Levetiracetam Actavis Group

Glavna informacija

  • Trgovački naziv:
  • Levetiracetam Actavis Group
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Levetiracetam Actavis Group
    Europska Unija
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Terapijska grupa:
  • Antiepileptici
  • Područje terapije:
  • Epilepsija
  • Terapijske indikacije:
  • Levetiracetam Actavis Group je indiciran kao monoterapija u liječenju parcijalnih napadaja sa ili bez sekundarne generalizacije u bolesnika od 16 godina života s dijagnozom epilepsije.

Druge informacije

Status

  • Izvor:
  • EMA - European Medicines Agency
  • Status autorizacije:
  • odobren
  • Broj odobrenja:
  • EMEA/H/C/002305
  • Datum autorizacije:
  • 05-12-2011
  • EMEA koda:
  • EMEA/H/C/002305
  • Zadnje ažuriranje:
  • 01-03-2018

Uputu o lijeku

B. UPUTA O LIJEKU

Uputa o lijeku: Informacija za bolesnika

Levetiracetam Actavis Group 100 mg/ml oralna otopina

levetiracetam

Pažljivo pročitajte cijelu uputu prije nego Vi ili Vaše dijete počnete uzimati ovaj lijek jer sadrži

Vama važne podatke.

Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.

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

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

njihovi znakovi bolesti jednaki Vašima.

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

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

Što se nalazi u ovoj uputi:

Što je Levetiracetam Actavis Group i za što se koristi

Što morate znati prije nego počnete uzimati Levetiracetam Actavis Group

Kako uzimati Levetiracetam Actavis Group

Moguće nuspojave

Kako čuvati Levetiracetam Actavis Group

Sadržaj pakiranja i druge informacije

1.

Što je Levetiracetam Actavis Group i za što se koristi

Levetiracetam jest antiepileptik (lijek koji se koristi u liječenju epileptičkih napadaja).

Levetiracetam Actavis Group se koristi:

samostalno u odraslih i adolescenata od 16. godine života s novodijagnosticiranom epilepsijom,

u liječenju određenog oblika epilepsije. Epilepsija je stanje u kojem bolesnici imaju ponavljane

epileptičke napadaje, Levetiracetam se koristi za oblik epilepsije u kojem napadaji započinju u

jednoj strani mozga, ali se nakon toga mogu proširiti na veće područje u obje strane mozga

(parcijalni napadaj sa ili bez sekundarne generalizacije). Vaš liječnik Vam je propisao

levetiracetam kako bi se smanjio broj napadaja.•

kao dodatna terapija uz druge antiepileptike

u liječenju:

parcijalnih napadaja sa sekundarnom generalizacijom ili bez nje u odraslih, adolescenata,

djece i dojenčadi od prvog mjeseca života

miokloničkih napadaja (kratki, iznenadni trzaj mišića ili skupine mišić

u odraslih i

adolescenata starijih od 12 godina života s juvenilnom

miokloničnom epilepsijom

primarno generaliziranih toničko-kloničkih napadaja (veliki napadaji, uključujući gubitak

svijesti) u odraslih i adolescenata starijih od 12 godina života s idiopatskom

generaliziranom epilepsijom (oblik epilepsije za koji se smatra da je genetski uvjetovan).

2.

Što morate znati prije nego počnete uzimati Levetiracetam Actavis Group

Nemojte uzimati Levetiracetam Actavis Group

ako ste alergični na levetiracetam, derivate pirolidona ili neki drugi sastojak ovog lijeka

(naveden u dijelu 6).

Upozorenja i mjere opreza

Obratite se svom liječniku prije nego uzmete

Levetiracetam Actavis Group

Ako patite od bubrežnih problema, slijedite upute svog liječnika koji će odlučiti treba li

prilagoditi Vašu dozu.

Ako primijetite usporen rast ili neočekivan razvoj djeteta u pubertetu, obavijestite svog

liječnika.

Mali broj ljudi liječenih antiepilepticima kao što je levetiracetam imali su misli o

samoozljeđivanju ili samoubojstvu. Ako imate bilo kakve simptome depresije i/ili samoubilačke

ideje, obavijestite svog liječnika.

Djeca i adolescenti

U djece i adolescenata mlađih od 16 godina Levetiracetam Actavis Group se ne primjenjuje

samostalno (monoterapija).

Drugi lijekovi i Levetiracetam Actavis Group

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

druge lijekove.

Ne uzimajte makrogol (lijek koji se koristi kao laksativ) jedan sat prije i jedan sat nakon uzimanja

levetiracetama zbog toga što se može smanjiti učinak levetiracetama.

Trudnoća i dojenje

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

liječniku za savjet prije nego uzmete ovaj lijek.

Levetiracetam Actavis Group se ne smije uzimati tijekom trudnoće, osim ako to nije neophodno.

Rizik od prirođenih mana za Vaše nerođeno dijete ne može se u potpunosti isključiti. U ispitivanjima

na životinjskim modelima utvrđeno je da je levetiracetam povezan s neželjenim reproduktivnim

učincima kada je primjenjivan u dozama većim nego što bi bile potrebne za kontrolu Vaših napadaja.

Tijekom liječenja ne preporučuje se dojenje.

