Tenox 10 mg tablete

Glavna informacija

  • Trgovački naziv:
  • Tenox 10 mg tablete
  • Doziranje:
  • 10 mg
  • Farmaceutski oblik:
  • tableta
  • Sastav:
  • Urbroj: svaka tableta sadrži 10 mg amlodipina u obliku amlodipinmaleata
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Krka d.d., Novo Mesto, Slovenija; Krka - farma d.o.o., Zagreb, Republika Hrvatska

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Tenox 10 mg tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Urbroj: 381-12-01/70-15-07

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-037799651
  • Datum autorizacije:
  • 23-03-2015
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacija za bolesnika

Tenox 5 mg tablete

Tenox 10 mg tablete

amlodipin

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

podatke.

Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.

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

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

njihovi znakovi bolesti jednaki Vašima.

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

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

Što se nalazi u ovoj uputi:

Što je Tenox i za što se koristi

Što morate znati prije nego počnete uzimati Tenox

Kako uzimati Tenox

Moguće nuspojave

Kako čuvati Tenox

Sadržaj pakiranja i druge informacije

1.

Što je Tenox i za što se koristi

Tenox sadrži djelatnu tvar amlodipin koja spada u skupinu lijekova koji se nazivaju antagonisti

kalcija.

Tenox se primjenjuje za liječenje

visokog krvnog tlaka (hipertenzije) ili za liječenje određenog tipa

boli u prsištu koja se naziva angina. Rijedak oblik angine naziva se Prinzmetalova ili varijantna

angina.

U bolesnika s visokim krvnim tlakom ovaj lijek djeluje tako da opušta krvne žile i tako omogućava

lakši protok krvi kroz njih. U bolesnika s anginom Tenox djeluje tako da poboljšava opskrbu srčanog

mišića krvlju, na taj način dovodeći više kisika u srce, što sprječava pojavu boli u prsištu. Vaš lijek

neće odmah ublažiti bol u prsištu izazvanu anginom.

2.

Što morate znati prije nego počnete uzimati Tenox

Nemojte uzimati Tenox:

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

druge antagoniste kalcija. Alergija se može očitovati u obliku svrbeža, crvenila kože ili tegoba

pri disanju.

ako imate jako niski tlak (tešku hipotenziju).

ako imate suženje

aortnog srčanog zaliska (stenozu aorte) ili kardiogeni šok (stanje u kojem

srce ne može opskrbiti tijelo s dovoljno krvi).

ako bolujete od zatajivanja srca nakon srčanog udara.

Upozorenja i mjere opreza

Obratite se svom liječniku ili ljekarniku prije nego uzmete Tenox.

Obavijestite svog liječnika ako imate ili ste imali bilo koje od navedenih stanja:

nedavni srčani udar

zatajivanje srca

jaki porast krvnog tlaka (hipertenzivnu krizu)

H A L M E D

23 - 03 - 2015

O D O B R E N O

bolest jetre

starije ste životne dobi i trebate povisiti dozu

Djeca i adolescenti

Tenox se nije ispitivao u djece mlađe od 6 godina. Tenox se smije koristiti samo za liječenje

hipertenzije u djece i adolescenata u dobi od 6 do 17 godina (vidjeti dio 3).

Za dodatne informacije obratite se svom liječniku.

Drugi lijekovi i Tenox

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

druge lijekove.

Tenox može utjecati na druge lijekove ili drugi lijekovi mogu utjecati na Tenox, kao što su:

ketokonazol, itrakonazol (lijekovi za liječenje infekcija gljivicama)

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

rifampicin, eritromicin, klaritromicin (antibiotici)

gospina trava (

Hypericum perforatum

verapamil, diltiazem (lijekovi za srce)

dantrolen (infuzija koja se koristi kod velikih odstupanja tjelesne temperature)

simvastatin (lijek za snižavanje kolesterola)

Ako već uzimate druge lijekove za snižavanje krvnog tlaka, Tenox može uzrokovati dodatno sniženje

krvnog tlaka.

Tenox s hranom i pićem

Bolesnici koji uzimaju Tenox ne smiju konzumirati sok od grejpa ili grejp. Sok od grejpa i grejp mogu

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

Tenoxa na snižavanje krvnog tlaka.

