Dalsy 20 mg ml sirup

Glavna informacija

  • Trgovački naziv:
  • Dalsy 20 mg/ml sirup
  • Doziranje:
  • 20 mg/ml
  • Farmaceutski oblik:
  • sirup
  • Sastav:
  • Urbroj: 1 ml sirupa sadrži 20 mg ibuprofena
  • Tip recepta:
  • na recept, u ljekarni neponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • AbbVie S.r.L. S.R., Campoverde di Aprilia (LT), Italija

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Dalsy 20 mg/ml sirup
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 100 ml sirupa u bočici, žlica ili štrcaljka za doziranje, u kutiji [HR-H-407408529-01]; 200 ml sirupa u bočici, žlica ili štrcaljka za doziranje, u kutiji [HR-H-407408529-02] Urbroj: 381-12-01/30-16-26

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-407408529
  • Datum autorizacije:
  • 30-04-2016
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku: sastav, indikacije, doziranje, nuspojave, interakcija, trudnoća, dojenje

Uputa o lijeku: Informacija za korisnika

Dalsy 20 mg/ml sirup

ibuprofen

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

podatke.

Sačuvajte ovu uputu. Možda ćete je trebati ponovo pročitati.

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

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

njihovi znakovi bolesti jednaki Vašima.

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

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

Što se nalazi u ovoj uputi:

1. Što je Dalsy sirup i za što se koristi?

2. Što morate znati prije nego počnete uzimati Dalsy sirup?

3. Kako uzimati Dalsy sirup?

4. Moguće nuspojave

5. Kako čuvati Dalsy sirup?

6. Sadržaj pakiranja i druge informacije

1. Što je Dalsy sirup i za što se koristi?

Dalsy sirup sadrži djelatnu tvar ibuprofen koji pripada skupini lijekova koji se nazivaju nesteroidni

protuupalni lijekovi ili NSAR lijekovi.

Dalsy sirup se može koristiti za ublažavanje bolova i upale kod bolesti kao što su reumatoidni artritis

(uključujući juvenilni reumatoidni artritis ili Stillovu bolest), ankilozni spondilitis, osteoartritis, giht,

otečeni zglobovi, bolno rame, burzitis, tendinitis, tenosinovitis, bol u donjem dijelu leđa, iščašenja i

uganuća.

Također se može koristiti za ublažavanje blagih do umjereno jakih bolova različita podrijetla kao što

zubobolja,

bolovi

nakon

operacija,

bolovi

menstruacije,

nakon

epiziotomije,

poslijeporođajna bol te glavobolja, uključujući i migrenu.

Dalsy sirup se koristi i za kratkotrajno liječenje povišene tjelesne temperature, u djece starije od tri

mjeseca (tjelesne težine iznad 5 kg).

2. Što morate znati prije nego počnete uzimati Dalsy sirup?

Nemojte uzimati Dalsy sirup:

ako ste alergični na ibuprofen ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6.)

ako ste bolovali od reakcija preosjetljivosti (bronhospazam (stezanje dušnica), astma, rinitis,

angioedem ili urtikarija) na acetilsalicilatnu kiselinu ili druge protuupalne lijekove

ako ste ranije imali krvarenja ili puknuća u probavnom sustavu povezana s primjenom lijekova iz

skupine nesteroidnih protuupalnih lijekova

ako imate čir na želucu/dvanaesniku ili krvarenje u probavnom sustavu ili ste imali ponavljajući

čir na želucu/dvanaesniku ili krvarenje u probavnom sustavu (dvije ili više dokazanih epizoda

čireva ili krvarenja)

ako imate teško zatajenje srca

ako imate teško zatajenje jetre

ako imate teško zatajenje bubrega

ako imate povećanu sklonost krvarenju ili aktivno krvarenje (uključujući krvarenje u mozgu)

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ako ste u posljednjem tromjesečju trudnoće

ako imate tešku dehidraciju (izraženi gubitak vode iz tijela uzrokovan povraćanjem, proljevom ili

nedostatnim unosom tekućine)

Ako niste sigurni odnosi li se nešto od navedenog na Vas, pitajte svog liječnika ili ljekarnika.

