Tulip 10 mg filmom obložene

Glavna informacija

  • Trgovački naziv:
  • Tulip 10 mg filmom obložene tablete
  • Doziranje:
  • 10 mg
  • Farmaceutski oblik:
  • filmom obložena tableta
  • Sastav:
  • Urbroj: jedna filmom obložena tableta sadrži 10 mg atorvastatina u obliku atorvastatinkalcija
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Lek Pharmaceuticals d.d., Ljubljana, Slovenija

Dokument

Lokalizacija

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

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 30 tableta u blisteru, u kutiji [HR-H-252074252-01]; 60 tableta u blisteru, u kutiji [HR-H-252074252-02]; 90 tableta u blisteru, u kutiji [HR-H-252074252-03] Urbroj: 381-12-01/70-16-08

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-252074252
  • Datum autorizacije:
  • 08-04-2016
  • Zadnje ažuriranje:
  • 05-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za bolesnika

Tulip 10 mg filmom obložene tablete

Tulip 20 mg filmom obložene tablete

Tulip 40 mg filmom obložene tablete

atorvastatin

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

podatke.

Sačuvajte ovu uputu. Možda ćete ju trebati ponovo pročitati.

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

Ovaj je lijek propisan samo 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 liječnika ili ljekarnika. To

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

Što se nalazi u ovoj uputi:

1. Što je Tulip i za što se koristi?

2. Što morate znati prije nego počnete uzimati Tulip?

3. Kako uzimati Tulip?

4. Moguće nuspojave

5. Kako čuvati Tulip?

6. Sadržaj pakiranja i druge informacije

1. Što je Tulip i za što se koristi?

Ovaj lijek pripada skupini lijekova poznatih pod nazivom statini, koji se primjenjuju za snižavanje

povišenih masnoća u krvi (lipida).

Ovaj lijek se koristi u odraslih, adolescenata i djece u dobi od 10 ili više godina za snižavanje lipida u

krvi, poznatih kao kolesterol i trigliceridi kada dijeta sa smanjenim unosom masnoća i promjene u

načinu života nisu dovele do zadovoljavajućeg učinka u bolesnika.

U odraslih osoba s povećanim rizikom od bolesti srca, ovaj lijek se također može primijeniti u svrhu

sprječavanja tog rizika čak i ako su vrijednosti kolesterola u krvi normalne. Tijekom liječenja morate

se i dalje pridržavati standardne dijete za snižavanje kolesterola.

2. Što morate znati prije nego počnete uzimati Tulip?

Nemojte uzimati Tulip:

ako ste alergični na atorvastatin ili bilo koje slične lijekove za snižavanje lipida u krvi, ili na bilo

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

ako ste ikad imali ili imate neku bolest jetre

ako ste imali neobjašnjiv poremećaj vrijednosti krvnih testova funkcije jetre

ako ste žena u generativnoj dobi (kad možete rađati), a ne primjenjujete neku vrstu kontracepcije

(sprječavanje neželjene trudnoće)

ako ste trudni ili pokušavate zatrudnjeti

ako dojite

Upozorenja i mjere opreza

Obratite se svom liječniku ili ljekarniku prije nego uzmete Tulip.

H A L M E D

08-04-2016

O D O B R E N O

U nastavku su navedeni razlozi zašto Tulip možda neće biti odgovarajući lijek za Vas:

ako ste pretrpjeli moždani udar s krvarenjem u mozak ili u mozgu imate male, tekućinom

ispunjene prostore, zaostale od prethodnih moždanih udara

ako imate problema s bubrezima

ako imate smanjenu aktivnost štitne žlijezde (hipotireozu)

ako ste imali ili imate ponavljajuće ili nerazjašnjene bolove u mišićima, ili je kod Vas ili u

Vašoj obitelji u prošlosti bilo mišićnih tegoba

prošlosti

imali

mišićnih

problema

tijekom

liječenja

drugim

lijekovima

snižavanje lipida (npr. drugim lijekovima iz skupine „statina“ ili „fibrata“)

ako redovito konzumirate veće količine alkohola

ako ste u prošlosti imali probleme s jetrom

ako ste stariji od 70 godina

ako uzimate ili ste u posljednjih 7 dana uzimali fusidatnu kiselinu (lijek za liječenje

bakterijskih infekcija) kroz usta (oralno) ili u obliku injekcije. Kombinacija fusidatne kiseline

i lijeka Tulip može dovesti do ozbiljnih problema s mišićima (rabdomiolize)

Prije uzimanja lijeka Tulip posavjetujte se sa svojim liječnikom ili ljekarnikom

ako bolujete od ozbiljnih problema s disanjem (respiratorna insuficijencija)

ako imate konstantnu mišićnu slabost. Možda će biti potrebni dodatni testovi i lijekovi kako

bi se to dijagnosticiralo i liječilo.