Trudnoća

Nije utvrđena sigurnost primjene amlodipina u trudnica. Ako mislite da ste trudni ili planirate

trudnoću, recite to svom liječniku prije uzimanja Tenoxa.

Dojenje

Nije poznato izlučuje li se amlodipin u majčino mlijeko. Ako dojite ili planirate dojiti, recite to svom

liječniku prije uzimanja Tenoxa.

Obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete bilo koji lijek.

Upravljanje vozilima i strojevima

Tenox može utjecati na Vašu sposobnost vožnje i upravljanja strojevima. Ako nakon uzimanja tableta

osjećate mučninu, omaglicu, umor ili glavobolju, nemojte voziti niti upravljati strojevima te se odmah

obratite liječniku.

3.

Kako uzimati Tenox

Uvijek uzmite ovaj lijek točno onako kako je opisano u ovoj uputi ili kako Vam je rekao Vaš liječnik

ili ljekarnik. Provjerite sa svojim liječnikom ili ljekarnikom ako niste sigurni.

Uobičajena početna doza je 5 mg Tenoxa jedanput na dan. Doza se može povisiti na 10 mg jedanput

na dan.

Lijek možete uzimati prije ili nakon obroka i pića. Lijek morate uzeti svakoga dana u isto vrijeme s

malo vode. Nemojte uzimati Tenox sa sokom od grejpa.

H A L M E D

23 - 03 - 2015

O D O B R E N O

Primjena u djece i adolescenata

Za djecu i adolescente (u dobi od 6-17 godina) preporučena uobičajena početna doza je 2,5 mg na dan.

Najviša preporučena doza iznosi 5 mg na dan. Tableta se može podijeliti u jednake doze.

Vrlo je važno da tablete uzimate redovito. Posjetite liječnika prije nego potrošite sve tablete.

Ako uzmete više Tenoxa nego što ste trebali

Uzimanje previše tableta može uzrokovati snižavanje ili čak opasno snižavanje krvnog tlaka. Možete

osjećati omaglicu, gubitak svijesti, nesvjesticu ili slabost. U slučaju jakog pada krvnog tlaka, može

nastupiti šok. Koža Vam može postati hladna i znojna i možete izgubiti svijest. U slučaju da ste uzeli

previše tableta Tenoxa, odmah potražite medicinsku pomoć.

Ako ste zaboravili uzeti Tenox

Ne brinite. Ako ste zaboravili uzeti jednu tabletu, potpuno preskočite tu dozu. Sljedeću dozu uzmite u

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

Ako prestanete uzimati Tenox

Liječnik će Vas savjetovati koliko dugo trebate uzimati lijek. Bolest se može ponovo pojaviti ako lijek

prestanete uzimati prije nego što Vam je to preporučio liječnik.

U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku ili ljekarniku.

4.

Moguće nuspojave

Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave

iako se one neće javiti kod svakoga.

Odmah

obavijestite svoga liječnika ako iskusite bilo koju od dolje navedenih, vrlo rijetkih ozbiljnih

nuspojava.

iznenadna pojava piskutavog disanja, bol u prsima, kratak dah ili tegobe s disanjem

oticanje očnih kapaka, lica ili usana

oticanje jezika i grla koje uzrokuje poteškoće s disanjem

teške kožne reakcije koje uključuju intenzivni kožni osip, koprivnjaču, crvenilo po cijelom

tijelu, jaki svrbež, stvaranje mjehurića, guljenje i oticanje kože, upalu sluznice (Stevens-

Johnsonov sindrom) ili druge alergijske reakcije

srčani udar, nepravilni ritam srca

upala gušterače koja može uzrokovati jaku bol u trbuhu i leđima, povezana s općim osjećajem

slabosti

Zabilježene su niže navedene

česte nuspojave

. Ako Vam bilo koja od nuspojava zadaje probleme ili

traje dulje od tjedan dana

obratite se svom liječniku.

Česte nuspojave

: javljaju se u do 1 na 10 korisnika

glavobolja, omaglica, pospanost (osobito na početku liječenja)

svjesni doživljaj otkucaja srca (palpitacije), crvenilo lica

bol u trbuhu, mučnina

oticanje gležnjeva (edem), umor.

