Atorvastatin Billev Pharma

Glavne informacije

  • Zaščiteno ime:
  • Atorvastatin Billev Pharma 40 mg filmsko obložene tablete
  • Farmacevtska oblika:
  • filmsko obložena tableta
  • Sestava:
  • atorvastatin 40 mg / 1 tableta
  • Pot uporabe:
  • Peroralna uporaba
  • Enote v paketu:
  • škatla z 90 tabletami (9 x 10 tablet v pretisnem omotu)
  • Tip zastaranja:
  • Rp - Predpisovanje in izdaja zdravila je le na recept
  • Uporabi za:
  • ljudje
  • Vrsta medicine:
  • Alopatska drog

Dokumentov

Lokalizacija

  • Na voljo v:
  • Atorvastatin Billev Pharma 40 mg filmsko obložene tablete
    Slovenija
  • Jezik:
  • slovenščina

Terapevtski podatki

  • Terapevtska skupina:
  • atorvastatin

Drugi podatki

Stanje

  • Source:
  • JAZMP - Javna agencija RS za zdravila in medicinske pripomočke - Slovenia Medicines Agency
  • Status dovoljenje:
  • Zdravilo z dovoljenjem za promet
  • Številka dovoljenja:
  • 10120-74/2016-6
  • Datum dovoljenje:
  • 20-02-2017
  • EAN koda:
  • 3837000136920
  • Zadnja posodobitev:
  • 18-01-2018

Podatki za bolnike: sestava, indikacije, neželeni učinki, odmerjanje, interakcij, nosečnost, dojenje

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Navodilo za uporabo

Atorvastatin Billev Pharma 10 mg filmsko obložene tablete

Atorvastatin Billev Pharma 20 mg filmsko obložene tablete

Atorvastatin Billev Pharma 40 mg filmsko obložene tablete

atorvastatin

Pred začetkom jemanja zdravila natančno preberite navodilo, ker vsebuje za vas pomembne

podatke!

Navodilo shranite. Morda ga boste želeli ponovno prebrati.

Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.

Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim. Njim bi lahko celo

škodovalo, čeprav imajo znake bolezni, podobne vašim.

Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom. Posvetujte

se tudi, če opazite katere koli neželene učinke, ki niso navedeni v tem navodilu. Glejte

poglavje 4.

Kaj vsebuje navodilo:

Kaj je zdravilo Atorvastatin Billev Pharma in za kaj ga uporabljamo

Kaj morate vedeti, preden boste vzeli zdravilo Atorvastatin Billev Pharma

Kako jemati zdravilo Atorvastatin Billev Pharma

Možni neželeni učinki

Shranjevanje zdravila Atorvastatin Billev Pharma

Vsebina pakiranja in dodatne informacije

1.

Kaj je zdravilo Atorvastatin Billev Pharma in za kaj ga uporabljamo

Zdravilo Atorvastatin Billev Pharma spada v skupino zdravil, imenovano statini, ki so zdravila za

uravnavanje ravni maščob v krvi.

Zdravilo Atorvastatin Billev Pharma se uporablja za znižanje zvišane ravni holesterola in trigliceridov

v krvi, kadar prehrana z malo maščob in spremembe življenjskega stila niso dovolj učinkovite. Če

imate povečano tveganje za srčne bolezni, se lahko zdravilo Atorvastatin Billev Pharma uporablja tudi

za zmanjševanje tega tveganja, čeprav je raven holesterola v vaši krvi normalna. Med zdravljenjem je

treba nadaljevati s standardno prehrano za zniževanje ravni holesterola.

2.

Kaj morate vedeti, preden boste vzeli zdravilo Atorvastatin Billev Pharma

Ne jemljite zdravila Atorvastatin Billev Pharma:

če ste alergični na atorvastatin ali podobna zdravila, ki se uporabljajo za zniževanje ravni

maščob v krvi, ali na katero koli sestavino tega zdravila (navedeno v poglavju 6);

če imate ali ste kdaj imeli kakšno jetrno bolezen;

če ste kdaj imeli nenormalne izvide krvnih preiskav za spremljanje delovanja jeter, pa vzrok ni

bil pojasnjen;

če ste ženska v rodni dobi in ne uporabljate zanesljive kontracepcijske zaščite;

če ste noseči ali če nameravate zanositi;

če dojite.

Opozorila in previdnostni ukrepi

Pred začetkom jemanja zdravila Atorvastatin Billev Pharma se posvetujte z zdravnikom ali

farmacevtom.

