Bloxan 100 mg tablete

Glavna informacija

  • Trgovački naziv:
  • Bloxan 100 mg tablete
  • Doziranje:
  • 100 mg
  • Farmaceutski oblik:
  • tableta
  • Sastav:
  • Urbroj: svaka tableta sadrži 100 mg metoprololtartarata
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Krka d.d., Novo Mesto, Slovenija

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Bloxan 100 mg tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 30 tableta u blisteru, u kutiji [HR-H-004450484-01] Urbroj: 381-12-01/70-15-07

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-004450484
  • Datum autorizacije:
  • 24-07-2015
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacija za korisnika

Bloxan 100

mg tablete

metoprololtartarat

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

podatke.

Sačuvajte ovu uputu. Možda ćete ju trebati ponovo 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 moguću nuspojavu koja nije navedena u ovoj uputi, vidjeti dio 4.

Što se nalazi u ovoj uputi:

Što je Bloxan i za što se koristi?

Što morate znati prije nego počnete uzimati Bloxan?

Kako uzimati Bloxan?

Moguće nuspojave

Kako čuvati Bloxan?

Sadržaj pakiranja i druge informacije

1.

Što je Bloxan i za što se koristi?

Bloxan sadržava djelatnu tvar metoprolol koji pripada skupini lijekova pod nazivom beta-blokatori.

Metoprolol smanjuje utjecaj hormona stresa na srce povezan s fizičkim i psihičkim naporom i time

usporava otkucaje srca i smanjuje krvni tlak.

Bloxan se primjenjuje u odraslih u liječenju brojnih i raznolikih stanja uključujući:

povišeni krvni tlak (hipertenzija),

bolove u prsima uzrokovane anginom (angina pektoris),

pojedine poremećaje srčanog ritma (ubrzani ili nepravilni otkucaji srca),

sprečavanje srčane smrti i ponovnog srčanog udara u bolesnika koji su ga već imali u prošlosti,

pretjeranu aktivnost štitne žlijezde (tireotoksikoza),

sprječavanje napada migrene.

2.

Što morate znati prije nego počnete uzimati Bloxan?

Nemojte uzimati Bloxan

ako ste u kardiogenom šoku (stanje u kojem srce ne istiskuje dovoljnu količinu krvi u tijelo)

ako imate teško zatajenje srca

ako ste alergični na metoprololtartarat ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu

6.),

ako ste alergični na bilo koje druge beta-blokatore,

ako imate ozbiljne poremećaje provođenja impulsa u srcu i/ili vrlo nizak puls,

ako imate tešku bolest perifernih arterija s mogućnošću nastanka gangrene,

ako imate snižen krvni tlak.

Budite oprezni s Bloxanom

Prije nego li započnete uzimati lijek, obavijestite liječnika ukoliko se neko od sljedećih stanja

odnosi na Vas:

bronhijalna astma

izražene smetnje zbog suženih bronha

tumor u blizini bubrega (feokromocitom)

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24 - 07 - 2015

O D O B R E N O

planiran kirurški zahvat (recite anesteziologu da uzimate ovaj lijek)

umjereni poremećaji provođenja impulsa u srcu

ozbiljno akutno stanje praćeno pretjeranom kiselošću krvi

uzimate digitalis (lijek za poremećaje srca)

Prinzmetalova angina (vrsta boli u prsima)

teško oštećena funkcija bubrega

poremećaji cirkulacije perifernih arterija

Djeca

Ovaj lijek se ne preporučuje za primjenu u djece.

Drugi lijekovi i Bloxan

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

druge lijekove.