Upozorenja i mjere opreza

Ako se bilo što od navedenog odnosi na Vas (ili niste sigurni), obratite se svom liječniku ili ljekarniku

prije nego uzmete Dalsy sirup:

ste imali ili bolujete od kroničnih upalnih bolesti crijeva (ulcerozni kolitis, Crohnova bolest)

ste imali oboljenja probavnog sustava budući je moguće pogoršanje bolesti. Ako tijekom

primjene Dalsy sirupa, posebno na početku liječenja, osjetite bilo kakav neuobičajeni simptom u

trbuhu, obratite se liječniku. U slučaju nastanka krvarenja ili čireva u probavnom sustavu, odmah

prekinite uzimanje lijeka i obratite se liječniku.

imate ili ste imali astmu ili alergijske bolesti jer je povećan rizik od suženja dišnih putova s

poteškoćama u disanju (bronhospazma)

patite od sezonskog alergijskog rinitisa, nosnih polipa ili kroničnog opstruktivnog poremećaja

dišnog sustava, jer je povećan rizik od alergijskih reakcija. One se mogu očitovati napadajima

astme, Quinckeovim edemom ili koprivnjačom.

imate tegobe s jetrom, bubrezima, srcem ili povišenim krvnim tlakom

ste skloni krvarenju i/ili uzimate lijekove koji utječu na zgrušavanje krvi.

ste trudni ili dojite

imate vodene kozice

bolujete od sistemskog eritematoznog lupusa ili miješane bolesti vezivnog tkiva (bolesti koja

zahvaća kožu, zglobove i bubrege)

imate dehidraciju (gubitak vode iz tijela uzrokovan povraćanjem, proljevom ili nedostatnim

unosom tekućine)

ste starije životne dobi jer je veća mogućnost pojave nuspojava (osobito krvarenja, čireva i

puknuća u probavnom sustavu)

imate nasljednu bolest nepodnošenja nekih šećera

Kao i drugi protuupalni lijekovi iz iste skupine, Dalsy sirup može sakriti simptome infekcije.

Tijekom

produljene

primjene

analgetika

može

pojaviti

glavobolja

koja

smije

liječiti

povišenim dozama lijeka.

Srčani i moždani udar

Protuupalni lijekovi/lijekovi protiv bolova poput ibuprofena mogu biti povezani s blago povećanim

rizikom od srčanog udara ili moždanog udara, naročito kada se upotrebljavaju u visokim dozama.

Nemojte prekoračiti preporučenu dozu ili trajanje liječenja.

Obratite se svom liječniku ili ljekarniku prije nego uzmete Dalsy sirup ako:

imate srčanih problema, uključujući zatajenje srca, anginu (bol u prsištu), ili ako ste imali srčani

udar, ugradnju premosnice, bolest perifernih arterija (slabu cirkulaciju u stopalima zbog uskih ili

začepljenih arterija) ili bilo koju vrstu moždanog udara (uključujući "mini moždani udar" ili

prolazni ishemijski napadaj).

imate visoki krvni tlak, dijabetes, visoki kolesterol, povijest srčane bolesti ili moždanog udara u

obitelji, ili ako ste pušač.

Ako se bilo što od gore navedenog odnosi na Vas, posavjetujte se sa svojim liječnikom ili ljekarnikom

prije nego počnete uzimati Dalsy sirup.

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Najmanja učinkovita doza

Uvijek se mora primijeniti najmanja učinkovita doza kako bi se smanjio rizik od nuspojava. Uzimanje

veće doze od preporučene može povećati rizik od nuspojava.

Djeca

Postoji rizik od oštećenja bubrega u dehidrirane djece i adolescenata.

Ibuprofen se ne preporuča djeci lakšoj od 5 kg.

Drugi lijekovi i Dalsy sirup

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

koje druge lijekove.

Dalsy sirup može utjecati na druge lijekove ili na njega mogu utjecati drugi lijekovi.

