Rivastigmine 3M Health Care Ltd

Glavna informacija

  • Trgovački naziv:
  • Rivastigmine 3M Health Care Ltd
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Rivastigmine 3M Health Care Ltd
    Europska Unija
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Terapijska grupa:
  • Transdermalni flaster
  • Područje terapije:
  • Alzheimerova bolest
  • Terapijske indikacije:
  • Simptomatsko liječenje blage do umjereno teške Alzheimerove demencije.

Druge informacije

Status

  • Izvor:
  • EMA - European Medicines Agency
  • Status autorizacije:
  • povučen
  • Broj odobrenja:
  • EMEA/H/C/003824
  • Datum autorizacije:
  • 03-04-2014
  • EMEA koda:
  • EMEA/H/C/003824
  • Zadnje ažuriranje:
  • 04-03-2018

Izvješće o ocjeni javnog

EMA/58565/2014

EMEA/H/C/003824

EPAR, sažetak za javnost

Rivastigmine 3M Health Care Ltd

rivastigmin

Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Rivastigmine 3M

Health Care Ltd. Objašnjava kako je Agencija ocijenila lijek da bi preporučila njegovo odobrenje u EU-u

te uvjete za njegovu primjenu. Svrha sažetka nije davati praktične savjete o korištenju lijeka

Rivastigmine 3M Health Care Ltd.

Praktične informacije o korištenju lijeka Rivastigmine 3M Health Care Ltd pročitajte u uputi o lijeku,

odnosno obratite se svom liječniku ili ljekarniku.

Što je Rivastigmine 3M Health Care Ltd i za što se koristi?

Rivastigmine 3M Health Care Ltd je lijek koji sadrži djelatnu tvar rivastigmin. Rivastigmine 3M Health

Care Ltd koristi se za liječenje bolesnika oboljelih od blage do umjereno teške Alzheimerove demencije,

progresivnog poremećaja mozga koji postepeno utječe na pamćenje. intelektualnu sposobnost i

ponašanje.

Rivastigmine 3M Health Care Ltd je „generički lijek”. To znači da je Rivastigmine 3M Health Care Ltd

sličan „referetnom lijeku” koji je već odobren u Europskoj uniji (EU) naziva Exelon. Više informacija o

biosličnim lijekovima potražite u dokumentu s pitanjima i odgovorima ovdje.

Kako se Rivastigmine 3M Health Care Ltd koristi?

Rivastigmine 3M Health Care Ltd izdaje se samo na liječnički recept i dostupan je u obliku

transdermalnih flastera, koji otpuštaju 4,6 ili 9,5 mg rivastigmina kroz kožu tijekom 24 sata.

Liječenje lijekom Rivastigmine 3M Health Care Ltd treba započeti i nadgledati liječnik s iskustvom u

dijagnosticiranju i liječenju Alzheimerove demencije. Liječenje treba započeti jedino ako postoji

njegovatelj koji će redovito davati i pratiti uzimanje lijeka Rivastigmine 3M Health Care Ltd od strane

bolesnika. Liječenje treba nastaviti dokle god bolesnik od toga ima terapijsku korist, no doza se može

smanjiti ili liječenje treba prekinuti ako se pojave nuspojave u bolesnika.

+44 (0)20 7418 8416

© European Medicines Agency, 2014. Reproduction is authorised provided the source is acknowledged.

Lijek više nema odobrenje za stavljanje u promet

Liječenje se započinje flasterom od 4,6 mg/24 h. Nakon najmanje četiri tjedna liječenja te ako se lijek

dobro podnosi, dozu od 4,6 mg/24 h potrebno je povećati na 9,5 mg/24 h. Liječenje treba nastaviti

dokle god bolesnik od toga ima terapijsku korist. Flasteri se nanose na čistu, suhu, neoštećenu kožu na

leđima, nadlaktici ili prsima, na kojoj nema dlaka, a mijenjaju se svaka 24 sata. Ne smiju se staviti na

nadraženu ili crvenu kožu, na bedro ili abdomen (trbuh) ili mjesta gdje dolazi do trenja uskom

odjećom. Flasteri se mogu nositi tijekom kupanja i toplog vremena. Flasteri se ne smiju rezati na

manje komade. Bolesnici mogu prijeći s terapije rivastigmin kapsulama ili oralnom otopinom na

flastere. Potpune informacije dostupne su u sažetku opisa svojstava lijeka (također dio EPAR-a).

Kako djeluje Rivastigmine 3M Health Care Ltd?

U bolesnika koji boluju od Alzheimerove demencije, određene živčane stanice u mozgu umiru, što

rezultira niskim razinama neurotransmitera acetilkolina (tvari koja omogućuje živčanim stanicama

međusobnu komunikaciju).

Djelatna tvar lijeka Rivastigmine 3M Health Care Ltd, rivastigmin djeluje blokirajući enzime koji

razgrađuju acetilkolin: acetilkolinesterazu i butirilkolinesterazu. Blokirajući ove enzime, Rivastigmine

3M Health Care Ltd omogućuje povišenje razina acetilkolina u mozgu, pomažući pri smanjivanju

simptoma ing to Alzheimerove demencije.

Kako se ispitivao lijek Rivastigmine 3M Health Care Ltd?

Budući da je Rivastigmine 3M Health Care Ltd generički lijek, ispitivanja na ljudima ograničena su na

testiranja kojima se utvrdila bioekvivaletnost s referentnim lijekom, Exelon. Dva lijeka su

bioekvivalenti ako stvaraju iste razine djelatne tvari u tijelu.

Koje su koristi i rizici povezani s lijekom Rivastigmine 3M Health Care Ltd?

Budući da je Rivastigmine 3M Health Care Ltd generički lijek, te je bioekvivalent s referentnim lijekom,

smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.

Zašto je lijek Rivastigmine 3M Health Care Ltd odobren?

Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji zaključilo je da je Rivastigmine 3M

Health Care Ltd dokazano usporediva lijeku Exelon u skladu sa zahtjevima EU. Stoga je CHMP

mišljenja da, kao i u slučaju lijeka Exelon, koristi od lijeka Rivastigmine 3M Health Care Ltd nadmašuju

s njim povezane rizike i preporučilo je njegovo odobrenje za korištenje u Europskoj uniji.

Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita

primjena lijeka Rivastigmine 3M Health Care Ltd?

Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Rivastigmine

3M Health Care Ltd. Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku, za

lijek Rivastigmine 3M Health Care Ltd uključene su sigurnosne informacije, uključujući odgovarajuće

mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju primjenjivati.

Dodatne informacije možete pronaći u sažetku plana upravljanja rizikom

Ostale informacije o lijeku Rivastigmine 3M Health Care Ltd

Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Rivastigmine 3M Health Care

Ltd vrijedi na prostoru Europske unije od 03. travnja 2014.

Rivastigmine 3M Health Care Ltd

EMA/58565/2014

Stranica 2/3

Lijek više nema odobrenje za stavljanje u promet

Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek Rivastigmine 3M

Health Care Ltd može se naći na internetskim stranicama Agencije:

ema.europa.eu/Find

medicine/Human medicines/European public assessment reports. Više informacija o liječenju lijekom

Rivastigmine 3M Health Care Ltd pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom

liječniku ili ljekarniku.

Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za referenti lijek može se naći

na internetskim stranicama Agencije.

Sažetak je posljednji put obnovljen 04.2014.

Rivastigmine 3M Health Care Ltd

EMA/58565/2014

Stranica 3/3

Lijek više nema odobrenje za stavljanje u promet

Uputu o lijeku

B. UPUTA O LIJEKU

Lijek više nema odobrenje za stavljanje u promet

Uputa o lijeku: Informacija za korisnika

Rivastigmin 3M Health Care Ltd. 4,6 mg/24 h transdermalni flaster

Rivastigmin 3M Health Care Ltd. 9,5 mg/24 h transdermalni flaster

rivastigmin

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

važne podatke.

Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.

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

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, ljekarnika ili medicinsku

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

Što se nalazi u ovoj uputi:

Što je Rivastigmin 3M Health Care Ltd. i za što se koristi

Što morate znati prije nego počnete primjenjivati Rivastigmin 3M Health Care Ltd.

Kako primjenjivati Rivastigmin 3M Health Care Ltd.

Moguće nuspojave

Kako čuvati Rivastigmin 3M Health Care Ltd.

Sadržaj pakiranja i druge informacije

1.

Što je Rivastigmin 3M Health Care Ltd. i za što se koristi

Djelatna tvar Rivastigmina 3M Health Care Ltd. je rivastigmin.

Rivastigmin pripada skupini tvari koje se nazivaju inhibitori kolinesteraze. U bolesnika s

Alzheimerovom demencijom, određene živčane stanice u mozgu odumiru, što ima za posljedicu nisku

koncentraciju neurotransmitera acetilkolina (tvari koja omogućuje živčanim stanicama da međusobno

komuniciraju). Rivastigmin djeluje tako da blokira enzime koji razgrađuju acetilkolin:

acetilkolinesterazu i butirilkolinesterazu. Blokiranjem tih enzima Rivastigmin 3M Health Care Ltd.

omogućava povećavanje koncentracije acetilkolina u mozgu te tako pomaže u smanjivanju simptoma

Alzheimerove bolesti.

Rivastigmin 3M Health Care Ltd. se primjenjuje u liječenju poremećaja pamćenja u odraslih bolesnika

s blagom do umjerenom Alzheimerovom demencijom, progresivnim poremećaj

em mozga koji

postupn

o utječe na pamćenje, intelektualne sposobnos

ti i ponašanje.

2.

Što morate znati prije nego počnete primjenjivati Rivastigmin 3M Health Care Ltd.

Nemojte primjenjivati Rivastigmin 3M Health Care Ltd.

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

Ako ste ikada imali alergijsku reakciju na sličnu vrstu lijeka (derivate karbamata).

ako imate kožnu reakciju koja se širi izvan područja pokrivenog flasterom, ako postoji

intenzivnija lokalna reakcija (poput mjehurića, pojačane upale kože, oticanja) te ako se one ne

povuku unutar 48 sati od uklanjanja transdermalnog flastera.

Ako se ovo odnosi na Vas, obratite se svom liječniku i ne koristite Rivastigmin 3M Health Care Ltd.

transdermalne flastere.

Upozorenja i mjere opreza

Obratite se svom liječniku prije nego primijenite Rivastigmin 3M Health Care Ltd.:

ako imate ili ste imali nepravilne otkucaje srca.

Lijek više nema odobrenje za stavljanje u promet

ako imate ili ste imali aktivni čir želuca.

ako imate ili ste imali otežano mokrenje.

ako imate ili ste imali napadaje.

ako imate ili ste imali astmu ili tešku bolest dišnih puteva.

ako imate drhtavicu.

ako imate malu tjelesnu težinu.

ako imate probavne reakcije poput osjećaja mučnine, povraćanje i proljeva. Možete dehidrirati

(izgubiti previše tekućine) ako povraćanje ili proljev potraju.

ako imate oštećenu funkciju jetre.

Ako se bilo što od navedenog odnosi na Vas, možda će Vas liječnik pobliže pratiti dok primjenjujete

ovaj lijek.

Ako nekoliko dana niste stavljali flaster, sljedeći flaster nemojte stavljati dok se ne posavjetujete sa

svojim liječnikom.

Primjena u djece i adolescenata

Nema relevantne primjene Rivastigmina 3M Health Care Ltd. u pedijatrijskoj populaciji u liječenju

Alzheimerove bolesti.

Drugi lijekovi i Rivastigmin 3M Health Care Ltd.

Molimo obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti

bilo koje druge lijekove.

Rivastigmin 3M Health Care Ltd. može utjecati na antikolinergičke lijekove (lijekovi koji se koriste za

ublažavanje grčeva ili spazama u želucu (npr. diciklomin), za liječenje Parkinsonove bolesti (npr.

amantadin) ili za sprječavanje putne mučnine (npr. difenhidramin, skopolamin ili meklizin).

Ako se, tijekom primjene Rivastigmin 3M Health Care Ltd. transdermalnih flastera, morate podvrgnuti

operaciji obavijestite svog liječnika da ih koristite jer oni mogu tijekom anestezije pojačati učinke

nekih mišićnih relaksansa.

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 primijenite ovaj lijek.

Ako ste trudni, potrebno je ocijeniti koristi od uporabe Rivastigmin 3M Health Care Ltd.

transdermalnih flastera u usporedbi s mogućim učincima na Vaše nerođeno dijete. Rivastigmin 3M

Health Care Ltd. treba izbjegavati tijekom trudnoće, osim

ako njegova primjena nije doista nužna.

