Elidel 10 mg g krema

Glavna informacija

  • Trgovački naziv:
  • Elidel 10 mg/g krema
  • Doziranje:
  • 10 mg/g
  • Farmaceutski oblik:
  • krema
  • Sastav:
  • Urbroj: 1 g kreme sadržava 10 mg pimekrolimusa
  • Tip recepta:
  • na recept, u ljekarni ograničeni recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Meda Pharma GmbH & Co. KG, Bad Homburg, Njemačka; MEDA Manufacturing Merignac, Merignac, Francuska

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Elidel 10 mg/g krema
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 30 g kreme u tubi, u kutiji [HR-H-820593463-01] Urbroj: 381-12-01/30-18-18

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-820593463
  • Datum autorizacije:
  • 03-01-2018
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

UPUTA O LIJEKU: Informacija za bolesnika

ELIDEL 10 mg/g krema

pimekrolimus

Paţljivo proĉitajte cijelu uputu prije nego poĉnete primjenjivati ovaj lijek jer sadrţi Vama vaţne

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 Elidel krema i za što se koristi

Što morate znati prije nego počnete primjenjivati Elidel kremu

Kako primjenjivati Elidel kremu

Moguće nuspojave

Kako čuvati Elidel kremu

Sadržaj pakiranja i druge informacije

1.

ŠTO JE ELIDEL KREMA I ZA ŠTO SE KORISTI

Elidel krema sadrži lijek zvan pimekrolimus. Ne sadrži steroide.

Elidel krema specifično djeluje protiv upale kože koja se naziva atopijski dermatitis (ekcem). Djeluje na

stanice u koži koje izazivaju upalu, uz pojavu crvenila i svrbeža karakterističnih za ekcem.

Krema se koristi za liječenje znakova i simptoma blagog do umjerenog ekcema (npr. crvenila i svrbeža)

kod djece (u dobi od 2 godine i starijih), adolescenata i odraslih. Kada se koristi za liječenje ranih

znakova i simptoma, može spriječiti napredovanje do teškog pogoršanja bolesti.

Elidel krema se primjenjuje tek nakon što ostali propisani lijekovi ili emolijenti nisu djelovali, ili ako vaš

liječnik preporuči da se ne koriste drugi lijekovi koji se izdaju na recept.

Morate se obratiti liječniku ako se nakon 6 tjedana ne osjećate bolje ili se osjećate lošije.

2.

ŠTO MORATE ZNATI PRIJE NEGO POĈNETE PRIMJENJIVATI ELIDEL KREMU

Pozorno slijedite sve upute dobivene od vašega liječnika.

Prije nego počnete primjenjivati Elidel kremu, pročitajte sljedeće informacije.

Nemojte primjenjivati Elidel kremu

ako ste alergiĉni (preosjetljivi) na pimekrolimus ili neki drugi sastojak ovog lijeka (naveden u dijelu

6.).

Budite posebno oprezni s Elidel kremom

Elidel nije odobren za primjenu kod djece mlaĊe od 2 godine. Stoga se u toj dobnoj skupini ne smije

primjenjivati. Molimo vas posavjetujete se s liječnikom.

H A L M E D

03 - 01 - 2018

O D O B R E N O

Upozorenja i mjere opreza

Ako, bez obzira na uzrok, imate oslabljen imunosni sustav (narušenu otpornost) porazgovarajte sa

svojim liječnikom prije nego počnete primjenjivati Elidel.

Elidel krema namijenjena je samo za lijeĉenje atopijskog dermatitisa. Nemojte je upotrebljavati za

liječenje drugih kožnih bolesti.

Elidel krema namijenjena je samo za vanjsku uporabu. Ne unosite je u nos, oči ni usta. Ako je

slučajno nanesete na ta mjesta, kremu morate temeljito obrisati i/ili isprati vodom. Morate paziti da je ne

progutate, ni zabunom ne unesete u usta kada ju npr. namažete na ruke.

Kremu ne nanosite na dijelove koţe zahvaćene aktivnom virusnom infekcijom poput groznice

(herpes simplex) ili vodenih kozica.

