Amlodipin Alkaloid-INT

Glavne informacije

  • Zaščiteno ime:
  • Amlodipin Alkaloid-INT 5 mg tablete
  • Farmacevtska oblika:
  • tableta
  • Sestava:
  • amlodipin 5 mg / 1 tableta
  • Pot uporabe:
  • Peroralna uporaba
  • Enote v paketu:
  • škatla s 30 tabletami (3 x 10 tablet v pretisnem omotu)
  • Tip zastaranja:
  • Rp - Predpisovanje in izdaja zdravila je le na recept
  • Uporabi za:
  • ljudje
  • Vrsta medicine:
  • Alopatska drog

Dokumentov

Lokalizacija

  • Na voljo v:
  • Amlodipin Alkaloid-INT 5 mg tablete
    Slovenija
  • Jezik:
  • slovenščina

Terapevtski podatki

  • Terapevtska skupina:
  • amlodipin

Drugi podatki

Stanje

  • Source:
  • JAZMP - Javna agencija RS za zdravila in medicinske pripomočke - Slovenia Medicines Agency
  • Status dovoljenje:
  • Zdravilo z dovoljenjem za promet
  • Številka dovoljenja:
  • 1001-16/2013-10
  • Datum dovoljenje:
  • 19-11-2014
  • EAN koda:
  • 3837000041699
  • Zadnja posodobitev:
  • 18-01-2018

Podatki za bolnike

JAZMP-R/001-17.10.2014

Navodilo za uporabo

Amlodipin Alkaloid-INT 5 mg tablete

amlodipinum

Pred začetkom jemanja zdravila natančno preberite navodilo, ker vsebuje za vas

pomembna navodila!

Navodilo shranite. Morda ga boste želeli ponovno prebrati.

Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom ali

medicinsko sestro.

Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim. Njim bi

lahko celo škodovalo, čeprav imajo znake bolezni, podobne vašim.

Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali

farmacevtom ali medicinsko sestro. Posvetujte se tudi, če opazite katere koli

neželene učinke, ki niso navedeni v tem navodilu. Glejte poglavje 4.

Kaj vsebuje navodilo

Kaj je zdravilo Amlodipin Alkaloid-INT in za kaj ga uporabljamo

Kaj morate vedeti, preden boste vzeli zdravilo Amlodipin Alkaloid-INT

Kako jemati zdravilo Amlodipin Alkaloid-INT

Možni neželeni učinki

Shranjevanje zdravila Amlodipin Alkaloid-INT

Vsebina pakiranja in dodatne informacije

1.

Kaj je zdravilo Amlodipin Alkaloid-INT in za kaj ga uporabljamo

Zdravilo Amlodipin Alkaloid-INT vsebuje zdravilno učinkovino amlodipin, ki sodi v

skupino zdravil, imenovanih zaviralci kalcijevih kanalčkov.

Zdravilo Amlodipin Alkaloid-INT se uporablja za zdravljenje visokega krvnega tlaka

(hipertenzije) ali napadov določenega tipa bolečin v prsih, ki jih imenujemo angina

pektoris, in njene redke oblike, imenovane Prinzmetalova oziroma variantna angina

pektoris.

Pri bolnikih z visokim krvnim tlakom zdravilo deluje tako, da sprošča krvne žile in s tem

omogoči lažji pretok krvi. Pri bolnikih z angino pektoris deluje zdravilo Amlodipin

Alkaloid-INT tako, da izboljša pretok krvi v srčni mišici, ki zato prejme več kisika, to pa

preprečuje bolečine v prsih. Zdravilo ne prinaša takojšnjega olajšanja bolečin v prsih, ki

jih povzroča angina pektoris.

JAZMP-R/001-17.10.2014

2.

Kaj morate vedeti, preden boste vzeli zdravilo Amlodipin Alkaloid-INT

Ne jemljite zdravila Amlodipin Alkaloid-INT:

če ste alergični na amlodipin ali katero koli sestavino tega zdravila (navedeno v

poglavju 6) ali kateri koli drug zaviralec kalcijevih kanalčkov. Alergija se lahko

kaže v obliki srbenja, pordelosti kože ali težav z dihanjem.

če imate močno znižan krvni tlak (hipotenzijo)

če imate zoženje aortne srčne zaklopke (aortno stenozo) ali kardiogeni šok (stanje,

pri katerem vaše srce ne zmore preskrbeti dovolj krvi za telo)

če imate srčno popuščanje po preboleli srčni kapi

Opozorila in previdnostni ukrepi

Pred začetkom jemanja zdravila Amlodipin Alkaloid-INT se posvetujte z zdravnikom ali

farmacevtom ali medicinsko sestro.

