Solven 10 mg filmom obložene

Glavna informacija

  • Trgovački naziv:
  • Solven 10 mg filmom obložene tablete
  • Doziranje:
  • 10 mg
  • Farmaceutski oblik:
  • filmom obložena tableta
  • Sastav:
  • Urbroj: svaka filmom obložena tableta sadrži 10 mg solifenacinsukcinata, što odgovara 7,5 mg solifenacina
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Mylan Hungary Kft, Komárom, Mađarska; McDermott Laboratories Limited, t/a Gerard Laboratories, Dublin 13, Irska; Mylan B.V., L

Dokument

Lokalizacija

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

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 3 tablete u blisteru, u kutiji [HR-H-917873551-01]; 5 tableta u blisteru, u kutiji [HR-H-917873551-02]; 10 tableta u blisteru, u kutiji [HR-H-917873551-03]; 20 tableta u blisteru, u kutiji [HR-H-917873551-04]; 30 tableta u blisteru, u kutiji [HR-H-917873551-05]; 30x1 tableta u perforiranom blisteru djeljiv na jedinične doze, u kutiji [HR-H-917873551-06]; 50 tableta u blisteru, u kutiji [HR-H-917873551-07]; 60 tableta u blisteru, u kutiji [HR-H-917873551-08]; 90 tableta u blisteru, u kutiji [HR-H-917873551-09]; 100 tableta u blisteru, u kutiji [HR-H-917873551-10]; 200 tableta u blisteru, u kutiji [HR-H-917873551-11]; 30 tableta u bočici, u kutiji [HR-H-917873551-12]; 50 tableta u bočici, u kutiji [HR-H-917873551-13]; 90 tableta u bočici, u kutiji [HR-H-917873551-14]; 100 tableta u bočici, u kutiji [HR-H-917873551-15]; 200 tableta u bočici, u kutiji [HR-H-917873551-16]; 250 tableta u bočici, u kutiji [HR-H-917873551-17]; 500 tableta u bočici, u kutiji [HR-H-917873551-18] Urbroj: 381-12-01/30-17-03

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-917873551
  • Datum autorizacije:
  • 13-09-2017
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

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UPUTA O LIJEKU

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Uputa o lijeku: Informacije za bolesnika

Solven 5 mg filmom obložene tablete

Solven 10 mg filmom obložene tablete

solifenacinsukcinat

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

podatke.

Sačuvajte ovu uputu. Moţda 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. Moţe 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 Solven i za što se koristi

Što morate znati prije nego počnete uzimati Solven

Kako uzimati Solven

Moguće nuspojave

Kako čuvati Solven

Sadrţaj pakiranja i druge informacije

1.

Što je Solven i za što se koristi

Solven sadrţi djelatnu tvar solifenacin koja spada u skupinu antikolinergika. Ti se lijekovi primjenjuju

za smanjenje aktivnosti prekomjerno aktivnog mokraćnog mjehura. Smanjuju učestalost mokrenja i

povećavaju količinu mokraće koja se moţe zadrţati u mokraćnom mjehuru.

Solven se upotrebljava za liječenje simptoma prekomjerno aktivnog mokraćnog mjehura. Ti simptomi

uključuju znakove snaţne, iznenadne potrebe za mokrenjem bez prethodnog upozorenja, učestale

poticaje na mokrenje, nehotično bjeţanje mokraće zbog nemogućnosti pravovremenog dolaska na

toalet.

2.

Što morate znati prije nego počnete uzimati Solven

Nemojte uzimati Solven:

ako ste alergični na solifenacin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6)

ako imate poteškoće u prolasku mokraće ili ne moţete potpuno isprazniti mokraćni mjehur

(retencija urina)

ako bolujete od teške bolesti ţeluca ili crijeva (uključujući toksični megakolon, komplikacije

povezane s ulcerativnim kolitisom)

ako imate bolest mišića, miastenia gravis koja moţe uzrokovati jaku slabost pojedinih mišića

ako imate ili postoji opasnost od povišenog očnog tlaka s postupnim gubitkom vida (glaukom)

ako ste na hemodijalizi

ako bolujete od teške bolesti jetre

ako bolujete od srednje teške bolesti jetre ili teške bolesti bubrega i ako istodobno uzimate

lijekove koji smanjuju izlučivanje lijeka solifenacin iz tijela (poput ketokonazola). Vaš liječnik

ili ljekarnik će Vas na to upozoriti.