Zdravilo Atorvastatin Billev Pharma za vas morda ni primerno iz naslednjih razlogov:

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če ste imeli možgansko kap s krvavitvami v možganih ali imate majhne žepke tekočine v

možganih zaradi prejšnjih kapi;

če imate težave z ledvicami;

če imate zmanjšano delovanje žleze ščitnice (hipotiroidizem);

če ste kdaj imeli ponavljajoče se ali nepojasnjene bolečine v mišicah ter osebno ali družinsko

zgodovino težav z mišicami. Svojemu zdravniku ali farmacevtu prav tako povejte, če se vam

pojavi stalna oslabelost mišic. Za diagnozo in zdravljenje bodo morda potrebne dodatne

preiskave in zdravila;

če ste zaradi zdravljenja z drugimi zdravili za zniževanje ravni maščob v krvi (npr. z drugimi

statini ali zdravili, imenovanimi fibrati) v preteklosti že imeli težave z mišicami;

če redno uživate večje količine alkohola;

če ste kdaj imeli kakšno bolezen jeter;

če ste starejši od 70 let.

Preden vzamete zdravilo Atorvastatin Billev Pharma, se posvetujte z zdravnikom ali s

farmacevtom

če imate hude težave z dihanjem.

Če karkoli od zgoraj naštetega velja za vas, vam bo vaš zdravnik pred zdravljenjem z zdravilom

Atorvastatin Billev Pharma in verjetno tudi med njim predpisal krvne preiskave, da bi ocenil tveganje

za pojav neželenih učinkov, povezanih z mišicami. Tveganje za neželene učinke, povezane z mišicami

(npr. rabdomiolizo), se poveča, če sočasno jemljete nekatera druga zdravila (glejte poglavje 2 "Druga

zdravila in zdravilo Atorvastatin Billev Pharma").

Če imate sladkorno bolezen ali če pri vas obstaja tveganje za pojav sladkorne bolezni, vas bo zdravnik

med jemanjem tega zdravila skrbno spremljal. Pri vas verjetno obstaja tveganje za pojav sladkorne

bolezni, če imate velike koncentracije sladkorjev in maščob v krvi, prekomerno telesno maso in visok

krvni tlak.

Druga zdravila in zdravilo Atorvastatin Billev Pharma

Nekatera zdravila lahko spremenijo učinek zdravila Atorvastatin Billev Pharma ali pa zdravilo

Atorvastatin Billev Pharma vpliva na njihov učinek. Takšno medsebojno delovanje lahko zmanjša

učinkovitost enega ali obeh zdravil. Lahko pa tudi poveča tveganje za neželene učinke ali njihovo

izrazitost (vključno s hudim propadanjem mišic, rabdomiolizo, ki je opisana v poglavju 4):

zdravila, ki spremenijo delovanje imunskega sistema, npr. ciklosporin;

nekateri antibiotiki ali zdravila proti glivicam, npr. eritromicin, klaritromicin, telitromicin,

ketokonazol, itrakonazol, vorikonazol, flukonazol, posakonazol, rifampicin, fusidna kislina;

druga zdravila za uravnavanje ravni maščob v krvi, npr. gemfibrozil, drugi fibrati, holestipol;

nekatera zdravila iz skupine zaviralcev kalcijevih kanalčkov, ki se uporabljajo za zdravljenje

angine pektoris (bolečine v prsnem košu) ali visokega krvnega tlaka, npr. amlodipin, diltiazem;

zdravila, ki uravnavajo srčni ritem, npr. digoksin, verapamil, amiodaron;

zdravila, ki se uporabljajo proti virusu HIV, npr. ritonavir, lopinavir, atazanavir, indinavir,

darunavir, kombinacija tipranavir/ritonavir itd.

nekatera zdravila, ki se uporabljajo za zdravljenje hepatitisa C, npr. telaprevir

druga zdravila, ki imajo z zdravilom Atorvastatin Billev Pharma medsebojne učinke, so

ezetimib (za zniževanje holesterola), varfarin (za preprečevanje strjevanja krvi), peroralni

kontraceptivi, stiripentol (antikonvulziv za zdravljenje epilepsije), cimetidin (za zdravljenje

zgage in peptične razjede), fenazon (proti bolečinam), kolhicin (za zdravljenje protina), antacidi

(za nevtralizacijo želodčne kisline, vsebujejo aluminij ali magnezij) in boceprevir (zdravilo za

zdravljenje bolezni jeter, kot je hepatitis C);

zdravila, ki se dobijo brez recepta: šentjanževka.

Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli

jemati katero koli drugo zdravilo.