Ako imate koţnu infekciju, posavjetujte se sa svojim lijeĉnikom prije primjene Elidela. Vaš liječnik

će možda zatražiti da odgovarajućim lijekom najprije izliječite infekciju. Nakon što infekcija na mjestima

gdje trebate nanositi kremu proĎe, možete započeti liječenje Elidelom. Ako se kožna infekcija javi

tijekom liječenja Elidelom, o tome morate obavijestiti svojega liječnika. Liječnik će možda zatražiti da

prekinete primjenu Elidela, dok se infekcija ne stavi pod odgovarajući nadzor.

Elidel može biti povezan s povećanim rizikom od teške infekcije virusom herpes simplex (herpetični

ekcem). Stoga, ako vam se na bilo kojem dijelu tijela pojave bolne ranice, o tome odmah obavijestite

svojega liječnika. Liječenje Elidelom se mora prekinuti dok infekcija ne proĎe.

Elidel može izazvati reakcije na mjestu primjene, npr. osjećaj vrućine i/ili pečenja. Te su reakcije

obično blage i kratkotrajne. Odmah obavijestite svojega liječnika ako imate tešku reakciju na Elidel.

Na mjesta na koja ste nanijeli Elidel nemojte stavljati zavoje, komprese ni flastere. Možete odjenuti

uobičajenu odjeću.

Tijekom liječenja Elidelom izbjegavajte pretjerano izlaganje sunĉanoj svjetlosti, UV-svjetiljkama i

boravak u solarijima. Ako ćete nakon primjene Elidela boraviti na otvorenom, odjenite odjeću koja vas ne

steže i zaštitite se odgovarajućim proizvodima za zaštitu od sunca, a vrijeme boravka na suncu skratite

najviše što možete.

Ako imate eritrodermiju (crvenilo gotovo cijeloga tijela) ili kožnu bolest zvanu Nethertonov sindrom,

porazgovarajte sa svojom liječnikom prije nego počnete primjenjivati Elidel.

Prije

nego

počnete

primjenjivati

Elidel

imate

bilo

koju

zloćudnu

koţnu

bolest

(tumor)

porazgovarajte sa svojim liječnikom.

Ako vam se tijekom liječenja Elidel kremom povećaju limfni ĉvorovi, obavijestite svojega liječnika.

Djeca

Primjena Elidel kreme kod bolesnika mlaĎih od 2 godine se ne preporučuje dok dodatni podaci ne

postanu dostupni.

Drugi lijekovi i Elidel krema

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

druge lijekove.

Ne preporučuje se primjena pimekrolimusa na mjestima cijepljenja, sve dok traje lokalna reakcija.

Primjena pimekrolimusa na mjestu cijepljenja, sve dok traje lokalna reakcija se ne preporučuje.

Ako imate prošireni ekcem, možda ćete morati prestati primjenjivati Elidel prije ikakvog cijepljenja.

Liječnik će vas obavijestiti ako će to biti potrebno.

H A L M E D

03 - 01 - 2018

O D O B R E N O

Elidel se ne smije primjenjivati istodobno s lijeĉenjem ultraljubiĉastim zrakama (kao što su UVA,

PUVA, UVB) ni sa sustavnim imunosupresivima (kao što su azatioprin ili ciklosporin).

Interakcije s drugim lijekovima koje uzimate nisu vjerojatne.

Elidel krema s hranom, pićem i alkoholom

U rijetkim slučajevima možete iskusiti crvenilo uz osjećaj vrućine, osip, pečenje, svrbež ili oticanje

kratko vrijeme nakon uzimanja alkohola.

Trudnoća i dojenje

Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se

svojemu lijeĉniku ili ljekarniku za savjet prije nego uzmete ovaj lijek. Ako ste trudni, Elidel ne

smijete primjenjivati.

Nije poznato da li se djelatna tvar iz Elidela izlučuje u majčino mlijeko nakon nanošenje lijeka na kožu.

Ako dojite, ne nanosite Elidel na dojke.

Upravljanje vozilima i strojevima

Nije poznat učinak Elidela na sposobnost upravljanja vozilima i rada sa strojevima.

Elidel krema sadrţi cetilni i stearilni alkohol

Može uzrokovati lokalne kožne reakcije.

Elidel sadrţi propilenglikol

Može nadražiti kožu.

3.