Upozorenja i mjere opreza

Obratite se svom liječniku ili ljekarniku prije nego uzmete Solven:

ako imate problema s praţnjenjem mokraćnog mjehura (opstrukcija mokraćnog mjehura) ili

imate poteškoće prolaza mokraće (slab tok mokraće). To povećava rizik od nakupljanja mokraće

u mokraćnom mjehuru (retencija urina).

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ako imate opstruktivne bolesti probavnog trakta (npr. zatvor)

ako postoji opasnost od smanjene aktivnosti probavnog trakta (ţeluca i crijeva). Vaš liječnik će

Vas na to upozoriti.

ako imate tešku bolest bubrega

ako imate srednje tešku bolest jetre

ako uzimate lijekove koji se nazivaju inhibitori CYP3A4 (kao što je ketokonazol) koji mogu

povećati količinu solifenacina u krvi

ako imate hijatnu herniju ili ţgaravicu i/ili uzimate odreĎene lijekove (kao što su bisfosfati) koji

mogu uzrokovati ili pogoršati upalu jednjaka

ako imate poremećaj ţivčanog sustava (autonomnu neuropatiju)

ako patite od promjene srčanog ritma (koji se primjećuje na EKG-u) ili ako imate nisku razinu

kalija u krvi.

Obavijestite svog liječnika prije nego počnete uzimati solifenacinsukcinat ako imate ili ste ikad imali

gore spomenuta stanja.

Vaš će liječnik provjeriti prije početka liječenja lijekom Solven postoje li drugi uzroci prekomjerno

aktivnog mokraćnog mjehura (poput srčane slabosti (slabijeg djelovanja srčane pumpe) ili bolesti

bubrega). Ako imate bakterijsku infekciju mokraćnog sustava Vaš će liječnik propisati antibiotik (lijek

za liječenje odreĎenih bakterijskih infekcija).

Djeca i adolescenti

Solven se ne smije primjenjivati u djece ili adolescenata mlaĎih od 18 godina.

Drugi lijekovi i Solven

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

druge lijekove.

Posebno je vaţno obavijestiti svog liječnika ukoliko uzimate:

druge antikolinergičke lijekove (kao što su atropin, oksibutini, hidroksizin, bupropion,

dekstrometorfan) jer bi to moglo izazvati pojačanje nuspojava oba lijeka

kolinergike (lijekove kao što su karbakol i pilokarpin) jer oni mogu smanjiti djelovanje

solifenacina

lijekove kao što su metoklopramid i cisaprid koji stimuliraju pokretljivost probavnog sustava.

Solifenacin moţe smanjiti učinak tih lijekova.

lijekove kao što su ketokonazol, ritonavir, nelfinavir, itrakonazol, verapamil i diltiazem koji

mogu smanjiti razgradnju solifenacina u tijelu

rifampicin, fenitoin i karbamazepin koji bi mogli povećati razgradnju solifenacina u tijelu.

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.

Trudnoća

Ne smijete uzimati lijek Solven ukoliko ste trudni osim ako to nije neophodno.

Dojenje

Ne smijete uzimati ovaj lijek ukoliko dojite jer se solifenacin izlučuje u majčino mlijeko.

Upravljanje vozilima i strojevima

Solifenacin moţe izazvati zamagljen vid i ponekad pospanost ili umor. Ako patite od navedenih

nuspojava nemojte voziti ili upravljati strojevima.

Solven sadrži laktozu

Ako Vam je liječnik rekao da ne podnosite neke vrste šećera, obratite se liječniku prije uzimanja ovog

lijeka.

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3.

Kako uzimati Solven

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

liječnikom ili ljekarnikom ako niste sigurni.

Tableta se uzima na usta i cijela proguta s malo vode. Moţe se uzimati uz hranu ili bez nje, ovisno o

Vašem izboru. Tabletu ne smijete lomiti.

Preporučena doza je 5 mg jedanput dnevno osim ako Vam liječnik ne preporuči 10 mg dnevno.

Bolesnici s oboljenjima jetre ili bubrega

Ako imate tešku bolest bubrega ili umjereno tešku bolest jetre ne biste smjeli uzimati dozu veću od

5 mg dnevno.

Ako uzmete više lijeka Solven nego što ste trebali

Ako ste uzeli previše lijeka Solven ili ako je dijete slučajno uzelo Solven, odmah obavijestite svog

liječnika ili ljekarnika.

Simptomi predoziranja mogu uključivati glavobolju, suha usta, omaglicu, pospanost i zamagljen vid,

halucinacije, pretjerano uzbuĎenje, grčevi (konvulzije), probleme s disanjem, ubrzane otkucaje srca

(tahikardija), nakupljanje mokraće u mjehuru (retencija mokraće), proširene zjenice (midrijaza).