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Zdravilo Atorvastatin Billev Pharma skupaj s hrano, pijačo in alkoholom

Za navodila, kako jemati zdravilo Atorvastatin Billev Pharma, glejte poglavje 3. Prosimo, upoštevajte

naslednje:

Grenivkin sok

Na dan ne spijte več kot enega ali dveh majhnih kozarcev grenivkinega soka, saj lahko velike količine

tega soka spremenijo učinek zdravila Atorvastatin Billev Pharma.

Alkohol

Med jemanjem tega zdravila se izogibajte pitju večjih količin alkohola. Za podrobnosti glejte

poglavje 2 "Opozorila in previdnostni ukrepi".

Nosečnost in dojenje

Ne jemljite zdravila Atorvastatin Billev Pharma, če ste noseči ali če nameravate zanositi.

Ne jemljite zdravila Atorvastatin Billev Pharma, če obstaja možnost, da zanosite, razen če uporabljate

učinkovito kontracepcijsko zaščito.

Ne jemljite zdravila Atorvastatin Billev Pharma, če dojite.

Varnost uporabe zdravila Atorvastatin Billev Pharma med nosečnostjo in dojenjem še ni bila

dokazana.

Posvetujte se z zdravnikom ali farmacevtom, preden vzamete to zdravilo.

Vpliv na sposobnost upravljanja vozil in strojev

To zdravilo običajno ne vpliva na sposobnost za vožnjo ali upravljanje strojev. Če pa to zdravilo

vpliva na vašo sposobnost, ne vozite ali upravljajte z orodji ali stroji.

Zdravilo Atorvastatin Billev Pharma vsebuje laktozo

Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred jemanjem tega zdravila

posvetujte s svojim zdravnikom.

3.

Kako jemati zdravilo Atorvastatin Billev Pharma

Pri jemanju tega zdravila natančno upoštevajte navodila zdravnika. Če ste negotovi, se posvetujte z

zdravnikom ali farmacevtom.

Pred začetkom zdravljenja vam bo zdravnik predpisal prehrano z majhno vsebnostjo holesterola, ki se

je morate držati tudi med zdravljenjem z zdravilom Atorvastatin Billev Pharma.

Priporočeni začetni odmerek je 10 mg zdravila Atorvastatin Billev Pharma enkrat na dan za odrasle in

otroke, stare 10 let in več. Zdravnik vam lahko predpiše večji odmerek, dokler ne boste dobivali

odmerka, ki ga potrebujete. Zdravnik bo odmerek prilagajal v presledku štirih tednov ali več. Največji

odmerek je 80 mg zdravila Atorvastatin Billev Pharma enkrat na dan za odrasle in 20 mg enkrat na

dan za otroke.

Tablete Atorvastatin Billev Pharma morate vzeti cele z nekaj vode. Vzamete jih lahko ob kateremkoli

času, s hrano ali brez nje. Tableto skušajte vzeti vsak dan ob istem času.

Trajanje zdravljenja z zdravilom Atorvastatin Billev Pharma bo določil zdravnik.

Če menite, da je učinek zdravila Atorvastatin Billev Pharma premočan ali prešibak, se posvetujte z

zdravnikom.

Če ste vzeli večji odmerek zdravila Atorvastatin Billev Pharma, kot bi smeli

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Če ste pomotoma vzeli preveč tablet Atorvastatin Billev Pharma (več kot znaša vaš običajni dnevni

odmerek), se za nasvet obrnite na svojega zdravnika ali najbližjo bolnišnico.

Če ste pozabili vzeti zdravilo Atorvastatin Billev Pharma

Če ste odmerek pozabili vzeti, vzemite naslednjega ob predpisanem času. Ne vzemite dvojnega

odmerka, če ste pozabili vzeti prejšnji odmerek.

Če imate dodatna vprašanja o uporabi zdravila ali želite prenehati z zdravljenjem, se posvetujte z

zdravnikom ali farmacevtom.

4.

Možni neželeni učinki

Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.

Če se pri vas pojavi kateri od spodaj navedenih resnih neželenih učinkov, prenehajte jemati

zdravilo in nemudoma obvestite svojega zdravnika ali pojdite v najbližjo bolnišnico na nezgodni

oddelek ali oddelek za nujno medicinsko pomoč.

Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov):

Huda alergijska reakcija, ki povzroči oteklost obraza, jezika in žrela, kar lahko povzroči velike

težave z dihanjem.

Resna bolezen s hudim luščenjem in otekanjem kože, nastajanjem mehurjev na koži, ustih, očeh

in spolovilih ter povišano telesno temperaturo. Kožni izpuščaj z rožnato-rdečimi mozolji, zlasti

na dlaneh ali podplatih, kjer lahko nastanejo mehurji.