Ne smijete dojiti tijekom liječenja Rivastigmin 3M Health Care Ltd. transdermalnim flasterima.

Upravljanje vozilima i strojevima

Liječnik će Vas obavijestiti dopušta li Vam bolest da sigurno upravljate vozilima i strojevima.

Rivastigmin 3M Health Care Ltd. transdermalni flasteri mogu uzrokovati nesvjesticu ili jaku

smetenost. Ako se osjećate slabo ili smeteno nemojte upravljati vozilima i strojevima niti izvoditi bilo

kakve zadatke koji zahtijevaju pozornost.

3.

Kako primjenjivati Rivastigmin 3M Health Care Ltd.

Uvijek primijenite ovaj lijek točno onako kako je opisano u ovoj uputi i kako Vam je rekao Vaš

liječnik. Provjerite sa svojim liječnikom, ljekarnikom ili medicinskom sestrom ako niste sigurni

VAŽNO:

Uklonite prethodni flaster prije stavljanja JEDNOG novog flastera.

Samo jedan flaster dnevno.

Ne režite flaster na komadiće.

Lijek više nema odobrenje za stavljanje u promet

Dlanom pritisnite flaster čvrsto na mjesto i držite tako najmanje 30 sekundi.

Kako započeti liječenje

Liječnik će Vam reći koji je Rivastigmin 3M Health Care Ltd. transdermalni flaster najprikladniji za

Vas.

Liječenje obično počinje Rivastigminom 3M Health Care Ltd. 4,6 mg/24 h.

Preporučena dnevna doza je Rivastigmin 3M Health Care Ltd. 9,5 mg/24 h. Ako se dobro

podnosi, liječnik može razmotriti povećavanje doze na 13,3 mg/24 h (3M Health Care Ltd.

trenutno nije u mogućnosti ponuditi ovu visku dozu, no ona može biti dostupna od drugih

nositelja odobrenja).

Smije se primijeniti samo jedan Rivastigmin 3M Health Care Ltd. flaster koji je potrebno

zamijeniti novim flasterom nakon 24 sata.

Tijekom liječenja liječnik Vam može prilagoditi dozu prema Vašim individualnim potrebama.

Ako niste stavljali flaster tri dana, prije nego što stavite sljedeći flaster posavjetujte se sa svojim

liječnikom. Liječenje transdermalnim flasterom može se nastaviti s istom dozom ako liječenje nije bilo

prekinuto dulje od tri dana. U suprotnom, liječnik će ponovno započeti Vaše liječenje Rivastigminom

3M Health Care Ltd. 4,6 mg/24 h.

Rivastigmin 3M Health Care Ltd. se može koristiti uz hranu, piće i alkohol.

Gdje treba postaviti Rivastigmin 3M Health Care Ltd. transdermalni flaster

Prije postavljanja flastera provjerite da Vam je koža čista, suha i bez dlaka, bez pudera, ulja,

hidratantne kreme ili losiona koji mogu spriječiti pravilno lijepljenje flastera za kožu, bez

posjekotina, osipa i/ili nadražaja.

Pažljivo uklonite postojeći flaster (ako ga imate) prije stavljanja novoga.

Više flastera

zalijepljenih na Vašem tijelu moglo bi Vas izložiti prevelikoj količini ovog lijeka, što

potencijalno može biti opasno.

Stavite

JEDAN

flaster na dan na

SAMO JEDNO

od m

ogućih mjesta prikazani

h na

dijagramima u nastavku:

Svaka 24 sata uklonite prethodni flaster prije nego što

stavite JEDAN novi flaster na SAMO JEDNO od sljedećih

mogućih mjesta.

lijeva nadlaktica

ili

desna nadlaktica

gornji dio lijevog

ili

desnog dijela prsnog koša

(izbjegavati dojke)

Lijek više nema odobrenje za stavljanje u promet

lijeva

ili

desna strana gornjeg dijela leđa

lijeva

ili

desna strana donjeg dijela leđa

Kada zamjenjujete flaster morate ukloniti flaster od prethodnog dana prije nego što stavite novi, svaki

put na drugo mjesto na koži (primjerice, jedan dan na desnu stranu tijela, zatim na lijevu stranu

sljedeći dan, te jedan dan na gornji dio tijela, pa na donji dio tijela drugi dan). Nemojte stavljati novi

flaster na isto mjesto na koži unutar 14 dana.

Kako staviti Rivastigmin 3M Health Care Ltd. transdermalni flaster

Rivastigmin 3M Health Care Ltd. flasteri su prozirni do zamućeni, plastični flasteri koji se lijepe na

kožu. Svaki je flaster zapakiran u vrećicu koja ga štiti do trenutka kada ste spremni postaviti ga. Ne

otvarajte vrećicu i ne vadite flaster sve do trenutka primjene.

Pažljivo skinite postojeći flaster prije nego što postavite novi.

Za bolesnike koji po prvi put počinju liječenje i za bolesnike koji

ponovno počinju primjenjivati Rivastigmin 3M Health Care Ltd.

nakon prekida liječenja, počnite od druge slike.

Svaki je flaster zapakiran u vlastitu zaštitnu vrećicu.

Vrećicu otvorite tek kada ste spremni postaviti flaster.

Otvorite vrećicu gdje je naznačeno i izvadite flaster iz

vrećice. Vrećica se može otvoriti na dva mjesta.

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Zaštitna folija pokriva ljepljivu stranu flastera.

Povucite jednu stranu zaštitne folije i ne dodirujte prstima

ljepljivi dio flastera.

Stavite ljepljivu stranu flastera na gornji ili donji dio leđa,

nadlakticu ili prsa i zatim povucite drugi dio zaštitne folije.

Zatim dlanom čvrsto pritisnite flaster najmanje 30 sekundi

kako biste bili sigurni da su se rubovi dobro zalijepili.

Ako će Vam to pomoći, možete na flaster napisati, primjerice,

dan u tjednu tankom kemijskom olovkom.

Flaster je potrebno stalno nostiti dok nije vrijeme da ga zamijenite novim. Možda ćete htjeti isprobati

neka druga mjesta za stavljanje novog flastera, kako biste našli ona koja su Vam najugodnija i na

kojima odjeća neće trljati flaster.

