Lodoz 10 mg 6 25

Glavna informacija

  • Trgovački naziv:
  • Lodoz 10 mg/6,25 mg filmom obložene tablete
  • Doziranje:
  • 10 mg + 6,25 mg
  • Farmaceutski oblik:
  • filmom obložena tableta
  • Sastav:
  • Urbroj: svaka filmom obložena tableta sadrži 10 mg bisoprololfumarata i 6,25 mg hidroklorotiazida
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Merck KGaA & Co. Werk Spittal, Spittal/Drau, Austrija; Merck Sante s.a.s., Semoy, Francuska; Merck KGaA, Darmstadt, Njemač

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Lodoz 10 mg/6,25 mg filmom obložene tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 30 tableta u blisteru, u kutiji [HR-H-693599830-01]; 90 tableta u blisteru, u kutiji [HR-H-693599830-02] Urbroj: 381-12-01/30-15-06

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-693599830
  • Datum autorizacije:
  • 30-09-2015
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za korisnika

LODOZ 2,5 mg / 6,25 mg filmom obložene tablete

LODOZ 5 mg / 6,25 mg filmom obložene tablete

LODOZ 10 mg / 6,25 mg filmom obložene tablete

bisoprololfumarat i hidroklorotiazid

Pažljivo pročitajte cijelu uputu prije nego 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 štetiti, čak i ako su

njihovi znakovi bolesti jednaki Vašima.

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

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

Što se nalazi u ovoj uputi:

Što je Lodoz i za što se koristi?

Što morate znati prije nego počnete uzimati Lodoz?

Kako uzimati Lodoz?

Moguće nuspojave

Kako čuvati Lodoz ?

Sadržaj pakiranja i druge informacije

1.

Što je Lodoz i za što se koristi?

Lodoz sadrži djelatne tvari bisoprolol i hidroklorotiazid:

Bisoprolol pripada grupi lijekova koji se nazivaju beta-blokatori i primjenjuje se za snižavanje

krvnog tlaka.

Hidroklorotiazid pripada grupi lijekova koji se nazivaju tiazidni diuretici. Doprinosi snižavanju

tlaka povećavajući izlučivanje urina.

Lodoz je namijenjen liječenju blago do umjereno povišenog krvnog tlaka.

2.

Što morate znati prije nego počnete uzimati Lodoz?

Lodoz nemojte uzimati ukoliko se neko od sljedećih stanja odnosi na Vas:

alergija (preosjetljivost) na bisoprolol, hidroklorotiazid, druge tiazide, sulfonamide ili bilo neki

drugi sastojak ovog lijeka (naveden u dijelu 6.)

teška astma

zatajenje srca koje nije kontrolirano terapijom ili kardiogeni šok (ozbiljno akutno stanje srca koje

uzrokuje izraziti pad krvnog tlaka i zatajenje cirkulacije)

neki oblici poremećaja srčanog ritma, naročito usporenog rada srca koji prouzrokuje tegobe,

poremećaja provođenja i bolesti poznate kao sick-sinus sindrom

neliječeni feokromocitom (tumor nadbubrežne žlijezde koji izlučuje tvari koje uzrokuju tešku

hipertenziju)

teških problemi cirkulacije krvi u rukama i nogama (naročito Raynaudovog sindroma praćenog

trncima, bljedilom ili modrenjem prstiju)

povećana kiselost krvi (metabolička acidoza) kao posljedica teške bolesti

teška bolest jetre ili bubrega

niske razine kalija u krvi, koja ne reagiraju na liječenje.

H A L M E D

08-03-2016

O D O B R E N O

Upozorenja i mjere opreza

Nikada nemojte naglo prekidati terapiju, naročito ako patite od bolesti srca (ishemijska bolest srca, npr.

angina pektoris).

U sljedećim slučajevima, prije početka liječenja Lodozom, obavijestite svojeg liječnika ukoliko se neko

od sljedećih stanja odnosi na Vas:

bolesti srca kao što su srčano zatajenje, poremećaji srčanog ritma ili Prizmentalova angina

manje teške tegobe cirkulacije krvi u rukama i nogama (naročito Raynaudov sindrom)

problemi s radom jetre ili bubrega

feokromocitom (tumor nadbubrežne žlijezde)

kronična bolest pluća ili manje teška astma

šećerna bolest

poremećaj rada štitnjače

psorijaza

strogo gladovanje

alergija na penicilin.

