Acetec

Main information

  • Trade name:
  • Acetec 20 mg Tablet
  • Dosage:
  • 20 mg
  • Pharmaceutical form:
  • Tablet
  • Units in package:
  • Blister pack, Cold form laminate/Al/PVC, 30 tablets
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Rolabo Outsourcing SL

Documents

Localization

  • Available in:
  • Acetec 20 mg Tablet
    New Zealand
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • · All grades of essential hypertension. · Renovascular hypertension.

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 8583
  • Authorization date:
  • 13-10-1998
  • Last update:
  • 27-09-2017

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

NEWZEALANDCONSUMER MEDICINEINFORMATION

ACETEC

EnalaprilmaleateTablets2.5mg,5mg,10 mg&20 mg

Whatisinthisleaflet

Thisleafletanswerssome common

questionsaboutACETEC.

Itdoesnotcontain all the available

information.Itdoesnottakethe

place oftalkingto yourdoctoror

pharmacist.

Allmedicineshave risksand

benefits.Yourdoctorhasweighed

therisks ofyou takingACETEC

againstthe benefitstheyexpectit

willhave foryou.

Ifyouhave any concernsabout

takingthis medicine,ask your

doctor orpharmacist.

Keepthis leafletwiththe

medicine.Youmayneed toread it

again.

WhatACETECis

used for

ACETECcontainsthe active

ingredientenalaprilmaleate.It

belongsto a group ofmedicines

calledAngiotensinConverting

Enzyme(ACE)inhibitors.

ACETEClowershigh blood

pressure,which doctorscall

hypertension.Itisalso used to treat

heartfailure.

Hypertension

Everyone hasblood pressure.This

pressure helpsgetyourblood all

around yourbody.Yourblood

pressure maybe differentat

differenttimesofthe day,

depending on howbusyorworried

you are.You havehypertension

(high blood pressure)when your

blood pressure stayshigherthan is

needed,even when youare calm

and relaxed.

There are usuallyno symptomsof

knowing thatyou havehypertension

isto have yourblood pressure

checked on a regularbasis.Ifhigh

blood pressure isnottreateditcan

lead to serioushealth problems.

Youmayfeelfineand haveno

symptoms,buteventually

hypertension cancause stroke,

heartdisease andkidneyfailure.

ACETEC helpstoloweryourblood

pressure.

HeartFailure

Heartfailuremeansthatthe heart

musclecannotpump blood strongly

enough to supplyall the blood

needed throughoutthe body.Heart

failureisnotthe same asheart

attackand doesnotmean thatthe

heartstopsworking.Heartfailure

maystart off withnosymptoms, but

asthecondition progresses,

patientsmayfeelshortofbreath or

maygettiredeasilyafterlight

physicalactivitysuch aswalking.

Somepatientsmaywake up short

ofbreath atnight.Fluidmaycollect

in differentpartsofthe body,often

firstnoticed asswollen anklesand

feet.

ACETEC helpsto treatheartfailure,

whetheryou havesymptomsornot.

Inmanypatientswith heartfailure

who have symptoms,ACETECmay

slowthe progression ofheartfailure

and reduce the need to go to

hospitalasa resultofheartfailure.

ACETECmayhelp some ofthese

patientslivelonger.

Inmanypatientswith heartfailure

who have no symptoms,ACETEC

mayhelpto stop the heartmuscle

fromgetting weaker.ACETECmay

also slowdown the developmentof

symptoms,such asshortnessof

breath,tirednessafterlightphysical

activity,orswelling ofthe ankles

andfeet.Thesepatientsmaybe

lesslikelyto have hospital stays

due toheartfailure.

Bytaking ACETEC,heartfailure

patientsmayhavelesschance of

Whenused to treatheartfailure,

ACETECisalmostalwaysused

withothermedicinescalled diuretics

orfluid tablets.Thesemedicines

helpthe kidneygetrid ofexcess

fluidfromthebody.

HowACETECworks

One ofthe waysACETEC helps

lowerblood pressure and treatheart

failureisthatitwidensblood

vessels.Thismeansthatblood is

able to passthroughthemmore

easilyand theheartdoesn'thaveto

pump ashard tomoveblood around

the body.Thisalso meansthat

when you place extrademandson

yourheart,such asduring exercise,

the heartmaycopebetterso you

maynotgetshortofbreathas

easily.