Obvestite svojega zdravnika, če imate ali ste kdaj v preteklosti imeli kaj od naslednjega:

nedavni srčni napad

srčno popuščanje

hudo zvišanje krvnega tlaka (hipertenzivna kriza)

bolezen jeter

če ste starejši in je pri vas potrebno povečanje odmerka

Otroci in mladostniki

Uporabe zdravila Amlodipin Alkaloid-INT pri otrocih, mlajših od 6 let, niso preučevali.

Zdravilo Amlodipin Alkaloid-INT se lahko uporablja za zdravljenje hipertenzije le pri

otrocih in mladostnikih, starih od 6 do 17 let (glejte poglavje 3).

Če potrebujete več informacij, se pogovorite z vašim zdravnikom.

Druga zdravila in zdravilo Amlodipin Alkaloid-INT

Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste

morda začeli jemati katero koli drugo zdravilo.

Zdravilo Amlodipin Alkaloid-INT lahko vpliva na druga zdravila (ali pa le-ta vplivajo

nanj), kot so:

ketokonazol, itrakonazol (zdravili za glivične okužbe)

ritonavir, indinavir, nelfinavir (t.i. zaviralci proteaze, ki se uporabljajo za

zdravljenje HIV)

rifampicin, eritromicin, klaritromicin (antibiotiki)

hypericum perforatum (šentjanževka)

verapamil, diltiazem (zdravili za bolezni srca)

dantrolen (infuzija pri hudih odstopanjih telesne temperature)

simvastatin (zdravilo za zdravljenje povišane ravni maščob v krvi)

Zdravilo Amlodipin Alkaloid-INT lahko še bolj zniža vaš krvni tlak, če že jemljete druga

zdravila za zniževanje visokega krvnega tlaka.

JAZMP-R/001-17.10.2014

Zdravilo Amlodipin Alkaloid-INT

skupaj s hrano, pijačo in alkoholom

Ljudje, ki jemljejo zdravilo Amlodipin Alkaloid-INT, ne smejo uživati grenivkinega soka

in grenivk. Uživanje le-teh lahko povzroči zvišanje ravni zdravilne učinkovine

(amlodipina) v krvi, kar lahko povzroči nenapovedljivo povečanje učinka zdravila

Amlodipin Alkaloid-INT na zniževanje krvnega tlaka.

Nosečnost, dojenje in plodnost

Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se

posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.

Nosečnost

Varnosti uporabe amlodipina med nosečnostjo niso ugotavljali. Če mislite, da ste noseči

ali če nameravate zanositi, povejte svojemu zdravniku, preden začnete jemati zdravilo

Amlodipin Alkaloid-INT.

Dojenje

Ni znano, ali se amlodipin izloča v materino mleko. Če dojite ali boste začeli dojiti,

povejte svojemu zdravniku, preden začnete jemati zdravilo Amlodipin Alkaloid-INT.

Vpliv na sposobnost upravljanja vozil in strojev

Zdravilo Amlodipin Alkaloid-INT lahko vpliva na vašo sposobnost vožnje in upravljanja

s stroji. Če zaradi tablet občutite slabost, omotico, utrujenost ali glavobol, ne vozite ali

upravljajte s stroji ter takoj pokličite vašega zdravnika.

Zdravilo Amlodipin Alkaloid-INT vsebuje laktozo

Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred uporabo tega

zdravila posvetujte s svojim zdravnikom.

3.

Kako jemati zdravilo Amlodipin Alkaloid-INT

Pri jemanju tega zdravila natančno upoštevajte navodila zdravnika ali farmacevta. Če ste

negotovi, se posvetujte z zdravnikom ali farmacevtom.

Priporočeni začetni odmerek zdravila Amlodipin Alkaloid-INT je 5 mg enkrat na dan.

Odmerek se lahko poveča na 10 mg enkrat na dan.

Vaše zdravilo lahko vzamete pred uživanjem hrane in pijače ali po tem. Najbolje je, da

zdravilo vzamete vsak dan ob istem času dneva. Tableto pogoltnite z nekaj tekočine.

Zdravila Amlodipin Alkaloid-INT ne jemljite z grenivkinim sokom.