Upravljanje vozilima i strojevima

Ako vozite ili upravljate alatima ili vozilima potreban je oprez jer se pri uzimanju lijeka Levetiracetam

Actavis Group može javiti osjećaj pospanosti. To se češće javlja na početku liječenja ili nakon

povećanja doze. Ne smijete voziti ili se koristiti strojevima dok se ne utvrdi da uzimanje lijeka

Levetiracetam Actavis Group ne utječe na Vaše sposobnosti za to.

Levetiracetam Actavis Group sadrži metilparahidroksibenzoat, propilparahidroksibenzoat i

maltitol

Levetiracetam Actavis Group oralna otopina sadrži metilparahidroksibenzoat (E218) i

propilparahidroksibenzoat (E216) koji mogu izazvati alergijske reakcije (koje mogu biti i odgođene).

Levetiracetam Actavis Group oralna otopina također sadrži maltitol. Ako Vam je liječnik rekao da

imate bolest nepodnošenja nekih šećera, prije nego što počnete uzimati ovaj lijek posavjetujte se sa

svojim liječnikom.

3.

Kako uzimati Levetiracetam Actavis Group

Uvijek uzmite ovaj lijek točno onako kako su Vam rekli Vaš liječnik ili ljekarnik. Provjerite sa svojim

liječnikom ili ljekarnikom ako niste sigurni.

Levetiracetam Actavis Group se mora uzimati dva puta na dan, jednom ujutro i jednom navečer, u

približno isto vrijeme svaki dan.

Uzmite oralnu otopinu prema uputama liječnika.

Monoterapija

Doz

a za odrasle i adolescente od 16. godine života:

Odgovarajuću dozu izmjerite pomoću štrcaljke od 10 ml koja se nalazi u pakiranju za bolesnike od

navršene 4 godine nadalje.

Uobičajena doza: Levetiracetam Actavis Group se uzima dva puta na dan, u dvije jednake doze, pri

čemu svaka pojedinačna doza iznosi između 5 ml (500 mg) i 15 ml (1500 mg).

Kad prvi put počnete uzimati Levetiracetam Actavis Group, liječnik će Vam propisati

manju dozu

tijekom 2 tjedna prije davanja najmanje uobičajene doze.

Dodatna terapija

Doza u odraslih i adolescenata (12 do 17 godina) koji imaju 50 kg ili više:

Odgovarajuću dozu izmjerite pomoću štrcaljke od 10 ml koja se nalazi u pakiranju za bolesnike od

navršene 4 godine nadalje.

Uobičajena doza:

Levetiracetam Actavis Group se uzima dva puta na dan, u dvije jednake doze, pri čemu svaka

pojedinačna doza iznosi između 5 ml (500 mg) i 15 ml (1500 mg).

Doza u djece od navršenih 6 mjeseci nadalje:

Liječnik će propisati najprikladniji farmaceutski oblik levetiracetama sukladno dobi, tjelesnoj težini i

dozi.

Za djecu od navršenih 6 mjeseci do manje od 4 godine,

odgovarajuću dozu izmjerite pomoću

štrcaljke od 3 ml koja se nalazi u pakiranju.

Za djecu od navršene 4 godine nadalje

odgovarajuću dozu izmjerite pomoću štrcaljke od 10 ml koja

se nalazi u pakiranju.

Uobičajena doza: Levetiracetam Actavis Group se uzima dva puta na dan, u dvije jednake doze, pri

čemu svaka pojedinačna doza iznosi između 0,1 ml (10 mg) i 0,3 ml (30 mg) po kilogramu tjelesne

težine djeteta. (Vidi tablicu ispod za primjere doze).

Doza u djece od navršenih 6 mjeseci nadalje:

Tjelesna težina

Početna doza: 0,1 ml/kg dva puta na dan

Najveća doza: 0,3 ml/kg dva puta na dan

6 kg

0,6 ml dva puta na dan

1,8 ml dva puta na dan

8 kg

0,8 ml dva puta na dan

2,4 ml dva puta na dan

10 kg

1 ml dva puta na dan

3 ml dva puta na dan

15 kg

1,5 ml dva puta na dan

4,5 ml dva puta na dan

20 kg

2 ml dva puta na dan

6 ml dva puta na dan

25 kg

2,5 ml dva puta na dan

7,5 ml dva puta na dan

Iznad 50 kg

5 ml dva puta na dan

15 ml dva puta na dan

Doza u dojenčadi (1 mjesec do manje od 6 mjeseci):

Za dojenčad od navršenog 1. mjeseca do manje od 6 mjeseci

odgovarajuću dozu izmjerite pomoću

štrcaljke od

1 ml

koja se nalazi u pakiranju.

Uobičajena doza: Levetiracetam Actavis Group se uzima dva puta na dan, u dvije jednake doze, pri

čemu svaka pojedinačna doza iznosi između 0,07 ml (7 mg) i 0,21 ml (21 mg) po kilogramu tjelesne

težine dojenčeta. (Vidi tablicu ispod za primjere doze).