Ako ste zaboravili uzeti lijek Solven

Ako ste zaboravili uzeti dozu lijeka, uzmite je čim se sjetite, osim ako nije vrijeme za sljedeću dozu.

Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu. Nikad nemojte uzeti više od

jedne doze dnevno. Ukoliko niste sigurni, uvijek se posavjetujte s liječnikom ili ljekarnikom.

Ako prestane uzimati lijek Solven

Ako ste prestali uzimati Solven, simptomi prekomjerno aktivnog mokraćnog mjehura se mogu vratiti

ili pogoršati. Uvijek se posavjetujte sa svojim liječnikom ako namjeravate prekinuti liječenje.

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

4.

Moguće nuspojave

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

Ako primijetite bilo koju od sljedećih nuspojava, prekinite uzimanje ovog lijeka i odmah se

obratite se svom liječniku ili otiĎite na hitni odjel najbliže bolnice:

Vrlo rijetke (mogu se javiti u do 1 na 10 000 osoba)

Angioedem (koţna alergija koja rezultira oticanjem tkiva neposredno ispod površine koţe) s

opstrukcijom dišnih putova (poteškoće s disanjem) prijavljen je u nekih bolesnika koji su

liječeni solifenacinsukcinatom.

Nepoznate (učestalost se ne moţe procijeniti iz dostupnih podataka)

Alergijski napad ili teške koţne reakcije (npr. stvaranje mjehura ili ljuštenje koţe).

Solven može uzrokovati sljedeće druge nuspojave:

Vrlo česte (mogu se javiti u više od 1 na 10 osoba)

suha usta.

Česte (mogu se javiti u do 1 na 10 osoba)

zamagljen vid

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zatvor, mučnina, probavne tegobe s osjećajem nadutosti, bol u trbuhu, podrigivanje, ţgaravica

(dispepsija).

Manje često (mogu se javiti u do 1 na 100 osoba)

upala mokraćnog sustava ili upala mokraćnog mjehura sa znakovima kao što su osjećaj boli ili

peckanja prilikom prolaza mokraće, bol u leĎima, mutna mokraća ili krv u mokraći. Obratite se

svom liječniku ako ste primijetili te znakove.

pospanost, poremećaj osjeta okusa (disgeuzija)

suhe (iritirane) oči

suhoća nosnih sluznica

refluksna bolest (gastro-ezofagealni refluks sa simptomima kao što su ţgaravica, oteţano

gutanje, neugodan gorak okus na početku grla ili u straţnjem dijelu usta)

suho grlo

suha koţa

poteškoće u prolasku mokraće

umor, zadrţavanje tekućine u donjem dijelu nogu (edem).

Rijetko (mogu se javiti u do 1 na 1000 osoba)

nakupljanje velike količine tvrde stolice u debelom crijevu (fekalna impakcija)

začepljenje u donjem dijelu crijeva (debelo crijevo)

zadrţavanje mokraće zbog nemogućnosti praţnjenja mjehura (retencija urina)

omaglica, glavobolja

povraćanje

svrbeţ, osip.

Vrlo rijetke (mogu se javiti u do 1 na 10 000 osoba)

halucinacije, smetenost

koprivnjača

osip s mrljama na koţi koje podsjećaju na ospice.

Nepoznate (učestalost se ne moţe procijeniti iz dostupnih podataka)

smanjeni apetit, visoke razine kalija u krvi što moţe uzrokovati nenormalan srčani ritam

povećani očni tlak

promjene električne aktivnosti srca (EKG), nepravilan srčani ritam

potpuno začepljenje crijeva (opstrukcija crijeva (ileus))

jaka zbunjenost koja moţe biti povezana s povećanom ili smanjenom aktivnosti, problemi sa

spavanjem te halucinacije

poremećaji glasa

poremećaji jetre ili promjene u radu jetre koje se mogu vidjeti u krvnim pretragama

mišićna slabost

poremećaji bubrega

nelagoda u trbuhu

crvenilo i ljuštenje koţe (eksfolijativni dermatitis)

osjećaj rada vlastitog srca, brţi otkucaji srca.

Prijavljivanje nuspojava

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

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

nacionalnog sustava za prijavu nuspojava; navedenog u Dodatku V. Prijavljivanjem nuspojava moţete

pridonijeti u procjeni sigurnosti ovog lijeka.

5.

Kako čuvati Solven

Lijek čuvajte izvan pogleda i dohvata djece.