Dodatno, razgovarajte sa svojim liječnikom:

ako bolujete od gihta, budući da Lodoz može povećati rizik od napada gihta

ako ćete biti podvrgnuti anesteziji (npr. radi operativnog zahvata) budući da Lodoz može imati

utjecaj na tjelesne reakcije u ovoj situaciji

ako ćete biti podvrgnuti desenzibilizacijskom liječenju, budući da bi Lodoz mogao pridonijeti

pojavi alergijskih reakcija, ili njihovoj težini

ako dojite, ili planirate dojenje

ako se namjeravate izlagati suncu ili umjetnom UV zračenju, budući da je kod nekih bolesnika

nakon izlaganja suncu došlo do pojave kožnog osipa. U ovom slučaju, tijekom liječenja

Lodozom, zaštitite svoju kožu

ako doživite akutno smanjenje oštrine vida ili bol u oku unutar nekoliko sati ili tjedana od početka

primjene lijeka. Neliječeni akutni glaukom zatvorenog kuta (poremećaj koji zahvaća oko) može

dovesti do trajnog gubitka vida. Smjesta o ovome obavijestite svog liječnika

Ako Vam se za vrijeme liječenja Lodozom pojave novi simptomi kao što su poteškoće s disanjem, kašalj,

piskanje (pri disanju, u plućima) nakon fizičke aktivnosti, itd., a ujedno bolujete od kronične bolesti pluća

ili manje teške astme odmah se javite svom liječniku.

Dodatna ispitivanja

Hidroklorotiazid utječe na ravnotežu vode i soli u Vašem tijelu. Liječnik će to možda htjeti provjeriti s

vremena na vrijeme. Ovo je naročito važno ako imate dodatna stanja koja se mogu pogoršati u slučaju

narušavanja ravnoteže elektrolita. Vaš liječnik će također provjeravati nivo masnoća, mokraćne kiseline i

glukoze u krvi.

Istodobna primjena ovog lijeka ne preporučuje se s litijem koji se primjenjuje kod nekih psihijatrijskih

poremećaja, ili lijekova za liječenje visokog krvnog tlaka, angine pektoris ili nepravilnog ritma rada srca

(kao što su verapamil, diltiazem ili bepridil) (vidjeti dio „Drugi lijekovi i Lodoz“).

Sportaši moraju obratiti pažnju da ovaj lijek sadrži tvari koje mogu dati pozitivnu reakciju na doping.

Drugi lijekovi i Lodoz

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

druge lijekove.

Lodoz uzimajte zajedno sa sljedećim lijekovima samo ako Vam je to odredio Vaš liječnik, jer se njihova

kombinacija u pravilu ne preporučuje (pogledajte dio „Upozorenja i mjere opreza“):

H A L M E D

08-03-2016

O D O B R E N O

određeni lijekovi za liječenje visokog krvnog tlaka, angine pektoris ili nepravilnog ritma rada srca

(poput verapamila, diltiazema ili bepridila) koji mogu povećati rizik od poremećaja ritma rada

srca

litij koji se primjenjuje pri liječenju određenih psihijatrijskih poremećaja.

Trudnoća, dojenje i plodnost

Primjena ovog lijeka tijekom trudnoće se ne preporučuje.

Primjena ovog lijeka tijekom dojenja se ne preporučuje.

Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate trudnoću, obratite se svom liječniku

ili ljekarniku za savjet prije nego uzmete ovaj lijek.

Upravljanje vozilima i strojevima

U pravilu, Lodoz ne narušava sposobnost upravljanja vozilima i strojevima. Međutim, individualni

odgovor može imati utjecaja na sposobnost koncentracije i reakcije. Ako dođe do toga, nemojte voziti ili

upravljati strojevima.

3.

Kako uzimati Lodoz?

Uvijek uzmite ovaj lijek točno onako kako Vam je rekao Vaš liječnik ili ljekarnik. Provjerite s Vašim

liječnikom ili ljekarnikom ako niste sigurni.

Preporučena početna doza je jedna Lodoz 2,5 mg / 6,25 mg tableta dnevno. Ako učinak sniženja krvnog

tlaka ove doze nije zadovoljavajući, doza će biti povećana na jednu Lodoz 5 mg / 6,25 mg tabletu dnevno,

a ako ova doza još uvijek ne odgovara, na jednu Lodoz 10 mg / 6,25 mg tabletu dnevno.

Lodoz uzmite ujutro i možete ga uzeti uz obrok. Tabletu progutajte s tekućinom i nemojte ju žvakati.

Nikada nemojte naglo prestati s terapijom (pogledajte dio „Ako prestanete uzimati Lodoz“).