Ask your doctor ifyouhave any

questionsaboutwhythis

medicine hasbeenprescribedfor

you.

Yourdoctormayhaveprescribedit

foranotherreason.

Thismedicineisavailableonlywith

a doctor’sprescription.

ACETECisnotaddictive.

Beforeyoutake

ACETEC

When you mustnottake

it

DonottakeACETECifyouhave

an allergyto:

anymedicinecontaining

enalaprilmaleateorany

other‘ACEinhibitor’

medicineforhigh blood

pressure orheartfailure

anyofthe ingredientslisted

atthe end ofthisleaflet.

Some ofthesymptomsofan

allergicreaction mayinclude:

shortnessofbreath;wheezing or

difficultybreathing;swelling ofthe

face,lips,tongue orotherpartsof

the body;rash,itching orhiveson

the skin.

Donottake ACETECifyouhave

ahistoryofswellingoftheface,

lips, tongue, throat, handsor

feet,fornoapparentreason.

Do nottake ACETECifyouhave

diabetes andaretakinga

medicine calledaliskirento

reduce bloodpressure.

Donottake this medicine ifyou

are pregnantor breastfeeding.

Yourbabymayabsorb this

medicinein thewomb orfrom

breastmilkandthere isapossibility

ofharmto the baby.

Donottake this medicineafter

theexpiry dateprintedonthe

packor ifthepackagingis tornor

showssignsoftampering.

Ifithasexpired orisdamaged,

return itto yourpharmacistfor

disposal.

Ifyouarenotsurewhether you

shouldstarttakingthis medicine,

talk toyour doctor.

Beforeyoustarttotake

it

Tellyour doctorifyouhave

allergiesto anyothermedicines,

foods,preservativesor dyes.

Tellyour doctorifyouare

pregnantorplantobecome

pregnantorare breast-feeding.

ACETEC should notbe used during

pregnancyorwhile breastfeeding.

Tellyour doctorifyouhave or

havehadanyofthefollowing

medicalconditions:

kidneydisease orare

undergoing dialysis

diabetes

heartproblems

lowblood pressure.

Tellyourdoctorifyou:

have recentlysufferedfrom

excessivevomitingor

diarrhoea

arefollowing averylowsalt

have surgeryor

anaesthesia scheduled,as

theremaybe asudden fall

in blood pressure

associated with

anaesthesia.

Ifyou havenottoldyourdoctor

aboutanyoftheabove, tell

him/herbefore youstarttaking

ACETEC.

Taking othermedicines

Tellyour doctororpharmacistif

youare takinganyother

medicines,including anythatyou

getwithoutaprescriptionfrom

your pharmacy,supermarketor

health foodshop.

SomemedicinesandACETECmay

interferewith each other.These

include:

medicinesused to treat

high blood pressure

diuretictablets–also called

fluid orwatertablets

lithium,amedicine used to

treatmood swingsand

some typesofdepression

potassiumtablets

potassium-containing salt

substitutes

potassium-sparing agents

(e.g.spironolactone,

eplerenone,triamterene,

amiloride)

non-steroidalanti-

inflammatorymedicines

(NSAIDsorCoxibs/COX-2

inhibitors),used to relieve

pain,swelling and other

symptomsofinflammation

arthritismedicinesincluding

gold therapy

insulin ororal antidiabetic

medicines.You should be

closelymonitored forlow

blood glucose levels,

especiallyduring the first

monthoftreatmentwith

ACETEC.

These medicinesmaybe affected

byACETECormayaffecthowwell

itworks.You mayneed different

amountsofyourmedicines,oryou

mayneed totake different

medicines.

Yourdoctorand pharmacisthave

moreinformation onmedicinesto

be carefulwith oravoidwhiletaking

HowtotakeACETEC

Followalldirectionsgiventoyou

byyourdoctor orpharmacist

carefully.

Theymaydifferfromthe information

contained inthisleaflet.

Ifyoudonotunderstand the

instructionsonthepack,ask

yourdoctoror pharmacistfor

help.

Howmuch to take

Yourdoctorwilltellyouhow

manytabletsyouneedtotake

eachday.Thisdependsonyour

conditionandwhether youare

takingothermedicines.Take

ACETEC onlyasprescribedby

yourdoctor.