Doza u dojenčadi (1 mjesec do manje od 6 mjeseci):

Težina

Početna doza: 0,07 ml/kg dva puta na dan

Najveća doza: 0,21 ml/kg dva puta na da

4 kg

0,3 ml dva puta na dan

0,85 ml dva puta na dan

5 kg

0,35 ml dva puta na dan

1,05 ml dva puta na dan

6 kg

0,45 ml dva puta na dan

1,25 ml dva puta na dan

7 kg

0,5 ml dva puta na dan

1,5 ml dva puta na dan

Način primjene:

Nakon mjerenja točne doze pomoću odgovarajuće štrcaljke, Levetiracetam Actavis Group oralna

otopina može se razrijediti u čaši vode ili u dječjoj bočici. Levetiracetam Actavis Group možete uzeti

sa ili bez hrane.

Upute za uporabu:

Upute za uporabu za štrcaljke od 10 ml

Otvorite bocu. Prije početka mjerenja provjerite da su prozirno graduirano tijelo štrcaljke i njen bijeli

klip u najnižem položaju. Kako biste odmjerili potrebnu dozu, s jednom rukom primite tijelo

graduirane štrcaljke a s drugom izvucite njen klip do oznake koja odgovara količini u mililitrima (ml)

koju je propisao Vaš liječnik (slika 1).

Uklonite štrcaljku iz boce držeći je za graduirano tijelo (slika 2).

Ispraznite sadržaj štrcaljke u čašu vode potiskivanjem klipa do dna štrcaljke. Obavezno popijte cijeli

sadržaj čaše. Sadržaj štrcaljke možete izravno dati u usta ili ga isprazniti na žlicu (slika 3).

Nakon uporabe štrcaljku isperite s vodom a bocu zatvorite plastičnim zatvaračem s navojem (slika 4).

Upute za uporabu za štrcaljke od 1 ml i 3 ml s nastavkom

Otvorite bocu i dobro utisnite nastavak za štrcaljku na vrat boce (slika 1).

Uzmite štrcaljku i malo izvucite klip (slika 2).

Utisnite vrh štrcaljke u otvor nastavka. Polako potisnite klip prema dolje kako biste unijeli zrak u bocu

(slika 3).

Okrenite bocu naopako; štrcaljka treba i dalje biti pričvršćena (slika 4).

Izvucite klip i napunite štrcaljku s količinom otopine koja je malo veća od propisane doze (slika 5).

Ako se u štrcaljki pojave mjehurići, neka boca bude i dalje okrenuta naopako. Lagano potisnite klip

prema unutra te ga opet izvucite van. To ponavljajte dok u štrcaljki ne bude više mjehurića (slika 6).

Polako potisnite klip do oznake koja odgovara količini u mililitrima (ml) koju je propisao Vaš liječnik

(slika 7).

Vratite bocu u uspravan položaj i uklonite štrcaljku (slika 8).

Maloj djeci nježno stavite vrh štrcaljke u usta na unutarnju stranu obraza. Polako potisnite klip tako da

dijete može progutati sadržaj štrcaljke. Sadržaj štrcaljke može se također isprazniti u čašu vode ili

dječju bočicu. Budite sigurni da su popili cijeli sadržaj čaše (slika 9).

Nakon uporabe štrcaljku isperite s vodom a bocu zatvorite plastičnim zatvaračem s navojem (slika 10).

Trajanje liječenja:

Levetiracetam Actavis Group se koristi za dugotrajno liječenje. Trebate nastaviti liječenje

lijekom Levetiracetam Actavis Group onoliko dugo koliko je liječnik odredio.

Nemojte prekinuti liječenje bez savjeta liječnika jer to može pojačati napadaje.

Ako uzmete više lijeka Levetiracetam Actavis Group nego što ste trebali:

Moguće nuspojave predoziranja lijekom Levetiracetam Actavis Group su pospanost, uznemirenost,

agresija, smanjena pozornost, smetnje disanja i koma.

Obavijestite liječnika ako ste uzeli veću količinu lijeka Levetiracetam Actavis Group nego što ste

trebali. Vaš će liječnik odrediti najbolji mogući način liječenja predoziranja.

Ako ste zaboravili uzeti Levetiracetam Actavis Group:

Obavijestite liječnika ako ste zaboravili uzeti jednu ili više doza.

Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.

Ako prestanete uzimati Levetiracetam Actavis Group

Ako prekidate liječenje lijekom Levetiracetam Actavis Group, , prekid mora biti postupan kako bi se

izbjeglo pojačanje napadaja.Ako Vaš liječnik odluči prekinuti liječenje lijekom Levetiracetam Actavis

Group, uputit će Vas kako postupno prekinuti liječenje lijekom Levetiracetam Actavis Group.

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

4.

Moguće nuspojave

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

Najčešće prijavljene nuspojave su nazofaringitis, izrazita pospanost, glavobolja, umor i omaglica. Na

početku liječenja ili nakon povećanja doze nuspojave poput pospanosti, umora i omaglice, mogu se

javiti češće. Te bi se nuspojave vremenom trebale smanjiti.

Vrlo često:

može zahvatiti više od 1 na 10 osoba

upala nosa i ždrijela;

somnolencija (pospanost), glavobolja.

Često:

može zahvatiti 1 do 10 korisnika na 100 osoba

anoreksija (gubitak apetita);

depresija, netrpeljivost ili agresivnost, tjeskoba, nesanica, nervoza ili razdražljivost;

konvulzije, porem

ećaj ravnoteže, omaglica (osjećaj nestabilnosti), bezvoljnost (nedostatak

energije i elana), tremor (nevoljno drhtanje);

vrtoglavica (osjećaj vrtnje);

kašalj;

bol u trbuhu, proljev, dispepsija (loša probava), povraćanje, mučnina;

osip;

astenija/umor (zamaranje).