Uporaba pri otrocih in mladostnikih

Za otroke in mladostnike (stare 6 -17 let) je priporočeni začetni odmerek 2,5 mg enkrat

na dan. Največji priporočeni dnevni odmerek je 5 mg. Amlodipina v jakosti 2,5 mg ni na

voljo, 2,5 mg odmerka pa ne smete pridobiti z delitvijo 5 mg tablete zdravila Amlodipin

Alkaloid-INT 5 mg tablete, ker te tablete niso namenjene delitvi na dva enaka odmerka.

JAZMP-R/001-17.10.2014

Razdelilna zareza je namenjena le delitvi tablete za lažje požiranje.

Pomembno je, da tablete jemljete redno. Ne čakajte, da porabite vse tablete, preden

obiščete zdravnika.

Če ste vzeli večji odmerek zdravila Amlodipin Alkaloid-INT, kot bi smeli

Jemanje preveč tablet lahko zniža ali celo nevarno zniža vaš krvni tlak. Morda boste

občutili omotico, rahlo zaspanost, omedlevico ali šibkost. Če je padec krvnega tlaka

dovolj močan, lahko padete v šok. Vaša koža lahko postane hladna in lepljiva, lahko tudi

izgubite zavest. Če ste vzeli preveč tablet zdravila Amlodipin Alkaloid-INT, nemudoma

poiščite zdravniško pomoč.

Če ste pozabili vzeti zdravilo Amlodipin Alkaloid-INT

Ne skrbite. Če pozabite vzeti tableto, odmerek popolnoma izpustite. Naslednji odmerek

vzemite ob običajnem času. Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji

odmerek.

Če ste prenehali jemati zdravilo Amlodipin Alkaloid-INT

Zdravnik vam bo svetoval, kako dolgo jemljite zdravilo. Če z jemanjem zdravila

prenehate prej kot vam je svetoval zdravnik, se vam stanje lahko spet poslabša.

Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom, farmacevtom

ali medicinsko sestro.

4.

Možni neželeni učinki

Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh

bolnikih.

Če med jemanjem zdravila opazite katerega koli od spodaj naštetih, zelo redkih, hudih

neželenih učinkov,

nemudoma

obiščite zdravnika.

nenadna zasoplost, bolečine v prsih, kratka sapa ali težave z dihanjem

otekanje očesnih vek, obraza ali ustnic

otekanje jezika in grla, ki zelo oteži dihanje

hude kožne reakcije, vključno s hudim kožnim izpuščajem, koprivnico,

pordelostjo kože po celem telesu, močnim srbenjem, pojavljanjem mehurjev,

lupljenjem in otekanjem kože, vnetjem sluzničnih membran (Stevens-Johnsonov

sindrom) in drugimi alergijskimi reakcijami

srčni napad, nenormalen srčni utrip

vnetje trebušne slinavke, ki lahko povzroči hude bolečine v trebuhu in hrbtu, ki

jih spremlja zelo slabo počutje

Poročali so o naslednjih

pogostih neželenih učinkih

. Če vam kateri koli od teh povzroča

težave ali

traja dlje kot 1 teden

pokličite zdravnika.

JAZMP-R/001-17.10.2014

Pogosti neželeni učinki

(pojavijo se lahko pri največ 1 od 10 bolnikov):

glavobol, omotica, zaspanost (še zlasti na začetku zdravljenja)

vročinski oblivi

bolečine v trebuhu, slabost s siljenjem na bruhanje (navzea)

otekanje gležnjev (edem), utrujenost

Ostali neželeni učinki, o katerih so poročali, so na spodnjem seznamu. Če kateri koli od

teh neželenih učinkov postane resen ali če opazite kateri koli neželeni učinek, ki ni

omenjen v tem navodilu, obvestite zdravnika ali farmacevta.

Občasni neželeni učinki

(pojavijo se lahko pri največ 1 od 100 bolnikov):

spremembe razpoloženja, tesnobnost, depresija, nespečnost

tresenje, motnje okušanja, omedlevica, šibkost

odrevenelost ali občutek mravljinčenja v vaših udih; izguba občutka za bolečino

motnje vida, dvojni vid, zvonjenje v ušesih

palpitacije (zavedanje bitja vašega srca)

nizek krvni tlak

kihanje/izcedek iz nosu zaradi vnetja nosne sluznice (rinitis)

spremenjene navade glede odvajanja blata, driska, zaprtje, slaba prebava, suha

usta, bruhanje (slabost)