Kako skinuti Rivastigmin 3M Health Care Ltd. transdermalni flaster

Lagano povucite jedan kraj flastera kako biste ga polako skinuli s kože. Ako Vam je na koži ostalo

nešto ljepila, lagano natopite površinu toplom vodom i blagim sapunom ili ga skinite uljem za bebe.

Alkohol i druge otapajuće tekućine (skidač laka za nokte ili druga otapala) ne smiju se korisiti.

Operite ruke sapunom i vodom nakon što ste skinuli flaster. U slučaju kontakta s očima ili ako Vam se

oči zacrvene nakon rukovanja flasterom, odmah ih isperite s puno vode i zatražite savjet liječnika ako

se simptomi ne povuku.

Možete li nositi Rivastigmin 3M Health Care Ltd. transdermalni flaster dok se kupate, plivate ili

boravite na suncu?

Kupanje, plivanje ili tuširanje ne bi trebalo utjecati na flaster. Pazite da se flaster ne odlijepi

tijekom tih aktivnosti.

Ne izlažite flaster vanjskim izvorima topline (npr. prekomjernoj sunčevoj svjetlosti, sauni,

solariju) tijekom duljih vremenskih razdoblja.

Što učiniti ako se flaster odlijepi

Ako se flaster odlijepi, stavite novi do kraja dana te ga zamijenite u uobičajeno vrijeme drugi dan.

Kada i koliko dugo koristiti Rivastigmin 3M Health Care Ltd. transdermalni flaster

Da biste imali koristi od liječenja trebate stavljati novi flaster svaki dan, po mogućnosti u isto

doba dana.

Lijek više nema odobrenje za stavljanje u promet

Potrebno je primijeniti samo jedan Rivastigmin 3M Health Care Ltd. flaster koji ćete zamijeniti

novim flasterom nakon 24 sata.

Ako primijenite više Rivastigmina 3M Health Care Ltd. nego što ste trebali

Ako ste zabunom stavili više od jednog flastera, skinite sve flastere sa svoje kože i obavijestite

liječnika da ste slučajno stavili više od jednog flastera. Možda ćete trebati liječničku pomoć. Neki ljudi

koji su slučajno primijenili previše Rivastigmina 3M Health Care Ltd. su osjećali mučninu, povraćali,

imali proljev, visoki krvni tlak i halucinacije. Također može doći do usporenih otkucaja srca i

nesvjestice.

Ako ste zaboravili primijeniti Rivastigmin 3M Health Care Ltd.

Ako ustanovite da ste zaboravili staviti flaster, odmah ga stavite. Sljedeći flaster možete staviti sljedeći

dan u uobičajeno vrijeme. Nemojte staviti dva flastera kako biste nadoknadili propušteni.

Ako prestanete primjenjivati Rivastigmin 3M Health Care Ltd.

Obratite se svom liječniku ili ljekarniku ako prestanete koristiti flaster.

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.

Možda ćete češće imati nuspojave kad počnete primjenjivati svoj lijek ili kod povećanja doze. Obično

će nuspojave polako nestati nakon što se Vaše tijelo navikne na lijek.

Odmah skinite flaster i obavijestite Vašeg liječnika, ako primijetite bilo koju od navedenih

nuspojava koje mogu postati ozbiljne:

Često

(mogu se javiti u do 1 na 10 ljudi)

Gubitak apetita

Osjećaj omaglice

Osjećaj nem

ira ili pospanosti

Inkontinencija m

okraće (nemogućnost zadržavanja mokraće)

Manje često

(mogu se javiti u do 1 na 100 ljudi)

Problemi s radom srca, poput ubrzanih ili usporenih otkucaja srca

Priviđanje stvari kojih zapravo nema (halucinacije)

Čir na želucu

Dehidracija (gubitak previše tekućine)

Hiperaktivnost (visoka razina aktivnosti, nemir)

Agresija

Rijetko

(mogu se javiti u do 1 na 1000 ljudi)

Nehotično padanje

Vrlo rijetko

(mogu se javiti u do 1 na 10 000 ljudi)

Ukočenost ruku ili nogu

Drhtanje ruku

Nepoznato

(učestalost nuspojava ne može se procijeniti iz dostupnih podataka)

Alergijska reakcija na mjestu primjene flastera, kao što su mjehurići ili upala kože

Pogoršanje znakova Parkinsonove bolesti – kao što su nevoljno drhtanje, ukočenost i poteškoće

pri kretanju

Upala gušterače – znakovi uključuju ozbiljnu bol u gornjem dijelu trbuha, često praćenu

mučninom ili povraćanjem

Lijek više nema odobrenje za stavljanje u promet

Brzi ili neujednačeni otkucaji srca

Visoki krvni tlak

Napadaji

Poremećaji jetre (žutilo kože, žute bjeloočnice, abnormalno tamna mokraća ili neobjašnjiva

mučnina, povraćanje, umor i gubitak apetita)

Promijenjene vrijednosti na pretragama koje pokazuju koliko dobro radi jetra

Osjećaj nemira

Odmah skinite flaster i obavijestite svog liječnika ako primijetite bilo koju od navedenih nuspojava.

Ostale nuspojave zabilježene uz primjenu Rivastigmin 3M Health Care Ltd. kapsula ili oralne

otopine, a koje se mogu pojaviti s flasterima:

Često

(mogu se javiti u do 1 na 10 ljudi)

Prekomjerno stvaranje sline

Gubitak apetita

Osjećaj nemira

Općenito loše osjećanje

Drhtanje ili osjećaj zbunjenosti

Pojačano znojenje

Manje često

(mogu se javiti u do 1 na 100 ljudi)

Nepravilan srčani ritam (npr. ubrzan rad srca)

Poteškoće sa snom

Slučajni padovi

Rijetko

(mogu se javiti u do 1 na 1000 ljudi)

Napadaji

Čir u crijevima

Bol u prsim

a – mo

že biti uzrokovan stezanjem srca

Vrlo rijetko

(mogu se javiti u do 1 na 10 000 ljudi)

Visoki krvni tlak

Upala gušterače – znakovi uključuju jaku bol u gornjem dijelu trbuha, često s osjećajem

mučnine ili povraćanjem

Krvarenje u crijevu – prikazuje se kao krv u stolici ili kada povraćate

Priviđanje stvari koje nisu prisutne (halucinacije)

U nekih je bolesnika koji su imali izrazitu mučninu došlo do pucanja cijevi koja povezuje Vaša

usta sa želucem (jednjak)

Prijavljivanje nuspojava

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

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 Rivastigmin 3M Health Care Ltd.