Manje često:

može zahvatiti 1 do 10 korisnika na 1000 osoba

smanjen broj krvnih pločica, smanjen broj bijelih krvnih stanica;

gubitak tjelesne težine, povećanje tjelesne težine;

pokušaj samoubojstva i suicidalne misli, mentalni poremećaj, poremećaj ponašanja,

halucinacije, srditost, smetenost, napadaj panike, emocionalna nestabilnost/promjene

raspoloženja, uznemirenost;

amnezija (gubitak pamćenja), smetnje pamćenja (zaboravljivost), poremećaj

koordinacije/ataksija (poremećaj koordinacije pokreta), parestezije (trnci), smetnje u

koncentraciji (gubitak koncentracije);

diplopija (dvoslike), zamagljen vid;

povišene/promijenjene vrijednosti testova jetrene funkcije nalazi funkcije jetre;

gubitak kose, ekcem, svrbež;

slabost mišića, mijalgija (bol u mišićima);

ozljeda.

Rijetko:

može zahvatiti 1 do 10 korisnika na 10 000 osoba

infekcija;

smanjen broj svih vrsta krvnih stanica;

teške alergijske reakcije (DRESS, anafilaktička reakcija [teška i ozbiljna alergijska reakcija],

Quinckeov edem [oticanje lica, usana, jezika i grla];

snižena koncentracija natrija u krvi;

samoubojstvo, poremećaj osobnosti (problemi u ponašanju), poremećaj mišljenja (sporo

razmišljanje, nemogućnost koncentriranja);

nekontrolirani mišićni grčevi koji zahvaćaju glavu, trup i udove, teškoće u kontroliranju

pokreta, hiperkinezija (hiperaktivnost);

upala gušterače;

zatajenje jetre, hepatitis;

osip kože koji se može formirati u mjehuriće i izgledati kao male mete (sa središnjim tamnim

točkama okruženim bljeđim područjem i tamnim prstenom oko ruba) (

erythema multiforme

jako rasprostranjen osip s mjehurićima i kožom koja se ljušti, osobito oko usta, nosa, očiju i

genitalija (

Stevens-Johnsonov sindrom

), i m

nogo teži oblik koji uzrokuje ljuštenje kože na više

od 30% površine tijela (

toksična epidermalna nekroliza

Prijavljivanje nuspojava

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

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

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

pridonijeti u procjeni sigurnosti ovog lijeka.

5.

Kako čuvati Levetiracetam Actavis Group

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i boci iza „Rok

valjanosti“.

Rok valjanosti odnosi se na zadnji dan navedenog mjeseca.

Nemojte koristiti nakon isteka 7 mjeseca od prvog otvaranja boce.

Ovaj lijek ne zahtijeva posebne uvjete čuvanja.

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 Levetiracetam Actavis Group sadrži

Djelatna tvar je levetiracetam. Jedan ml sadrži 100 mg levetiracetama.

Drugi sastojci su: natrijev citrat, citratna kiselina hidrat, metilparahidroksibenzoat (E218),

propilparahidroksibenzoat (E216), amonijev glicirizat, glicerin, glicerol (E422), tekući maltitol (E965),

acesulfamkalij (E950), aroma grožđa (sadrži propilenglikol), pročišćena voda.

Kako Levetiracetam Actavis Group izgleda i sadržaj pakiranja

Levetiracetam Actavis Group 100 mg/ml oralna otopina je bistra, blijedo žućkasto-smeđa otopina.

Staklena boca od 300 ml lijeka Levetiracetam Actavis Group (za djecu u dobi od 4 godine i stariju,

adolescente i odrasle) pakirana je u kartonsku kutiju koja još sadrži štrcaljku za usta od 10 ml (s

oznakom na svakih 0,25 ml).

Staklena boca od 300 ml lijeka Levetiracetam Actavis Group (za dojenčad u dobi od 6 mjeseci i stariju

i djecu u dobi od 2 do 4 godine) pakirana je u kartonsku kutiju koja još sadrži štrcaljku za usta od 3 ml

(s oznakom na svakih 0,1 ml) i nastavak za štrcaljku.

Staklena boca od 300 ml lijeka Levetiracetam Actavis Group (za dojenčad u dobi od 1 mjeseca do

manje od 6 mjeseci) pakirana je u kartonsku kutiju koja još sadrži štrcaljku za usta od 1 ml (s oznakom

na svakih 0,05 ml) i nastavak za štrcaljku.

Na tržištu se ne moraju nalaziti sve veličine pakiranja.

Nositelj odobrenja za stavljanje lijeka u promet

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78

220 Hafnarfjörður

Island

Proizvođač

Balkanpharma-Troyan AD

1 Krayrechna Str,

Troyan 5600

Bugarska

Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje

lijeka u promet:

België/Belgique/Belgien

Aurobindo Pharma B.V.

Nederland / Pays-Bas / Niederlande

Tél/Tel: +31 (0)35 542 99 33

Lietuva

UAB “Actavis Baltics”

Tel: +370 5 260 9615

България

Актавис ЕАД

Teл.: +359 2 9321 861

Luxembourg/Luxemburg

Aurobindo Pharma B.V.