Mišična šibkost, občutljivost na dotik ali bolečina, še posebej, če jo spremljata slabo počutje ali

vročina, lahko nastane zaradi nenormalne razgradnje mišic. Nenormalna razgradnja mišic se ne

ustavi vedno, tudi če prenehate jemati atorvastatin, in je lahko smrtno nevarna ter lahko

povzroča težave z ledvicami.

Zelo redki neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 bolnikov):

Nepričakovano ali nenavadno krvavenje ali modrice so lahko znak za težave z jetri. Takoj ko je

mogoče, se posvetujte z zdravnikom.

Ostali možni neželeni učinki pri jemanju zdravila Atorvastatin Billev Pharma

Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov):

vnetje nosnih prehodov, bolečine v žrelu ali grlu, krvavitev iz nosu,

alergijske reakcije,

zvišana raven sladkorja v krvi (če imate sladkorno bolezen, morate še naprej skrbno spremljati

raven krvnega sladkorja), zvišana raven kreatin kinaze v krvi,

glavobol,

navzea (slabost s siljenjem na bruhanje), zaprtje, vetrovi, prebavne težave, driska,

bolečine v sklepih, mišicah in v hrbtu,

rezultati krvnih preiskav, ki kažejo na nenormalno delovanje vaših jeter.

Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov):

anoreksija (izguba apetita), pridobivanje telesne mase, zniževanje ravni sladkorja v krvi (če

imate sladkorno bolezen, morate še naprej skrbno spremljati raven sladkorja v krvi),

nočne more, nespečnost,

omotica, otrplost ali mravljinčenje v prstih na rokah in nogah, zmanjšana občutljivost za dotik

ali bolečino, spremembe okušanja, izguba spomina,

zamegljen vid,

zvonjenje v ušesih in/ali v glavi,

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bruhanje, spahovanje, bolečina v zgornjem in spodnjem delu trebuha, pankreatitis (vnetje

trebušne slinavke, ki povzroči bolečine v trebuhu),

vnetje jeter (hepatitis),

izpuščaj, kožni izpuščaj in srbenje, koprivnica, izpadanje las,

bolečine v vratu, utrujenost mišic,

utrujenost, slabo počutje, šibkost, bolečina v prsih, otekanje (zlasti gležnjev - edem), povišana

telesna temperatura,

pozitiven izvid preiskave urina za bele krvne celice.

Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov):

motnje vida,

nepričakovano krvavenje ali modrice,

zastoj žolča (rumeno obarvanje kože in očesne beločnice),

poškodba tetive.

Zelo redki neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 bolnikov):

alergijska reakcija – simptomi lahko vključujejo nenadno piskanje v pljučih in bolečino ali

tiščanje v prsih, otekanje vek, obraza, ustnic, ust, jezika ali žrela, oteženo dihanje in kolaps,

izguba sluha,

ginekomastija (povečanje prsi pri moških).

Neželeni učinki neznane pogostnosti (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti):

stalna oslabelost mišic.

Možni neželeni učinki, opisani z nekaterimi statini (zdravili iste vrste):

težave v spolnosti,

depresija,

težave z dihanjem, vključno z nenehnim kašljanjem in/ali zasoplostjo ali povišano telesno

temperaturo,

sladkorna bolezen; verjetnost, da se pri vas pojavi sladkorna bolezen, je večja, če imate velike

koncentracije sladkorjev in maščob v krvi, prekomerno telesno maso in visok krvni tlak. Med

jemanjem tega zdravila vas bo spremljal zdravnik.

Poročanje o neželenih učinkih

Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom. Posvetujte se tudi,

če opazite neželene učinke, ki niso navedeni v tem navodilu. O neželenih učinkih lahko poročate tudi

neposredno na:

Univerzitetni klinični center Ljubljana, Interna klinika

Center za zastrupitve

Zaloška cesta 2

SI-1000 Ljubljana

Faks: + 386 (0)1 434 76 46

e-pošta: farmakovigilanca@kclj.si

S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega

zdravila.

5.

Shranjevanje zdravila Atorvastatin Billev Pharma

Zdravilo shranjujte nedosegljivo otrokom!

Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in

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pretisnem omotu poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega

meseca.

Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo in vlago.

Za shranjevanje zdravila ni posebnih temperaturnih omejitev.

Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke. O načinu odstranjevanja

zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom. Taki ukrepi pomagajo varovati okolje.

6.

Vsebina pakiranja in dodatne informacije

Kaj vsebuje zdravilo Atorvastatin Billev Pharma

Zdravilna učinkovina je atorvastatin. Ena filmsko obložena tableta vsebuje 10 mg, 20 mg ali

40 mg atorvastatina v obliki kalcijevega atorvastatinata.