Ako imate dijabetes ili ste izloženi riziku od razvoja šećerne bolesti (dijabetesa), za vrijeme liječenja

ovim lijekom Vaš liječnik će Vas pažljivo nadzirati. Vjerojatno je da ste izloženi riziku od razvoja

dijabetesa ako imate visoke razine šećera i masnoća u krvi, prekomjernu težinu i visok krvni tlak.

Ako se bilo što od gore navedenog odnosi na Vas, liječnik će Vas uputiti na pretragu krvi prije, a

možda i tijekom liječenja lijekom Tulip, kako bi predvidio Vaš rizik od mogućih mišićnih nuspojava.

Poznato je da se rizik od mišićnih nuspojava, npr. rabdomiolize, povećava kod istodobnog uzimanja

određenih lijekova (vidjeti dio 2, „Drugi lijekovi i Tulip“).

Djeca i adolescenti

Nije utvrđen dugoročni učinak atorvastatina na razvoj djece i adolescenata jer su trenutna iskustva u

ovoj skupini ograničena.

Drugi lijekovi i Tulip

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

koje druge lijekove, uključujući i one koje ste nabavili bez recepta.

Postoje određeni lijekovi koji mogu promijeniti učinak lijeka Tulip ili se njihov učinak može

promijeniti uzimanjem lijeka Tulip. Ovakva vrsta interakcije može umanjiti učinak jednog ili oba

lijeka. Posljedično se može povećati opasnost od nuspojava ili težina nuspojava, uključujući ozbiljno

stanje razaranja mišića poznato kao rabdomioliza, što je opisano u dijelu 4:

lijekovi koji mijenjaju način djelovanja Vašeg imunološkog sustava, npr. ciklosporin.

određeni lijekovi za liječenje bakterijskih infekcija (antibiotici) ili lijekovi protiv gljivičnih

oboljenja, npr. eritromicin, klaritromicin, telitromicin, ketokonazol, vorikonazol, flukonazol,

posakonazol, rifampicin, fusidatna

kiselina

ako trebate uzeti oralni oblik fusidatne kiseline za liječenje bakterijskih infekcija, morat ćete

privremeno prestati uzimati ovaj lijek. Vaš liječnik će vam reći kada je sigurno ponovno

početi uzimati Tulip. Uzimanje ovog lijeka s fusidatnom kiselinom, rijetko može dovesti do

slabosti mišića, osjetljivosti ili boli (rabdomioliza). Za više informacija o rabdomiolizi vidjeti

dio 4.

drugi lijekovi za regulaciju razine masnoća npr. gemfibrozil, drugi fibrati, kolestipol

H A L M E D

08-04-2016

O D O B R E N O

neki od blokatora kalcijevih kanala koji se primjenjuju za liječenje angine pektoris ili

povišenog krvnog tlaka, npr. amlodipin

,

diltiazem; lijekovi za regulaciju srčanog ritma npr.

digoksin, verapamil, amiodaron

lijekovi

koji

primjenjuju

liječenje

infekcije

HIV-om,

npr.

ritonavir,

lopinavir,

atazanavir, indinavir, darunavir, fosamprenavir, kombinacija tipranavir/ritonavir itd.

neki lijekovi koji se koriste u liječenju hepatitisa C npr. telaprevir ili boceprevir

ostali lijekovi koji stupaju u interakcije s lijekom Tulip, uključujući ezetimib (lijek koji

snižava kolesterol), varfarin (lijek koji sprječava zgrušavanje krvi), oralne kontraceptive (za

sprječavanje začeća), stiripentol (lijek protiv epileptičkih napadaja), cimetidin (koristi se u

liječenju žgaravice i vrijeda/čira na želucu), fenazon (lijek protiv bolova), kolhicin (lijek koji

se koristi u liječenju gihta) i antacide (lijekovi protiv probavnih tegoba koji sadrže aluminij

ili magnezij).

lijekovi koji se mogu dobiti bez recepta: kao na primjer gospina trava

Tulip s hranom i pićem

U dijelu 3. pročitajte kako uzimati Tulip.