Pays-Bas / Niederlande

Tél/Tel: +31 (0)35 542 99 33

Česká republika

Actavis CZ a.s.

Tel: +420 251 113 002

Magyarország

Actavis Hungary Kft.

Tel.: +36 1 501 7001

Danmark

Actavis A/S

Tlf: +45 72 22 30 00

Malta

Actavis Ltd.

Tel: +35621693533

Deutschland

PUREN Pharma GmbH & Co. KG

Telefon: +49 (0)89 558909 0

Nederland

Aurobindo Pharma B.V.

Tel: +31 (0)35 542 99 33

Eesti

UAB “Actavis Baltics” Eesti Filiaal

Tel: +372 6100 565

Norge

Actavis Norway AS

Tlf: +47 815 22 099

Ελλάδα

Specifar ABEE

Τηλ: +30 210 5401500

Österreich

Actavis GmbH

Tel: +43 (0)662 435 235 00

España

Aurovitas Spain, S.A.U.

Tfno.: +34 91 630 86 45

Polska

Actavis Export Int. Ltd., Malta

Kontakt w Polsce:

Tel.: (+48 22) 512 29 00

France

Arrow Génériques

Tél: +33 4 72 72 60 72

Portugal

Aurovitas, Unipessoal, Lda

Tel: +351 214 185 104

Hrvatska

PharmaVigil d.o.o.

Tel: +385(1)3890-676

România

Actavis SRL

Tel: +40 21 318 17 77

Ireland

Actavis Ireland Limited

Tel: +353 (0)21 4619040

Slovenija

Apta Medica Internacional d.o.o.

Tel: +386 51 615 015

Ísland

Actavis Group PTC ehf.

Sími: +354 550 3300

Slovenská republika

Actavis s.r.o.

Tel: +421 2 3255 3800

Italia

Aurobindo Pharma (Italia) s.r.l.

Tel: +39 0296392601

Suomi/Finland

Actavis Oy

Puh/Tel: +358 (0)9 348 233

Κύπρος

A. Potamitis Medicare Ltd

Τηλ: +357 22583333

Sverige

Actavis AB

Tel: +46 8 13 63 70

Latvija

UAB “Actavis Baltics” Latvijas filiāle

Tel: +371 67304300

Actavis UK Limited

Tel: +44 1271 385257

Ova uputa je zadnji puta revidirana u

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Drugi izvori informacija

Detaljnije inform

acije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove:

http://www.ema.europa.eu/.

13-11-2018

The importance of vector abundance and seasonality

The importance of vector abundance and seasonality

Published on: Mon, 12 Nov 2018 00:00:00 +0100 This joint ECDC‐EFSA report assesses whether vector count data (abundance) and the way these change throughout the year (seasonality) can provide useful information about vector‐borne diseases epidemiological processes of interest, and therefore, whether resources should be devoted to collecting such data. The document also summarises what measures of abundance and seasonality can be collected for each vector group (mosquitoes, sandflies, midges and ticks), ...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Outcome of a public consultation on the draft guidance on the scientific requirements for health claims related to muscle function and physical performance

Outcome of a public consultation on the draft guidance on the scientific requirements for health claims related to muscle function and physical performance

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on a draft guidance on the scientific requirements for health claims related to muscle function and physical performance, prepared by the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), supported by the Working Group on Claims. The draft guidance was endorsed by the Panel for public consultation ...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The product Bergazym® P100 contains a xylanase which is produced by a non‐genetically modified strain of Trichoderma reesei. The additive is available in a coated granular form and it is intended to be used as a zootechnical additive (functional group: digestibility enhancers) for chickens for fattening, and weaned piglets at the dose of 1,500 EPU/kg feed. The production strain and the additive were fully characterised in a previous assessment of the Panel o...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Training courses on “Steering an Expert Knowledge Elicitation” and “Use of the Expert Knowledge Elicitation Guidance in Risk Assessments for EFSA Management” and “Conduct of the Sheffield protocol for an Expert Knowledge Elicitation”

Training courses on “Steering an Expert Knowledge Elicitation” and “Use of the Expert Knowledge Elicitation Guidance in Risk Assessments for EFSA Management” and “Conduct of the Sheffield protocol for an Expert Knowledge Elicitation”

Published on: Mon, 29 Oct 2018 00:00:00 +0100 This report presents the results from an exploratory study in 2016 on clear communication of scientific assessment results. It had a specific focus on the communication of scientific uncertainties in EFSA scientific opinions. Qualitative methods were applied to the design and communication of an opinion summary and uncertainty statements related to that opinion, and to collect evidence on how different stakeholder groups responded to them. The study tested t...

Europe - EFSA - European Food Safety Authority Publications

25-10-2018

Safety of zinc chelate of methionine sulfate for the target species

Safety of zinc chelate of methionine sulfate for the target species

Published on: Wed, 24 Oct 2018 00:00:00 +0200 Zinc chelate of methionine sulfate is intended to be used as a nutritional additive (functional group: compounds of trace elements). The additive is zinc chelated with methionine in a molar ratio 1:1. It is intended to supply zinc as a nutritional additive to all animal species/categories. In 2017, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of zinc chelate of methionine su...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 Revision 1 (FGE.200 Rev1). In FGE.200, genotoxicity studies were provided for one representative substance, namely hex‐2(trans)‐enal [FL‐no: 05.073], and for other two substances in the same subgroup, namely 2‐dodecenal [FL‐no: 05.03...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Abond Group Inc. recalls Tubeez Baby Bath Support

Abond Group Inc. recalls Tubeez Baby Bath Support

The bath support’s suction cups may not adhere to the bath surface, making it unstable and cause it to possibly tip over while in use. In addition, an infant can slip underneath the front support bar and become lodged under water posing a drowning hazard.