Druge sestavine zdravila so natrijev hidroksid, natrijev lavrilsulfat, hidroksipropilceluloza,

laktoza monohidrat (glejte poglavje 2: "Zdravilo Atorvastatin Billev Pharma vsebuje laktozo"),

mikrokristalna celuloza, premreženi natrijev karmelozat, krospovidon in magnezijev stearat v

jedru tablete ter polivinilalkohol, titanov dioksid (E171), makrogol 3000 in smukec v filmski

oblogi.

Izgled zdravila Atorvastatin Billev Pharma in vsebina pakiranja

10 mg filmsko obložene tablete so bele, okrogle, rahlo izbočene, s prirezanimi robovi, premer tablet je

6 mm.

20 mg filmsko obložene tablete so bele, okrogle, rahlo izbočene, s prirezanimi robovi, premer tablet je

8 mm.

40 mg filmsko obložene tablete so bele, okrogle, rahlo izbočene, s prirezanimi robovi, premer tablet je

10 mm.

Na voljo so škatle po 4, 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98 in 100 filmsko obloženih tablet v

pretisnih omotih.

Na trgu morda ni vseh navedenih pakiranj.

Način in režim izdaje zdravila Atorvastatin Billev Pharma

Predpisovanje in izdaja zdravila je le na recept.

Imetnik dovoljenja za promet z zdravilom

Billev Pharma ApS, Slotsmarken 10, 2970 Hørsholm, Danska

Izdelovalec

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

Navodilo je bilo nazadnje revidirano dne 26. 2. 2016.

6-12-2018

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen.

FDA - U.S. Food and Drug Administration

8-11-2018

Manage Your Asthma: Know Your Triggers and Treatment Options

Manage Your Asthma: Know Your Triggers and Treatment Options

You can manage your asthma by taking medications approved by the FDA. Before going to the pharmacy, get a proper diagnosis from a doctor and together develop an asthma action plan.

FDA - U.S. Food and Drug Administration

7-11-2018

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

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

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

Health Canada

3-11-2018

Janssen Issues Voluntary Nationwide Recall for one lot of ORTHO-NOVUM 1/35 and two lots of ORTHO-NOVUM 7/7/7 Due to Incorrect Veridate Dispenser Instructions

Janssen Issues Voluntary Nationwide Recall for one lot of ORTHO-NOVUM 1/35 and two lots of ORTHO-NOVUM 7/7/7 Due to Incorrect Veridate Dispenser Instructions

Janssen Pharmaceuticals, Inc. has initiated a voluntary recall of one lot of ORTHO-NOVUM 1/35 (norethindrone / ethinyl estradiol) Tablets and two lots of ORTHO-NOVUM 7/7/7 (norethindrone / ethinyl estradiol) Tablets to the pharmacy level. The patient information provided inside affected packages of ORTHO-NOVUM does not include the appropriate instructions for the Veridate dispenser.

FDA - U.S. Food and Drug Administration

30-10-2018

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP  75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP 75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level. These products are being recalled due to the presence of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Irbesartan, USP manufactured by Aurobindo Pharma Limited. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a...

FDA - U.S. Food and Drug Administration

29-10-2018

Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Aurobindo Pharma Limited is voluntarily recalling 22 Batches of the drug substance Irbesartan due to the presence of an impurity, N-nitrosodiethylamine (NDEA). The impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC).

FDA - U.S. Food and Drug Administration

22-10-2018

Promise Pharmacy Issues Voluntary Nationwide Recall of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% Sterile Due to Small Particulate Floating in the Solution

Promise Pharmacy Issues Voluntary Nationwide Recall of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% Sterile Due to Small Particulate Floating in the Solution

Promise Pharmacy is voluntarily recalling one lot of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% sterile, 3ml vials, to the patient consumer level. The product has been found to have unidentified small particulate floating in the solution.

FDA - U.S. Food and Drug Administration

11-9-2018

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Botanicals and preparations derived from these are among the substances frequently added to foods and food supplements, yet the safety of many botanicals has not been systematically assessed. In the context of the EU‐FORA fellowship programme, the fellow performed an assessment on the safety of the botanical Gymnema sylvestre, in accordance with EFSA's guidance on the assessment of safety of botanicals. Although preparations of G. sylvestre are marketed as f...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance

Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance

Pharm D Solutions, LLC is voluntarily recalling all sterile compounded drug products within expiry to the clinic, physician or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.

FDA - U.S. Food and Drug Administration

7-9-2018

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

, SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.