Molimo Vas da uzmete u obzir sljedeće:

Sok od grejpa

Nemojte piti više od jedne do 2 male čaše soka od grejpa dnevno, budući da velike količine tog soka

mogu izmijeniti učinak lijeka Tulip.

Alkohol

Izbjegavajte piti veće količine alkohola dok uzimate ovaj lijek. Za detalje vidjeti dio 2. „Upozorenja i

mjere opreza“.

Trudnoća i dojenje

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

liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.

Nemojte uzimati ovaj lijek ako ste trudni ili pokušavate zatrudnjeti.

Nemojte

uzimati

ovaj

lijek

ukoliko

žena

generativnoj

dobi

(kad

možete

rađati),

primjenjujete pouzdane kontracepcijske mjere.

Nemojte uzimati ovaj lijek ako dojite.

Sigurnost primjene ovog lijeka tijekom trudnoće i dojenja za sada nije dokazana.

Upravljanje vozilima i strojevima

U normalnim okolnostima ovaj lijek ne utječe ili zanemarivo utječe na Vašu sposobnost upravljanja

vozilima ili rukovanja strojevima. Ako primijetite da ovaj lijek utječe na te sposobnosti, nemojte

upravljati vozilom odnosno strojevima.

Tulip sadrži laktozu

Ovaj lijek sadrži laktozu. Ako Vam je liječnik rekao da ne podnosite neke šećere, savjetujte se

s njim prije uzimanja ovog lijeka.

3. Kako uzimati Tulip?

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

liječnikom ili ljekarnikom ako niste sigurni.

Prije početka liječenja, liječnik će Vam odrediti dijetu za snižavanje kolesterola, s kojom morate

nastaviti i tijekom uzimanja ovog lijeka.

H A L M E D

08-04-2016

O D O B R E N O

Uobičajena početna doza lijeka Tulip je 10 mg jednom dnevno, za odrasle i djecu u dobi od 10 ili

više godina. Ukoliko je potrebno, liječnik može povisivati dozu sve dok se ne postigne željeni

terapijski učinak. Liječnik će dozu prilagođavati u intervalima od 4 tjedna ili dulje. Maksimalna doza

lijeka Tulip je 80 mg jednom dnevno za odrasle i 20 mg jednom dnevno za djecu.

Tablete treba progutati čitave, s malo tekućine,

u bilo koje doba dana, neovisno o obrocima.

Nastojte uzimati

lijek svakog dana u isto vrijeme.

Trajanje liječenja ovim lijekom određuje Vaš liječnik.

Ako smatrate da je učinak ovog lijeka prejak ili preslab, posavjetujte se s liječnikom ili ljekarnikom.

Ako ste uzeli više tableta Tulip nego što ste trebali

Ako ste slučajno uzeli previše tableta Tulip (više od Vaše uobičajene dnevne doze) odmah zatražite

savjet svog liječnika ili najbliže bolnice.

Ako ste zaboravili uzeti Tulip

Ako ste zaboravili uzeti lijek, jednostavno uzmite sljedeću dozu u predviđeno vrijeme.

Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu.

Ako prestanete uzimati Tulip

Ako imate dodatnih pitanja o primjeni ovog lijeka, ili ako želite prekinuti liječenje, zatražite savjet

svog liječnika ili ljekarnika.

4. Moguće nuspojave

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

Ako primijetite bilo koju od niže navedenih ozbiljnih nuspojava, prestanite s uzimanjem lijeka

i odmah obavijestite svog liječnika ili se uputite u najbližu zdravstvenu ustanovu ili stanicu za

hitnu pomoć.