Health Canada

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

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

12-9-2018

Food chemical occurrence data: nominations open for stakeholder group

Food chemical occurrence data: nominations open for stakeholder group

Food chemical occurrence data: nominations open for stakeholder group

Europe - EFSA - European Food Safety Authority Press Releases & News Stories

11-9-2018

Risk ranking of chemical and microbiological hazards in food

Risk ranking of chemical and microbiological hazards in food

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Risk ranking is a versatile tool used to prioritise activities performed by public health regulatory bodies. It also allows efficient communication between all stakeholders in the process of risk analysis. However, risk ranking methods are still not optimal. Because of the different approaches employed in the risk assessment of microbiological agents and chemicals, it is difficult to rank them together using the same metrics. In our work, we first discuss di...

Europe - EFSA - European Food Safety Authority Publications

4-9-2018

BPA update: working group to start reviewing new studies

BPA update: working group to start reviewing new studies

BPA update: working group to start reviewing new studies

Europe - EFSA - European Food Safety Authority Press Releases & News Stories

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

30-8-2018

Jean Coutu Group recalls ibiZ Portable USB Wall Chargers

Jean Coutu Group recalls ibiZ Portable USB Wall Chargers

The chargers can overheat and melt, posing afire and burnhazard.

Health Canada

29-8-2018

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Published on: Thu, 16 Aug 2018 00:00:00 +0200 4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the avai...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Published on: Mon, 13 Aug 2018 00:00:00 +0200 EFSA was requested by the European Commission to provide scientific assistance under Article 31 of Regulation (EC) No 178/2002 regarding the evaluation of data concerning the necessity of bromoxynil as a herbicide to control a serious danger to plant health which cannot be contained by other available means including non‐chemical methods, in accordance with Article 4(7) of Regulation (EC) No 1107/2009. In this context, EFSA organised a commenting phase with ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

10-8-2018

Recall Re-Announcement: Unitary Products Group of York International Corp. recalls Coleman, Coleman Evcon and Red T brand furnaces

Recall Re-Announcement: Unitary Products Group of York International Corp. recalls Coleman, Coleman Evcon and Red T brand furnaces

The furnaces can overheat causing the heat exchanger to crack, burn-through and in extreme cases cause furnace wrapper burn-through. This can lead to heating and possible burning of the drywall and other combustibles adjacent to the furnace, which poses a risk of significant property damage, personal injury or death.

Health Canada

7-8-2018

Recall Re-Announcement:Unitary Products Group of York International Corp. recallsColeman, Coleman Evcon and Red T brand furnaces

Recall Re-Announcement:Unitary Products Group of York International Corp. recallsColeman, Coleman Evcon and Red T brand furnaces

The furnaces can overheat causing the heat exchanger to crack, burn-through and in extreme cases cause furnace wrapper burn-through. This can lead to heating and possible burning of the drywall and other combustibles adjacent to the furnace, which poses a risk of significant property damage, personal injury or death.

Health Canada

17-7-2018

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA today confirmed a voluntary recall to the consumer / user level of 29 lots of single and 51 lots of combination valsartan medicines distributed under the Actavis label in the U.S. due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceutical. The impurity detected in the API is N- nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking wat...

FDA - U.S. Food and Drug Administration

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

19-6-2018

Mine Safety Appliances Company LLC recalls MSA Nuevo Wrap Safety Glasses

Mine Safety Appliances Company LLC recalls MSA Nuevo Wrap Safety Glasses

Testing by the CSA Group has shown that glasses distributed between October 2017 and April 2018 do not comply with the side impact requirements of the safety standard for eye and face protectors. The affected safety glasses may not provide adequate protection against side impact, posing a risk of eye injury.

Health Canada

8-6-2018

Orphan designation:  Mepolizumab,  for the: Treatment of Churg-Strauss syndrome

Orphan designation: Mepolizumab, for the: Treatment of Churg-Strauss syndrome

On 12 March 2013, orphan designation (EU/3/13/1116) was granted by the European Commission to Glaxo Group Ltd, United Kingdom, for mepolizumab for the treatment of Churg-Strauss syndrome.

Europe - EMA - European Medicines Agency

29-10-2018

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Active substance: clopidogrel / acetylsalicylic acid) - Centralised - 2-Monthly update - Commission Decision (2018)7249 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1144/WS1433/0051

Europe -DG Health and Food Safety

25-10-2018

Canigen L4 (Intervet International B.V.)

Canigen L4 (Intervet International B.V.)

Canigen L4 (Active substance: Leptospira interrogans serogroup Canicola serovar Portland-vere/Leptospira interrogans serogroup Icterohaemorrhagiae serovar Copenhageni/Leptospira interrogans serogroup Australis serovar Bratislava/Leptospira kirschneri serogroup Grippotyphosa serovar Dadas) - Centralised - Yearly update - Commission Decision (2018)7138 of Thu, 25 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Actavis (Actavis Group PTC ehf.)

