šećerna bolest ili diabetes melitus)

imate nisku razinu kalija u krvi

imate pretjerano aktivnu štitnjaču

bolujete od tumora srži nadbubrežne žlijezde koji proizvode epinefrin ili norepinefrin

idete na operaciju ili ćete primati tvari za uspavljivanje (takozvane halogenirane anestetike).

Djeca i adolescenti

Ovaj lijek se ne primjenjuje u djece s astmom ispod 12 godina.

Ovaj lijek se ne primjenjuje u djece i adolescenata s KOPB-om ispod 18 godina.

Drugi lijekovi i Atimos

Obavijestite Vašeg liječnika ako primjenjujete, nedavno ste primijenili ili biste mogli primijeniti bilo

koje druge lijekove.

Neki lijekovi mogu utjecati na djelovanje Atimosa, a meĎu njima su sljedeći lijekovi:

za liječenje poremećenog srčanog ritma (na primjer, kinidin, dizopiramid, prokainamid)

za liječenje srčane bolesti (na primjer, digitalis)

za liječenje začepljenog nosa (na primjer, efedrin)

beta adrenergički blokatori koji se primjenjuju u liječenju srčanih bolesti ili povišenog očnog

tlaka (glaukoma), u obliku tableta ili kapi za oko

koji sadrže eritromicin (koriste za liječenje infekcija)

za liječenje simptoma depresije: inhibitori monoaminooksidaze (na primjer, fenelzin i

izokarboksazid) ili triciklički antidepresivi (na primjer, amitriptilin i imipramin)

za liječenje teških psihičkih poremećaja (na primjer, kloropromazin i trifluperazin)

za liječenje alergijskih reakcija (kao što su antihistaminici, na primjer, terfenadin, astemizol,

mizolastin)

za liječenje bronhalne astme (na primjer, teofilin, aminofilin ili steroidi)

za izlučivanje viška vode iz tijela (kao što su diuretici)

za liječenje Parkinsonove bolesti (na primjer, levodopa)

lijekovi koji sadrže oksitocin, koji izaziva kontrakcije maternice

za liječenje slabe aktivnosti štitnjače (na primjer, tiroksin).

Dodavanje lijekova koji se zovi antikolinergici (kao što su tiotropij ili ipratropij bromid) liječenju

Atimosom može pomoći otvaranju Vaših dišnih putova još više.

Ostala posebna upozorenja

Zbog tegoba s disanjem, propisani su Vam i kortikosteroidi. Važno je da ih nastavite redovito

koristiti. Nemojte prestati uzimati te lijekove niti mijenjati dozu kad počnete uzimati Atimos.

Trudnoća i dojenje

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.

Uzimanje Atimosa za vrijeme trudnoće se preporuča samo ako je to apsolutno neophodno.

Ako dojite, obavijestite o tome Vašeg liječnika prije nego počnete uzimati ovaj lijek.

Upravljanje vozilima i strojevima

Atimos najvjerojatnije neće imati nikakav utjecaj na sposobnost upravljanja vozilima i rada sa

strojevima.

Atimos sadrţi etanol.

Atimos sadrži malu količinu alkohola. Jedan potisak iz inhalatora sadrži oko 9 mg etanola.

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3.

Kako primjenjivati Atimos?

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

liječnikom ako niste sigurni.

Doziranje

Astma

Doza Atimosa koju morate udahnuti ovisi o vrsti i težini astme koju imate.

Dozu će Vam odrediti Vaš liječnik pa je važno redovito uzimati samo propisanu dozu.

Preporučena doza za odrasle, uključujući starije bolesnike i adolescente u dobi od 12 i više godina, je

1 udah ujutro i 1 udah navečer. To znači da trebate uzeti ukupno 2 udaha (24 mikrograma) Atimosa na

dan.

Ako bolujete od težeg oblika astme, liječnik Vam može propisati 4 udaha na dan (48 mikrograma),

2 ujutro i 2 navečer.

4 udaha, tj. 48 mikrograma Atimosa, maksimalna je dnevna doza i važno je da ne uzmete više od

ukupne dnevne doze koju Vam je liječnik propisao.

