Atere 10 mg g krema

Glavna informacija

  • Trgovački naziv:
  • Atere 10 mg/g krema
  • Doziranje:
  • 10 mg/g
  • Farmaceutski oblik:
  • krema
  • Sastav:
  • Urbroj: 1 g kreme sadrži 10 mg terbinafinklorida
  • Tip recepta:
  • na recept, u ljekarni neponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • mibe GmbH Arzneimittel, Brehna, Njemačka

Dokument

Lokalizacija

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

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 15 g kreme u tubi, u kutiji [HR-H-664829608-01]; 30 g kreme u tubi, u kutiji [HR-H-664829608-02] Urbroj: 381-12-01/70-17-03

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-664829608
  • Datum autorizacije:
  • 12-12-2017
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za bolesnika

Atere 10 mg/g krema

terbinafinklorid

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 Vašem liječniku ili ljekarniku.

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

znakovi bolesti jednaki Vašima.

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

Što morate znati prije nego počnete primjenjivati Atere kremu?

Kako primjenjivati Atere kremu?

Moguće nuspojave

Kako čuvati Atere kremu?

Sadržaj pakiranja i druge informacije

1.

Što je Atere krema i za što se koristi?

Atere krema sadrži djelatnu tvar terbinafin. Terbinafin je antimikotik, lijek koji ubija gljivične

uzročnike Vaših kožnih problema.

Koristi se za liječenje:

tinea pedis (atletskog stopala),

tinea cruris (gljivičnih infekcija prepona)

tinea corporis (gljivičnih infekcija na ostalim dijelovima tijela)

kožne kandidijaze (intertrigo ili osip uzrokovan znojenjem)

pityriasis (tinea) versicolor

Kako Atere krema djeluje?

Atere krema ima dugotrajno djelovanje. Kada se primjenjuje u preporučenim dozama, manje od 10 od

100 osoba, koje pate od atletskog stopala, ponovno dobiju infekciju 3 mjeseca nakon početka terapije.

Kako znate imate li jedan od sljedećih problema?

Tinea pedis (atletsko stopalo) se javlja jedino na stopalima (najčešće oba, ali ne uvijek), često izmeĎu

nožnih prstiju. Može se javiti i na gornjem dijelu stopala, na tabanima ili drugim dijelovima stopala.

Najčešći oblik atletskog stopala uzrokuje pucanje ili ljuštenje kože, ponekad uz blago oticanje, plikove

ili vlažne čireve. Atere krema preporuča se za atletsko stopalo kada se javlja izmeĎu nožnih prstiju.

Ako imate gljivičnu infekciju noktiju (gljivice u i ispod nokta), s promjenom boje noktiju i promjenom

strukture nokta (debeo, ljuskav), morate se posavjetovati s Vašim liječnikom jer Atere krema nije

prikladna za ovakvu vrstu infekcije.

Tinea cruris (gljivična infekcija prepona) se javlja u pregibima gdje je koža naborana i, osobito ako

su vlažni, izaziva svrbež. To se često odnosi na prepone i unutrašnju stranu bedara, gdje su obično

obje strane zahvaćene, ali je često jedna strana zahvaćenija od druge. Može se širiti dalje,izmeĎu nogu

do stražnjice ili gore prema trbuhu. Može se takoĎer pojaviti ispod grudi, ispod pazuha ili drugim

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O D O B R E N O

naboranim područjima. Ovaj osip ima jasnu granicu, a može uključivati i pojavu plikova. Izaziva

svrbež.

Tinea corporis se može pojaviti bilo gdje na tijelu, a najčešće na glavi, vratu, licu ili rukama.

Uglavnom nalikuje okruglim površinama crvenog osipa, ali se takoĎer može pojaviti u vidu ljuskavih

mrlja i uzrokovati svrbež.

Kožna kandidijaza (intertrigo ili osip uzrokovan znojenjem) se takoĎer pojavljuje u pregibima gdje je

kože naborana i koja su mokra od znoja (npr. ispod grudi, ispod pazuha). Češće se javlja u starijih i

pretilih bolesnika ili u onih koji imaju dodatna oboljenja kao što je npr. šećerna bolest (dijabetes).

Uzrokuje crvenilo, svrbež i ljuštenje kože.

Pityriasis veriscolor se pojavljuje na koži u obliku ljuskavih površina koje postaju bijele uslijed

gubitka pigmenta. To je osobito vidljivo u ljeto budući da okolna koža normalno tamni. Najčešće se

pojavljuje na trupu (ispod vrata, prema struku), vratu i rukama, a može se ponovno pojaviti unutar

nekoliko mjeseci, naročito kod vrućeg vremena i znojenja.