Samo za pakiranje u boci: nakon prvog otvaranja iskoristiti u roku od 100 dana.

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

oznake „EXP“. Rok valjanosti odnosi se na zadnji dan navedenog mjeseca.

Za ovaj se lijek ne primjenjuju posebne mjere čuvanja.

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

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

6. Sadržaj pakiranja i druge informacije

Što Solven sadrţi

Djelatna tvar je solifenacinsukcinat.

Solven 5 mg: Svaka filmom obloţena tableta sadrţi 5 mg solifenacinsukcinata, što odgovara

3,8 mg solifenacina.

Solven 10 mg: Svaka filmom obloţena tableta sadrţi 10 mg solifenacinsukcinata, što odgovara

7,5 mg solifenacina.

Drugi sastojci su:

Jezgra tablete:

laktoza hidrat, kukuruzni škrob, hipermeloza (E464), talk, magnezijev stearat (E572)

Ovojnica tablete:

Solven 5 mg: hipromeloza, titanijev dioksid (E171), propilenglikol, ţuti ţeljezov oksid (E172)

Solven 10 mg: hipromeloza, titanijev dioksid (E171), propilenglikol, crveni ţeljezov oksid

(E172), ţuti ţeljezov oksid (E172)

Kako Solven izgleda i sadržaj pakiranja

Solven 5 mg: Ţuta, filmom obloţena okrugla bikonveksna tableta s oznakom „M” na jednoj strani

tablete i oznakom „SF” iznad oznake „5” na drugoj strani tablete.

Solven 10 mg: Ruţičasta, filmom obloţena okrugla bikonveksna tableta s oznakom „M” na jednoj

strani tablete i oznakom „SF” iznad oznake „10” na drugoj strani tablete.

Veličine pakiranja:

Blister pakiranja koja sadrţe 3, 5, 10, 20, 30, 30 x 1, 50, 60, 90, 100, 200 tableta.

Pakiranja u boci od 30, 50, 90, 100, 200, 250, 500 tableta.

Na trţištu se ne moraju nalaziti sve veličine pakiranja.

Nositelj odobrenja za stavljanje lijeka u promet

Mylan S.A.S.

117 allee des Parcs

69 800 Saint Priest

Francuska

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ProizvoĎači

Mylan Hungary Kft

H-2900 Komárom, Mylan utca 1, MaĎarska

McDermott Laboratories Limited koji posluje kao Gerard Laboratories

35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Irska

Mylan B.V.

Dieselweg 25, 3752 LB Bunschoten, Nizozemska

Predstavnik nositelja odobrenja za Republiku Hrvatsku

Mylan Hrvatska d.o.o.

Koranska 2

10000 Zagreb

Hrvatska

Tel: +385 1 23 50 599

Ovaj lijek je odobren u državama članicama Europskog gospodarskog prostora (EGP) pod

sljedećim nazivima:

Austrija: Solifenacin succinate Mylan 5 mg, 10 mg Filmtabletten

Belgija: Solifenacine Mylan 5 mg, 10 mg filmomhulde tabletten

Cipar: Solifenacin / Mylan

Češka Republika: Solifenacin Mylan 5 mg, 10 mg, potahované tablety

Danska: Solifenacin Mylan

Finska: Solifenacin Mylan

Francuska: SOLIFENACINE MYLAN 5 mg, 10 mg, comprimé pelliculé

Njemačka: Solifenacinsuccinat Mylan 5 mg, 10 mg Filmtabletten

Grčka: Solifenacin / Mylan

Island: Solifenacin Mylan

Irska: Solifenacin succinate 5 mg, 10 mg Film-coated tablets

Italija: Solifenacina Mylan

Luksemburg: Solifenacine Mylan 5 mg, 10 mg comprimés pelliculés

Norveška: Solifenacin Mylan

Poljska: Solifenacin Mylan

Portugal: Solifenacina Mylan

Rumunjska: Solifenacin Mylan 5 mg, 10 mg comprimate filmate

Slovačka: Solifenacin Mylan 5 mg, 10 mg, filmom obalené tablety

Španjolska: Solifenacina Mylan 5 mg, 10 mg comprimidos recubiertos con película

Švedska: Solifenacin Mylan

Nizozemska: Solifenacinesuccinaat Mylan 5 mg, 10 mg, filmomhulde tabletten

Ujedinjeno Kraljevstvo: Solifenacin succinate 5 mg, 10 mg Film-coated tablets

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u rujnu 2017..

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24-10-2018

Vita Health Products Recall (2018-10-24)

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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.

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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...

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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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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