Kronična opstruktivna plućna bolest (KOPB)

Preporučena doza za odrasle (u dobi od 18 godina ili više), uključujući starije bolesnike, je 1 udah

ujutro i 1 udah navečer. To znači da morate ukupno uzeti 2 udaha (24 mikrograma) Atimosa na dan.

Ako bolujete od težeg oblika KOPB-a, liječnik Vam može propisati 4 udaha na dan (48 mikrograma),

2 udaha ujutro i 2 navečer.

4 udaha, tj. 48 mikrograma Atimosa, maksimalna je dnevna doza i važno je da ne uzmete više od

ukupne dnevne doze koju Vam je liječnik propisao.

Nikad nemojte uzeti više od 2 udaha odjedanput.

Primjena u djece i adolescenata

Ovaj lijek nije prikladan za primjenu u djece s astmom ispod 12 godina.

Ovaj lijek nije prikladan za primjenu u bolesnika s KOPB-om ispod 18 godina.

Nemojte primijeniti Atimos za liječenje iznenadnih napada nedostatka zraka. Trebate koristiti

“pumpicu” koju Vam je liječnik propisao za tu svrhu, te je uvijek nosite sa sobom.

Ako primijenite više Atimosa nego što ste trebali

Možete primijetiti da Vam srce radi brže nego obično i da se osjećate nesigurno. Može se javiti i

glavobolja, nevoljno drhtanje, mučnina, povraćanje te pospanost. Potražite čim prije savjet Vašeg

liječnika.

Ako ste zaboravili primijeniti Atimos

Ako ste zaboravili primijeniti Atimos, uzmite ga čim se sjetite. Ako je uskoro vrijeme za uzimanje

sljedeće doze, nemojte uzeti dozu koju ste propustili. Samo uzmite sljedeću dozu u uobičajeno

vrijeme. Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.

Nemojte prestati uzimati niti smanjivati dozu Atimosa ili nekog drugog lijeka za tegobe s disanjem,

samo zato što se osjećate bolje, a da se prethodno niste o tome posavjetovali s Vašim liječnikom. Jako

je važno redovito uzimati te lijekove.

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Nemojte povećati svoju dozu Atimosa, a da se prethodno niste o tome posavjetovali s Vašim

liječnikom.

Ako osjetite da ostajete bez zraka ili osjetite piskanje pri disanju dok uzimate Atimos, nastavite

uzimati Atimos, ali čim prije posjetite liječnika, jer Vam je možda potrebno dodatno liječenje.

Jednom kad astma bude pod kontrolom, Vaš liječnik može smatrati prikladnim da Vam postupno

smanji dozu Atimosa.

Način primjene

Važno je znati kako ispravno koristiti inhalator. Vaš liječnik, medicinska sestra ili ljekarnik pokazat

će Vam kako ispravno koristiti inhalator. Morate pažljivo slijediti njihove upute, tako da znate kako,

kada i koliko udaha trebate uzeti. Točne upute nalaze se u ovoj Uputi o lijeku. Ako niste sigurni što

učiniti ili imate problema s inhaliranjem, potražite savjet Vašeg liječnika, medicinske sestre ili

ljekarnika.

Provjeravanje inhalatora. Ako imate novi inhalator ili ga niste koristili 3 dana ili više, prije uporabe

jedan potisak treba osloboditi u zrak, kako biste provjerili radi li inhalator ispravno.

Trebate stajati ili uspravno sjediti dok koristite inhalator.

Uklonite zaštitni poklopac s nastavka za usta i držite inhalator palcem i kažiprstom, kako je

prikazano na slici.

Izdahnite što više možete.

Držite inhalator u okomitom položaju tako da palac postavite s donje strane, ispod nastavka za

usta. Nastavak za usta stavite izmeĎu zubi i čvrsto ga obuhvatite usnicama.

Duboko udahnite kroz usta i istodobno pritisnite gornji dio inhalatora prema dolje, kako biste

oslobodili jedan potisak.