FDA - U.S. Food and Drug Administration

28-8-2018

New recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones

New recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones

The EU's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted new recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones (bone metastases). Xofigo should only be used in symptomatic patients who have had two previous treatments for prostate cancer and who cannot be treated with other medicines.

Danish Medicines Agency

20-8-2018

August 17, 2018: Unlicensed Pharmacy Technician Pleads Guilty to Working at New England Compounding Center

August 17, 2018: Unlicensed Pharmacy Technician Pleads Guilty to Working at New England Compounding Center

August 17, 2018: Unlicensed Pharmacy Technician Pleads Guilty to Working at New England Compounding Center

FDA - U.S. Food and Drug Administration

31-7-2018

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling two lots of Piperacillin and Tazobactam for injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP. Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level. One vial from lot# PP0317012-A was found to contain particulate matter, identified as glass within the vial and another vial from lot# PP0317059-A was fo...

FDA - U.S. Food and Drug Administration

28-7-2018

Ranier’s Rx Laboratory Issues Voluntary Recall of All Sterile Compounded Products Within Expiry Due to Lack of Sterility Concerns

Ranier’s Rx Laboratory Issues Voluntary Recall of All Sterile Compounded Products Within Expiry Due to Lack of Sterility Concerns

Ranier’s Rx Laboratory is voluntarily recalling all sterile compounded drug products within expiry to the hospital or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.

FDA - U.S. Food and Drug Administration

13-7-2018

Scientific guideline:  Guideline on good pharmacogenomic practice - First version, adopted

Scientific guideline: Guideline on good pharmacogenomic practice - First version, adopted

This guideline provides recommendations for the conduct of genomic studies in relation to medical therapy in order to provide high quality information on the impact of genomic variability on drug response. Primary focus is on the analysis of genomic germline DNA. The analysis of somatic DNA and genomic biomarkers for cancer treatment is not being discussed and might be developed as an Annex or in separate guidance.

Europe - EFSA - European Food Safety Authority EFSA Journal

11-7-2018

July 10, 2018: Former Des Moines Pharmacy Technician Sentenced for Illegally Tampering with Fentanyl

July 10, 2018: Former Des Moines Pharmacy Technician Sentenced for Illegally Tampering with Fentanyl

July 10, 2018: Former Des Moines Pharmacy Technician Sentenced for Illegally Tampering with Fentanyl

FDA - U.S. Food and Drug Administration

26-11-2018

Wakix (Bioprojet Pharma)

Wakix (Bioprojet Pharma)

Wakix (Active substance: Pitolisant hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7974 of Mon, 26 Nov 2018

Europe -DG Health and Food Safety

26-11-2018

Alunbrig (Takeda Pharma A/S)

Alunbrig (Takeda Pharma A/S)

Alunbrig (Active substance: brigatinib) - Centralised - Authorisation - Commission Decision (2018)7976 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4248/

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2081 (Pharma Gateway AB)

EU/3/18/2081 (Pharma Gateway AB)

EU/3/18/2081 (Active substance: 3-(3-(3,5-dimethyl-1H-pyrazol-4-yl)propoxy)-4-fluorobenzoic acid) - Orphan designation - Commission Decision (2018)7790 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/096/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (Active substance: Recombinant human interleukin-3 truncated diphtheria toxin fusion protein) - Transfer of orphan designation - Commission Decision (2018)7816 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/064/15/T/02

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2101 (TMC Pharma Services Ltd)

EU/3/18/2101 (TMC Pharma Services Ltd)

EU/3/18/2101 (Active substance: Setmelanotide) - Orphan designation - Commission Decision (2018)7811 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/143/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2091 (Pharma Gateway AB)

EU/3/18/2091 (Pharma Gateway AB)

EU/3/18/2091 (Active substance: Glucagon) - Orphan designation - Commission Decision (2018)7801 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/108/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2083 (MaaT PHARMA)

EU/3/18/2083 (MaaT PHARMA)

EU/3/18/2083 (Active substance: Allogeneic faecal microbiota, pooled) - Orphan designation - Commission Decision (2018)7792 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/123/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Active substance: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride) - Orphan designation - Commission Decision (2018)7791 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/040/18

Europe -DG Health and Food Safety

12-11-2018

Neupro (UCB Pharma S.A.)

Neupro (UCB Pharma S.A.)