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i vrećici iza

Rok valjanosti/EXP. Rok valjanosti odnosi se na zadnji dan navedenog mjeseca.

Čuvati u originalnom pakiranju radi zaštite od svjetlosti.

Ne koristiti ovaj lijek ako je flaster oštećen ili ima znakove otvaranja.

Nakon što skinete flaster presavinite ga na pola tako da su ljepljive strane okrenute prema

unutra i pritisnite ih jednu o drugu. Vratite iskorišteni flaster u vrećicu i odložite ga tako da mu

djeca nemaju pristup. Ne dodirujte oči prstima i operite ruke sapunom i vodom nakon

uklanjanja flastera. Ako se u Vašoj zajednici spaljuje kućno smeće, flaster možete baciti u

Lijek više nema odobrenje za stavljanje u promet

kućno smeće. U suprotnom vratite iskorištene flastere u ljekarnu, po mogućnosti u originalnom

pakiranju.

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

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

6.

Sadržaj pakiranja i druge informacije

Što Rivastigmin 3M Health Care Ltd. sadrži

Djelatna tvar je rivastigmin.

Rivastigmin 3M Health Care Ltd. 4,6 mg/24 h transdermalni flasteri: Jedan flaster koji

oslobađa 4,6 mg rivastigmina tijekom 24 sata ima površinu 4,15 cm

i sadrži 7,17 mg

rivastigmina.

Rivastigmin 3M Health Care Ltd. 9,5 mg/24 h transdermalni flasteri: Jedan flaster koji

oslobađa 9,5 mg rivastigmina tijekom 24 sata ima površinu 8,3 cm

i sadrži 14,33 mg

rivastigmina.

Drugi sastojci su poliester, etilvinilacetat, ljepilo od akrilatnog kopolimera i izopropil miristat.

Kako Rivastigmin 3M Health Care Ltd. izgleda i sadržaj pakiranja

Flasteri su pravokutnog oblika, zaobljenih kuteva, približnih dimenzija 2,5 cm s 1,8 cm (Rivastigmin 3M

Health Care Ltd. 4,6 mg/24 h transdermalni flaster) ili 3,5 cm s 2,6 cm (Rivastigmin 3M Health Care

Ltd. 9,5 mg/24 h transdermalni flaster).

Jedan transdermalni flaster sastoji se od tri sloja: potpornog sloja, ljepljivog sloja koji sadrži lijek i

prozirne zaštitne folije koja se može skinuti. Potporni sloj je proziran do zamućen s oznakom „R5“

(Rivastigmin 3M Health Care Ltd. 4,6 mg/24 h transdermalni flaster) ili „R10“ (Rivastigmin 3M Health

Care Ltd. 9,5 mg/24 h transdermalni flaster).

Jedan transdermalni flaster zatvoren je u jednu vrećicu. Transdermalni flasteri dostupni su u

pakiranjima koja sadrže 7, 30, 60 i 90 vrećica. Na tržištu se ne moraju nalaziti sve veličine pakiranja.

Nositelj odobrenja za stavljanje lijeka u promet

3M Health Care Limited,

1 Morley Street,

Loughborough,

Leicestershire,

LE11 1EP

Ujedinjeno Kraljevstvo

Proizvođač

Enestia

Klöcknerstraat 1

3930 Hamont-Achel

Belgija

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

lijeka u promet:

3M Health Care Limited,

1 Morley Street,

Loughborough,

Leicestershire,

LE11 1EP

Ujedinjeno Kraljevstvo

Tel: +44 (0)1509 611611

Lijek više nema odobrenje za stavljanje u promet

Ova uputa je zadnji puta revidirana u {mjesec GGGG}

Drugi izvori informacija

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

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

Lijek više nema odobrenje za stavljanje u promet

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

14-11-2018

FDA alerts doctors, patients about risk of complications when certain implanted pumps are used to deliver pain medications not approved for use with the devices

FDA alerts doctors, patients about risk of complications when certain implanted pumps are used to deliver pain medications not approved for use with the devices

FDA alerted health care providers and patients about the serious complications that can occur when using medications not approved for use with implanted pumps that deliver medication into the spinal fluid to treat or manage pain.

FDA - U.S. Food and Drug Administration

7-11-2018

Several store-brand pain or sinus relief tablets recalled because consumers may be unable to access important safety information

Several store-brand pain or sinus relief tablets recalled because consumers may be unable to access important safety information

Vita Health Products is voluntarily recalling several store-brand (Care, Exact, Life, and Pharmasave) over-the-counter drugs used for pain or sinus relief because of a labelling issue. Consumers may be unable to peel open the wrap-around label on the bottle to access the warning statements, or the label may not peel off completely, which may make it difficult to read some of the important safety information.

Health Canada

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant, Nichino Europe Co. Ltd., submitted application request to the competent national authority in the Netherlands to evaluate confirmatory data that were identified for pyraflufen‐ethyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted data were sufficient to confirm the MRLs for citrus fruits, tree nuts, pome fruits, stone fruits, table and wine grapes, curra...

Europe - EFSA - European Food Safety Authority Publications

5-10-2018

FDA allows marketing of first self-fitting hearing aid controlled by the user

FDA allows marketing of first self-fitting hearing aid controlled by the user

FDA allows marketing of a new device, the Bose Hearing Aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment (hearing loss). This is the first hearing aid authorized for marketing by the FDA that enables the user to fit, program and control the hearing aid on his or her own, without assistance from a health care provider.

FDA - U.S. Food and Drug Administration

17-9-2018

September 11, 2018: Columbus Pharmacist Sentenced for Health Care Fraud Scheme

September 11, 2018: Columbus Pharmacist Sentenced for Health Care Fraud Scheme

September 11, 2018: Columbus Pharmacist Sentenced for Health Care Fraud Scheme

FDA - U.S. Food and Drug Administration

28-8-2018

Pfizer, Inc. Issues A Voluntary Nationwide Recall Of One Lot Of Children’s Advil® Suspension Bubble Gum Flavored 4 FL OZ Bottle

Pfizer, Inc. Issues A Voluntary Nationwide Recall Of One Lot Of Children’s Advil® Suspension Bubble Gum Flavored 4 FL OZ Bottle

Pfizer Consumer Healthcare, a division of Pfizer Inc., is voluntarily recalling one lot of Children’s Advil® Suspension Bubble Gum Flavored 4 FL OZ Bottle because of customer complaints that the dosage cup provided is marked in teaspoons and the instructions on the label are described in milliliters (mL).