Primjerice:

drugi protuupalni lijekovi za ublažavanje bolova, uključujući i selektivne inhibitore

ciklooksigenaze 2 (COX-2)

srčani glikozidi (digoksin)

kortikosteroidi (za liječenje upala)

lijekovi koji su antikoagulansi (tj. razrjeđuju krv/sprječavaju zgrušavanje krvi, primjerice

aspirin/acetilsalicilatna kiselina, varfarin)

antitrombotici (klopidogrel i tiklodipin)

selektivni inhibitori ponovne pohrane serotonina (za liječenje depresije)

litij

acetilsalicilatna kiselina

lijekovi koji snižavaju visoki krvni tlak (ACE inhibitori poput kaptoprila, beta blokatori poput

atenolola, antagonisti receptora angiotenzina-II kao što je losartan)

duretici (lijekovi za izmokravanje)

zidovudin (antivirusni lijek)

metotreksat (za liječenje nekih oblika karcinoma)

ciklosporin ili takrolimus (imunosupresivni lijekovi koji se koriste nakon presađivanja organa, ili

za liječenje autoimunih bolesti)

neki antibiotici za liječenje infekcija (kinoloni, aminoglikozidi)

mifepriston

lijekovi iz skupine sulfoniluree (za liječenje šećerne bolesti)

kolestiramin (za liječenje visokih razina kolesterola)

biljni preparati koji sadržavaju Gingko bilobu

vorikonazol ili flukonazol (lijekovi za liječenje gljivičnih infekcija)

alkohol

fenitoin (za liječenje epilepsije)

probenecid i sulfinpirazon

Ako se bilo što od navedenoga odnosi na Vas ili niste sigurni, posavjetujte se sa svojim liječnikom ili

ljekarnikom prije nego počnete uzimati Dalsy sirup.

Liječenje Dalsy sirupom moglo bi također utjecati na neke druge lijekove ili bi oni mogli utjecati na

Dalsy sirup. Uvijek provjerite s Vašim liječnikom ili ljekarnikom prije upotrebe lijeka Dalsy sirup

zajedno s drugim lijekovima.

Dalsy sirup s hranom, pićem i alkoholom

Dalsy sirup se može uzeti istodobno s hranom i pićem.

Tijekom istodobne primjene alkohola, mogu se povećati nuspojave NSAR lijekova, posebice one

povezane s probavnim ili središnjim živčanim sustavom. Također, u većoj mjeri u kombinaciji s

alkoholom ibuprofen može utjecati na Vaše vrijeme reagiranja tj. budnost.

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Trudnoća, dojenje i plodnost

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

liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.

Tijekom prvih šest mjeseci trudnoće ibuprofen se ne smije primijeniti osim u neophodnim situacijama

po savjetu liječnika. Ibuprofen se ne smije koristiti u posljednjem tromjesečju trudnoće.

Ne preporuča se primjena ibuprofena tijekom dojenja.

Uporaba ibuprofena može smanjiti plodnost žena i ne preporuča se kod žena koje pokušavaju začeti.

Upravljanje vozilima i strojevima

Ibuprofen može utjecati na Vaše vrijeme reagiranja. Može izazvati omaglicu, pospanost, umor i

smetnje vida. Potreban je oprez kod upravljanja vozilom, strojevima ili obavljanja poslova koji

zahtijevaju budnost. Ovo vrijedi u većoj mjeri kada se ibuprofen koristi u kombinaciji s alkoholom.

Dalsy sirup sadrži metilparahidroksibenzoat (E218) i propilparahidroksibenzoat (E216).

Mogu uzrokovati alergijske reakcije (moguće i odgođene reakcije preosjetljivosti).

Dalsy sirup sadrži sorbitol i saharozu.

Ako Vam je liječnik rekao da ne podnosite neke šećere, savjetujte se s liječnikom prije uzimanja ovog

lijeka. O tome treba voditi računa u bolesnika sa šećernom bolesti. Može štetiti zubima.

Dalsy sirup sadrži žuto azo bojilo Sunset Yellow (E110).

Može uzrokovati alergijske reakcije.

3. Kako uzimati Dalsy sirup?

Uvijek uzmite ovaj lijek točno onako Vam je rekao Vaš liječnik ili ljekarnik. Provjerite sa svojim

liječnikom ili ljekarnikom ako niste sigurni.