Forhighbloodpressure:

Formostpatients,theusualstarting

dose is5 mgtaken once a day.

Somepatientsmayneed alower

starting dose.The dose mayneed

to beincreased depending on your

blood pressure.

For heartfailure:

The usualstarting dose is2.5mg

taken once a day.Depending on

yourresponse,thisdose mayneed

to beincreased up to 20mg each

day.Thisdose maybetaken once a

dayordivided into twodosesper

day.

Howtotakeit

Swallow thetabletswith afull

glassofwater.

Whentotakeit

Take yourmedicineat aboutthe

same time(s)eachday.

Takingitatthe sametime(s)each

daywill havethe besteffect.Itwill

alsohelp you rememberwhen to

take it.

Itdoesnotmatterifyoutake this

medicine before orafterfood.

Howlong to takeit

Continue takingyour medicine

foras longasyour doctortells

you.

Thismedicine helpscontrol your

high blood pressure and helps

improve yourheartfailure,butdoes

notcure it.Itisimportanttokeep

takingyourmedicineeven ifyou

feelwell.

Ifyou forgetto takeit

Ifitisalmosttimeforyournext

dose,skipthedose youmissed

and takeyournextdosewhen

youare meantto.

Otherwise,take itassoonasyou

remember,andthengoback to

takingyour medicineas you

wouldnormally.

Donottake a doubledose to

makeup forthedosethatyou

missed.

Thismayincrease the chance of

you getting anunwanted side effect.

Ifyou arenotsurewhatto do,

askyourdoctor orpharmacist.

Ifyouhavetroubleremembering to

take yourmedicine,askyour

pharmacistforsome hints.

Ifyou taketoo much

(overdose)

Immediatelytelephone your

doctoror theNationalPoisons

InformationCentre (0800 POISON

or 0800 764 766)for advice,orgo

toAccidentandEmergency at

thenearesthospital, ifyouthink

thatyouor anyone else mayhave

takentoomuchACETEC.Do this

evenifthere are nosignsof

discomfortorpoisoning.You may

need urgentmedicalattention.

Symptomsofan overdosemay

includedizzinessand light-

headedness.

Whileyou areusing

ACETEC

Thingsyou mustdo

Ifyouare abouttobe startedon

anynewmedicine,remindyour

doctorandpharmacistthatyou

are takingACETEC.

Tellanyother doctors,dentists,

andpharmacists whotreatyou

Ifyouaregoingtohave surgery,

tellthe surgeonor anaesthetist

thatyouare takingthis medicine.

Ifyoubecome pregnantwhile

takingthis medicine,tellyour

doctorimmediately.

Ifyouare abouttohave any

bloodtests,tellyourdoctor that

youaretakingthis medicine.

Itmayinterferewiththe resultsof

some tests.

Keepallofyour doctor’s

appointmentsso thatyour

progresscanbechecked.

Yourdoctormaydo sometests

fromtimetotime to makesurethe

medicine isworking and toprevent

unwanted sideeffects.

Ifyou feel anylight-headedness

ordizzinessafter youtake your

firstdose ofACETECor ifyour

doseisincreased, tell your

doctorimmediately.Thisis

especiallyimportantifyouare

takingACETEC for heartfailure.

Make sure youdrinkenough

waterduringexercise andhot

weatherwhenyouare taking

ACETEC,especially ifyousweat

alot.

Ifyouhave excessive vomiting

and/ordiarrhoea while taking

ACETEC,tellyourdoctor.

Thingsyou mustnotdo

DonottakeACETECtotreatany

othercomplaintsunlessyour

doctortellsyou to.

Donotgive your medicineto

anyoneelse,eveniftheyhave

the samecondition asyou.

Donotstoptakingyour medicine

orlowerthedosagewithout

checkingwithyourdoctor.

Thingsto becarefulof

Becarefuldrivingor operating

machineryuntilyouknowhow

ACETECaffectsyou.

Thismedicine maycausedizziness

and light-headednessin some

peopleespeciallyafterthefirstdose

orifthe dose isincreased.Ifyou

have anyofthesesymptoms,do not

anything else thatcouldbe

dangerous.

Be carefulwhen drinking alcohol

whileyouaretaking this

medicine.

Ifyoudrinkalcohol,dizzinessand

light-headednessmaybe worse.

Ifyou feel light-headed, dizzyor

faintwhen getting outofbed or

standingup,getup slowly.