2.

Što morate znati prije nego počnete primjenjivati Atere kremu?

Nemojte primjenjivati Atere kremu

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

Upozorenja i mjere opreza

Obratite se Vašem liječniku ili ljekarniku prije nego primijenite Atere kremu

Atere krema namijenjena je samo za vanjsku primjenu, odnosno primjenu na koži

Ne upotrebljavajte Atere kremu u području usta i ne gutajte ju.

Izbjegavajte dodir kreme s očima jer može izazvati iritaciju očiju. Ako Vam krema slučajno uĎe

u oči, uklonite ju i temeljito isperite oči mlazom vode. Ako se nelagoda nastavi, posjetite

liječnika.

Atere kremu čuvajte izvan pogleda i dohvata djece.

Djeca i adolescenti

Atere

krema ne smije se primjenjivati u djece mlaĎe od 12 godina.

Drugi lijekovi i Atere krema

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

primijeniti bilo koje druge lijekove.

Ne primjenjujte druge lijekove na područje liječeno Atere kremom.

Trudnoća, dojenje i plodnost

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

liječniku ili ljekarniku za savjet prije nego primijenite ovaj lijek.

Atere

krema se ne smije primjenjivati tijekom trudnoće, osim ako Vam liječnik ne kaže drugačije.

Djelatna tvar kreme, terbinafin, izlučuje se u majčino mlijeko. Atere krema ne smije se primjenjivati

tijekom dojenja. Dojenčad ne smije doći u dodir s liječenom kožom, uključujući i dojke.

Upravljanje vozilima i strojevima

Atere krema ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.

Atere krema sadrži cetilni i stearilni alkohol koji mogu izazvati lokalne kožne reakcije (npr.

kontaktni dermatitis).

Atere krema sadrži benzilni alkohol koji može uzrokovati blagi lokalni nadražaj.

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3.

Kako primjenjivati Atere kremu?

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

Vašim liječnikom ili ljekarnikom ako niste sigurni.

Važno je ispravno primijeniti Atere kremu. Pažljivo slijedite upute.

Ako imate gljivično oboljenje nokta (gljivice u i ispod nokta), s promjenom boje i strukture nokta

(debeo, ljuskav), morate se posavjetovati s Vašim liječnikom jer lijek Atere krema NIJE prikladan za

liječenje infekcije ove vrste. Terbinafin u obliku tableta, dostupan samo uz recept, bi se mogao

koristiti za liječenje gljivica na noktima.

Kako primijeniti Atere kremu?

Odrasli i djeca starija od 12 godina:Operite i osušite zahvaćenu kožu i okolna područja te zatim

operite ruke.

Odvrnite zatvarač i kod prve uporabe probušite vrh tube šiljkom koji se nalazi unutar zatvarača,

potom nježno stisnite tubu.

Primijenite dovoljno kreme za stvaranje tankog sloja na oboljeloj koži i okolnim područjima.

Nježno utrljajte kremu.

Zatvorite tubu.

Operite ruke nakon što ste dodirnuli oboljelu kožu kako ne biste proširili infekciju na sebi ili ju

prenijeli na druge.

Ako liječite infekciju koja se nalazi u pregibu Vašeg tijela, možete prekriti liječeno područje gazom,

osobito noću. Upotrijebite novu, čistu gazu kod svake primjene kreme.

Koliko često i koliko dugo primjenjivati Atere kremu?

Primjenjujte Atere kremu na sljedeći način:

Atletsko stopalo: jednom dnevno, 1 tjedan

Tinea cruris i tinea corporis: jednom dnevno, 1 tjedan

Kožna kandidijaza (intertrigo ili osip od vrućine, uslijed znojenja): jednom ili dva puta

dnevno, 1 ili 2 tjedna. Ovo oboljenje može nalikovati gljivičnim oboljenjima tinea cruris ili

tinea corporis, ali se češće javlja u starijih i pretilih bolesnika, kod kojih je koža u pregibima

vlažna, ili kod bolesnika s dodatnim oboljenjima kao što je npr. šećerna bolest (dijabetes). Za

liječenje kožne kandidijaze može biti neophodan dulji period liječenja (2 tjedna).

Pityriasis versicolor: jednom ili dva puta dnevno, 2 tjedna.

Primjenjujte Atere kremu u preporučenom razdoblju, čak i ako se stanje čini boljim nakon nekoliko

dana. Stanje se obično poboljša unutar nekoliko dana, ali se može ponovno pogoršati ako se krema ne

primjenjuje redovito ili se primjena prerano prekine.