Neupro (Active substance: Rotigotine) - Centralised - Yearly update - Commission Decision (2018)7551 of Mon, 12 Nov 2018

Europe -DG Health and Food Safety

1-11-2018

Protopic (Leo Pharma A/S)

Protopic (Leo Pharma A/S)

Protopic (Active substance: Tacrolimus) - Centralised - Yearly update - Commission Decision (2018)7343 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

29-10-2018

Sustiva (Bristol-Myers Squibb Pharma EEIG)

Sustiva (Bristol-Myers Squibb Pharma EEIG)

Sustiva (Active substance: efavirenz) - Centralised - 2-Monthly update - Commission Decision (2018)7252 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/249/II/145/G

Europe -DG Health and Food Safety

25-10-2018

Xtandi (Astellas Pharma Europe B.V.)

Xtandi (Astellas Pharma Europe B.V.)

Xtandi (Active substance: enzalutamide) - Centralised - 2-Monthly update - Commission Decision (2018)7132 of Thu, 25 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2639/II/39G

Europe -DG Health and Food Safety

22-10-2018

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Active substance: mixture of polynuclear iron(iii)-oxyhydroxide, sucrose and starches) - Centralised - Yearly update - Commission Decision (2018)6972 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

16-10-2018

Dexxience (Portola Pharma UK Limited)

Dexxience (Portola Pharma UK Limited)

Dexxience (Active substance: betrixaban) - Refusal of authorisation - Commission Decision (2018)6226 of Tue, 16 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4309

Europe -DG Health and Food Safety

2-10-2018

Lamivudine Teva Pharma B.V. (Teva B.V.)

Lamivudine Teva Pharma B.V. (Teva B.V.)

Lamivudine Teva Pharma B.V. (Active substance: Lamivudine) - Centralised - Yearly update - Commission Decision (2018)6476 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

1-10-2018

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Active substance: Synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker) - Transfer of orphan designation - Commission Decision (2018)6399 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/16/T/01

Europe -DG Health and Food Safety

24-9-2018

NeuroBloc (Sloan Pharma S.a.r.l.)

NeuroBloc (Sloan Pharma S.a.r.l.)

NeuroBloc (Active substance: Botulinum Toxin Type B) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6221 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000301/T/0101

Europe -DG Health and Food Safety

24-9-2018

Rasilez (Noden Pharma DAC)

Rasilez (Noden Pharma DAC)

Rasilez (Active substance: aliskiren) - Centralised - Yearly update - Commission Decision (2018)6229 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Kigabeq (ORPHELIA Pharma SAS)

Kigabeq (ORPHELIA Pharma SAS)

Kigabeq (Active substance: vigabatrin) - Centralised - Authorisation - Commission Decision (2018)6224 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4534

Europe -DG Health and Food Safety

24-9-2018

INCRELEX (Ipsen Pharma)

INCRELEX (Ipsen Pharma)

INCRELEX (Active substance: Mecasermin) - Centralised - Yearly update - Commission Decision (2018)6240 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

19-9-2018

Pregabalin Mylan Pharma (Mylan S.A.S.)

Pregabalin Mylan Pharma (Mylan S.A.S.)

Pregabalin Mylan Pharma (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 6097 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3962/T/08

Europe -DG Health and Food Safety

19-9-2018

Agenda:  Agenda – 12th Pharmacovigilance stakeholder forum

Agenda: Agenda – 12th Pharmacovigilance stakeholder forum

Europe - EMA - European Medicines Agency

19-9-2018

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

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

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

Europe - EMA - European Medicines Agency

17-9-2018

 European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep

European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep

This joint Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) meeting will include results of the 2017 EMA perception survey. EMA regulatory science to 2025 will be discussed together with updates on Good Pharmacovigilance Practices (GVP). The Topic Group on Digital media and health will feedback to the working parties’ members. Participants will also receive an update on ongoing work on electronic product information and on availability of authorised med...

Europe - EMA - European Medicines Agency

12-9-2018

 Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

This information day will update participants on the Agency’s medicine risk management activities and provide advice to marketing authorisation holders and applicants on drafting a risk management plan (RMP) in view of the full implementation of the second revision of the RMP template after the transitional period has elapsed. It will also provide an opportunity for an exchange of experiences with this template between regulators and industry. A dedicated session will discuss the streamlining of safety s...

Europe - EMA - European Medicines Agency

12-9-2018

ADCETRIS (Takeda Pharma A/S)

ADCETRIS (Takeda Pharma A/S)

ADCETRIS (Active substance: Brentuximab vedotin) - Centralised - Annual renewal - Commission Decision (2018)5973 of Wed, 12 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2455/R/58

Europe -DG Health and Food Safety

29-8-2018

Cometriq (Ipsen Pharma)

Cometriq (Ipsen Pharma)

Cometriq (Active substance: cabozantinib) - PSUSA - Modification - Commission Decision (2018)5761 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10180/201711

Europe -DG Health and Food Safety

29-8-2018

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Noden Pharma DAC)

Rasilez HCT (Active substance: aliskiren hemifumarate / hydrochlorothiazide) - Centralised - Renewal - Commission Decision (2018)5769 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/964/R/87

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Active substance: (S)-(-)-3-(4-aminophenyl)-2-methoxypropanoic acid) - Orphan designation - Commission Decision (2018)5728 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/075/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Active substance: Autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor) - Orphan designation - Commission Decision (2018)5739 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/049/18

Europe -DG Health and Food Safety

27-8-2018

Yescarta (Kite Pharma EU B.V.)