Bloxan ulazi u interakcije s velikim brojem drugih lijekova. Ako uzimate bilo koji od sljedećih

lijekova, provjerite je li Vaš liječnik s time upoznat, jer ćete možda morati promijeniti svoju terapiju:

propafenon,

amiodaron,

kinidin,

verapamil,

diltiazem,

klonidin,

disopiramid

hidralazin,

digitalis/digoksin (lijekovi za liječenje bolesti srca i cirkulacije).

barbiturati (lijekovi za liječenje epilepsije).

nesteroidni protuupalni lijekovi (za bol i temperaturu, npr. indometacin i celekoksib).

adrenalin (lijek za liječenje akutnog šoka i ozbiljnih alergijskih reakcija).

fenilpropanolamin (lijek za liječenje otekle sluznice nosa).

difenhidramin (lijek za liječenje alergija).

terbinafin (lijek za liječenje gljivičnih infekcija na koži).

rifampicin (lijek za liječenje tuberkuloze).

ostali beta-blokatori (npr. kapi za oči).

MAO inhibitori (lijekovi za liječenje depresije i Parkinsonove bolesti).

inhalacijski anestetici (lijekovi za anesteziju).

lijekovi za liječenje šećerne bolesti u obliku tableta (antidijabetici za primjenu kroz usta).

cimetidin (lijek za liječenje žgaravice i povrata kiseline iz želuca).

lijekovi za liječenje depresije (paroksetin, fluoksetin i sertralin).

Bloxan s hranom i pićem

Bloxan tablete se moraju uzimati na prazan želudac, uz malo vode.

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.

Metoprolol se ne smije koristiti tijekom trudnoće i dojenja osim ako se njegova primjena ne smatra

neophodnom.

Beta-blokatori uključujući metoprolol mogu štetno djelovati na fetus i uzrokovati preuranjen porod.

Metoprolol može uzrokovati usporavanje otkucaja srca fetusa i novorođenčeta.

Metoprolol se izlučuje u majčino mlijeko i može štetno utjecati na dijete.

Upravljanje vozilima i strojevima

Metoprolol može narušiti Vašu sposobnost reagiranja te uzrokovati pojavu omaglice i umora, stoga, ne

vozite i ne rukujte alatima ili strojevima sve dok ne utvrdite kakvo djelovanje ove tablete imaju na

Vas. Sami procijenite možete li upravljati vozilima i strojevima. Primjena lijeka je jedan od faktora

koji mogu utjecati na ove sposobnosti zbog njegovih učinaka i/ili nuspojava. Opis učinaka te

nuspojave prikazane su u drugim poglavljima ove upute o lijeku. Molimo Vas pročitajte cijelu uputu.

Imate li dodatnih pitanja, obratite se svom liječniku ili ljekarniku

Bloxan sadrži laktozu

Ako Vam je liječnik rekao da ne podnosite neke šećere, savjetujte se s liječnikom prije uzimanja ovog

lijeka.

H A L M E D

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O D O B R E N O

3.

Kako uzimati Bloxan?

Uvijek uzmite primijenite ovaj lijek točno onako kako je opisano u ovoj uputi ili kako Vam je rekao

Vaš liječnik ili ljekarnik. Provjerite s Vašim liječnikom ili ljekarnikom ako niste sigurni.

Tableta se može prepoloviti na jednake doze, ali se ne smije drobiti ili žvakati.

Tabletu treba uzeti kroz usta, na prazan želudac, s najmanje pola čaše tekućine. Doza koja je potrebna

Vama ovisi o stanju Vašeg organizma te istodobnom uzimanju drugih lijekova.

Uobičajene doze su:

Povišeni krvni tlak (hipertenzija):

Početna je doza 1-2 tablete (100-200 mg) na dan uzeta

odjednom ili raspodijeljena na dva puta dnevno. Nije li učinak zadovoljavajući, liječnik može

postupno povećavati dozu ili dodati drugi lijek.

Angina pektoris; poremećaji srčanog ritma:

1-2 tablete (100-200 mg) na dan uzeta odjednom ili

raspodijeljena na dva puta dnevno.

Sprječavanje ponovnog srčanog udara u bolesnika koji su ga već imali u prošlosti:

100 mg

ujutro i navečer

Pretjerana aktivnost štitne žlijezde (tireotoksikoza):

početna doza je 50 mg tri do četiri puta na

dan, daljnju dozu će odrediti Vaš liječnik.

