Concor 10 mg filmom obložene

Glavna informacija

  • Trgovački naziv:
  • Concor 10 mg filmom obložene tablete
  • Doziranje:
  • 10 mg
  • Farmaceutski oblik:
  • filmom obložena tableta
  • Sastav:
  • Urbroj: svaka filmom obložena tableta sadrži 10 mg bisoprololfumarata
  • 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 KGaA, Darmstadt, Njemačka; Famar Lyon, Saint-Genis Laval, Fran

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Concor 10 mg filmom obložene tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 30 tableta u blisteru, u kutiji [HR-H-747818074-01]; 50 tableta u blisteru, u kutiji [HR-H-747818074-02]; 60 tableta u blisteru, u kutiji [HR-H-747818074-03]; 90 tableta u blisteru, u kutiji [HR-H-747818074-04] Urbroj: 381-12-01/70-15-09

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-747818074
  • Datum autorizacije:
  • 28-08-2015
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacija za korisnika

Concor 5 mg filmom obložene tablete

Concor 10 mg filmom obložene tablete

bisoprololfumarat

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 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 Concor i za što se koristi

Što morate znati prije nego počnete uzimati Concor

Kako uzimati Concor

Moguće nuspojave

Kako čuvati Concor

Sadržaj pakiranja i druge informacije

1.

Što je Concor i za što se koristi

Djelatna tvar lijeka Concor je bisoprolol. Bisoprolol pripada skupini lijekova koja se još naziva beta-

blokatori. Ova skupina lijekova utječe na tjelesni odgovor na neke živčane impulse, osobito u srcu.

Kao rezultat, bisoprolol usporava otkucaje srca i povećava učinkovitost srca kao pumpe. Pri tome, srce

može raditi bolje, uz manje zahtjeve za krvi i kisikom.

Concor se primjenjuje kod liječenja povišenog krvnog tlaka i angine pektoris.

2.

Što morate znati prije nego počnete uzimati Concor

Nemojte uzimati Concor ako se neko od sljedećih stanja odnosi na Vas:

alergije (preosjetljivosti) na bisoprolol ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)

teška astma

teški problemi s cirkulacijom u Vašim udovima (kao što je Raynaudov sindrom), stanje koje

može uzrokovati da Vaši prsti ruku i nogu trnu ili postanu blijedi ili poplave

neliječeni feokromocitom koji je rijedak tumor nadbubrežne žlijezde

metabolička acidoza koja je stanje kod kojeg je previše kiseline u krvi.

Nemojte uzimati Concor ako imate neki od sljedećih problema sa srcem:

akutno srčano zatajenje

pogoršanje srčanog zatajenja koje zahtjeva injekciju lijeka u venu, što pojačava sposobnost

kontrakcije srca

kardiogeni šok koji je ozbiljno akutno stanje srca koji uzrokuje nizak krvni tlak i zatajenje

cirkulacije

određena srčana stanja pri kojima dolazi do vrlo usporenog pulsa ili nepravilnog ritma srca

(AV blok drugog ili trećeg stupnja, sindrom bolesnog sinusnog čvora, tzv. „sick sinus

sindrom“, sinus-atrijski blok)

nizak krvni tlak koji uzrokuje probleme

usporeni puls koji uzrokuje probleme.

H A L M E D

28 - 12 - 2017

O D O B R E N O

Upozorenja i mjere opreza

Obratite se svom liječniku ili ljekarniku prije nego uzmete Concor.

Ukoliko se neko od sljedećih stanja odnosi na Vas, posavjetujte se sa svojim liječnikom prije uzimanja

Concora; liječnik će možda odrediti dodatne mjere (npr. uvesti dodatnu terapiju ili češće kontrole):

šećerna bolest

strogo gladovanje

desenzibilizacijsko liječenje u tijeku (npr. za sprječavanje alergijskog rinitisa)

određena stanja (kao što su poremećaji srčanog ritma ili Prinzmetalova angina)

blaži problemi s cirkulacijom u rukama i nogama

kronična bolest pluća ili manje teška astma

u povijesti bolesti imate ljuskav osip (psorijazu)

tumor nadbubrežne žlijezde (feokromocitom)

poremećaj rada štitnjače

Dodatno, recite svojem liječniku ako ste planirani za:

desenzibilizacijsko liječenje jer Concor može pojačati vjerojatnost pojave alergijske reakcije ili

njenu težinu

anesteziju (npr. radi operacije) jer Concor može imati utjecaja na reakciju Vašeg tijela u ovoj

situaciji.

Drugi lijekovi i Concor

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

druge lijekove.

Nemojte uzimati sljedeće lijekove uz Concor bez posebne preporuke svojeg liječnika:

Određeni kalcijski antagonisti koji se koriste za liječenje visokog krvnog tlaka, angine pektoris ili

poremećaja srčanog ritma kao što su verapamil i diltiazem.

Određeni lijekovi za liječenje visokog krvnog tlaka kao što su klonidin, metildopa, moksonidin,

rilmenidin. Međutim, nemojte prestati uzimati ove lijekove bez prethodnog savjetovanja sa svojim

liječnikom.