KAKO PRIMJENJIVATI ELIDEL KREMU

Uvijek primjenite ovaj lijek toĉno onako kako vam je rekao vaš lijeĉnik ili ljekarnik. Provjerite sa

svojim lijeĉnikom ili ljekarnikom ako niste sigurni.

Elidel možete nanositi na kožu svih dijelova tijela, uključujući glavu, lice, vrat i mjesta gdje se koža

nabire.

Kremu nanosite u skladu s niţe navedenim uputama:

operite ruke i osušite ih

otvorite tubu (pri prvom otvaranju šiljkom na vrhu poklopca morate probiti zaštitni pokrov tube)

istisnite kremu na prst

nanesite Elidel u tankom sloju tako da potpuno prekriva zahvaćenu kožu

kremu nanosite samo na područja zahvaćena ekcemom

kremu utrljajte lagano i potpuno

tubu ponovno zatvorite zatvaračem.

Kremu treba nanositi dvaput na dan, na primjer jedanput ujutro i jedanput navečer. Zajedno s

Elidelom možete upotrebljavati i ovlaživače kože (emolijente). Upotrebljavate li ovlaživače, morate ih

nanositi odmah nakon Elidela.

Neposredno nakon nanošenja Elidela nemojte se kupati, tuširati ni plivati. Time biste mogli isprati kremu.

Koliko dugo primjenjivati Elidel

Dugotrajno liječenje ne smije biti neprekidno, već isprekidano. Prekinite primjenu Elidela čim ekcem

proĎe.

Kremu primjenjujte toliko dugo koliko vam je savjetovao vaš liječnik.

Ako ne doĊe do poboljšanja nakon 6 tjedana lijeĉenja, ili se ekcem pogorša, lijeĉenje prekinite i

posavjetujte se sa svojim liječnikom.

H A L M E D

03 - 01 - 2018

O D O B R E N O

Pri dugotrajnom liječenju ekcema, Elidel počnite primjenjivati čim se pojave znakovi ili simptomi

(crvenilo i svrbež). To pomaže spriječavanju teškog pogoršanja bolesti.

Ako se opet jave znakovi i simptomi, liječenje treba ponovno započeti.

Ako primijenite više Elidel kreme nego što ste trebali

Ako ste nanijeli na kožu više kreme nego što ste trebali, jednostavno ju obrišite.

Ako ste zaboravili primijeniti Elidel kremu

Ako ste zaboravili nanijeti kremu, učinite to čim bude moguće i zatim nastavite prema uobičajenom

rasporedu. MeĎutim, ako je uskoro vrijeme za sljedeće nanošenje, preskočite propuštenu dozu i nastavite

s uobičajenim doziranjem. Nemojte nanositi više kreme kako biste nadoknadili propuštenu dozu.

Ako prestanete primjenjivati Elidel kremu

U slučaju ikakvih pitanja u vezi s primjenom ovog lijeka, obratite se svojemu liječniku ili ljekarniku.

Ako ste zabunom progutali malo Elidel kreme

Ako ste vi ili netko drugi zabunom progutali Elidel, odmah obavijestite svojega liječnika.

4.

MOGUĆE NUSPOJAVE

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

Najčešće nuspojave izazvane Elidelom su reakcije na mjestu primjene (kao što je neugodan osjećaj). Te

su reakcije općenito blage/umjerene, javljaju se na početku liječenja te su kratkotrajne.

Neke nuspojave mogu biti ozbiljne

Rijetke nuspojave (javljaju se kod manje od jedne na 1000 osoba)

angioedem- znakovi obuhvaćaju svrbež, koprivnjaču (urtikariju), crvene mrlje na rukama, nogama i

grlu, oticanje grla i jezika, oticanje oko očiju i usana, otežano disanje i gutanje.

Vrlo rijetke nuspojave (javljaju se kod manje od jedne na 10 000 osoba)

anafilaktička reakcija: kožni osip koji uključuje crvenilo i svrbež kože, oticanje ruku, nogu, gležnjeva,

lica, usnica, usta ili grla (ovi simptomi takoĎer su opisani kao angioedem i mogu uzrokovati otežano

gutanje ili disanje) i možete osjećati nesvjesticu.