Atere krema trebala bi poboljšati stanje Vaše kože za nekoliko dana. MeĎutim, potpuno izliječenje

oštećene kože nakon povlačenja infekcije traje duže, i do 4 tjedna. Atere krema nastavlja djelovati i

nakon završetka s liječenjem. Poboljšanje se nastavlja premda više ne primjenjujete kremu.

Ako niste zamijetili znakove poboljšanja unutar dva tjedna od početka primjene, posavjetujte se s

Vašim liječnikom ili ljekarnikom.

Potpomaganje liječenja

Kako biste potpomogli liječenje, održavajte zahvaćeno područje čistim redovitim pranjem. Pažljivo ga

osušite bez trljanja, laganim doticanjem. Nastojte da ne češete oboljelo područje premda može svrbiti

jer to može izazvati daljnje oštećenje i usporiti proces cijeljenja ili dovesti do proširenja infekcije.

Budući da se ove infekcije mogu prenijeti na druge ljude, koristite vlastiti ručnik i odjeću i nemojte ih

dijeliti s drugima. Redovito ih perite kako biste se zaštitili od ponovne infekcije.

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Ako primijenite više Atere kreme nego što ste trebali

Ako Vi ili netko drugi slučajno proguta dio Atere kreme, obavijestite Vašeg liječnika koji će Vam

savjetovati što učiniti. U slučaju gutanja veće količine Atere kreme, mogući su sljedeći simptomi:

glavobolja, mučnina, bol u gornjem dijelu trbuha, omaglica.

Ako ste zaboravili primijeniti Atere kremu

Ako ste zaboravili primijeniti kremu, nanesite ju što prije i nastavite s normalnom primjenom. Ako se

sjetite

vrijeme

sljedeće

primjene,

nanesite

uobičajenu

količinu

nastavite

normalnom

primjenom. Ne primjenjujte dvostruku dozu kako biste nadoknadili zaboravljenu.

Nastojte primjenjivati kremu na način koji je propisan. To je važno jer izostavljanje doza nosi rizik

ponovne pojave infekcije.

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 izazvati nuspojave iako se one neće pojaviti kod svakoga.

PRESTANITE primjenjivati Atere kremu i odmah potražite medicinsku pomoć ako imate bilo

koji od sljedećih simptoma koji bi mogli biti posljedica alergijske reakcije:

teškoće pri disanju ili gutanju;

oticanje lica, usana, jezika ili grla;

jak svrbež kože s crvenim osipom ili ispupčenjima.

Česte nuspojave (mogu se javiti u manje od 1 na 10 osoba);

Ljuštenje kože, svrbež.

Manje česte nuspojave (mogu se javiti u manje od 1 na 100 osoba);

Oštećenje kože, svrbež, poremećaji kože, promjene boje kože, crvenilo, osjećaj peckanja kože, bol, bol

na mjestu primjene, iritacija na mjestu primjene.

Rijetke nuspojave (mogu se javiti u manje od 1 na 1000 osoba);

Iritacija očiju, suha koža, upalne bolesti kože pod nazivom ekcem i kontaktni dermatitis, pogoršanje

simptoma infekcije.

Prijavljivanje nuspojava

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

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

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

Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka

5.

Kako čuvati Atere kremu?

Ovaj lijek se čuvajte izvan pogleda i dohvata djece.

Ne smrzavati.

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

kreme nakon prvog otvaranja kreme je 6 mjeseci.

Nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad. Pitajte svog ljekarnika kako baciti

lijekove koje više ne koritite. Ove će mjere pomoći u očuvanju okoliša.

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O D O B R E N O

6.

Sadržaj pakiranja i druge informacije

Što Atere krema sadrži?

Djelatna tvar je terbinafinklorid.

1 gram kreme sadrži 10 mg terbinafinklorida te sljedeće pomoćne tvari: voda, pročišćena; cetilni i

stearilni alkohol; izopropilmiristat; cetilpalmitat; sorbitanstearat; benzilni alkohol; polisorbat 60;

natrijev hidroksid.

Kako Atere krema izgleda i sadržaj pakiranja?

Atere 10 mg/g krema je pakirana u tubama od 15g i 30g. Svaka tuba nalazi se u kartonskoj kutiji.

Nositelj odobrenja za stavljanje lijeka u promet i proizvoĎač

Nositelj odobrenja

Mibe Pharmaceuticals d.o.o., Branitelja domovinskog rata 8, 42 230 Ludbreg

ProizvoĎač

mibe GmbH Arzneimittel, Münchener Strasse 15, 06796 Brehna, Njemačka

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je posljednji put revidirana u prosincu 2017.

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O D O B R E N O

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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