izpadanje las in dlak, čezmerno znojenje, srbeča koža, rdeče zaplate na koži,

razbarvanost kože

motnje uriniranja, pogosto uriniranje ponoči, zvečana pogostost uriniranja

nezmožnost doseganja erekcije (impotenca); nelagodje v dojkah ali čezmerna rast

tkiva dojke pri moških

šibkost, bolečine, slabo počutje

bolečine v sklepih ali mišicah, mišični krči, bolečine v hrbtu

zvečanje ali zmanjšanje telesne mase

Redki neželeni učinki

(pojavijo se lahko pri največ 1 od 1.000 bolnikov):

zmedenost

Zelo redki neželeni učinki

(pojavijo se lahko pri največ 1 od 10.000 bolnikov):

znižanje števila belih krvnih celic, znižanje števila krvnih ploščic, kar lahko

povzroči večjo nagnjenost k podplutbam; nagnjenost h krvavitvam (poškodba

rdečih krvnih celic)

preveč sladkorja v krvi (hiperglikemija)

motnja živcev, ki lahko povzroči šibkost, mravljinčenje ali odrevenelost

kašelj, otekanje dlesni

napenjanje v trebuhu (gastritis)

nenormalno delovanje jeter, vnetje jeter (hepatitis), porumenelost kože

(zlatenica), zvišanje ravni jetrnih encimov, kar se lahko pokaže pri nekaterih

laboratorijskih preiskavah

zvečana napetost mišic

vnetje krvnih žil, pogosto s kožnim izpuščajem

občutljivost na svetlobo

JAZMP-R/001-17.10.2014

motnje, ki združujejo okorelost, tremor in/ali motnje gibanja

Poročanje o neželenih učinkih

Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom ali

medicinsko sestro. Posvetujte se tudi, če opazite neželene učinke, ki niso navedeni v tem

navodilu. O neželenih učinkih lahko poročate tudi neposredno na

Univerzitetni klinični center Ljubljana, Interna klinika

Center za zastrupitve

Zaloška cesta 2

SI-1000 Ljubljana

Faks: + 386 (0)1 434 76 46

e-pošta: farmakovigilanca@kclj.si

S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o

varnosti tega zdravila.

5.

Shranjevanje zdravila Amlodipin Alkaloid-INT

Zdravilo shranjujte nedosegljivo otrokom!

Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na

škatli in pretisnem omotu poleg oznake EXP (okrajšava za rok uporabnosti). Rok

uporabnosti zdravila se izteče na zadnji dan navedenega meseca.

Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo. Tablete vzemite iz

pretisnega omota tik pred uporabo.

Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke. O načinu

odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom. Taki

ukrepi pomagajo varovati okolje.

6.

Vsebina pakiranja in dodatne informacije

Kaj vsebuje zdravilo Amlodipin Alkaloid-INT

Zdravilna učinkovina je amlodipin.

Ena tableta zdravila Amlodipin Alkaloid-INT 5 mg tablete vsebuje 5 mg

amlodipina v obliki amlodipinijevega besilata (6,934 mg).

Druge sestavine zdravila so laktoza monohidrat, mikrokristalna celuloza (E460) in

magnezijev stearat (E572).

Izgled zdravila Amlodipin Alkaloid-INT in vsebina pakiranja

Zdravilo Amlodipin Alkaloid-INT 5 mg tablete so okrogle, bikonveksne,

bele tablete z

razdelilno zarezo na eni strani.

JAZMP-R/001-17.10.2014

Zdravilo je na voljo v škatli, ki vsebuje 30 tablet. Tablete so pakirane v pretisni omot iz

Al-PVC folije. Vsaka škatla vsebuje 3 pretisne omote po 10 tablet in navodilo za

uporabo.

Način in režim izdaje zdravila Amlodipin Alkaloid-INT

Predpisovanje in izdaja zdravila je le na recept.

Imetnik dovoljenja za promet in izdelovalec

Alkaloid-INT d.o.o.

Šlandrova ulica 4

1231 Ljubljana-Črnuče

Slovenija

Telefon: +386 1 300 42 90

Faks: +386 1 300 42 91

E-pošta: info@alkaloid.si

Navodilo je bilo nazadnje revidirano dne 17.10.2014

16-11-2018

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Pest categorisation of Sternochetus mangiferae

Pest categorisation of Sternochetus mangiferae

Published on: Mon, 29 Oct 2018 00:00:00 +0100 The European Commission requested EFSA to conduct a pest categorisation of Sternochetus mangiferae (Coleoptera: Curculionidae), a monophagous pest weevil whose larvae exclusively feed on mango seeds, whereas adults feed on mango foliage. S. mangiferae is a species with reliable methods available for identification. It is regulated in the EU by Council Directive 2000/29/EC where it is listed in Annex IIB as a harmful organism whose introduction into EU Protec...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Pest categorisation of Aleurocanthus spp.