Standing up slowly,especiallywhen

you getupfrombed orchairs,will

helpyourbodygetused to the

change inpositionand blood

pressure.Ifthisproblemcontinues

orgetsworse,talkto yourdoctor.

Sideeffects

Tellyour doctororpharmacistas

soonaspossibleifyoudo not

feelwellwhileyou aretaking

ACETEC.

Thismedicinehelpsmostpeople

withhigh blood pressure and heart

failure,butitmayhaveunwanted

side effectsinafewpeople.All

medicinescan have side effects.

Sometimestheyare serious,most

ofthetimetheyarenot.You may

needmedical attentionifyou get

some ofthe side effects.

Donotbe alarmedby the

followinglistsofside effects.

Youmay notexperience any of

them.

Ask your doctoror pharmacistto

answer anyquestions youmay

have.

Tellyourdoctororpharmacistif

younoticeanyofthefollowing

andthey worryyou:

light-headednessor

dizziness

headache

fatigue

drycough

mild stomach upsetssuch

asfeeling sick,diarrhoea,

orstomach pains

muscle cramps.

Theyare usuallymild.

Tellyourdoctorimmediatelyyou

noticeanyofthefollowing:

changesin the wayyour

heartbeats,forexample,if

you noticeitbeatingfaster

fainting

yellowing ofthe skinand

eyes,also calledjaundice

itchyskin rash orotherskin

problems

signsofworrying or

frequentinfectionssuch as

fever,severechills,sore

throatormouth ulcers

passing lessurine than is

normalforyou

signsofdehydrationsuch

asnausea,vomiting,

muscle cramps,headache,

drowsinessand tiredness.If

untreated,mentalconfusion

and fitsmaydevelop.Your

doctormayneed to monitor

yourblood sodiumlevels.

The abovelistincludesseriousside

effectsthatmayrequire medical

attention.Seriousside effectsare

rare.

Ifanyofthefollowinghappen,

stoptakingACETEC andgoto

AccidentandEmergency atyour

nearesthospital:

swelling oftheface,lips,

mouthorthroatwhichmay

causedifficultyin

swallowing orbreathing

swelling ofthe hands,feet,

orankles

pinkish,itchyswellingson

theskin,also called hives

chestpain,angina

wheezinessdue to

tightnessin the chest

collapse,numbnessor

weaknessofarmsorlegs.

The abovelistincludesveryserious

side effects.Youmayneed urgent

medical attention orhospitalisation.

These side effectsareveryrare.

Tellyour doctororpharmacistif

younoticeanything thatis

makingyou feelunwell.

Otherside effectsnotlisted above

mayalso occurin some people.

Someofthesideeffects (for

example,changesinblood

pressure,potassiumlevels)can

onlybefound when yourdoctor

doestestsfromtimeto timeto

AfterusingACETEC

Storage

Keepyourtabletsinthepack

untilitistimeto takethem.

Ifyoutakethe tabletsoutofthe

packtheymaynotkeep well.

Keepyourtabletsinacooldry

place wherethetemperature stays

below25°C.

Do notstoreACETECoranyother

medicine inthe bathroomorneara

sink.Do notleaveiton awindowsill

orinthe car.

Heatand dampnesscan destroy

somemedicines.

Keepitwhere childrencannot

reachit.

Alocked cupboard atleastone-and-

ahalfmetresabovethe ground isa

goodplace to storemedicines.

Disposal

Ifyourdoctortellsyouto stop

takingthis medicine ortheexpiry

date haspassed,ask your

pharmacistwhattodo withany

medicine thatisleftover.

Productdescription

Whatitlookslike

ACETEC2.5mgtabletsarewhite,

ovalshaped biconvextablets,

debossed with “2.5”scoreline“G”

on one side and scoreline on the

otherside.

ACETEC 5mgtabletsare white arc

triangle shaped biconvextablets,

debossed with “5”over“G”on one

sideand scoreline on the otherside.

ACETEC10mg tabletsarerusty

red,arctriangle shaped biconvex

tablets,debossed with “10”over“G”

on one side and scoreline on the

otherside.

ACETEC20mg tabletsarepeach,

arctriangle shaped biconvex

tablets,debossed with “20”over“G”

on one side and scoreline on the

otherside.