Poremećaj rada srca s nepravilnim otkucajima srca:

100 mg jednom dnevno. Ukoliko je

potrebno, doza se može povećati.

Sprječavanje migrene

: 100-200 mg na dan primijenjenih odjednom ili raspodijeljeno u dvije

doze.

Vaš liječnik će odrediti odgovarajuću početnu dozu i pratiti stanje.

Progutajte svoje tablete u cijelosti, uz gutljaj vode.

Ne prekidajte naglo s uzimanjem tableta, jer to može uzrokovati pogoršanje Vašeg stanja.

Uvijek se najprije posavjetujte sa svojim liječnikom.

Bloxan se ne preporučuje djeci.

Moguće je da će osobe s teškim oštećenjem jetre trebati uzimati manju dozu.

Ako uzmete više Bloxana nego što ste trebali

Ukoliko ste uzeli veću dozu nego što biste smjeli, odmah se posavjetujte s liječnikom ili nazovite odjel

hitne službe Vama najbliže bolnice.

Ako ste zaboravili uzeti Bloxan

Ako ste zaboravili uzeti dozu, uzmite je čim se sjetite, a zatim uzmite svoju sljedeću dozu u

uobičajeno vrijeme.

Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu tabletu.

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

4.

Moguće nuspojave

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

Prijavljene nuspojave su razvrstane prema učestalosti:

Vrlo često (u 1 ili više od 1 na 10 osoba koje uzimaju lijek)

Umor.

Često (u do 1 do 10 osoba na 100 osoba koji uzimaju lijek):

Glavobolja, omaglica

H A L M E D

24 - 07 - 2015

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Usporeni otkucaji srca, nepravilni otkucaji srca

Hladne ruke i noge

Osjećaj kratkoće daha/nedostatka zraka prilikom napora

Mučnina, povraćanje, bol u trbuhu, proljev, konstipacija (zatvor)

Manje često (u 1 do 10 osoba na 1000 osoba koje uzimaju lijek)

Depresija, noćne more, poremećaji spavanja

Utrnulost ili trnci u rukama i nogama

Bol u prsima, pogoršanje zatajenja srca

Velik pad tlaka tijekom infarkta srca

Osjećaj nedostatka zraka ili čujno, piskutavo disanje (bronhospazam)

Osip kože i/ili svrbež

Zadržavanje vode (edem), dobivanje na težini

Rijetko (u do 1 do 10 osoba na 1000 osoba koji uzimaju lijek):

Smanjen broj trombocita (trombocitopenija)

Poremećaj pamćenja, smetenost, halucinacije, nervoza, tjeskoba

Suhoća i bolna osjetljivost očiju ili poteškoće s vidom

Zujanje u ušima

Srčane aritmije

Gubitak svijesti

Promjene okusa

Promjene rezultata testova funkcije jetre

Fotoosjetljivost, pojačano znojenje, gubitak kose, pogoršanje psorijaze

Privremeno smanjenje spolnog nagona

Nepoznata učestalost (učestalost se ne može procijeniti iz dostupnih podataka)

Smanjena sposobnost koncentriranja

Konjuktivitis (upala očne spojnice)

Gangrena u bolesnika s poremećajima cirkulacije

Hunjavica

Suha usta

Hepatitis (upalna bolest jetre)

Grčevi mišića, bolni zglobovi

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 Bloxan?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Čuvati na temperaturi ispod 25

Čuvati u originalnom pakiranju radi zaštite od vlage.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju. Rok valjanosti

odnosi se na zadnji dan navedenog mjeseca.

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24 - 07 - 2015

O D O B R E N O

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

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

6.

Sadržaj pakiranja i druge informacije

Što Bloxan sadrži?

Djelatna tvar je metoprololtartarat. Svaka tableta sadrži 100

metoprololtartarata.