Doziranje

Odrasli i adolescenti (stariji od 12 godina, tjelesne težine iznad 40 kg): Preporučena doza je 1200-

1800 mg dnevno podijeljeno u više doza. U nekim slučajevima se mogu primijeniti i manje doze od

600-1200 mg. Kod teških i akutnih stanja, doza se može povećati do trenutka uspostave kontrole nad

akutnim stanjem pri čemu ukupna dnevna doza ne smije premašiti 2400 mg.

Razmak između pojedinih doza ne smije biti manji od 4 sata.

Djeca starija od 3 mjeseca (tjelesne težine iznad 5 kg): Uobičajena dnevna doza je 20–30 mg po

kilogramu tjelesne težine uzetih u razmacima. Ovo se može postići na sljedeći način:

Dob/tjelesna težina

Učestalost

Pojedinačna doza

3-6 mjeseci

(5-7 kg)

do 3 puta dnevno

2,5 ml (50 mg)

6-12 mjeseci

(7-10 kg)

3 puta dnevno

2,5 ml (50 mg)

1-2 godine

(10-14,5 kg)

3 – 4 puta dnevno

2,5 ml (50 mg)

3-7 godina

(14,5-25 kg)

3 – 4 puta dnevno

5 ml (100 mg)

8-12 godina

(25-40 kg)

3 – 4 puta dnevno

10 ml (200 mg)

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Ibuprofen se ne preporuča djeci tjelesne težine manje od 5 kg.

U slučajevima juvenilnog reumatoidnog artritisa liječnik može povećati dozu i do 40 mg/kg tjelesne

težine uzetih u razmacima.

Stariji: Nije potrebna posebna prilagodba doze, osim ako imate oštećenje bubrežne ili jetrene funkcije

kada će možda biti potrebno da Vam liječnik individualno prilagodi dozu.

Oštećenje funkcije bubrega i jetre: Nije potrebno smanjenje doze ako imate blago do umjereno

oštećenje bubrežne ili jetrene funkcije. U slučaju teškog zatajenja bubrega ili jetre, ne smijete uzimati

ovaj lijek.

Način primjene

Za primjenu kroz usta.

Pakiranje sadrži štrcaljku za usta od 5 ml (graduiranu po 0,25 ml) ili mjernu žličicu od 5 ml.

Bočicu treba dobro protresti prije uporabe.

Kako bi se postigao brži početak djelovanja, doza se može uzeti na prazan želudac. Ako imate

osjetljiviji želudac preporuča se uzimanje Dalsy sirupa s hranom.

Može se pojaviti prolazni osjećaj pečenja u ustima ili grlu.

Ako uzmete više Dalsy sirupa nego što ste trebali

netko

drugi

nehotice

uzeli

znatno

veće

doze

lijeka

nego

što

preporučeno

(predoziranje), odmah obavijestite svojeg liječnika ili se obratite najbližoj bolničkoj hitnoj službi.

Ukoliko je došlo do predoziranja značajnim količinama Dalsy sirupa, simptomi se obično javljaju

unutar 4 do 6 sati, a najčešći su mučnina, povraćanje, bolovi u trbuhu, otupljenost i omamljenost.

Ako ste zaboravili uzeti Dalsy sirup

Ako zaboravite uzeti lijek, učinite to što je prije moguće, osim ako je blizu vrijeme za uzimanje iduće

doze.

U tom slučaju ne

uzimajte

propuštenu dozu.

Nemojte

uzeti

dvostruku

dozu

kako

biste

nadoknadili zaboravljenu dozu.

U slučaju bilo kakvih nejasnoća ili 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 razviti kod svakoga.

Neželjeni učinci mogu se umanjiti primjenom najmanje učinkovite doze kroz najkraće moguće

vrijeme potrebno za kontroliranje simptoma.