Ingredients

ACETEC contains2.5,5,10 or20

mg ofenalaprilmaleateasthe

activeingredient.

Italso contains:

sodiumhydrogen carbonate

pregelatinized starch

maizestarch

lactose monohydrate

magnesiumstearate

iron oxide red (10mg)

iron oxide brown (20 mg)

Thismedicine doesnotcontain

sucrose,gluten,tartrazine orany

otherazo dyes.

Ifyou wanttoknow

more

Should you have anyquestions

regarding thisproduct,please

contactyourpharmacistordoctor.

Who suppliesthis

medicine

Distributedin NewZealand by:

Mylan NewZealand Ltd,

POBox11183,

Ellerslie,

Auckland.

Telephone:(09)579 2792

DateofInformation

9August2013

(Based on datasheetdated7

August2013)

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Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Published on: Tue, 20 Nov 2018 The feed additive Monteban® G100, containing the active substance narasin, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 60–70 mg/kg complete feed. Narasin is produced by fermentation. Limited data on the taxonomic identification of the production strain did not allow the proper identification of strain NRRL 8092 as Streptomyces aureofaciens. The FEEDAP Panel cannot conclude on the absence of genetic determinants for ...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Extensive literature search, selection for relevance and data extraction of studies related to the toxicity of PCDD/Fs and DL‐PCBs in humans

Extensive literature search, selection for relevance and data extraction of studies related to the toxicity of PCDD/Fs and DL‐PCBs in humans

Published on: Tue, 20 Nov 2018 To enable the hazard identification and characterisation in the risk assessment for humans related to the seventeen 2,3,7,8‐substituted dioxins (PCCDs) and furans (PCDFs) and the twelve dioxin‐like polychlorinated biphenyls (DL‐PCBs), EFSA outsourced an extensive literature search (ELS), followed by selection for relevance and extraction of relevant data for consideration in the risk assessment. Two tailored search strategies for Web of Science (WoS) and PubMed for identif...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Published on: Tue, 20 Nov 2018 The European Commission asked EFSA for a scientific opinion on the risks for animal and human health related to the presence of dioxins (PCDD/Fs) and DL‐PCBs in feed and food. The data from experimental animal and epidemiological studies were reviewed and it was decided to base the human risk assessment on effects observed in humans and to use animal data as supportive evidence. The critical effect was on semen quality, following pre‐ and postnatal exposure. The critical s...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Setting of an import tolerance for mandipropamid in cocoa beans

Setting of an import tolerance for mandipropamid in cocoa beans

Published on: Tue, 20 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Agro GmbH submitted a request to the competent national authority in Austria to set a maximum residue level (MRL) for the active substance mandipropamid in cocoa beans imported from Nigeria and Cameroon. The data submitted in support of the request were found to be sufficient to derive a MRL proposal of 0.06 mg/kg. Adequate analytical methods for enforcement are available to control the res...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

November 20, 2018: Rochester Man Pleads Guilty to Smuggling Counterfeit Cialis and Viagra into the United States

November 20, 2018: Rochester Man Pleads Guilty to Smuggling Counterfeit Cialis and Viagra into the United States

November 20, 2018: Rochester Man Pleads Guilty to Smuggling Counterfeit Cialis and Viagra into the United States

FDA - U.S. Food and Drug Administration

20-11-2018

Vijf winnaars van energieneutrale sportprojecten kunnen aan de slag

Vijf winnaars van energieneutrale sportprojecten kunnen aan de slag

Op 20 november zijn de vijf winnaars van de Innovation Challenge Energieneutrale Sportaccommodaties, vanuit het programma Sportinnovator, bekendgemaakt. De innovatieve ideeën voor energiebesparing bij sportaccommodaties hebben groen licht gekregen. Ze ontvangen hiervoor steun van het ministerie van Volksgezondheid, Welzijn en Sport om innovatie in de sport te bevorderen. Onderstaande initiatieven krijgen 100.000 euro om het idee in de praktijk door te voeren.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

15-11-2018

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

Europe - EFSA - European Food Safety Authority Publications

8-11-2018

Theme event on big data and medicine

Theme event on big data and medicine

The U.S. Food and Drug Administration, FDA, The European Medicines Agency, EMA, and Novo Nordisk are among the speakers when The Danish Medicines Agency on 20 November 2018 puts focus on big data and medicine under the event heading “From Big Data to Real World Evidence”.