Zadržite dah onoliko dugo koliko možete, a potom izvadite inhalator iz usta.

Ako morate uzeti još jedan udah, zadržite inhalator u okomitom položaju oko pola minute prije

nego ponovite korake od br. 2. do br. 5.

Nakon primjene uvijek vratite zaštitni poklopac na nastavak za usta, kako biste ga zaštitili od

prašine i nečistoće. Čvrsto ga pritisnite tako da “sjedne” na mjesto.

VAŢNO: Nemojte ţuriti kroz korake br. 2., 3., 4. i 5.

Važno je početi što sporije udisati neposredno prije početka korištenja inhalatora.

Ako vidite “maglicu” kako izlazi iz vrha inhalatora ili sa strane Vaših usta, Atimos Vam neće

doprijeti u pluća kao što bi trebao. Uzmite drugi udah paţljivo slijedeći upute od koraka br. 2.

nadalje.

Ako nemate dovoljno jake ruke, možda će Vam biti lakše držati inhalator objema rukama. Stavite oba

kažiprsta na gornji dio inhalatora i oba palca na donji dio, ispod nastavka za usta.

Ako imate bilo kakvih poteškoća, obratite se liječniku, medicinskoj sestri ili ljekarniku.

Čišćenje

Važno je redovito čistiti inhalator, najmanje jedanput ili dva puta na tjedan kako biste osigurali da

ispravno radi.

Izvucite metalni spremnik iz plastičnog kućišta inhalatora i uklonite poklopac s nastavka za usta.

Isperite plastično kućište i poklopac nastavka za usta toplom vodom.

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Nemojte stavljati metalni spremnik u vodu.

Ostavite na toplom mjestu, kako bi se potpuno osušio. Izbjegavajte preveliku toplinu.

Vratite spremnik i poklopac nastavka za usta na mjesto.

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

ljekarniku.

4.

Moguće nuspojave

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

Moguće nuspojave navedene su u daljnjem tekstu prema učestalosti. Ako niste sigurni kakve su te

navedene nuspojave, zamolite liječnika da Vam objasni.

Ako Vam se pogorša disanje ili piskanje pri disanju nakon uporabe inhalatora prestanite

koristiti Atimos i odmah o tome obavijestite Vašeg liječnika. Uzrok tome je sužavanje dišnih putova

u plućima, ali to se dogaĎa samo u rijetkim slučajevima.

Česte nuspojave koje se mogu javiti u 1 na 10 osoba:

neobično ubrzan rad srca i osjećaj lupanja srca,

kašalj, drhtanje, glavobolja.

Manje česte nuspojave koje se mogu javiti u manje od 1 na 100 osoba:

grčevi u mišićima, bol u mišićima,

mučnina, uznemirenost, nemir, poremećaji spavanja, omaglica,

promijenjen ili oštećen osjet okusa, nadraženost grla,

abnormalno ubrzan rad srca, poremećen srčani ritam s ubrzanim radom srca,

abnormalno niske razine kalija u krvi, povećane razine šećera u krvi, povećane razine

inzulina, slobodnih masnih kiselina, glicerola i ketona u krvi, pojačano znojenje.

Rijetke nuspojave koje se mogu javiti u manje od 1 na 1000 osoba:

preskakanje otkucaja srca izazvano preranim stezanjem srčanih klijetki, osjećaj stezanja u

prsima, povećanje ili sniženje krvnog tlaka,

piskanje pri disanju neposredno nakon korištenja inhalatora, jaki pad vrijednosti krvnog tlaka,

upala bubrega,

alergijska reakcija kao što je svrbež, osip, sužavanje dišnih putova (bronhospazam),

koprivnjača, oticanje kože i sluznica koji traje nekoliko dana.

Vrlo rijetke nuspojave koje se mogu javiti u manje od 1 na 10 000 osoba:

pogoršanje astme,

otežano disanje, oticanje šaka i/ili stopala,

nepravilan rad srca, smanjen broj krvnih pločica, jaka razdražljivost, poremećeno ponašanje,

halucinacije.