U

slučaju

pojave

sljedećih

nuspojava,

odmah

prestanite

s

uzimanjem

lijeka

te

se

javite

liječniku:

- kožni osip, ozljede sluznica ili drugi znakovi preosjetljivosti kože

- oticanje lica, jezika, grla, poteškoće s disanjem (angioedem, anafilaktički šok)

- pojava ili pogoršanje znakova infekcije (npr. nekroza mekih tkiva i veziva), posebno uz vodene

kozice

- jaka glavobolja, povišena tjelesna temperatura, ukočenost vrata i preosjetljivost na svjetlost

- krvava stolica

- izrazito tamno obojena stolica (kao katran)

- povraćanje svježe krvi ili tamnih komadića koji izgledaju kao zrna kave.

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Sljedeće nuspojave se mogu pojaviti pri primjeni ovog lijeka:

Česte (mogu se pojaviti izmeĎu 1 i 10 na 100 bolesnika)

omaglica, glavobolja

loša probava, proljev, mučnina, povraćanje, bolovi u trbuhu, nadutost, zatvor, krv u stolici,

povraćanje krvi, krvarenje u probavnom sustavu

osip

umor.

Manje česte (mogu se pojaviti izmeĎu 1 i 10 na 1000 bolesnika)

curenje iz nosa (rinitis)

preosjetljivost

nesanica, tjeskoba

neobični osjeti na koži kao što su utrnulost, trnci, bockanje, žarenje ili mravinjanje (parestezija),

jaka pospanost

smetnje vida

smetnje sluha, zujanje u ušima, vrtoglavica (vertigo)

astma, stezanje dušnica (bronzospazam), dispneja

gastritis, čir na dvanaesniku/želucu, vrijed (ulceracije) u ustima, puknuća u probavnom sustavu

upala jetre (hepatitis), žutica, poremećaj funkcije jetre

koprivnjača, svrbež, purpura, angioedem, fotosenzitivnost

različiti oblici toksičnosti za bubrege, uključujući tubulointersticijski nefritis, nefrotski sindrom i

zatajenje bubrega.

Rijetke (mogu se pojaviti u manje od 1 na 1000 bolesnika)

aseptički meningitis

poremećaji

krvi

limfnog

sustava

(leukopenija,

trombocitopenija,

aplastična

anemija,

neutropenija, agranulocitoza i hemolitička anemija)

anafilaktična reakcija

depresija, stanje zbunjenosti, halucinacije

optički neuritis

toksična optička neuropatija

ozljeda jetre

otok (edem).

Vrlo rijetke (mogu se pojaviti u manje od 1 na 10000 bolesnika)

zatajenje srca, infarkt miokarda

povišeni krvni tlak

upala gušterače

zatajenje jetre

teške kožne reakcije (npr. multiformni eritem, bulozne reakcije uključujući Stevens-Johnsonov

sindrom i toksičnu epidermalnu nekrolizu)

teške

reakcije

preosjetljivosti.

Simptomi

mogu

biti:

oticanje

lica,

jezika

grla,

dispneja,

tahikardija, hipotenzija do razine životno ugrožavajućeg šoka.

Nepoznate (učestalost se ne može procijeniti na temelju dostupnih podataka):

kolitis i Crohnova bolest.

Prijavljivanje nuspojava

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

svaku moguću nuspojavu koja nije navedena u ovoj uputi. Nuspojave možete prijaviti izravno putem

nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V. Prijavljivanjem nuspojava možete

pridonijeti u procjeni sigurnosti ovog lijeka.

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O D O B R E N O

5. Kako čuvati Dalsy sirup?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Lijek ne zahtjeva posebne uvjete čuvanja

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

odnosi se na zadnji dan navedenog mjeseca.

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

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

6. Sadržaj pakiranja i druge informacije

Što Dalsy sirup sadrži?

Djelatna tvar je ibuprofen.

1 ml sirupa sadrži 20 mg ibuprofena

5 ml sirupa sadrži 100 mg ibuprofena.

Drugi

sastojci

(pomoćne

tvari)

metilparahidroksibenzoat

(E218),

propilparahidroksibenzoat

(E216), citratna kiselina hidrat, kaolin, glicerol, sorbitol tekući nekristalizirajući, saharoza, natrijev

benzoat (E211), žuto azo bojilo Sunset Yellow (E110), aroma naranče D717 BBA, polisorbat 80, agar

i pročišćena voda.