Pest categorisation of Aleurocanthus spp.

Published on: Mon, 29 Oct 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Aleurocanthus spp., a well‐defined insect genus of the whitefly family Aleyrodidae (Arthropoda: Hemiptera). Difficulties within the taxonomy of the genus give doubt about the ability to accurately identify some members to species level. Nevertheless, the genus is thought to currently include about ninety species mainly reported from tropical and subtropical areas. The genus is listed in Council Dir...

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

17-10-2018

Pest categorisation of Stagonosporopsis andigena

Pest categorisation of Stagonosporopsis andigena

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of Stagonosporopsis andigena, the causal agent of black blight of potato, for the EU. The pest is a well‐defined fungal species and reliable methods exist for its detection and identification. S. andigena is present in Bolivia and Peru. The pest is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC as Phoma andina, meaning its introduction into the EU is prohibited. The ma...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Thecaphora solani

Pest categorisation of Thecaphora solani

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of the fungus Thecaphora solani, the causal agent of smut of potato, for the EU. The identity of the pest is well established and reliable methods exist for its detection and identification. T. solaniis present in Bolivia, Chile, Colombia, Ecuador, Mexico, Panama, Peru and Venezuela. The pathogen is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC, meaning its introducti...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum, which are well‐defined and distinguishable tree fungal pathogens of the family Cronartiaceae. In 2018, these species were moved from the genus Endocronartium to the genus Cronartium. These pathogens are not known to be present in the EU and are regulated in Council Directive 2...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Melampsora farlowii

Pest categorisation of Melampsora farlowii

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Melampsora farlowii, a well‐defined and distinguishable fungus of the family Melampsoraceae. M. farlowii is the causal agent of a leaf and twig rust of hemlocks (Tsuga spp.) in eastern North America. The pathogen is regulated in Council Directive 2000/29/EC (Annex IAI) as a harmful organism whose introduction into the EU is banned. M. farlowii ...

Europe - EFSA - European Food Safety Authority Publications

12-10-2018

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy

FDA - U.S. Food and Drug Administration

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

9-10-2018

Ukrop’s Homestyle Foods, LLC Announces Recalls Because of Possible Health Risk

Ukrop’s Homestyle Foods, LLC Announces Recalls Because of Possible Health Risk

Johnston County Hams’ country ham was recalled due to its potential for contamination with Listeria monocytogenes; therefore, Ukrop’s made the decision that any products that contained country ham or came into contact with equipment used to process the country ham are being recalled due to the potential to be contaminated with Listeria monocytogenes.

FDA - U.S. Food and Drug Administration

9-10-2018

Peer review of the pesticide risk assessment for the active substance flumioxazin in light of negligible exposure data submitted

Peer review of the pesticide risk assessment for the active substance flumioxazin in light of negligible exposure data submitted

Published on: Mon, 08 Oct 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State, Czech Republic, for the pesticide active substance flumioxazin are reported. The European Commission requested EFSA to conduct a peer review and provide its conclusions on whether exposure of humans to flumioxazin can be considered negligible, taking into account the European Commission's draft guidance on th...

Europe - EFSA - European Food Safety Authority Publications

20-9-2018

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters

Getinge is voluntarily initiating a Worldwide recall involving a field correction of approximately 5,223 Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps (IABP) sold by Datascope Corp., for a potential interruption and/or inability to start therapy to the patient regarding the use of certain Intra-Aortic Balloons (IABs) prior to or during the use with Cardiosave IABP for users who are at altitudes above 3200 feet/975 meters. This condition could potentially lead to patient hemodynamic instability.

FDA - U.S. Food and Drug Administration

20-9-2018

Siu & Sons Int'l Trading recalls Color Fantastik Assorted Rubber Animal Toys

Siu & Sons Int'l Trading recalls Color Fantastik Assorted Rubber Animal Toys

Health Canada's sampling and evaluation program has determined that the rubber animals do not meet the Canadian safety requirements for toys. The squeakers inside the rubber animals can be easily removed; these small parts pose a choking hazard to young children.

Health Canada

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

FDA provides update on its ongoing investigation into valsartan products; and reports on the finding of an additional impurity identified in one firm’s already recalled products

FDA provides update on its ongoing investigation into valsartan products; and reports on the finding of an additional impurity identified in one firm’s already recalled products

FDA update on the ongoing investigation into valsartan impurities, recalls and current findings.