Danish Medicines Agency

29-10-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new consideration of labeling for sesame allergies

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new consideration of labeling for sesame allergies

Food allergies have touched the lives of most of us. Thousands of Americans experience life-threatening, food-related reactions each year, and an estimated 20 people die from them annually. In some cases, such reactions occur despite a careful reading of packaged food labels by conscientious consumers. To me, that’s unacceptable. The FDA is committed to advancing our efforts to help ensure that Americans have access to the information they need about common allergens in packaged foods.

FDA - U.S. Food and Drug Administration

24-10-2018

G & C Raw, LLC is Expanding Recall to Include All Product Lots Manufactured from February 27, 2018 Through July 20, 2018, Because of Possible Listeria Monocytogenes Health Risk

G & C Raw, LLC is Expanding Recall to Include All Product Lots Manufactured from February 27, 2018 Through July 20, 2018, Because of Possible Listeria Monocytogenes Health Risk

G & C Raw, of Versailles, OH is recalling all products lots manufactured from February 27, 2018 through July 20, 2018, as a precaution because they have the potential to be contaminated with Listeria monocytogenes

FDA - U.S. Food and Drug Administration

4-10-2018

Nederland organiseert wereldwijde conferentie tegen antibioticaresistentie

Nederland organiseert wereldwijde conferentie tegen antibioticaresistentie

Samen met de Wereldgezondheidorganisatie (WHO) zal Nederland in april 2019 een wereldwijde ministeriële conferentie organiseren over de strijd tegen antibioticaresistentie. Dat heeft minister Bruno Bruins (Medische Zorg) bekend gemaakt tijdens de G20-bijeenkomst in Argentinië. Bij deze bijeenkomst maakte Bruins afspraken met zijn collega’s uit de grootste 20 economieën van de wereld over een gezamenlijke aanpak van gezondheidsvraagstukken. Mede door jarenlange inzet van Nederland, staat antibioticaresist...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

21-9-2018

Pending EC decision:  Buvidal, buprenorphine, Opinion date: 20-Sep-2018

Pending EC decision: Buvidal, buprenorphine, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Emgality, galcanezumab, Opinion date: 20-Sep-2018

Pending EC decision: Emgality, galcanezumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  RoActemra, tocilizumab, Opinion date: 20-Sep-2018

Pending EC decision: RoActemra, tocilizumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Venclyxto, venetoclax, Opinion date: 20-Sep-2018

Pending EC decision: Venclyxto, venetoclax, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Jivi, damoctocog alfa pegol, Opinion date: 20-Sep-2018

Pending EC decision: Jivi, damoctocog alfa pegol, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Gilenya, fingolimod, Opinion date: 20-Sep-2018

Pending EC decision: Gilenya, fingolimod, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Apealea, paclitaxel, Opinion date: 20-Sep-2018

Pending EC decision: Apealea, paclitaxel, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Alunbrig, brigatinib, Opinion date: 20-Sep-2018

Pending EC decision: Alunbrig, brigatinib, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Cabometyx , cabozantinib, Opinion date: 20-Sep-2018

Pending EC decision: Cabometyx , cabozantinib, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Luxturna, voretigene neparvovec, Opinion date: 20-Sep-2018

Pending EC decision: Luxturna, voretigene neparvovec, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Fulphila, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Fulphila, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Pelmeg, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Pelmeg, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Ziextenzo, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Ziextenzo, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Poteligeo, mogamulizumab, Opinion date: 20-Sep-2018

Pending EC decision: Poteligeo, mogamulizumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Pifeltro, doravirine, Opinion date: 20-Sep-2018

Pending EC decision: Pifeltro, doravirine, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Published on: Thu, 20 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member State...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

Published on: Thu, 20 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience AG submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance clothianidin to accommodate the use on potatoes imported from Canada. The data submitted in support of the request were found to be sufficient to derive a MRL proposal. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority Publications

20-9-2018

Pending EC decision:  Xtandi, enzalutamide, Opinion date: 20-Sep-2019

Pending EC decision: Xtandi, enzalutamide, Opinion date: 20-Sep-2019

Europe - EMA - European Medicines Agency

24-12-2018

ACCM meeting statement, Meeting 20, 16 November 2018

ACCM meeting statement, Meeting 20, 16 November 2018

ACCM meeting statement for 16 November 2018 published

Therapeutic Goods Administration - Australia

21-12-2018

Consultation: Fees and charges proposal 2019-20

Consultation: Fees and charges proposal 2019-20

The TGA is seeking comments from interested parties on the proposed changes in fees and charges for 2019-2020. Closing date: 8 February 2018