Ako osjetite bilo koji od navedenih simptoma kratko vrijeme nakon primjene Elidel kreme, prestanite

primjenjivati kremu i odmah obavijestite svojega lijeĉnika.

Ostale nuspojave mogu ukljuĉivati

Vrlo ĉeste nuspojave (javljaju se kod više od jedne na 10 osoba)

osjećaj vrućine i/ili pečenja na mjestu primjene.

Ĉeste nuspojave (javljaju se kod više od jedne na 100 osoba)

nadražaj, svrbež i crvenilo kože na mjestu nanošenja kreme.

kožne infekcije (kao što je folikulitis).

Manje ĉeste nuspojave (javljaju se kod manje od jedne na 100 osoba)

kožne infekcije kao što su impetigo (bakterijska infekcija kože), mjehurići i kraste na usnici (herpes

simplex),

mjehurićasto-krastav

osip

kože

(herpes

zoster),

herpes

simplex

dermatitis (herpetični

ekcem), molluscum contagiosum (virusna infekcija kože), bradavice i furunkuli (gnojni čirevi).

reakcije na mjestu primjene kao što su osip, bol, osjećaj peckanja, blago ljuštenje kože, suhoća,

oteklina i pogoršanje simptoma ekcema.

H A L M E D

03 - 01 - 2018

O D O B R E N O

Rijetke nuspojave (javljaju se kod manje od jedne na 1000 osoba)

crvenilo uz osjećaj vrućine, osip, pečenje, svrbež ili oteklina kratko vrijeme nakon uzimanja alkohola.

promjene boje kože (postaje tamnija ili svjetlija od boje okolne kože).

Kod bolesnika koji su upotrebljavali Elidel kremu zabilježeni su slučajevi raka, uključujući rak limfnih

čvorova ili kože.

Slučajevi povećanja limfnih čvorova su zabilježeni kod bolesnika koji su uzimali Elidel kremu. No,

povezanost s liječenjem Elidel kremom nije utvrĎena.

Prijavljivanje nuspojava

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

moguću nuspojavu koja nije navedena u ovoj uputi. Nuspojave možete prijaviti izravno putem

nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.

Prijavljivanjem nuspojava možete pridonijeti procjeni sigurnosti ovog lijeka.

5.

KAKO ĈUVATI ELIDEL KREMU

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

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

odnosi se na zadnji dan navedenog mjeseca.

Čuvati na temperaturi ispod 25°C. Ne zamrzavati.

Čuvati u originalnom pakiranju. Tubu treba čvrsto zatvarati.

Jednom otvorena tuba smije se upotrebljavati do 12 mjeseci. Korisno je upisati datum otvaranja tube na

kutiju.

Nikada nemojte nikakve lijekove bacati u otpadne vode. Pitajte svojega ljekarnika kamo odložiti lijekove

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

6.

SADRŢAJ PAKIRANJA I DRUGE INFORMACIJE

Što Elidel krema sadrţi

djelatna tvar je pimekrolimus. Jedan gram Elidel kreme sadržava 10 mg pimekrolimusa.

pomoćne tvari su: trigliceridi srednje duljine lanca, oleilni alkohol, propilenglikol, stearilni alkohol,

cetilni alkohol, monogliceridi i digliceridi, natrijev cetostearilsulfat, benzilni alkohol, bezvodna

citratna kiselina, natrijev hidroksid, pročišćena voda.

Kako Elidel krema izgleda i sadrţaj pakiranja

Elidel krema je bjelkasta, bez mirisa, ne ostavlja mrlje i lako je razmaziva.

Dostupna je u tubi s 30 g.

Nositelj odobrenja za stavljanje lijeka u promet

Mylan Hrvatska d.o.o.

Koranska 2

10000 Zagreb

ProizvoĊaĉi

MEDA Pharma GmbH & Co. KG

Benzstr.1, 61352 Bad Homburg

Njemačka

H A L M E D

03 - 01 - 2018

O D O B R E N O

MEDA Manufacturing Merignac

Avenue J. F. Kennedy

BP 90100

33704 Mérignac Cedex

Francuska

Naĉin i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u sijeĉnju 2018.

H A L M E D

03 - 01 - 2018

O D O B R E N O

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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