FDA - U.S. Food and Drug Administration

11-9-2018

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Novel foods could represent a sustainable alternative to traditional farming and conventional foodstuffs. Starting in 2018, Regulation (EU) 2283/2015 entered into force, laying down provisions for the approval of novel foods in Europe, including insects. This Approved Regulation establishes the requirements that enable Food Business Operators to bring new foods into the EU market, while ensuring high levels of food safety for European consumers. The present ...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Published on: Mon, 27 Aug 2018 00:00:00 +0200 EFSA regards the household as a stage in the food chain that is important for the final number of food‐borne infections. The fate of a pathogen in the private kitchen largely depends on consumer hygiene during preparation of food and on its proper cooking, especially in the case of meat. Unfortunately, detailed information on the microbiological survival in meat products after heating in the consumer kitchen is lacking. The aim of the study was to improve th...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Assessment of occupational and dietary exposure to pesticide residues

Assessment of occupational and dietary exposure to pesticide residues

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Plant protection products (PPPs) are pesticides containing at least one active substance that drives specific actions against pests (diseases). PPPs are regulated in the EU and cannot be placed on the market or used without prior authorisation. EFSA assesses the possible risks of the use of active substances to humans and environment. Member States decide whether or not to approve their use at EU level. Furthermore, Member States decide at national level on ...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Livestock Health and Food Chain Risk Assessment

Livestock Health and Food Chain Risk Assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The EUFORA fellowship programme ‘Livestock Health and Food Chain Risk Assessment’ was proposed by the Animal and Plant Health Agency (APHA), a British governmental institution responsible for safeguarding animal and plant health in the UK. The working programme, which was organised into four different modules, covered a wide range of aspects related to risk assessment including identification of emerging risks, risk prioritisation methods, scanning surveilla...

Europe - EFSA - European Food Safety Authority Publications

10-9-2018

Health Canada updates Canadians on estimates of health risks for recalled valsartan drugs containing NDMA

Health Canada updates Canadians on estimates of health risks for recalled valsartan drugs containing NDMA

OTTAWA –Health Canada is sharing the results of its review of potential long-term health effects involving valsartan drugs that were found to contain the impurity N-nitrosodimethylamine (NDMA). Health Canada scientists have assessed the available data to determine the potential increased risk of developing cancer, to help put the risk into context for Canadians.

Health Canada

10-9-2018

Jay Trends Inc. recalls Tempered Glass of the Sunbeam Linear Fire Table

Jay Trends Inc. recalls Tempered Glass of the Sunbeam Linear Fire Table

In some circumstances the tempered glass pane may break or shatter unexpectedly into small pieces and may pose laceration injuries to consumers.

Health Canada

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

31-8-2018

Alcon Announces Voluntary Global Market Withdrawal of CyPass Micro-Stent for Surgical Glaucoma

Alcon Announces Voluntary Global Market Withdrawal of CyPass Micro-Stent for Surgical Glaucoma

Reflecting its uncompromising commitment to patient safety, Alcon today announced an immediate, voluntary market withdrawal of the CyPass Micro-Stent from the global market. In addition, Alcon advises surgeons to immediately cease further implantation with the CyPass Micro-Stent and to return any unused devices to Alcon. This decision and corresponding recommendation is based on an analysis of five-year post-surgery data from the COMPASS-XT long-term safety study. The US Food and Drug Administration (FD...

FDA - U.S. Food and Drug Administration

29-8-2018

Hellolife, Inc. Issues Voluntary Worldwide Recall of Neuroveen, Respitrol, Thyroveev and Compulsin due to Possible Microbial Contamination

Hellolife, Inc. Issues Voluntary Worldwide Recall of Neuroveen, Respitrol, Thyroveev and Compulsin due to Possible Microbial Contamination

HelloLife, Inc. in Grand Rapids, MI is initiating a voluntary recall of four different products, Neuroveen, Respitrol, Thyroveev and Compulsin, within expiry, to the retail and consumer level due to possible microbial contamination. Neuroveen has been tested and found to be contaminated with Staphylococcus saprophyticus and Burkholderia cepacia. Compulsin has been identified as containing Burkholderia cepacia. Respitrol and Thyroveev are still pending bacterial identification. Each product being recalled...

FDA - U.S. Food and Drug Administration

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

Update of the tolerable upper intake level for vitamin D for infants

Update of the tolerable upper intake level for vitamin D for infants

Published on: Tue, 07 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 the draft Scientific Opinion on the update of the tolerable upper intake level for vitamin D for infants. This draft Scientific Opinion was prepared by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) and endorsed by the Panel for public consultation by written procedure on 9 April 20...