Druge zabilježene nuspojave navedene su u sljedećem popisu. Ako bilo koja od njih postane ozbiljna

ili ako uočite neku nuspojavu koja nije navedena u ovoj uputi, molimo Vas da o tome obavijestite svog

liječnika ili ljekarnika.

Manje česte nuspojave

: javljaju se u do 1 na 100 korisnika

promjene raspoloženja, tjeskoba, depresija, nesanica

drhtanje, poremećaj okusa, gubitak svijesti, slabost

osjećaj umrtvljenosti ili trnci u udovima, gubitak osjeta boli

poremećaji vida, dvoslike, zvonjenje u ušima

H A L M E D

23 - 03 - 2015

O D O B R E N O

niski krvni tlak

kihanje/curenje nosa uzrokovano upalom sluznice nosa (rinitis)

poremećaj u radu crijeva, proljev, zatvor, loša probava, suha usta, povraćanje

ispadanje kose, pojačano znojenje, svrbež kože, mjestimično crvenilo kože, promjena boje kože

poremećaj mokrenja, povećan nagon za noćno mokrenje, povećana učestalost mokrenja

nemogućnost postizanja erekcije, povećanje ili napetost grudi u muškaraca

slabost, bol, osjećaj opće slabosti

bol u zglobovima ili mišićima, grčevi u mišićima, bol u leđima

smanjenje ili povećanje tjelesne težine

Rijetke nuspojave

: javljaju se u 1 na 1000 korisnika):

smetenost

Vrlo rijetke nuspojave

: javljaju se u do 1 na 10000 korisnika):

smanjeni broj bijelih krvnih stanica, smanjeni broj trombocita što može dovesti do neuobičajene

pojava modrica ili lakog krvarenja (oštećenje crvenih krvnih stanica)

povišenje šećera u krvi (hiperglikemija)

poremećaj živaca koji mogu uzrokovati slabost, trnce ili umrtvljenost

kašalj, oticanje desni

nadimanje trbuha (gastritis)

poremećaj funkcije jetre, upala jetre (hepatitis), žuto obojenje kože (žutica), povišenje razine

jetrenih enzima koji mogu utjecati na neke medicinske pretrage

povišena mišićna napetost

upala krvnih žila, često povezana s kožnim osipom

osjetljivost na svjetlost

poremećaj koji obuhvaća ukočenost, drhtanje i/ili poremećaj pokreta

Ako bilo koja nuspojava postane ozbiljna ili ako primijetite bilo koju nuspojavu koja nije navedena u

ovoj uputi, potrebno je obavijestiti liječnika ili ljekarnika.

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:

Agencija za lijekove i medicinske proizvode (HALMED)

Odsjek za farmakovigilanciju

Roberta Frangeša Mihanovića 9

10 000 Zagreb

Republika Hrvatska

Fax: + 385 (0)1 4884 119

Website: www.halmed.hr

e-mail: nuspojave@halmed.hr

Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.

5.

Kako čuvati Tenox

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Čuvati na temperaturi ispod 30

Čuvati u originalnom pakiranju radi zaštite od svjetlosti i vlage.

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

H A L M E D

23 - 03 - 2015

O D O B R E N O

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

6.

Sadržaj pakiranja i druge informacije

Što Tenox sadrži

Djelatna tvar je amlodipin. Svaka tableta sadrži 5 mg amlodipina u obliku amlodipinmaleata ili

10 mg amlodipina u obliku amlodipinmaleata.

Drugi sastojci su: celuloza, mikrokristalična; škrob, prethodno geliran; natrijev škroboglikolat,

vrste A; silicijev dioksid, koloidni, bezvodni; magnezijev stearat.

Kako Tenox izgleda i sadržaj pakiranja

Tablete; bijele, okrugle, blago izbočene, ukošenih rubova, s razdjelnim urezom na jednoj strani.

Tableta se može razdijeliti na jednake doze.

Tenox je dostupan u blisterima po 10 tableta, a svaka kutija sadrži ukupno 30, 60 ili 90 tableta.

Nositelj odobrenja za stavljanje lijeka u promet

KRKA - FARMA d.o.o., Radnička cesta 48, 10 000 Zagreb, Hrvatska

Proizvođač

KRKA - FARMA d.o.o., Radnička cesta 48, 10 000 Zagreb, Hrvatska

KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u

ožujku 2015.

H A L M E D

23 - 03 - 2015

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