Provjerite sa svojim liječnikom prije uzimanja sljedećih lijekova uz Concor; Vaš liječnik će možda

trebati češće provjeravati Vaše stanje:

Određeni kalcijski antagonisti koji se primjenjuju pri liječenju visokog krvnog tlaka ili angine pektoris

kao što su nifedipin, felodipin i amlodipin (antagonisti dihidropiridinskog tipa).

Antiaritmici razreda I (npr. kinidin, dizopiramid, lidokain, fenitoin, flekainid, propafenon). Ovi se

lijekovi primjenjuju pri liječenju nepravilnog ritma rada srca.

Antiaritmici razreda III (npr. amiodaron). Ovi se lijekovi primjenjuju pri liječenju nepravilnog ritma

rada srca.

Beta-blokatori za vanjsku primjenu (npr. kapi za oči kod liječenja glaukoma).

Lijekovi s učinkom na živčani sustav koji se primjenjuju za stimulaciju unutarnjih organa ili liječenje

glaukoma (parasimpatomimetici) ili u hitnim slučajevima za liječenje teških cirkulatornih stanja

(simpatomimetici kao što su izoprenalin i dobutamin).

Antidijabetici, uključujući inzulin.

Anestetici (npr. tijekom operativnih zahvata).

H A L M E D

28 - 12 - 2017

O D O B R E N O

Digitalis koji se primjenjuje pri liječenju zatajenja srca.

Nesteroidni protuupalni lijekovi. Ovi lijekovi primjenjuju se pri liječenju artritisa, boli ili upala

(npr. ibuprofen ili diklofenak).

Adrenalin, lijek koji se primjenjuje pri liječenju teških, po život opasnih alergijskih reakcija i srčanog

zastoja.

Drugi lijekovi koji mogu sniziti krvni tlak kao željeni ili neželjeni učinak (npr. antihipertenzivi,

triciklički antidepresivi, barbiturati, fenotiazini).

Meflokin, lijek koji se primjenjuje za profilaksu ili liječenje malarije.

Trudnoća i dojenje

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

liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.

Vaš liječnik će odlučiti smijete li uzimati Concor tijekom trudnoće.

Nije poznato prelazi li bisoprolol u majčino mlijeko. Stoga se dojenje tijekom liječenja Concorom ne

preporučuje.

Upravljanje vozilima i strojevima

Ovisno o tome kako podnosite lijek, sposobnost upravljanja vozilima i strojevima može biti narušena.

Molimo, budite naročito oprezni na početku terapije, nakon promjena u liječenju ili u kombinaciji s

alkoholom.

3.

Kako uzimati Concor

Uvijek uzmite ovaj lijek točno onako kako je opisano u ovoj uputi ili kako su Vam rekli Vaš liječnik ili

ljekarnik. Provjerite sa svojim liječnikom ili ljekarnikom ako niste sigurni.

Liječenje je potrebno započeti niskim dozama koje se potom lagano povećavaju. U svim slučajevima

doziranje je potrebno individualno prilagođavati, naročito prema pulsu i uspješnosti terapije.

Doza

Kod obje navedene indikacije uobičajena doza je jedna tableta Concor 5 mg ili pola tablete Concor 10

mg (što odgovara 5 mg bisoprolola) jednom na dan.

Ako je potrebno, dozu se može povećati na jednu tabletu Concor 10 mg ili 2 tablete Concor 5 mg (što

odgovara 10 mg bisoprolola) jednom na dan.

Maksimalna preporučena doza je 20 mg bisoprolola jednom na dan.

Trajanje terapije

U pravilu, liječenje Concorom je dugotrajno.

Doziranje kod problema s radom jetre ili bubrega

Kod bolesnika s poremećajima rada jetre ili bubrega, blage do umjerene jakosti, u pravilu nije potrebno

prilagođavanje doze. Kod bolesnika s terminalnim bubrežnim zatajenjem (klirens kreatinina < 20

ml/min) i kod bolesnika s teškim poremećajima rada jetre, dnevna doza bisoprolola ne smije biti veća

od 10 mg.

Primjena u starijih osoba

Kod starijih osoba nije potrebno prilagođavanje doze.

H A L M E D

28 - 12 - 2017

O D O B R E N O

Primjena u djece

Concor se ne smije primjenjivati u djece.

Način primjene

Concor uzmite ujutro, prije, za vrijeme ili nakon doručka. Tablete je potrebno progutati cijele, uz

dovoljno tekućine i ne smiju se žvakati. Tableta se može razdijeliti na jednake doze.

Ako uzmete više Concora nego što ste trebali

Ako ste uzeli više Concora nego što ste trebali, odmah obavijestite svog liječnika. Vaš liječnik će

odlučiti o potrebnim mjerama.

Znakovi predoziranja Concorom uključuju usporene otkucaje srca (bradikardija), akutno suženje dišnih

putova što izaziva poteškoće s disanjem (bronhospazam), značajan pad krvnog tlaka, akutno zatajenje

srca i pad šećera u krvi.

Ako ste zaboravili uzeti Concor

Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu. Svoju uobičajenu dozu

uzmite sljedeće jutro.