Kako Dalsy sirup izgleda i sadržaj pakiranja?

Dalsy sirup je narančaste boje.

Smeđa polietilenska bočica sa 100 ml sirupa ili 200 ml sirupa.

Na tržištu se ne moraju nalaziti sve veličine pakiranja.

Pakiranje sadrži štrcaljku za usta od 5 ml (graduiranu po 0,25 ml) ili mjernu žličicu od 5 ml.

Nositelj odobrenja za stavljanje lijeka u promet i proizvoĎač

Nositelj odobrenja:

Mylan Hrvatska d.o.o.

Koranska 2

10 000 Zagreb

ProizvoĎač:

AbbVie S.r.l.

S.R. 148 Pontina km 52 snc

04011 Campoverde di Aprilia (LT)

Italija

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u studenom 2016.

H A L M E D

28 - 03 - 2017

O D O B R E N O

17-1-2019

Safety and efficacy of 8‐mercapto‐p‐menthan‐3‐one and p‐menth‐1‐ene‐8‐thiol belonging to chemical group 20 when used as flavourings for all animal species

Safety and efficacy of 8‐mercapto‐p‐menthan‐3‐one and p‐menth‐1‐ene‐8‐thiol belonging to chemical group 20 when used as flavourings for all animal species

Published on: Wed, 16 Jan 2019 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of two compounds belonging to chemical group 20 (aliphatic and aromatic mono‐ and di‐thiols and mono‐, di‐, tri‐, and polysulfides with or without additional oxygenated functional groups). 8‐Mercapto‐p‐menthan‐3‐one [12.038] and p‐menth‐1‐ene‐8‐thiol [12.085] are currently ...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Safety and efficacy of Deccox® (decoquinate) for chickens for fattening

Safety and efficacy of Deccox® (decoquinate) for chickens for fattening

Published on: Mon, 14 Jan 2019 Deccox®, containing decoquinate as the active substance, is a feed additive intended to be used for the prevention of coccidiosis in chickens for fattening at a dose range of 20–40 mg/kg complete feed. Decoquinate from Deccox® is safe for chickens for fattening at the highest applied concentration in complete feed of 40 mg/kg. No practically relevant interactions with other additives or veterinary drugs exist except with bentonite. Decoquinate does not have antibacterial a...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-1-2019

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries, Ltd. is voluntarily recalling three lots of Vecuronium Bromide for Injection, 10 mg (lyophilized powder), and one lot of Vecuronium Bromide for Injection, 20 mg (lyophilized powder) to the hospital level. The Vecuronium Bromide for Injection has been found to contain particulate matter identified as glass.

FDA - U.S. Food and Drug Administration

21-12-2018

Peer review of the pesticide risk assessment of the active substance propanil

Peer review of the pesticide risk assessment of the active substance propanil

Published on: Thu, 20 Dec 2018 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Italy for the pesticide active substance propanil and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of t...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-12-2018

Avian influenza overview August – November 2018

Avian influenza overview August – November 2018

Published on: Thu, 20 Dec 2018 Between 16 August and 15 November 2018, 14 highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments in Bulgaria and seven HPAI A(H5N6) outbreaks, one in captive birds in Germany and six in wild birds in Denmark and the Netherlands were reported in the European Union (EU). No human infection due to HPAI A(H5N8) and A(H5N6) viruses have been reported in Europe so far. Seroconversion of people exposed during outbreaks in Russia has been reported in...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-12-2018

Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

Torrance, CA, Asclemed USA Inc is voluntarily recalling 20 lots of Dyural-40 and 61 lots of Dyural-80, to the user level. The products include recalled Sodium Chloride, USP, 0.9% manufactured by Fresenius Kabi, which has been recalled due to product labeling incorrectly stating stoppers do not contain latex.