Yescarta (Kite Pharma EU B.V.)

Yescarta (Active substance: axicabtagene ciloleucel) - Centralised - Authorisation - Commission Decision (2018)5718 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4480

Europe -DG Health and Food Safety

27-8-2018

Entyvio (Takeda Pharma A/S)

Entyvio (Takeda Pharma A/S)

Entyvio (Active substance: vedolizumab) - PSUSA - Modification - Commission Decision (2018)5712 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10186/201711

Europe -DG Health and Food Safety

27-8-2018

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Active substance: Fondaparinux sodium) - PSUSA - Modification - Commission Decision (2018)5708 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/403/PSUSA/1467-201712

Europe -DG Health and Food Safety

17-8-2018

EU/3/17/1870 (Pharma Gateway AB)

EU/3/17/1870 (Pharma Gateway AB)

EU/3/17/1870 (Active substance: Thymidine and deoxycytidine) - Transfer of orphan designation - Commission Decision (2018)5403 of Fri, 17 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/317/16/T/01

Europe -DG Health and Food Safety

7-8-2018

EU/3/18/2049 (Inozyme Pharma Ireland Ltd)

EU/3/18/2049 (Inozyme Pharma Ireland Ltd)

EU/3/18/2049 (Active substance: Recombinant human ectonucleotide pyrophosphatase/phosphodiesterase 1 fused to the Fc fragment of IgG1) - Orphan designation - Commission Decision (2018)5281 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/053/18

Europe -DG Health and Food Safety

6-8-2018

Kyntheum (Leo Pharma A/S)

Kyntheum (Leo Pharma A/S)

Kyntheum (Active substance: brodalumab) - Centralised - Yearly update - Commission Decision (2018)5383 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2048 (Pharma Gateway AB)

EU/3/18/2048 (Pharma Gateway AB)

EU/3/18/2048 (Active substance: N-acetylgalactosamine-conjugated synthetic double-stranded oligomer specific to serpin family A member 1 gene) - Orphan designation - Commission Decision (2018)5280 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/061/18

Europe -DG Health and Food Safety

1-8-2018

Ucedane (Lucane Pharma)

Ucedane (Lucane Pharma)

Ucedane (Active substance: carglumic acid) - Centralised - Yearly update - Commission Decision (2018)5230 of Wed, 01 Aug 2018

Europe -DG Health and Food Safety

1-8-2018

Opdivo (Bristol-Myers Squibb Pharma EEIG)

Opdivo (Bristol-Myers Squibb Pharma EEIG)

Opdivo (Active substance: nivolumab) - Centralised - 2-Monthly update - Commission Decision (2018)5204 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3985/II/41

Europe -DG Health and Food Safety

30-7-2018

Ceplene (Noventia Pharma Srl)

Ceplene (Noventia Pharma Srl)

Ceplene (Active substance: Histamine dihydrochloride) - Centralised - Renewal - Commission Decision (2018)5116 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/796/R/36

Europe -DG Health and Food Safety

23-7-2018

Dificlir (Astellas Pharma Europe B.V.)

Dificlir (Astellas Pharma Europe B.V.)

Dificlir (Active substance: fidaxomicin) - Centralised - Yearly update - Commission Decision (2018)4889 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

23-7-2018

Qarziba (EUSA Pharma (UK) Limited)

Qarziba (EUSA Pharma (UK) Limited)

Qarziba (Active substance: dinutuximab beta) - Centralised - Yearly update - Commission Decision (2018)4886 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

19-7-2018

Aplidin (Pharma Mar S.A.)

Aplidin (Pharma Mar S.A.)

Aplidin (Active substance: plitidepsin) - Refusal of authorisation - Commission Decision (2018)4831 of Thu, 19 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4354

Europe -DG Health and Food Safety

13-7-2018

Briviact (UCB Pharma S.A.)

Briviact (UCB Pharma S.A.)

Briviact (Active substance: brivaracetam) - Centralised - 2-Monthly update - Commission Decision (2018)4715 of Fri, 13 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3898/II/10/G

Europe -DG Health and Food Safety