Rijetko

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

ozbiljna alergijska reakcija s oticanjem lica, jezika i grla koja može prouzročiti teške poteškoće s

disanjem (angioedem)

životno ugrožavajuće kožne reakcije preosjetljivosti koje uključuju intenzivno ljuštenje i oticanje

kože, stvaranje mjehura na koži, ustima, očima i spolnim organima, uz povišenu tjelesnu

temperaturu (Stevens-Johnsonov sindrom i toksična epidermalna nekroliza) ili kožni osip s

ružičasto-crvenim mrljama, osobito na dlanovima ili tabanima, uz moguću pojavu mjehura

(multiformni eritem).

mišićna slabost, osjetljivost ili bol; osobito ako se pritom ne osjećate dobro ili imate visoku

temperaturu, uzrok može biti neuobičajeno oštećenje mišića koje može ugrožavati život i

dovesti do problema s bubrezima zvano rabdomioliza (vidjeti dio 2.)

Vrlo rijetko

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

životno ugrožavajuća alergijska reakcija (anafilaksija) koja uključuje simptome poput svrbeža

kože i trnjenja sluznice usne šupljine, zatim nagle pojave piskutavog disanja praćenog bolovima

ili osjećajem stezanja u prsima, oticanje očnih kapaka, lica, usana, usta, jezika ili grla, otežano

disanje i gutanje, što može dovesti do stezanja dišnih puteva, pada tlaka i kolapsa.

ako primijetite neočekivano ili neuobičajeno krvarenje, ili pojavu modrica, žuticu, to mogu biti

simptomi zatajenja jetre.

H A L M E D

08-04-2016

O D O B R E N O

Druge moguće nuspojave koje se mogu javiti uz primjenu ovog lijeka:

Često

(mogu se javiti u manje od 1 na 10 osoba):

• upala nosnih putova, grlobolja, krvarenje iz nosa

• alergijske reakcije

• porast vrijednosti šećera u krvi (ukoliko imate dijabetes/šećernu bolest, nastavite s pozornim

praćenjem razine šećera u krvi),

• glavobolja

• mučnina, zatvor, vjetrovi, probavne tegobe, proljev

• bolovi u zglobovima, bolovi i grčevi u mišićima i bolovi u leđima, oticanje zglobova

• rezultati krvnih pretraga koji ukazuju na poremećaje funkcije jetre

• porast enzima kreatin kinaze u krvi, što može ukazivati na probleme s mišićima

Manje često

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

• bolovi u trbuhu koji mogu biti znak upale gušterače (pankreatitis)

• simptomi kao što su mučnina, povraćanje, bolovi u trbuhu, gubitak apetita, umor, slabost, koji

mogu biti znakovi upale jetre (hepatitisa). U ozbiljnijim slučajevima mogu se javiti žuta boja kože ili

očiju (žutica) i tamno obojeni urin. Ako primijetite neke od ovih simptoma odmah se javite svom

liječniku.

gubitak apetita, porast tjelesne težine

pad vrijednosti šećera u krvi (ukoliko imate dijabetes, nastavite s pozornim praćenjem razina šećera

u krvi)

• noćne more, nesanica

• omaglica, obamrlost ili trnci u prstima ruku i nogu, smanjena osjetljivost na bol ili dodir, promjene

osjeta okusa, gubitak pamćenja

• zamućen vid

• zvonjenje u ušima i/ili glavi

• povraćanje, podrigivanje

• kožni osip i svrbež, koprivnjača, ispadanje kose

• bolovi u vratu, zamor mišića

• umor, opće loše osjećanje, slabost, bolovi u prsima, oticanje posebice gležnjeva (edemi), povišena

tjelesna temperatura

• leukociti (bijele krve stanice) u urinu, što se može vidjeti na nalazima pretraga

Rijetko

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

• smetnje vida

• neočekivana krvarenja ili pojava modrica

• smanjenje ili zastoj protoka žuči (kolestaza)

• ozljede tetiva.

Vrlo rijetk

o (mogu se javiti u manje od 1 na 10 000 osoba):

• gubitak sluha

• povećanje dojki u muškaraca i žena (ginekomastija)

Nepoznato

(učestalost se ne može procijeniti iz dostupnih podataka)

mišićna slabost koja je konstantna (imunološki posredovana nekrotizirajuća miopatija)

Moguće nuspojave zabilježene pri uporabi nekih statina (lijekova iste vrste):

• seksualne tegobe

• depresija

• tegobe s disanjem, uključujući stalni kašalj i/ili zaduhu ili povišenu tjelesnu temperaturu, posebice

uz produljenu terapiju

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

prekomjernu težinu i visok krvni tlak. Vaš će Vas liječnik pažljivo nadzirati za vrijeme liječenja

ovim lijekom.