FDA - U.S. Food and Drug Administration

28-8-2018

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

FDA - U.S. Food and Drug Administration

17-8-2018

Temporary Total Artificial Heart Companion 2 Driver System by SynCardia Systems: Letter to Health Care Providers - Risk of Mortality and Stroke

Temporary Total Artificial Heart Companion 2 Driver System by SynCardia Systems: Letter to Health Care Providers - Risk of Mortality and Stroke

FDA has reviewed the final results from the post-approval study conducted by SynCardia Systems, LLC. for their Temporary Total Artificial Heart (TAH-t) Companion 2 Driver System (C2 Driver System). These final results indicate a higher mortality rate and higher stroke rate for patients initially supported with the C2 Driver System compared to patients initially supported with the previous generation driver, the Circulatory Support System (CSS) Console.

FDA - U.S. Food and Drug Administration

16-8-2018

August 16, 2018: Genesee County Physician and Two Others Charged with Health Care Fraud

August 16, 2018: Genesee County Physician and Two Others Charged with Health Care Fraud

August 16, 2018: Genesee County Physician and Two Others Charged with Health Care Fraud

FDA - U.S. Food and Drug Administration

8-8-2018

Risks Associated with Use of Rupture of Membranes Tests - Letter to Health Care Providers

Risks Associated with Use of Rupture of Membranes Tests - Letter to Health Care Providers

The FDA is reminding health care providers that tests to detect rupture of the amniotic membranes should not be used without other clinical assessments to make critical patient management decisions.

FDA - U.S. Food and Drug Administration

8-8-2018

FDA alerts healthcare providers, women about risks associated with improper use of rupture of membranes tests

FDA alerts healthcare providers, women about risks associated with improper use of rupture of membranes tests

FDA alerts healthcare providers, women about risks associated with improper use of rupture of membranes tests

FDA - U.S. Food and Drug Administration

2-8-2018

"Jian Pai Natural Skin Care Cream" contains antifungal drugs not listed on the label, which may pose serious health risks

"Jian Pai Natural Skin Care Cream" contains antifungal drugs not listed on the label, which may pose serious health risks

Health Canada testing of “Jian Pai Natural Skin Care Cream,” also called ‘’Yikangshuang,” found that it contains two antifungal drugs (fluconazole and miconazole) that are not listed on the product label, and may pose serious health risks.

Health Canada

13-7-2018

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. -- that is used in the manufacture of the subject product ...

FDA - U.S. Food and Drug Administration

28-6-2018

June 28, 2018: Southern District of Florida Charges 124 Individuals Responsible for $337 Million in False Billing as Part of National Healthcare Fraud Takedown

June 28, 2018: Southern District of Florida Charges 124 Individuals Responsible for $337 Million in False Billing as Part of National Healthcare Fraud Takedown

June 28, 2018: Southern District of Florida Charges 124 Individuals Responsible for $337 Million in False Billing as Part of National Healthcare Fraud Takedown

FDA - U.S. Food and Drug Administration

26-6-2018

Home Hardware Stores Ltd. recalls Home Flexible Multi-Purpose Lighter

Home Hardware Stores Ltd. recalls Home Flexible Multi-Purpose Lighter

Health Canada's sampling and evaluation program has determined that these lighters do not meet the Lighters Regulations in Canada and may pose a fire or burn hazard. Specifically the lighters:

Health Canada

19-6-2018

Various Aortic Endovascular Graft Systems: Letter to Health Care Providers - UPDATE on Type III Endoleaks

Various Aortic Endovascular Graft Systems: Letter to Health Care Providers - UPDATE on Type III Endoleaks

Based on new information, the Endologix AFX with Strata device is at greater risk for a Type III endoleak compared to other endovascular AAA graft systems.

FDA - U.S. Food and Drug Administration

12-6-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance medical product communications to support drug competition and value-based health care

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance medical product communications to support drug competition and value-based health care

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance medical product communications to support drug competition and value-based health care

FDA - U.S. Food and Drug Administration

4-6-2018

Liquid-filled Intragastric Balloons by Apollo Endosurgery and ReShape Lifesciences: Letter to Health Care Providers - New Labeling About Potential Risks

Liquid-filled Intragastric Balloons by Apollo Endosurgery and ReShape Lifesciences: Letter to Health Care Providers - New Labeling About Potential Risks

FDA has approved new labeling for the Orbera and ReShape balloon systems with more information about possible death associated with the use of these devices.

FDA - U.S. Food and Drug Administration

1-11-2018

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

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

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

FDA - U.S. Food and Drug Administration

1-11-2018

The @US_FDA warns patients & health care providers should not change drug treatment based on results from certain genetic tests w/ unapproved claims to predict a patient’s response to specific medications. Read the Safety Communication here:  https://go.u

The @US_FDA warns patients & health care providers should not change drug treatment based on results from certain genetic tests w/ unapproved claims to predict a patient’s response to specific medications. Read the Safety Communication here: https://go.u

The @US_FDA warns patients & health care providers should not change drug treatment based on results from certain genetic tests w/ unapproved claims to predict a patient’s response to specific medications. Read the Safety Communication here: https://go.usa.gov/xPysF  #MedicalDevice

FDA - U.S. Food and Drug Administration

18-10-2018

Kivexa (ViiV Healthcare BV)

Kivexa (ViiV Healthcare BV)

Kivexa (Active substance: abacavir / Lamivudine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6924 of Thu, 18 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000581/T/0076

Europe -DG Health and Food Safety

2-10-2018

Nexium Control (Pfizer Healthcare Ireland)

Nexium Control (Pfizer Healthcare Ireland)

Nexium Control (Active substance: esomeprazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6474 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002618/T/0023

Europe -DG Health and Food Safety

2-10-2018

Ritemvia (Celltrion Healthcare Hungary Kft.)

Ritemvia (Celltrion Healthcare Hungary Kft.)