Zoledronic acid Actavis (Actavis Group PTC ehf.)

Zoledronic acid Actavis (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6488 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

24-9-2018

Karvezide (Sanofi-Aventis groupe)

Karvezide (Sanofi-Aventis groupe)

Karvezide (Active substance: Irbesartan / hydrochlorothiazide) - Centralised - Yearly update - Commission Decision (2018)6222 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

21-9-2018

Scientific guideline:  Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health, draft: consultation open

Scientific guideline: Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health, draft: consultation open

The objective of this document is to review available information on the use of aminopenicillins and their beta-lactamase inhibitor combinations in veterinary medicines in the EU, their effect on the emergence of antimicrobial resistance (AMR) and the potential impact of resistance on human and animal health. The document provides information for the risk profiling, as recommended by the Antimicrobial Advice ad hoc Expert Group (AMEG) of the EMA.

Europe - EMA - European Medicines Agency

17-9-2018

 European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep

European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep

This joint Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) meeting will include results of the 2017 EMA perception survey. EMA regulatory science to 2025 will be discussed together with updates on Good Pharmacovigilance Practices (GVP). The Topic Group on Digital media and health will feedback to the working parties’ members. Participants will also receive an update on ongoing work on electronic product information and on availability of authorised med...

Europe - EMA - European Medicines Agency

11-9-2018

 Risk assessment guideline focus group meeting, European Medicines Agency, London, UK, From: 19-Sep-2018, To: 19-Sep-2018

Risk assessment guideline focus group meeting, European Medicines Agency, London, UK, From: 19-Sep-2018, To: 19-Sep-2018

The Antimicrobials Working Party of the European Medicines Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) is holding a focus group meeting with stakeholders to discuss the revision of the antimicrobial veterinary medicinal product risk assessment guideline, following a public consultation on the draft revised guideline ending on 31 October 2018. The meeting will focus on topics identified during this public consultation. This guideline aims to provide guidance to marketing authorisat...

Europe - EMA - European Medicines Agency

11-9-2018

 Focus group meeting  on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

Focus group meeting on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

This meeting will allow a direct exchange of views between the Agency’s working party and stakeholders on its draft reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation (EMA/CVMP/849775/2017). It complements the public consultation on this reflection paper ending on 31 January 2019. The reflection paper follows considerations in the report on a pilot project that aimed to develop and test non-experimental appr...

Europe - EMA - European Medicines Agency

7-9-2018

 European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting, European Medicines Agency, London, UK, From: 08-Jun-2018, To: 08-Jun-2018

European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting, European Medicines Agency, London, UK, From: 08-Jun-2018, To: 08-Jun-2018

The 2018 face-to-face meeting of Enpr-EMA networks and coordinating members takes place after the annual open workshop on 8 June. The networks meeting will focus on the outcome of the 2018 annual workshop of the 7 June and the action plan for 2018/2019.

Europe - EMA - European Medicines Agency

7-9-2018

 2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 07-Jun-2018, To: 07-Jun-2018

2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 07-Jun-2018, To: 07-Jun-2018

Enpr-EMA will hold its tenth annual workshop on 7-8 June 2018 at EMA. The workshop brings relevant stakeholders together to discuss requirements, barriers and opportunities for the conduct of high-quality clinical studies in children. The overall theme of this year’s workshop will be a ‘holistic approach to paediatric research’. Highlights of this year’s workshop include: i) short perspectives of the various stakeholders involved in paediatric research (patient/young people advisory groups, research netw...

Europe - EMA - European Medicines Agency

3-9-2018

TGA-Industry Working Group on Good Manufacturing Practice (GMP) (TIWGG)

TGA-Industry Working Group on Good Manufacturing Practice (GMP) (TIWGG)

New TIWGG meeting summaries now available

Therapeutic Goods Administration - Australia

18-8-2018

EU/3/16/1645 (Salzman Group Ltd)

EU/3/16/1645 (Salzman Group Ltd)

EU/3/16/1645 (Active substance: Cannabidiol) - Transfer of orphan designation - Commission Decision (2018)4806 of Sat, 18 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/248/15/T/01

Europe -DG Health and Food Safety

6-8-2018

Insulin lispro Sanofi (Sanofi-Aventis groupe)

Insulin lispro Sanofi (Sanofi-Aventis groupe)

Insulin lispro Sanofi (Active substance: insulin lispro) - Centralised - Yearly update - Commission Decision (2018)5375 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

1-8-2018

Nimenrix (Pfizer Europe MA EEIG)

Nimenrix (Pfizer Europe MA EEIG)

Nimenrix (Active substance: Meningococcal group A, C, W-135 and Y conjugate vaccine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5220 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2226/T/80

Europe -DG Health and Food Safety

23-7-2018

Trobalt (Glaxo Group Ltd)

Trobalt (Glaxo Group Ltd)

Trobalt (Active substance: retigabine) - Centralised - Withdrawal - Commission Decision (2018)4887 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

23-7-2018

Irbesartan Zentiva (Sanofi-Aventis groupe)

Irbesartan Zentiva (Sanofi-Aventis groupe)

Irbesartan Zentiva (Active substance: Irbesartan) - Centralised - Yearly update - Commission Decision (2018)4892 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

18-7-2018

HSCC announced today a new workstream, conducted under the Task Group, that will discuss and seek input on a software bill of materials (SBOM) for medical devices. SBOMs can ensure that users have better understanding of what software elements are in a me

HSCC announced today a new workstream, conducted under the Task Group, that will discuss and seek input on a software bill of materials (SBOM) for medical devices. SBOMs can ensure that users have better understanding of what software elements are in a me

HSCC announced today a new workstream, conducted under the Task Group, that will discuss and seek input on a software bill of materials (SBOM) for medical devices. SBOMs can ensure that users have better understanding of what software elements are in a medical device.