Europe - EFSA - European Food Safety Authority Publications

22-8-2018

Santevia Water System Inc. recalls PureEasy Shower Filter

Santevia Water System Inc. recalls PureEasy Shower Filter

The housing can unexpectedly separate releasing the mineral contents into the eyes.

Health Canada

22-8-2018

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling ALL LOTS within expiry of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industr...

FDA - U.S. Food and Drug Administration

21-8-2018

Companies can now apply for authorisation to produce cannabis bulk and cannabis primary products

Companies can now apply for authorisation to produce cannabis bulk and cannabis primary products

On 1 July 2018, a new executive order entered into force which gives companies the possibility of cultivating medicinal cannabis and producing cannabis bulk and cannabis primary products from Danish-grown cannabis.

Danish Medicines Agency

18-8-2018

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probabl...

FDA - U.S. Food and Drug Administration

17-8-2018

Animal Drug Under Fee Amendments Reauthorized Through September 2023 to Allow for FDA’s Continued Timely Review of Animal Drug Applications

Animal Drug Under Fee Amendments Reauthorized Through September 2023 to Allow for FDA’s Continued Timely Review of Animal Drug Applications

On 8/14/18, the Animal Drug and Animal Generic Drug User Fee Amendments of 2018 was signed into law to reauthorize ADUFA and AGDUFA. These programs help FDA maintain a predictable and timely animal drug review process, foster innovation, and expedite access to new therapies for animals.

FDA - U.S. Food and Drug Administration

10-8-2018

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Ma...

FDA - U.S. Food and Drug Administration

26-7-2018

Medical Devices Safety Update Volume 6, Number 4, July 2018

Medical Devices Safety Update Volume 6, Number 4, July 2018

Be aware of cross-reactivity with home-use self-test ovulation kits, TGA undertakes product safety review into intragastric balloon systems

Therapeutic Goods Administration - Australia

19-7-2018

K9 Natural Ltd recalls K9 Natural Frozen Chicken Feast Raw Pet Food 11lb bags

K9 Natural Ltd recalls K9 Natural Frozen Chicken Feast Raw Pet Food 11lb bags

K9 Natural Ltd is voluntarily recalling K9 Natural Frozen Chicken Feast 11lb bags, batch number #150517, that were imported into the Canadian market in July 2017 because they have the potential to be contaminated with Listeria monocytogenes. No other K9 Natural products are affected in Canada.

Health Canada

19-7-2018

Valsartan-Containing Products: Update Health Professional and Consumer on Recent Recalled Products

Valsartan-Containing Products: Update Health Professional and Consumer on Recent Recalled Products

The investigation into valsartan-containing products is ongoing and there are currently three voluntary recalls related to the NDMA impurity detected in the valsartan

FDA - U.S. Food and Drug Administration

18-7-2018

Intragastric balloon systems

Intragastric balloon systems

Safety information for Intragastric Balloon Systems

Therapeutic Goods Administration - Australia

11-7-2018

Phase I clinical trials and non-commercial clinical trials now exempt from fees

Phase I clinical trials and non-commercial clinical trials now exempt from fees

Fees are no longer charged for Phase I clinical trials and non-commercial clinical trials of medicines. This is the result of the Growth Plan for Life Science and the Budget for 2018. The new rules entered into force on 1 July 2018.

Danish Medicines Agency

28-6-2018

Ambient air quality: ANSES recommends the surveillance of 1,3-butadiene and the enhanced monitoring of ultrafine particles (UFPs) and carbon black

Ambient air quality: ANSES recommends the surveillance of 1,3-butadiene and the enhanced monitoring of ultrafine particles (UFPs) and carbon black

The European monitoring strategy for air quality relies heavily on quality standards for a number of pollutants. Advances in knowledge on the toxicity of substances and their emissions in the atmosphere have shown that certain pollutants that may have an impact on human health are not currently taken into account in regulatory monitoring. ANSES therefore received a formal request from the Ministries of Ecology and Health to propose a list of new priority pollutants for this air quality monitoring to supp...

France - Agence Nationale du Médicament Vétérinaire

21-6-2018

Now Health Group Inc. Recalls Select Now Real Food® Zesty Sprouting Mix Because of Possible Health Risk

Now Health Group Inc. Recalls Select Now Real Food® Zesty Sprouting Mix Because of Possible Health Risk

NOW Health Group, Inc. (NOW), of Bloomingdale, Illinois, is recalling its NOW Real Food® Zesty Sprouting Mix – Product Code 7271, Lot #3031259 and Lot #3038165 – because its primary ingredient, Crimson Clover Seeds, has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may b...