Therapeutic Goods Administration - Australia

20-12-2018

Namuscla (Lupin Europe GmbH)

Namuscla (Lupin Europe GmbH)

Namuscla (Active substance: Mexiletine) - New authorisation - Commission Decision (2018)9133 of Thu, 20 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4584

Europe -DG Health and Food Safety

20-12-2018

Bevespi Aerosphere (AstraZeneca AB)

Bevespi Aerosphere (AstraZeneca AB)

Bevespi Aerosphere (Active substance: glycopyrronium bromide / formoterol) - New authorisation - Commission Decision (2018)9127 of Thu, 20 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4245

Europe -DG Health and Food Safety

19-12-2018


Enalapril: List of nationally authorised medicinal products - PSUSA/00001211/201803

Enalapril: List of nationally authorised medicinal products - PSUSA/00001211/201803

Enalapril: List of nationally authorised medicinal products - PSUSA/00001211/201803

Europe - EMA - European Medicines Agency

18-12-2018


Human medicines European public assessment report (EPAR): Vabomere, meropenem / vaborbactam, Urinary Tract Infections,Bacteremia,Bacterial Infections,Respiratory Tract Infections,Pneumonia,Pneumonia, Ventilator-Associated, Date of authorisation: 20/11/20

Human medicines European public assessment report (EPAR): Vabomere, meropenem / vaborbactam, Urinary Tract Infections,Bacteremia,Bacterial Infections,Respiratory Tract Infections,Pneumonia,Pneumonia, Ventilator-Associated, Date of authorisation: 20/11/20

Human medicines European public assessment report (EPAR): Vabomere, meropenem / vaborbactam, Urinary Tract Infections,Bacteremia,Bacterial Infections,Respiratory Tract Infections,Pneumonia,Pneumonia, Ventilator-Associated, Date of authorisation: 20/11/2018, Status: Authorised

Europe - EMA - European Medicines Agency

18-12-2018


Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, Date of authorisation: 20/11/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, Date of authorisation: 20/11/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, Date of authorisation: 20/11/2018, Status: Authorised

Europe - EMA - European Medicines Agency

12-12-2018


Human medicines European public assessment report (EPAR): Exondys, eteplirsen, Muscular Dystrophy, Duchenne, Date of refusal: 20/09/2018, Status: Refused

Human medicines European public assessment report (EPAR): Exondys, eteplirsen, Muscular Dystrophy, Duchenne, Date of refusal: 20/09/2018, Status: Refused

Human medicines European public assessment report (EPAR): Exondys, eteplirsen, Muscular Dystrophy, Duchenne, Date of refusal: 20/09/2018, Status: Refused

Europe - EMA - European Medicines Agency

5-12-2018

TGA presentation: Webinar: Advertising therapeutic goods in 2019: The Code basics – 20 November

TGA presentation: Webinar: Advertising therapeutic goods in 2019: The Code basics – 20 November

The slides from TGA's webinar on Advertising Code Basics have been published

Therapeutic Goods Administration - Australia

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Pixuvri,pixantrone (dimaleate), decision type: , therapeutic area: , PIP number: P/0227/2018

Opinion/decision on a Paediatric investigation plan (PIP): Pixuvri,pixantrone (dimaleate), decision type: , therapeutic area: , PIP number: P/0227/2018

Opinion/decision on a Paediatric investigation plan (PIP): Pixuvri,pixantrone (dimaleate), decision type: , therapeutic area: , PIP number: P/0227/2018

Europe - EMA - European Medicines Agency

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

Europe -DG Health and Food Safety

26-11-2018

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

FDA - U.S. Food and Drug Administration

16-11-2018

Latuda (Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.)

Latuda (Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.)

Latuda (Active substance: lurasidone) - Centralised - Renewal - Commission Decision (2018)7674 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2713/R/20

Europe -DG Health and Food Safety

14-11-2018

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Active substance: tolvaptan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7604 of Wed, 14 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2788/T/20

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6434 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/056/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03

Europe -DG Health and Food Safety