Primjena u djece

Iskustva primjene Lodoza u djece su ograničena te se stoga njegova primjena ne preporučuje u ovoj

populacija.

Lodoz s hranom i pićem

Lodoz se može i ne mora uzeti uz obrok, ali mora se uzeti ujutro.

Ako uzmete više Lodoza nego što ste trebali

Ako ste uzeli više Lodoza nego što ste smjeli, odmah se obratite svojem liječniku. Ovisno o stupnju

predoziranja, Vaš liječnik će odlučiti o potrebnim mjerama.

Simptomi predoziranja bisoprololom i hidroklorotiazidom mogu uključivati pad krvnog tlaka, usporenje

srčanog ritma, iznenadne probleme rada srca, omaglicu, mučninu, pospanost, iznenadne probleme s

disanjem, pad šećera u krvi.

Ako ste zaboravili uzeti Lodoz

Ako ste zaboravili uzeti Lodoz, uzmite ga čim ste se sjetili. Nakon toga, sljedeći dozu uzmite u

uobičajeno vrijeme. Međutim, ako se bliži vrijeme uzimanja sljedeće doze, preskočite propuštenu dozu i

uzmite samo dozu koju trebate uzeti prema rasporedu uzimanja lijeka.

Nemojte uzimati dvostruku dozu ovog lijeka kako biste nadoknadili zaboravljenu dozu.

H A L M E D

08-03-2016

O D O B R E N O

Ako prestanete uzimati Lodoz

Nemojte prestati uzimati Lodoz bez da Vas je na to uputio Vaš liječnik. U suprotnom, Vaše zdravstveno

stanje bi se moglo ozbiljno pogoršati. Ako trebate prestati s terapijom, u pravilu, Vaš liječnik će Vas

uputiti kako postepeno smanjivati dozu.

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

ljekarniku.

4.

Moguće nuspojave

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

Česte nuspojave

(mogu se javiti u manje od 1 na 10 osoba):

osjećaj hladnoće i utrnulost u udovima

umor, omaglica, glavobolja. Ovi se simptomi obično događaju početkom liječenja, u pravilu su

blagi i obično nestaju 1-2 tjedna nakon početka liječenja

poremećaji probavnog sustava kao što su mučnina, povraćanje, proljev, zatvor.

Manje česte nuspojave

(mogu se javiti u manje od 1 na 100 osoba):

mišićna slabost, grčevi u mišićima, osjećaj slabosti

usporen rad srca, smetnje srčanog ritma, pogoršanje srčanog zatajenja, pad krvnog tlaka nakon

stajanja ili ustajanja

smetnje spavanja, depresija, gubitak apetita

problemi s disanjem kod bolesnika koji imaju astmu ili kroničnu bolest bronha

povećana razina kreatinina ili ureje u krvi

abdominalne tegobe

povišenje razine amilaza (enzimi koji sudjeluju u procesu probave)

poremećena ravnoteža tekućina i elektrolita

povećana razina masnoća, kolesterola, mokraćne kiseline ili šećera u krvi; povećana razina šećera

u urinu.

Rijetke nuspojave

(mogu se javiti u manje od 1 na 1000 osoba):

noćne more, halucinacije

reakcije preosjetljivosti (reakcije alergijskog tipa) kao što su svrbež, iznenadno crvenilo lica ili

kožni osip, također nakon izlaganja suncu; urtikarija, sitne ljubičasto-crvene točkice na koži

uzrokovane krvarenjem pod kožom (purpura)

porast nekih jetrenih enzima, hepatitis i žutica

smetnje potencije

smetnje sluha

alergijski rinitis (alergijsko curenje nosa); smanjeni tok suza, smetnje vida

pad broja bijelih krvnih stanica u krvi (leukocitopenija) ili pad krvnih pločica koje sudjeluju u

zgrušavanju krvi (trombocitopenija)

sinkopa.

Vrlo rijetke nuspojave

(mogu se javiti u manje od 1 na 10 000 osoba):

nadraženost i crvenilo očiju (konjunktivitis), opadanje kose

nastanak ili pogoršanje postojećeg ljuskavog osipa (psorijaza) ili pojava debelih ljuskavih mrlja

na koži (kožni lupus eritematodes)

bol u prsima

ozbiljno smanjenje broja bijelih krvnih stanica u krvi (agranulocitoza)

upala gušterače

stanje kod kojeg je Vaša krv preslabo kisela (metabolička alkaloza)

alergijske (anafilaktičke) reakcije, teške bulozne reakcije (Lyellov sindrom).