Neke nuspojave, kao što su nevoljno drhtanje, mučnina, poremećen ili smanjen osjet okusa,

nadraženost grla, pojačano znojenje, nemir, glavobolja, omaglica i grčevi u mišićima, mogu slabjeti

tijekom jednog do dva tjedna neprekidnog uzimanja lijeka protiv astme.

Prijavljivanje nuspojava

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

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

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

Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.

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5.

Kako čuvati Atimos?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Nemojte koristiti dulje od tri mjeseca od datuma kad ste preuzeli inhalator u ljekarni.

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

valjanosti odnosi se na zadnji dan navedenog mjeseca.

Prije izdavanja lijeka bolesniku lijek treba čuvati u hladnjaku na temperaturi od 2-8°C.

Nakon izdavanja lijeka bolesniku lijek treba čuvati na temperaturi ispod 30°C.

Ako inhalator postane jako hladan, izvadite metalni spremnik iz plastičnog kućišta i grijte ga meĎu

dlanovima nekoliko minuta prije uporabe. Nikad ga nemojte zagrijavati na neki drugi način.

Upozorenje: Spremnik sadrži stlačenu tekućinu. Nemojte ga izlagati temperaturama iznad 50

Nemojte bušiti spremnik.

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.

Sadrţaj pakiranja i druge informacije

Što Atimos sadrţi?

Djelatna tvar je formoterolfumarat dihidrat.

Jedna potiskom ispuštena doza sadrži 12 mikrograma formoterolfumarat dihidrata, što odgovara

udahnutoj dozi od 10,1 mikrograma.

Drugi sastojci su: kloridna kiselina, etanol i norfluran (HFA 134a).

Kako Atimos izgleda i sadrţaj pakiranja?

Atimos je bistra, bezbojna do žućkasta inhalacijska otopina u aluminijskom spremniku pod tlakom

zatvorenom odmjernim ventilom i uloženom u plastični aktivator s nastavkom za usta i zaštitnim

poklopcem.

Pakiranje sadrži jedan spremnik koji sadrži 100 ili 120 doza.

Nositelj odobrenja za stavljanje lijeka u promet i proizvoĎač

Nositelj odobrenja:

Chiesi Pharmaceuticals GmbH

Gonzagagasse 16/16

1010 Beč

Austrija

ProizvoĎač:

Chiesi Farmaceutici S.p.A.

26/A, via Palermo

43122 Parma

Italija

Chiesi Pharmaceuticals GmbH

Gonzagagasse 16/16

1010 Beč

Austrija

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Predstavnik nositelja odobrenja za Republiku Hrvatsku

Providens d.o.o.

Kaptol 24

10 000 Zagreb

Republika Hrvatska

tel: 00 385 1 48 74 500

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je posljednji put revidirana u rujnu 2017.

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

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

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

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

The importance of vector abundance and seasonality

The importance of vector abundance and seasonality

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

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

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

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

Published on: Fri, 02 Nov 2018 00:00:00 +0100 The applicant BASF SE submitted a request to the competent national authority in Belgium to evaluate the confirmatory data that were identified for kresoxim‐methyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the confirmatory data requirement, a new study on the storage stability of kresoxim‐methyl residues in animal matrices was submitted. The data gap was considered ...

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

26-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

FDA approves new drug to treat influenza

FDA approves new drug to treat influenza

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

FDA - U.S. Food and Drug Administration

23-10-2018

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

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

Published on: Mon, 22 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residue trials on strawberries, onions, garlic, tomatoes, peppers, cucumbers, artichokes, leeks and rape seeds were submitted. The data gaps are considere...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

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

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

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

FDA - U.S. Food and Drug Administration

16-10-2018

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

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

Published on: Mon, 15 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in United Kingdom to evaluate the confirmatory data that were identified for teflubenzuron in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new metabolism study on leafy crops, a study investigating the nature of residues under standard hydrolytic conditions and a validated ...