Ritemvia (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)6480 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Trizivir (ViiV Healthcare BV)

Trizivir (ViiV Healthcare BV)

Trizivir (Active substance: abacavir, lamivudine, zidovudine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6483 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/338/T/108

Europe -DG Health and Food Safety

2-10-2018

Telzir (ViiV Healthcare BV)

Telzir (ViiV Healthcare BV)

Telzir (Active substance: Fosamprenavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6468 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/534/T/93

Europe -DG Health and Food Safety

2-10-2018

Celsentri (ViiV Healthcare BV)

Celsentri (ViiV Healthcare BV)

Celsentri (Active substance: maraviroc) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6467 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/811/T/56

Europe -DG Health and Food Safety

25-9-2018

Single use devices should not be reused. Your health care provider or emergency personnel may be able to assist you in obtaining a supply of single use devices during an emergency. Click the link to find out how to safely reuse multiple use devices:  http

Single use devices should not be reused. Your health care provider or emergency personnel may be able to assist you in obtaining a supply of single use devices during an emergency. Click the link to find out how to safely reuse multiple use devices: http

Single use devices should not be reused. Your health care provider or emergency personnel may be able to assist you in obtaining a supply of single use devices during an emergency. Click the link to find out how to safely reuse multiple use devices: https://go.usa.gov/xPjCj  pic.twitter.com/yVSNlc5Qb0

FDA - U.S. Food and Drug Administration

25-9-2018

Pelgraz (Accord Healthcare Limited)

Pelgraz (Accord Healthcare Limited)

Pelgraz (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)6288 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/003961/0000

Europe -DG Health and Food Safety

24-9-2018

#FDA announces the release of the Collaborative Communities Toolkit for interested stakeholder organizations to work together on healthcare challenges. Learn about the program, download the Toolkit, and submit comments:  https://go.usa.gov/xPjKX pic.twitt

#FDA announces the release of the Collaborative Communities Toolkit for interested stakeholder organizations to work together on healthcare challenges. Learn about the program, download the Toolkit, and submit comments: https://go.usa.gov/xPjKX pic.twitt

#FDA announces the release of the Collaborative Communities Toolkit for interested stakeholder organizations to work together on healthcare challenges. Learn about the program, download the Toolkit, and submit comments: https://go.usa.gov/xPjKX  pic.twitter.com/iQsKIAAQTn

FDA - U.S. Food and Drug Administration

24-9-2018

Blitzima (Celltrion Healthcare Hungary Kft.)

Blitzima (Celltrion Healthcare Hungary Kft.)

Blitzima (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)6228 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Active substance: lenalidomide) - Centralised - Authorisation - Commission Decision (2018)6237 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4857

Europe -DG Health and Food Safety

19-9-2018

 12th Pharmacovigilance stakeholder forum, European Medicines Agency, London, UK, From: 24-Sep-2018, To: 24-Sep-2018

12th Pharmacovigilance stakeholder forum, European Medicines Agency, London, UK, From: 24-Sep-2018, To: 24-Sep-2018

This forum brings together regulators with patients, healthcare professionals and industry, to take stock of what we have achieved and what needs to be the focus over the coming years.

Europe - EMA - European Medicines Agency

17-9-2018

 European Medicines Agency (EMA) Human Scientific Committees' Working Party with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 26-Sep-2018, To: 26-Sep-2018

European Medicines Agency (EMA) Human Scientific Committees' Working Party with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 26-Sep-2018, To: 26-Sep-2018

This Healthcare Professionals' Working Party (HCPWP) plenary meeting will include discussions on advances in clinical practice and the scientific and regulatory challenges. Members will also be invited to present how they are including regulatory sciences in fellowships and young researchers’ training. Feedback will be given from the representatives of the Scientific Committees.

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

7-9-2018

Newsletter:  Human medicines highlights - September 2018

Newsletter: Human medicines highlights - September 2018

This newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency.

Europe - EMA - European Medicines Agency

25-8-2018

#ICYMI This past week was Healthy Contact Lens Week. The FDA encourages everyone to take care of their contact lenses by proper cleaning, routine exams and visits, and following the FDA and @CDCgov to stay informed on contact lens safety  https://go.usa.g

#ICYMI This past week was Healthy Contact Lens Week. The FDA encourages everyone to take care of their contact lenses by proper cleaning, routine exams and visits, and following the FDA and @CDCgov to stay informed on contact lens safety https://go.usa.g

#ICYMI This past week was Healthy Contact Lens Week. The FDA encourages everyone to take care of their contact lenses by proper cleaning, routine exams and visits, and following the FDA and @CDCgov to stay informed on contact lens safety https://go.usa.gov/xUuSb  #OnePairTakeCare pic.twitter.com/hNCAOAmJVQ

FDA - U.S. Food and Drug Administration

22-8-2018

Routine eye exams and visiting your eye doctor will help ensure and maintain healthy eyes for everyone. #OnePairTakeCare #FDA #MedicalDevicepic.twitter.com/SQYFz30oFy

Routine eye exams and visiting your eye doctor will help ensure and maintain healthy eyes for everyone. #OnePairTakeCare #FDA #MedicalDevicepic.twitter.com/SQYFz30oFy

Routine eye exams and visiting your eye doctor will help ensure and maintain healthy eyes for everyone. #OnePairTakeCare #FDA #MedicalDevice pic.twitter.com/SQYFz30oFy

FDA - U.S. Food and Drug Administration

22-8-2018

Cholib (Mylan IRE Healthcare Ltd)

Cholib (Mylan IRE Healthcare Ltd)

Cholib (Active substance: fenofibrate / simvastatin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5632 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2559/T/20

Europe -DG Health and Food Safety

21-8-2018

It’s Contact Lens Health Week and the FDA is working to ensure safe and useful devices are available to patients and consumers. Check out our recent contact lens approvals:  https://go.usa.gov/xUz4M  and https://go.usa.gov/xUz4t  #OnePairTakeCarepic.twitt

It’s Contact Lens Health Week and the FDA is working to ensure safe and useful devices are available to patients and consumers. Check out our recent contact lens approvals: https://go.usa.gov/xUz4M  and https://go.usa.gov/xUz4t  #OnePairTakeCarepic.twitt

It’s Contact Lens Health Week and the FDA is working to ensure safe and useful devices are available to patients and consumers. Check out our recent contact lens approvals: https://go.usa.gov/xUz4M  and https://go.usa.gov/xUz4t  #OnePairTakeCare pic.twitter.com/PcxUGHgwoV

FDA - U.S. Food and Drug Administration

20-8-2018

Contact Lens Health Week is here and the FDA and @CDCgov are reminding you of safe measures to ensure proper use of contact lenses. Check out the CDC’s Healthy Habits Mean Healthy Eye video #OnePairTakeCarepic.twitter.com/jxiBHA3CiT