FDA - U.S. Food and Drug Administration

14-11-2018

The @US_FDA issues a safety communication cautioning doctors & patients of the risks associated w/ using medications that are not approved for use w/ implanted pumps that are delivered into the spinal fluid to treat or   manage pain:  https://go.usa.gov/x

The @US_FDA issues a safety communication cautioning doctors & patients of the risks associated w/ using medications that are not approved for use w/ implanted pumps that are delivered into the spinal fluid to treat or manage pain: https://go.usa.gov/x

The @US_FDA issues a safety communication cautioning doctors & patients of the risks associated w/ using medications that are not approved for use w/ implanted pumps that are delivered into the spinal fluid to treat or manage pain: https://go.usa.gov/xPfuw  #FDA #MedicalDevice pic.twitter.com/kgDSx2PQzn

FDA - U.S. Food and Drug Administration

13-11-2018

EU/3/17/1863 (Celgene Europe B.V.)

EU/3/17/1863 (Celgene Europe B.V.)

EU/3/17/1863 (Active substance: Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human B cell maturation antigen with 4-1BB and CD3-zeta intracellular signalling domains) - Transfer of orphan designation - Commission Decision (2018)7574 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/270/16/02

Europe -DG Health and Food Safety

1-11-2018

The @US_FDA issues a letter to health care providers regarding possible battery failure in Getinge's Maquet/Datascope intra-aortic balloon pumps. Read the letter here:  https://go.usa.gov/xPyHT  #MedicalDevice

The @US_FDA issues a letter to health care providers regarding possible battery failure in Getinge's Maquet/Datascope intra-aortic balloon pumps. Read the letter here: https://go.usa.gov/xPyHT  #MedicalDevice

The @US_FDA issues a letter to health care providers regarding possible battery failure in Getinge's Maquet/Datascope intra-aortic balloon pumps. Read the letter here: https://go.usa.gov/xPyHT  #MedicalDevice

FDA - U.S. Food and Drug Administration

17-9-2018

Scientific guideline:  Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

Scientific guideline: Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

The Guideline on the investigation of medicinal products in the term and preterm neonates was prepared during the period from 2007 to 2009 and came into effect in 2010 (EMEA/536810/2008). Considerable experience of assessing PIP applications covering neonatal age subset has been gained since then and it has become apparent that some essential questions arise repeatedly during the assessment of Paediatric Investigation Plans (PIP) applications for products intended to be investigated and used in neonates....

Europe - EMA - European Medicines Agency

28-8-2018

EU/3/18/2059 (IntraBio Ltd)

EU/3/18/2059 (IntraBio Ltd)

EU/3/18/2059 (Active substance: Acetylleucine) - Orphan designation - Commission Decision (2018)5731 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/095/18

Europe -DG Health and Food Safety

20-8-2018

Tune into CDC Facebook today at 2 pm ET for a Facebook Live chat on contact lens wear and care.  https://www.facebook.com/CDC/  #OnePairTakeCarepic.twitter.com/Akf1Dz93Xx

Tune into CDC Facebook today at 2 pm ET for a Facebook Live chat on contact lens wear and care. https://www.facebook.com/CDC/  #OnePairTakeCarepic.twitter.com/Akf1Dz93Xx

Tune into CDC Facebook today at 2 pm ET for a Facebook Live chat on contact lens wear and care. https://www.facebook.com/CDC/  #OnePairTakeCare pic.twitter.com/Akf1Dz93Xx

FDA - U.S. Food and Drug Administration

29-6-2018

New warnings on labels of medicines containing neuromuscular blocking agents

New warnings on labels of medicines containing neuromuscular blocking agents

New requirements for neuromuscular blocking agent containing medicines come into effect on 2 July

Therapeutic Goods Administration - Australia

27-6-2018

Copalia HCT (Novartis Europharm Limited)

Copalia HCT (Novartis Europharm Limited)

Copalia HCT (Active substance: amlodipine besylate / valsartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4082 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1159/T/67

Europe -DG Health and Food Safety

27-6-2018

Exforge (Novartis Europharm Limited)

Exforge (Novartis Europharm Limited)

Exforge (Active substance: amlodipine / valsartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4085 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/716/T/96

Europe -DG Health and Food Safety

27-6-2018

Dafiro HCT (Novartis Europharm Limited)

Dafiro HCT (Novartis Europharm Limited)

Dafiro HCT (Active substance: amlodipine besylate / valsartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4084 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1160/T/68

Europe -DG Health and Food Safety