H A L M E D

08-04-2016

O D O B R E N O

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 u procjeni sigurnosti ovog lijeka.

5. Kako čuvati Tulip?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Ovaj lijek čuvajte na temperaturi ispod 25

C, zaštićen od vlage.

Ovaj lijek čuvajte u originalnom pakiranju.

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

valjanosti odnosi se na zadnji dan navedenog mjeseca.

Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad. Pitajte svog ljekarnika kako

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

6. Sadržaj pakiranja i druge informacije

Što Tulip sadrži?

Djelatna tvar je atorvastatin.

Jedna Tulip

filmom

obložena

tableta

sadrži 10

atorvastatina

obliku

atorvastatinkalcija.

Drugi sastojci su:

Jezgra

Tulip 10 mg, Tulip 20 mg, Tulip 40 mg

Mikrokristalična

celuloza,

laktoza

hidrat,

umrežena

karmelozanatrij,

hidroksipropilceluloza,

polisorbat 80, magnezijev oksid, bezvodni koloidni silicijev dioksid, magnezijev stearat.

Ovojnica

Tulip 10 mg

hipromeloza, hidroksipropilceluloza, titanijev dioksid, makrogol 6000

, talk.

Tulip 20 mg, Tulip 40 mg

Hipromeloza, hidroksipropilceluloza, titanijev dioksid, makrogol 6000, talk, žuti željezov (III) oksid

(E172).

Kako izgleda Tulip i sadržaj pakiranja?

Tulip 10 mg tablete su bijele do gotovo bijele, okrugle, blago izbočene filmom obložene tablete s

oznakom HLA 10 na jednoj strani, dimenzije 9 mm.

Tulip 20 mg tablete su svijetložute, okrugle, blago izbočene filmom obložene tablete s oznakom

HLA 20 na jednoj strani, dimenzije 9 mm.

Tulip 40 mg tablete su svijetložute, okrugle, blago izbočene filmom obložene tablete s oznakom

HLA 40 na jednoj strani, dimenzije 11 mm.

Tulip 10 mg: 30 (3x10), 60 (6x10) ili 90 (9x10) filmom obloženih tableta u blisteru

Tulip 20 mg: 30 (3x10), 60 (6x10) ili 90 (9x10) filmom obloženih tableta u blisteru

Tulip 40 mg: 30 (3x10) ili 60 (6x10) filmom obloženih tableta u blisteru

H A L M E D

08-04-2016

O D O B R E N O

Nositelj odobrenja za stavljanje lijeka u promet i proizvođač

Nositelj odobrenja

Sandoz d.o.o., Maksimirska 120, Zagreb

Proizvođač

Lek Pharmaceuticals d.d., Verovškova 57, Ljubljana, Slovenija

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u travnju 2016.

H A L M E D

08-04-2016

O D O B R E N O

24-10-2018

Vita Health Products Recall (2018-10-24)

Vita Health Products Recall (2018-10-24)

Health Canada

18-10-2018

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

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

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

Health Canada

18-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

10-10-2018

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

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

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

FDA - U.S. Food and Drug Administration

10-10-2018

Enforcement Report for the Week of October 10, 2018

Enforcement Report for the Week of October 10, 2018

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

FDA - U.S. Food and Drug Administration

24-9-2018

FDA Announces Availability of Resources for Animal Drug Sponsors

FDA Announces Availability of Resources for Animal Drug Sponsors

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

FDA - U.S. Food and Drug Administration

19-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

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

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

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

FDA - U.S. Food and Drug Administration

11-9-2018

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Published on: Mon, 10 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Greece for the pesticide active substance alpha‐cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Update of the Xylella spp. host plant database