H A L M E D

08-03-2016

O D O B R E N O

Nuspojave nepoznate učestalosti

(ne mogu se procijeniti iz dostupnih podataka):

intersticijska plućna bolest.

kratkovidnost

bol u oku (mogući znakovi akutnog glaukoma zatvorenog kuta)

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 Lodoz?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

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

<

Rok valjanosti

>

Rok valjanosti odnosi se na zadnji dan navedenog mjeseca.

Ovaj lijek čuvajte na temperaturi ispod 30 °C.

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 Lodoz sadrži

Lodoz 2,5 mg / 6,25 mg:

Djelatne tvari su bisoprololfumarat i hidroklorotiazid. Jedna filmom obložena tableta sadrži 2,5

mg bisoprololfumarata i 6,25 mg hidroklorotiazida.

Druge pomoćne tvari su:

Jezgra tablete:

magnezijev stearat, krospovidon, kukuruzni škrob, prethodno geliran kukuruzni

škrob, mikrokristalična celuloza, bezvodni kalcijev hidrogenfosfat.

Ovojnica:

polisorbat 80, žuti željezov oksid (E172), makrogol 400, titanijev dioksid (E171),

hipromeloza.

Lodoz 5 mg / 6,25 mg:

Djelatne tvari su bisoprololfumarat i hidroklorotiazid. Jedna filmom obložena tableta sadrži 5 mg

bisoprololfumarata i 6,25 mg hidroklorotiazida.

Druge pomoćne tvari su:

Jezgra tablete:

koloidni bezvodni silicijev dioksid, magnezijev stearat, mikrokristalična celuloza,

kukuruzni škrob, bezvodni kalcijev hidrogenfosfat.

Ovojnica:

žuti željezov oksid (E172), crveni željezov oksid (E172), polisorbat 80, makrogol 400,

titanijev dioksid (E171), hipromeloza.

Lodoz 10 mg / 6,25 mg:

Djelatne tvari su bisoprololfumarat i hidroklorotiazid. Jedna filmom obložena tableta sadrži

10 mg bisoprololfumarata i 6,25 mg hidroklorotiazida.

Druge pomoćne tvari su:

Jezgra tablete:

koloidni bezvodni

silicijev dioksid, magnezijev stearat, mikrokristalična celuloza,

kukuruzni škrob, bezvodni kalcijev hidrogenfosfat.

Ovojnica:

polisorbat 80, makrogol 400, hipromeloza, titanijev dioksid (E171).

H A L M E D

08-03-2016

O D O B R E N O

Kako Lodoz izgleda i sadržaj pakiranja?

Lodoz 2,5 mg / 6,25 mg:

žuta, okrugla, bikonveksna, s gornje strane utisnut oblik srca, a s donje strane

brojka „2.5“.

Lodoz 5 mg / 6,25 mg:

pastelno ružičasta, okrugla, bikonveksna, s gornje strane utisnut oblik srca, a s

donje strane brojka „5“.

Lodoz 10 mg / 6,25 mg:

bijela, okrugla, bikonveksna, s gornje strane utisnut oblik srca, a s donje strane

brojka „10“.

Svako pakiranje sadrži 30 ili 90 tableta. Na tržištu se ne moraju nalaziti sve veličine pakiranja.

Nositelj odobrenja za stavljanje lijeka u promet i proizvođač

Nositelj odobrenja:

Merck d.o.o., Ulica Andrije Hebranga 32-34, 10 000 Zagreb.

Proizvođač:

Merck KGaA, Frankfurter Straße 250, Darmstadt, Njemačka

Merck SANTE s.a.s. 2, Rue du Pressoir Vert, Semoy Francuska

Merck KGaA & Co. Werk Spittal, Hösslgasse 20, Spittal/Drau, Austrija

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji put revidirana u ožujku 2016.

H A L M E D

08-03-2016

O D O B R E N O

18-10-2018

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Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

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Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

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Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

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10-10-2018

Enforcement Report for the Week of October 10, 2018

Enforcement Report for the Week of October 10, 2018

Recently Updated Records for the Week of October 10, 2018 Last Modified Date: Tuesday, October 09, 2018

FDA - U.S. Food and Drug Administration

24-9-2018

FDA Announces Availability of Resources for Animal Drug Sponsors

FDA Announces Availability of Resources for Animal Drug Sponsors

The FDA is making available two pre-recorded webinars and a slide presentation to help drug sponsors understand recent changes to the submission process for new animal drug applications and related submissions. The changes take effect 10/1/2018.