Drugi sastojci su: laktoza hidrat; celuloza, mikrokristalična; natrijev škroboglikolat, vrst A;

silicijev dioksid, koloidni, bezvodni; povidon i magnezijev stearat.

Kako Bloxan izgleda i sadržaj pakiranja?

Tablete su okrugle, bijele, s razdjelnom crtom na jednoj strani.

Tableta se može razdijeliti na jednake doze.

Bloxan je dostupan u blisterima po 10 tableta, a svaka kutija sadrži ukupno 30 tableta.

Nositelj odobrenja za stavljanje lijeka u promet

KRKA - FARMA d.o.o., Radnička cesta 48, 10000 Zagreb, Hrvatska

Proizvođač

KRKA d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u srpnju 2015.

H A L M E D

24 - 07 - 2015

O D O B R E N O

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Europe - EFSA - European Food Safety Authority Publications

28-8-2018

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

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

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

FDA - U.S. Food and Drug Administration

14-8-2018

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix LLC, is voluntarily recalling lot: 112710 of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa capsules, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend to the consumer level. These products have been tested by the U.S. Food and Drug Administration (“FDA”) and found to be contaminated with High Microbial Loads. Additionally, this serves as a update to a previous press release posted on June 30th 2018, concerning Blissful...

FDA - U.S. Food and Drug Administration

3-8-2018

Scientific guideline:  Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance, adopted

Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

22-6-2018

Metronidazole intravenous infusion 500 mg/100 mL bag

Metronidazole intravenous infusion 500 mg/100 mL bag

Shortage and althernative supply of Metronidazole intravenous infusion 500 mg/100 mL bag

Therapeutic Goods Administration - Australia

15-6-2018

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

At least 43 patient reported adverse event after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared i...

FDA - U.S. Food and Drug Administration

12-6-2018

Blokhuis: harde feiten gif in sigaretten zeer zorgelijk

Blokhuis: harde feiten gif in sigaretten zeer zorgelijk

Teer, nicotine en koolmonoxide gehalten in sigaretten die gemeten worden volgens de Canadian Intense (CI) methode zijn minimaal twee keer zo hoog als de gehalten gemeten met de wettelijke voorgeschreven ISO methode waarmee de EU en dus ook Nederland werkt. In sommige gevallen liggen de gehaltes zelfs tot meer dan 20 keer hoger. Dat blijkt uit onderzoek van het RIVM, dat 100 sigaretten onder de loep nam. Staatssecretaris Paul Blokhuis (VWS) heeft als opdrachtgever het onderzoek vandaag in ontvangst genome...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

17-5-2018

Shoreside Enterprises Issues Voluntary Nationwide Recall of 7K and Poseidon 4500 (Extreme 1000 Mg) Due to Presence of Undeclared Sildenafil and Tadalafil

Shoreside Enterprises Issues Voluntary Nationwide Recall of 7K and Poseidon 4500 (Extreme 1000 Mg) Due to Presence of Undeclared Sildenafil and Tadalafil

Shoreside Enterprises, Inc. is voluntarily recalling 7K (Lot specific: Lot #RO) and Poseidon 4500 (Extreme 1000 mg) (Lot specific: Lot #20117BL) to the consumer level. FDA analysis found the samples of these products to contain undeclared Sildenafil and/or Tadalafil. Sildenafil and Tadalafil are active ingredients in two FDA-approved prescription drugs used for the treatment of erectile dysfunction (ED).

FDA - U.S. Food and Drug Administration

3-5-2018

CVM eSubmitter Webinar 1 Agenda

CVM eSubmitter Webinar 1 Agenda

CVM will host the first of a three-part webinar series to provide information on the use of CVM’s electronic submission tool, eSubmitter, in the new animal drug application approval process. These webinars will support the use of eSubmitter as we move to 100% electronic submission.