Update of the Xylella spp. host plant database

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

Europe - EFSA - European Food Safety Authority Publications

10-9-2018

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

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

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

FDA - U.S. Food and Drug Administration

7-9-2018

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

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

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

FDA - U.S. Food and Drug Administration

1-9-2018

Spodoptera frugiperda partial risk assessment

Spodoptera frugiperda partial risk assessment

Published on: Fri, 31 Aug 2018 00:00:00 +0200 EFSA was asked for a partial risk assessment of Spodoptera frugiperda for the territory of the EU focussing on the main pathways for entry, factors affecting establishment, risk reduction options and pest management. As a polyphagous pest, five commodity pathways were examined in detail. Aggregating across these and other pathways, we estimate that tens of thousands to over a million individual larvae could enter the EU annually on host commodities. Instigat...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

22-8-2018

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

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

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

FDA - U.S. Food and Drug Administration

10-8-2018

Enforcement Report for the Week of July 25, 2018

Enforcement Report for the Week of July 25, 2018

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

FDA - U.S. Food and Drug Administration

12-11-2018

Spinraza (Biogen Netherlands B.V.)

Spinraza (Biogen Netherlands B.V.)

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

Europe -DG Health and Food Safety

23-10-2018

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

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

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

Europe -DG Health and Food Safety

22-10-2018

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

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

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

Europe -DG Health and Food Safety

19-10-2018

Recocam (Bimeda Animal Health Limited)

Recocam (Bimeda Animal Health Limited)

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

Europe -DG Health and Food Safety

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

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

Europe -DG Health and Food Safety

19-9-2018

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Eli Lilly Nederland B.V.)

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

Europe -DG Health and Food Safety

19-9-2018

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Mylan S.A.S.)

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

Europe -DG Health and Food Safety

10-9-2018

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

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

Europe -DG Health and Food Safety

10-9-2018

Alkindi (Diurnal Limited)

Alkindi (Diurnal Limited)

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

Europe -DG Health and Food Safety

10-9-2018

Retacrit (Hospira UK Limited)

Retacrit (Hospira UK Limited)

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

Europe -DG Health and Food Safety

10-9-2018

Silapo (STADA Arzneimittel AG)

Silapo (STADA Arzneimittel AG)

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

Europe -DG Health and Food Safety

4-9-2018

ACM meeting statement, Meeting 10, 2 August 2018

ACM meeting statement, Meeting 10, 2 August 2018

The Advisory Committee on Medicines meeting statement is now available

Therapeutic Goods Administration - Australia

22-8-2018

BTVPUR (Merial)

BTVPUR (Merial)

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

Europe -DG Health and Food Safety

10-8-2018

Torisel (Pfizer Europe MA EEIG)

Torisel (Pfizer Europe MA EEIG)

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

Europe -DG Health and Food Safety

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

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

Europe -DG Health and Food Safety

10-8-2018

Lymphoseek (Norgine B.V.)

Lymphoseek (Norgine B.V.)

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

Europe -DG Health and Food Safety

10-8-2018

Sivextro (Merck Sharp and Dohme B.V.)

Sivextro (Merck Sharp and Dohme B.V.)

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

Europe -DG Health and Food Safety

10-8-2018

Cubicin (Merck Sharp and Dohme B.V.)

Cubicin (Merck Sharp and Dohme B.V.)

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

Europe -DG Health and Food Safety

10-8-2018

Thalidomide Celgene (Celgene Europe B.V.)

Thalidomide Celgene (Celgene Europe B.V.)

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

Europe -DG Health and Food Safety

10-8-2018

CANCIDAS (Merck Sharp and Dohme B.V.)

CANCIDAS (Merck Sharp and Dohme B.V.)

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

Europe -DG Health and Food Safety

10-8-2018

Tesavel (Merck Sharp and Dohme B.V.)

Tesavel (Merck Sharp and Dohme B.V.)

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

Europe -DG Health and Food Safety

10-8-2018

Januvia (Merck Sharp and Dohme B.V.)

Januvia (Merck Sharp and Dohme B.V.)

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

Europe -DG Health and Food Safety

10-8-2018

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Pfizer Europe MA EEIG)

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

Europe -DG Health and Food Safety

7-8-2018

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

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

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

FDA - U.S. Food and Drug Administration

7-8-2018

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Accord Healthcare Limited)

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

Europe -DG Health and Food Safety

30-7-2018

Zalmoxis (MolMed S.p.A.)

Zalmoxis (MolMed S.p.A.)

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

Europe -DG Health and Food Safety

27-7-2018

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

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

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

Europe -DG Health and Food Safety