FDA - U.S. Food and Drug Administration

18-7-2018

THREAD: We’re proud to work with the public-private Healthcare Sector Coordinating Council’s Medical Technology & Health IT Task Group to address @HHSgov Cybersecurity Task Force Report recommendations related to medical device cybersecurity:  https://hea

THREAD: We’re proud to work with the public-private Healthcare Sector Coordinating Council’s Medical Technology & Health IT Task Group to address @HHSgov Cybersecurity Task Force Report recommendations related to medical device cybersecurity: https://hea

THREAD: We’re proud to work with the public-private Healthcare Sector Coordinating Council’s Medical Technology & Health IT Task Group to address @HHSgov Cybersecurity Task Force Report recommendations related to medical device cybersecurity: https://healthsectorcouncil.org/health-sector-mobilizes-against-cyber-threats/ …

FDA - U.S. Food and Drug Administration

18-7-2018

EU/3/16/1718 (Salzman Group Ltd)

EU/3/16/1718 (Salzman Group Ltd)

EU/3/16/1718 (Active substance: Cannabidiol) - Transfer of orphan designation - Commission Decision (2018)4807 of Wed, 18 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/110/16/T/01

Europe -DG Health and Food Safety

17-7-2018

Karvea (Sanofi-Aventis groupe)

Karvea (Sanofi-Aventis groupe)

Karvea (Active substance: Irbesartan) - Centralised - Yearly update - Commission Decision (2018)4781 of Tue, 17 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

International work-sharing pilot - Apalutamide (Erlyand)

International work-sharing pilot - Apalutamide (Erlyand)

Apalutamide (Erlyand) is the first medicine approved via ACSS Consortium’s NCE working group

Therapeutic Goods Administration - Australia

3-7-2018

Revinty Ellipta (Glaxo Group Ltd)

Revinty Ellipta (Glaxo Group Ltd)

Revinty Ellipta (Active substance: fluticasone furoate / vilanterol) - Corrigendum - Commission Decision (2014)3040 of Tue, 03 Jul 2018

Europe -DG Health and Food Safety

3-7-2018

Relvar Ellipta (Glaxo Group Ltd)

Relvar Ellipta (Glaxo Group Ltd)

Relvar Ellipta (Active substance: fluticasone furoate/vilanterol) - Corrigendum - Commission Decision (2013)8089 of Tue, 03 Jul 2018

Europe -DG Health and Food Safety

19-6-2018

Iscover (Sanofi-Aventis groupe)

Iscover (Sanofi-Aventis groupe)

Iscover (Active substance: Clopidogrel) - Centralised - Yearly update - Commission Decision (2018)3888 of Tue, 19 Jun 2018

Europe -DG Health and Food Safety

14-6-2018

Incruse (Glaxo Group Ltd)

Incruse (Glaxo Group Ltd)

Incruse (Active substance: umeclidinium bromide) - Centralised - Yearly update - Commission Decision (2018)3855 of Thu, 14 Jun 2018

Europe -DG Health and Food Safety

14-6-2018

ACSS public statement, 27-28 October 2017

ACSS public statement, 27-28 October 2017

ACSS Consortium Generic Medicines Working Group public statement for Brazil meeting, October 2017

Therapeutic Goods Administration - Australia

11-6-2018

Bexsero (GlaxoSmithKline Vaccines S.r.l.)

Bexsero (GlaxoSmithKline Vaccines S.r.l.)

Bexsero (Active substance: Meningococcal group B Vaccine (rDNA, component, adsorbed)) - Centralised - 2-Monthly update - Commission Decision (2018)3769 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2333/II/59

Europe -DG Health and Food Safety

30-5-2018

AUBAGIO (Sanofi-Aventis groupe)

AUBAGIO (Sanofi-Aventis groupe)

AUBAGIO (Active substance: Teriflunomide) - Centralised - Renewal - Commission Decision (2018)3467 of Wed, 30 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2514/R/16

Europe -DG Health and Food Safety

29-5-2018

EU/3/18/2026 (Alnylam UK Limited)

EU/3/18/2026 (Alnylam UK Limited)

EU/3/18/2026 (Active substance: Synthetic double-stranded siRNA oligonucleotide targeted against transthyretin mRNA, with six phosphorothioate linkages in the backbone, and nine 2'-fluoro and thirty-five 2'-O-methyl nucleoside residues in the sequence, which is covalently linked via a phosphodiester group to a ligand containing three N-acetylgalactosamine residues) - Orphan designation - Commission Decision (2018)3394 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/019/18

Europe -DG Health and Food Safety