Contact Lens Health Week is here and the FDA and @CDCgov are reminding you of safe measures to ensure proper use of contact lenses. Check out the CDC’s Healthy Habits Mean Healthy Eye video #OnePairTakeCarepic.twitter.com/jxiBHA3CiT

Contact Lens Health Week is here and the FDA and @CDCgov are reminding you of safe measures to ensure proper use of contact lenses. Check out the CDC’s Healthy Habits Mean Healthy Eye video #OnePairTakeCare pic.twitter.com/jxiBHA3CiT

FDA - U.S. Food and Drug Administration

17-8-2018

Next week is Healthy Contact Week. Join the @CDCgov for a Facebook Live chat on Monday August 20th at 2 PM for a conversation on contact lens use.  http://facebook.com/CDC/   #OnePairTakeCarepic.twitter.com/7HDQYrdPBv

Next week is Healthy Contact Week. Join the @CDCgov for a Facebook Live chat on Monday August 20th at 2 PM for a conversation on contact lens use. http://facebook.com/CDC/  #OnePairTakeCarepic.twitter.com/7HDQYrdPBv

Next week is Healthy Contact Week. Join the @CDCgov for a Facebook Live chat on Monday August 20th at 2 PM for a conversation on contact lens use. http://facebook.com/CDC/  #OnePairTakeCare pic.twitter.com/7HDQYrdPBv

FDA - U.S. Food and Drug Administration

17-8-2018

#FDA issues letter to healthcare providers on the final post-approval study results & risks associated with #SynCardia TAH-t: C2 Driver System.  https://go.usa.gov/xUeYd  #MedicalDevices

#FDA issues letter to healthcare providers on the final post-approval study results & risks associated with #SynCardia TAH-t: C2 Driver System. https://go.usa.gov/xUeYd  #MedicalDevices

#FDA issues letter to healthcare providers on the final post-approval study results & risks associated with #SynCardia TAH-t: C2 Driver System. https://go.usa.gov/xUeYd  #MedicalDevices

FDA - U.S. Food and Drug Administration

8-8-2018

Letter to Health Care Providers: Risks Associated with Use of Rupture of Membrane Tests   https://go.usa.gov/xUAt4  #MedicalDevice #FDA

Letter to Health Care Providers: Risks Associated with Use of Rupture of Membrane Tests https://go.usa.gov/xUAt4  #MedicalDevice #FDA

Letter to Health Care Providers: Risks Associated with Use of Rupture of Membrane Tests https://go.usa.gov/xUAt4  #MedicalDevice #FDA

FDA - U.S. Food and Drug Administration

7-8-2018

Accofil (Accord Healthcare Limited)

Accofil (Accord Healthcare Limited)

Accofil (Active substance: Filgrastim) - Centralised - Yearly update - Commission Decision (2018)5428 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

7-8-2018

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Active substance: memantine) - Centralised - Renewal - Commission Decision (2018)5421 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2766/R/10

Europe -DG Health and Food Safety

6-8-2018

Human medicines highlights - August 2018

Human medicines highlights - August 2018

This newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency.

Europe - EMA - European Medicines Agency

6-8-2018

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)5386 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

23-7-2018

Rituzena (Celltrion Healthcare Hungary Kft.)

Rituzena (Celltrion Healthcare Hungary Kft.)

Rituzena (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)4884 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

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

13-7-2018

Vizamyl (GE Healthcare Ltd)

Vizamyl (GE Healthcare Ltd)

Vizamyl (Active substance: flutemetamol (18F)) - Centralised - Yearly update - Commission Decision (2018)4614 of Fri, 13 Jul 2018

Europe -DG Health and Food Safety

10-7-2018

Human medicines highlights - July 2018

Human medicines highlights - July 2018

This newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency.

Europe - EMA - European Medicines Agency

4-7-2018

Docetaxel Accord (Accord Healthcare Limited)

Docetaxel Accord (Accord Healthcare Limited)

Docetaxel Accord (Active substance: Docetaxel) - Centralised - Yearly update - Commission Decision (2018)4341 of Wed, 04 Jul 2018

Europe -DG Health and Food Safety

3-7-2018

Temozolomide Accord (Accord Healthcare Limited)

Temozolomide Accord (Accord Healthcare Limited)

Temozolomide Accord (Active substance: temozolomide) - Centralised - Yearly update - Commission Decision (2018) 4240 of Tue, 03 Jul 2018

Europe -DG Health and Food Safety

27-6-2018

Nexium Control (Pfizer Consumer Healthcare Limited)

Nexium Control (Pfizer Consumer Healthcare Limited)

Nexium Control (Active substance: esomeprazole) - Centralised - Renewal - Commission Decision (2018) 4111 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2618/R/21

Europe -DG Health and Food Safety

11-6-2018

Pemetrexed Accord (Accord Healthcare Limited)

Pemetrexed Accord (Accord Healthcare Limited)

Pemetrexed Accord (Active substance: pemetrexed) - Centralised - Yearly update - Commission Decision (2018)3761 of Mon, 11 Jun 2018

Europe -DG Health and Food Safety

4-6-2018

UPDATE to Letter to Health Care Providers: Potential risks with liquid-filled intragastric balloons – Additional Information Regarding Death Reports-  https://go.usa.gov/xQGf8  #FDA #MedicalDevice

UPDATE to Letter to Health Care Providers: Potential risks with liquid-filled intragastric balloons – Additional Information Regarding Death Reports- https://go.usa.gov/xQGf8  #FDA #MedicalDevice

UPDATE to Letter to Health Care Providers: Potential risks with liquid-filled intragastric balloons – Additional Information Regarding Death Reports- https://go.usa.gov/xQGf8  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

30-5-2018

Bortezomib Accord (Accord Healthcare Limited)

Bortezomib Accord (Accord Healthcare Limited)

Bortezomib Accord (Active substance: bortezomib) - Centralised - Variation - Commission Decision (2018)3460 of Wed, 30 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3984/X/8

Europe -DG Health and Food Safety

18-5-2018

Juluca (ViiV Healthcare UK Limited)

Juluca (ViiV Healthcare UK Limited)

Juluca (Active substance: dolutegravir / rilpivirine) - Centralised - Authorisation - Commission Decision (2018)3161 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4427

Europe -DG Health and Food Safety