Europe - EFSA - European Food Safety Authority Publications

5-10-2018

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

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

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

FDA - U.S. Food and Drug Administration

2-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

24-9-2018

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

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

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

FDA - U.S. Food and Drug Administration

13-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

12-9-2018

Enforcement Report for the Week of September 12, 2018

Enforcement Report for the Week of September 12, 2018

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

FDA - U.S. Food and Drug Administration

7-9-2018

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

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

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

FDA - U.S. Food and Drug Administration

7-9-2018

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

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

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

Europe - EMA - European Medicines Agency

1-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Review of the existing MRLs for fenbuconazole

Review of the existing MRLs for fenbuconazole

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

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

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

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

Published on: Tue, 07 Aug 2018 00:00:00 +0200 During the project seven standard operating procedures (SOP) were developed for the four data domains (zoonoses, chemical contaminant, pesticide residues and veterinary medical products residues). The SOPs describe 1) How the national governance of risk assessment data is organised, 2) how data are collected and validated before delivering to EFSA covering all four domains, 3) How data is transferred to EFSA, 4) how to respond to EFSA request for clarificati...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Product Quest Manufacturing LLC Recalls All Nasal Products and Baby Oral Gels Manufactured at Florida Facility Due to Possible Microbial Contamination

Product Quest Manufacturing LLC Recalls All Nasal Products and Baby Oral Gels Manufactured at Florida Facility Due to Possible Microbial Contamination

Product Quest Manufacturing (“Product Quest”) announced its voluntary recall of Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist due to a finding of microbial contamination identified as Pseudomonas aeruginosa.

FDA - U.S. Food and Drug Administration

29-8-2018

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

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

Published on: Tue, 28 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance sintofen. To assess the occurrence of sintofen residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Mon, 27 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance prochloraz. To assess the occurrence of prochloraz residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as th...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Fri, 24 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance napropamide. To assess the occurrence of napropamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Mon, 13 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance myclobutanil. To assess the occurrence of myclobutanil residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, the MRLs established by the Codex Alimentarius Com...

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

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

28-8-2018

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

FDA - U.S. Food and Drug Administration

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

8-8-2018

Product Quest Manufacturing LLC Issues Voluntary Nationwide Recall of CVS Health 12 Hour Sinus Relief Nasal Mist Due to Microbiological Contamination

Product Quest Manufacturing LLC Issues Voluntary Nationwide Recall of CVS Health 12 Hour Sinus Relief Nasal Mist Due to Microbiological Contamination

Holly Hill, FL, Product Quest Manufacturing (“Product Quest”) is voluntarily recalling Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist, a clear, colorless liquid, to the consumer level. The product was found to have had microbiological contamination identified as Pseudomonas aeruginosa.

FDA - U.S. Food and Drug Administration

12-11-2018

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

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

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

Europe -DG Health and Food Safety

12-10-2018

Irbesartan Zentiva (Zentiva k.s.)

Irbesartan Zentiva (Zentiva k.s.)

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

Europe -DG Health and Food Safety

1-10-2018

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

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

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

Europe -DG Health and Food Safety

1-10-2018

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

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

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

Europe -DG Health and Food Safety

26-9-2018

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

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

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

FDA - U.S. Food and Drug Administration

19-9-2018

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

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

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

FDA - U.S. Food and Drug Administration

19-9-2018

Memantine Mylan (Mylan S.A.S.)

Memantine Mylan (Mylan S.A.S.)

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

Europe -DG Health and Food Safety

14-9-2018

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

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

Europe - EMA - European Medicines Agency

12-9-2018

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

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

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

FDA - U.S. Food and Drug Administration

12-9-2018

ADCETRIS (Takeda Pharma A/S)

ADCETRIS (Takeda Pharma A/S)

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

Europe -DG Health and Food Safety

11-9-2018

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

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

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

Europe - EMA - European Medicines Agency

5-9-2018

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

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

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

FDA - U.S. Food and Drug Administration

7-8-2018

ACMD meeting statement, Meeting 40, 12 April 2018

ACMD meeting statement, Meeting 40, 12 April 2018

Advisory Committee on Medical Devices meeting statement

Therapeutic Goods Administration - Australia