FDA - U.S. Food and Drug Administration

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement

FDA - U.S. Food and Drug Administration

11-9-2018

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Published on: Mon, 10 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Greece for the pesticide active substance alpha‐cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Update of the Xylella spp. host plant database

Update of the Xylella spp. host plant database

Published on: Mon, 10 Sep 2018 00:00:00 +0200 Following a request from the European Commission, EFSA periodically updates the database on the host plants of Xylella spp. While previous editions of the database (2015 and 2016) dealt with the species Xylella fastidiosa only, this database version addresses the whole genus Xylella, including therefore both species X. fastidiosa and Xylella taiwanensis. The database now includes information on host plants of Xylella spp. retrieved from scientific literature...

Europe - EFSA - European Food Safety Authority Publications

10-9-2018

USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry

USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry

WASHINGTON, Sept. 10, 2018 – U.S. Secretary of Agriculture Sonny Perdue, DVM and U.S. Food and Drug Administration Commissioner Scott Gottlieb, M.D. today announced a joint public meeting to be held on Oct. 23-24, 2018 to discuss the use of cell culture technology to develop products derived from livestock and poultry.

FDA - U.S. Food and Drug Administration

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

1-9-2018

Spodoptera frugiperda partial risk assessment

Spodoptera frugiperda partial risk assessment

Published on: Fri, 31 Aug 2018 00:00:00 +0200 EFSA was asked for a partial risk assessment of Spodoptera frugiperda for the territory of the EU focussing on the main pathways for entry, factors affecting establishment, risk reduction options and pest management. As a polyphagous pest, five commodity pathways were examined in detail. Aggregating across these and other pathways, we estimate that tens of thousands to over a million individual larvae could enter the EU annually on host commodities. Instigat...

Europe - EFSA - European Food Safety Authority Publications

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

29-8-2018

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 10 Aug 2018 00:00:00 +0200 This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process General Plastic (EU register No RECYC153), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes orig...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 In June 2016, EFSA received a mandate from the national food competent authorities of five European countries (Denmark, Finland, Iceland, Norway and Sweden) to provide a dietary reference value (DRV) for sugars, with particular attention to added sugars. A draft protocol was developed with the aim of defining as much as possible beforehand the strategy that will be applied for collecting data, appraising the relevant evidence, and analysing and integrating t...

Europe - EFSA - European Food Safety Authority Publications

22-8-2018

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food, Inc. of Portland, OR is expanding its voluntary recall to include an additional quantity of Rad Cat Raw Diet across all varieties with Best By dates of 10/19/18 through 12/3/19 because it has the potential to be contaminated with Listeria monocytogenes. Radagast Pet Food is conducting this voluntary recall out of an abundance of caution because of its strong commitment to food safety and quality.

FDA - U.S. Food and Drug Administration

10-8-2018

Enforcement Report for the Week of July 25, 2018

Enforcement Report for the Week of July 25, 2018

Recently Updated Records for the Week of July 25, 2018 Last Modified Date: Friday, August 10, 2018

FDA - U.S. Food and Drug Administration

18-7-2018

Orphan designation:  Recombinant humanised anti-human interleukin-1 beta monoclonal antibody,  for the: Treatment of Behçet’s disease

Orphan designation: Recombinant humanised anti-human interleukin-1 beta monoclonal antibody, for the: Treatment of Behçet’s disease

On 1 October 2010, orphan designation (EU/3/10/796) was granted by the European Commission to XOMA Ireland Ltd, Ireland, for recombinant humanised anti-human interleukin-1 beta monoclonal antibody for the treatment of Behçet’s disease.

Europe - EMA - European Medicines Agency

12-11-2018

Spinraza (Biogen Netherlands B.V.)

Spinraza (Biogen Netherlands B.V.)