Ako prestanete uzimati Concor

Nikada nemojte prestati s uzimanjem Concora bez savjetovanja sa svojim liječnikom. U suprotnom,

Vaše zdravstveno stanje bi se moglo ozbiljno pogoršati. Naročito kod bolesnika s ishemijskom bolesti

srca, liječenje se ne smije naglo prekidati. Ako je prekid liječenja potreban, liječnik će Vas uputiti kako

postepeno smanjivati dozu.

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 one neće javiti kod svakoga.

Ove su nuspojave opisane prema učestalosti pojavljivanja:

Često (mogu se pojaviti kod do 1 na 10 osoba):

umor, malaksalost, omaglica, glavobolja: Ove nuspojave događaju se posebno na početku

liječenja. U pravilu su blage i obično nestaju za 1-2 tjedna;

osjećaj hladnoće ili utrnulosti u ekstremitetima;

pad krvnog tlaka;

probavne tegobe kao što su mučnina, povraćanje, proljev, zatvor.

Manje često (mogu se pojaviti kod do 1 na 100 osoba):

usporenje rada srca (bradikardija);

pogoršanje srčanog zatajenja;

nepravilan rad srca;

opća slabost;

smetnje u spavanju;

depresija;

problemi s disanjem, bronhospazam kod bolesnika s astmom ili kroničnom bolesti dišnih

putova;

mišićna slabost i grčevi.

Rijetko (mogu se pojaviti kod do 1 na 1000 osoba):

povišene masnoće u krvi;

smanjena količina suza;

H A L M E D

28 - 12 - 2017

O D O B R E N O

poremećaji sluha;

alergijski rinitis;

povišena razina jetrenih enzima (ALT, AST), upala jetre (hepatitis);

reakcije preosjetljivosti kao što su svrbež, crvenilo, osip;

smetnje potencije;

noćne more, halucinacije

nesvjestica.

Vrlo rijetko (mogu se pojaviti kod do 1 na 10 000 osoba):

iritacija i crvenilo oka (konjunktivitis);

pojava ili pogoršanje ljuskavog osipa (psorijaza), psorijatični osip;

gubitak kose.

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 Concor

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji iza oznake 'EXP'.

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 Concor sadrži

Djelatna tvar lijeka Concor je bisoprololfumarat.

Concor 5 mg: Svaka filmom obložena tableta sadrži 5 mg bisoprololfumarata.

Concor 10 mg: Svaka filmom obložena tableta sadrži 10 mg bisoprololfumarata.

Pomoćne tvari su:

Jezgra tablete: koloidni, bezvodni silicijev dioksid, magnezijev stearat, mikrokristalična celuloza,

krospovidon, kukuruzni škrob, bezvodni kalcijev hidrogenfosfat.

Ovojnica tablete: žuti željezov oksid (E172), dimetikon 100, makrogol 400, titanijev dioksid (E171),

hipromeloza.

Concor 10 mg filmom obložene tablete u ovojnici dodatno sadrže crveni željezov oksid (E 172).

Kako Concor izgleda i sadržaj pakiranja

Concor 5 mg su filmom obložene tablete, svjetložute boje, oblika srca, s razdjelnim urezom.

Svako pakiranje sadrži 30, 50, 60 ili 90 filmom obloženih tableta u blisteru (PVC/Al).

Concor 10 mg su filmom obložene tablete, svjetlonarančaste boje, oblika srca, s razdjelnim urezom.

Svako pakiranje sadrži 30, 50, 60 ili 90 filmom obloženih tableta u blisteru (PVC/Al).

Na tržištu se ne moraju se nalaziti sve veličine pakiranja.

H A L M E D

28 - 12 - 2017

O D O B R E N O

Nositelj odobrenja za stavljanje gotovog lijeka u promet i proizvoĎač

Nositelj odobrenja:

Merck d.o.o., Ulica Andrije Hebranga 32-34, 10000 Zagreb, Hrvatska

ProizvoĎač:

Merck KGaA, Frankfurter Strasse 250, 64293 Darmstadt, Njemačka

Merck KGaA & Co., Werk Spittal, Hösslgasse 20, 9800 Spittal/Drau, Austrija

Famar Lyon, 29, Avenue Charles de Gaulle, 69230 Saint-Genis Laval, Francuska.

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji put revidirana u prosincu 2017.

H A L M E D

28 - 12 - 2017

O D O B R E N O

24-10-2018

Vita Health Products Recall (2018-10-24)

Vita Health Products Recall (2018-10-24)

Health Canada

18-10-2018

Mom Life Market recalls 10" & 16" Personalized Stuffed Plush Bunnies

Mom Life Market recalls 10" & 16" Personalized Stuffed Plush Bunnies

The recalled products may contain phthalate levels that exceed the allowable levels.

Health Canada

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

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

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

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

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

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

10-10-2018

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

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

Eight and Company LLC, d/b/a Sprayology is voluntarily recalling all lots within expiry from 10/18-7/22 of its aqueous-based homeopathic product line for human use. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.

FDA - U.S. Food and Drug Administration

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

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