FDA - U.S. Food and Drug Administration

28-2-2018

Help 100% & Pure Natural & Body Slim capsules

Help 100% & Pure Natural & Body Slim capsules

Help 100% & Pure Natural & Body Slim Capsules pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

8-9-2017

The Icelandic Medicines Agency advertises a vacancy for an inspector in its Inspection Unit

The Icelandic Medicines Agency advertises a vacancy for an inspector in its Inspection Unit

The Icelandic Medicines Agency advertises a vacancy for an inspector. The Agency is looking for a candidate who is willing and able to work on demanding and interesting tasks, including travels in Iceland and abroad on behalf of the Agency. The vacancy is a full post (100%).

IMA - Icelandic Medicines Agency

3-7-2017

The Icelandic Medicines Agency wishes to recruit experts to its Licencing Unit

The Icelandic Medicines Agency wishes to recruit experts to its Licencing Unit

The Agency advertises two vacancies for experts in its Quality Assessment Team. The Agency is looking for strong candidates who are willing to work on challenging and interesting tasks. Each vacancy is a full position (100%). Application deadline is up to and including 16 July 2017.

IMA - Icelandic Medicines Agency

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

2-10-2018

NexoBrid (MediWound Germany GmbH)

NexoBrid (MediWound Germany GmbH)

NexoBrid (Active substance: Concentrate of proteolytic enzymes enriched in bromelain) - PSUSA - Modification - Commission Decision (2018)6460 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10028/201712

Europe -DG Health and Food Safety

19-9-2018

Kadcyla (Roche Registration GmbH)

Kadcyla (Roche Registration GmbH)

Kadcyla (Active substance: Trastuzumab emtansine) - Centralised - Renewal - Commission Decision (2018)6100 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2389/R/39

Europe -DG Health and Food Safety

23-8-2018

 Minutes of the 100th meeting of the Management Board: 6-7 June 2018

Minutes of the 100th meeting of the Management Board: 6-7 June 2018

Europe - EMA - European Medicines Agency

27-7-2018

EU/3/12/1003 (bluebird bio (Germany) GmbH)

EU/3/12/1003 (bluebird bio (Germany) GmbH)

EU/3/12/1003 (Active substance: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA) - Transfer of orphan designation - Commission Decision (2018)5033 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/009/12/T/01

Europe -DG Health and Food Safety

27-6-2018

PANTOLOC Control (Takeda GmbH)

PANTOLOC Control (Takeda GmbH)

PANTOLOC Control (Active substance: pantoprazole) - PSUSA - Modification - Commission Decision (2018)4105 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1100/PSUSA/2285/201708

Europe -DG Health and Food Safety

6-6-2018

Agenda:  Agenda for the 100th meeting of the Management Board

Agenda: Agenda for the 100th meeting of the Management Board

Europe - EMA - European Medicines Agency

5-6-2018

Agenda:  Draft agenda for the 100th meeting of the Management Board

Agenda: Draft agenda for the 100th meeting of the Management Board

Europe - EMA - European Medicines Agency

24-5-2018

Tybost (Gilead Sciences International Limited)

Tybost (Gilead Sciences International Limited)

Tybost (Active substance: cobicistat) - PSUSA - Modification - Commission Decision (2018)3255 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10081/201708

Europe -DG Health and Food Safety

24-5-2018

Stribild (Gilead Sciences International Limited)

Stribild (Gilead Sciences International Limited)

Stribild (Active substance: elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil (as fumarate)) - PSUSA - Modification - Commission Decision (2018)3277 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2574/PSUSA/10082/201708

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Active substance: 4-{[(2R,3S,4R,5S)-4-(4-chloro-2-fluoro-phenyl)-3-(3-chloro-2-fluoro-phenyl)-4-cyano-5-(2,2-dimethyl-propyl)-pyrrolidine-2-carbonyl]-amino}-3-methoxy-benzoic acid) - Transfer of orphan designation - Commission Decision (2018)3149 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/14/T/01

Europe -DG Health and Food Safety