Spinraza (Active substance: nusinersen) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7550 of Mon, 12 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4312/T/10

Europe -DG Health and Food Safety

23-10-2018

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Active substance: Pegylated recombinant human interleukin-10) - Transfer of orphan designation - Commission Decision (2018)6994 of Tue, 23 Oct 2018

Europe -DG Health and Food Safety

22-10-2018

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Active substance: Sildenafil citrate) - Transfer of orphan designation - Commission Decision (2018)6993 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/068/10/T/01

Europe -DG Health and Food Safety

19-10-2018

Recocam (Bimeda Animal Health Limited)

Recocam (Bimeda Animal Health Limited)

Recocam (Active substance: Meloxicam) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6954 of Fri, 19 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2247/T/10

Europe -DG Health and Food Safety

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety

19-9-2018

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Active substance: olaratumab) - Centralised - Annual renewal - Commission Decision (2018)6105 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4216/R/10

Europe -DG Health and Food Safety

19-9-2018

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 5971 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4078/T/10

Europe -DG Health and Food Safety

10-9-2018

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Active substance: netupitant / palonosetron) - Centralised - Yearly update - Commission Decision (2018)5947 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

10-9-2018

Alkindi (Diurnal Limited)

Alkindi (Diurnal Limited)

Alkindi (Active substance: hydrocortisone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5945 of Mon, 10 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4416/T/03

Europe -DG Health and Food Safety

10-9-2018

Retacrit (Hospira UK Limited)

Retacrit (Hospira UK Limited)

Retacrit (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5946 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

10-9-2018

Silapo (STADA Arzneimittel AG)

Silapo (STADA Arzneimittel AG)

Silapo (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5944 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

4-9-2018

ACM meeting statement, Meeting 10, 2 August 2018

ACM meeting statement, Meeting 10, 2 August 2018

The Advisory Committee on Medicines meeting statement is now available

Therapeutic Goods Administration - Australia

22-8-2018

BTVPUR (Merial)

BTVPUR (Merial)

BTVPUR (Active substance: Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 4)) - Centralised - 2-Monthly update - Commission Decision (2018)5630 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2231/II/10

Europe -DG Health and Food Safety

10-8-2018

Torisel (Pfizer Europe MA EEIG)

Torisel (Pfizer Europe MA EEIG)

Torisel (Active substance: Temsirolimus) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5521 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/799/T/71

Europe -DG Health and Food Safety

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

Brinavess (Active substance: vernakalant hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5523 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1215/T/31

Europe -DG Health and Food Safety

10-8-2018

Lymphoseek (Norgine B.V.)

Lymphoseek (Norgine B.V.)

Lymphoseek (Active substance: tilmanocept) - Centralised - Yearly update - Commission Decision (2018)5520 of Fri, 10 Aug 2018

Europe -DG Health and Food Safety

10-8-2018

Sivextro (Merck Sharp and Dohme B.V.)

Sivextro (Merck Sharp and Dohme B.V.)

Sivextro (Active substance: tedizolid phosphate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5522 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2846/T/28

Europe -DG Health and Food Safety

10-8-2018

Cubicin (Merck Sharp and Dohme B.V.)

Cubicin (Merck Sharp and Dohme B.V.)

Cubicin (Active substance: Daptomycin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5519 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/637/T/69

Europe -DG Health and Food Safety

10-8-2018

Thalidomide Celgene (Celgene Europe B.V.)

Thalidomide Celgene (Celgene Europe B.V.)

Thalidomide Celgene (Active substance: Thalidomide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5524 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/823/T/57

Europe -DG Health and Food Safety

10-8-2018

CANCIDAS (Merck Sharp and Dohme B.V.)

CANCIDAS (Merck Sharp and Dohme B.V.)

CANCIDAS (Active substance: caspofungin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5517 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/379/T/67

Europe -DG Health and Food Safety

10-8-2018

Tesavel (Merck Sharp and Dohme B.V.)

Tesavel (Merck Sharp and Dohme B.V.)

Tesavel (Active substance: sitagliptin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5518 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/910/T/65

Europe -DG Health and Food Safety

10-8-2018

Januvia (Merck Sharp and Dohme B.V.)

Januvia (Merck Sharp and Dohme B.V.)

Januvia (Active substance: sitagliptin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4511 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/722/T/65

Europe -DG Health and Food Safety

10-8-2018

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Active substance: bortezomib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5515 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4207/T/10

Europe -DG Health and Food Safety

7-8-2018

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

FDA - U.S. Food and Drug Administration

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

30-7-2018

Zalmoxis (MolMed S.p.A.)

Zalmoxis (MolMed S.p.A.)

Zalmoxis (Active substance: Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (?LNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2)) - Centralised - Renewal - Commission Decision (2018)5118 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2801/R/10

Europe -DG Health and Food Safety

27-7-2018

EU/3/11/868 (Celgene Europe B.V.)

EU/3/11/868 (Celgene Europe B.V.)

EU/3/11/868 (Active substance: Lenalidomide) - Transfer of orphan designation - Commission Decision (2018)5045 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/160/10/T/01

Europe -DG Health and Food Safety