FDA - U.S. Food and Drug Administration

17-12-2018


Draft cabozantinib tablet 20 mg, 40 mg and 60 mg, capsule 20 4 mg and 80 mg product-specific bioequivalence guidance

Draft cabozantinib tablet 20 mg, 40 mg and 60 mg, capsule 20 4 mg and 80 mg product-specific bioequivalence guidance

Draft cabozantinib tablet 20 mg, 40 mg and 60 mg, capsule 20 4 mg and 80 mg product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

14-12-2018

Risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food

Risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food

Published on: Thu, 13 Dec 2018 The European Commission asked EFSA for a scientific evaluation on the risks to human health related to the presence of perfluorooctane sulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) in food. Regarding PFOS and PFOA occurrence, the final data set available for dietary exposure assessment contained a total of 20,019 analytical results (PFOS n = 10,191 and PFOA n = 9,828). There were large differences between upper and lower bound exposure due to analytical methods with i...

Europe - EFSA - European Food Safety Authority Publications

14-12-2018

Analysis of hunting statistics collection frameworks for wild boar across Europe and proposals for improving the harmonisation of data collection

Analysis of hunting statistics collection frameworks for wild boar across Europe and proposals for improving the harmonisation of data collection

Published on: Thu, 13 Dec 2018 Heterogeneities in the wild boar data collection frameworks across Europe were analysed using questionnaires to explore comparability of hunting data in the short term and propose a common framework for future collection. Fifty‐seven respondents representing 32 countries covering more than 95% of European territory participated to the questionnaire. The most frequently recorded information in the official statistics included the quantity of animals shot per hunting ground ...

Europe - EFSA - European Food Safety Authority Publications

11-12-2018


The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Madrid, Spain, from 20/05/2019 to 22/05/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Madrid, Spain, from 20/05/2019 to 22/05/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Madrid, Spain, from 20/05/2019 to 22/05/2019

Europe - EMA - European Medicines Agency

11-12-2018


The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, London, United Kingdom, from 11/02/2019 to 20/02/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, London, United Kingdom, from 11/02/2019 to 20/02/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, London, United Kingdom, from 11/02/2019 to 20/02/2019

Europe - EMA - European Medicines Agency

21-11-2018

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi USA is voluntarily recalling 163 lots of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial to the user level. The product insert states that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the vial label for the 20mL vial also state that the stoppers do not contain latex. The product is being recalled because the stoppers contain n...

FDA - U.S. Food and Drug Administration

21-11-2018

Enforcement Report for the Week of November 21, 2018

Enforcement Report for the Week of November 21, 2018

Recently Updated Records for the Week of November 21, 2018 Last Modified Date: Tuesday, November 20, 2018

FDA - U.S. Food and Drug Administration

21-11-2018

Implementation and verification of PBPK modelling codes of TCDD in rats and humans into Berkeley Madonna

Implementation and verification of PBPK modelling codes of TCDD in rats and humans into Berkeley Madonna

Published on: Tue, 20 Nov 2018 The goal of the current work was to implement and verify previously published rat and human PBPK modelling codes for TCDD into Berkeley Madonna. The US‐EPA has used these PBPK models in the reassessment of TCDD. A procurement contract has been set up to explore the possibilities to adequately run the models and reproduce previously published results. The implementation of the available codes in Berkeley Madonna was carried out at RIKILT‐WUR under the framework agreement wi...

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 Experimental Animals

Extensive Literature Search, Selection for Relevance and Data Extraction of Studies Related to the Toxicity of PCDD/Fs and DL‐PCBs in Experimental Animals

Published on: Tue, 20 Nov 2018 Polychlorinated dibenzodioxins (PCDD), polychlorinated dibenzofurans (PCDFs) and dioxin‐like polychlorinated biphenyls (DL‐PCBs) are detected ubiquitously in the environment, diet and human tissues. The European Food Safety Authority (EFSA) CONTAM Panel received a mandate from the European Commission for a scientific opinion on the risks for human and animal health related to the presence of dioxins and DL‐PCBs in food and feed. To support preparatory work for the hazard i...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

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

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

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

17-9-2018

Agenda:  Agenda - CHMP agenda of the 17-20 September 2018 meeting

Agenda: Agenda - CHMP agenda of the 17-20 September 2018 meeting

Europe - EMA - European Medicines Agency