Azolar 30 mg tablete

Glavna informacija

  • Trgovački naziv:
  • Azolar 30 mg tablete
  • Doziranje:
  • 30 mg
  • Farmaceutski oblik:
  • tableta
  • Sastav:
  • Urbroj: jedna tableta sadrži 30 mg aripiprazola
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Belupo lijekovi i kozmetika d.d., Koprivnica, Republika Hrvatska

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Azolar 30 mg tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 30 tableta u blisteru, u kutiji [HR-H-451904670-01] Urbroj: 381-12-01/30-14-07

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-451904670
  • Datum autorizacije:
  • 22-12-2014
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacija za korisnika

AZOLAR 10 mg tablete

AZOLAR 15 mg tablete

AZOLAR 30 mg tablete

aripiprazol

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

podatke.

Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.

Ako imate dodatnih pitanja, obratite se svom liječniku ili ljekarniku.

Ovaj je lijek propisan samo Vama. Nemojte ga davati drugima. Može im naškoditi, čak i ako

su njihovi znakovi bolesti jednaki Vašima.

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

uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi. Pogledajte dio 4.

Što se nalazi u ovoj uputi:

1. Što su AZOLAR tablete i za što se koriste

2. Što morate znati prije nego počnete uzimati AZOLAR tablete

3. Kako uzimati AZOLAR tablete

4. Moguće nuspojave

5. Kako čuvati AZOLAR tablete

6. Sadržaj pakiranja i druge informacije

1. ŠTO SU AZOLAR TABLETE I ZA ŠTO SE KORISTE

AZOLAR tablete pripadaju skupini lijekova koji se zovu antipsihotici.

Koristi se za liječenje odraslih i adolescenata u dobi od 15 ili više godina koji boluju od bolesti

karakterizirane simptomima poput onih da osoba čuje, vidi ili osjeća stvari kojih nema, a mogu

se javiti i sumnjičavost, pogrešno vjerovanje, nepovezan govor i ponašanje te emocionalna

tupost. Osobe s ovom bolešću također mogu osjećati depresiju, krivnju, tjeskobu ili napetost.

AZOLAR tablete koriste se za liječenje odraslih osoba te adolescenata u dobi od 13 godina i

starijih koji boluju od stanja čiji su simptomi “povišeno” raspoloženje, pretjerana količina

energije, potreba za manjom količinom sna nego obično, vrlo brz govor i ubrzan tijek misli te

ponekad teška razdražljivost.

Ovaj lijek također sprječava povratak takvog stanja u odraslih bolesnika koji su prethodno imali

odgovor na terapiju AZOLAR tabletama.

2. ŠTO MORATE ZNATI PRIJE NEGO POČNETE UZIMATI AZOLAR TABLETE

Nemojte uzimati AZOLAR tablete

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

Upozorenja i mjere opreza

Obratite se svom liječniku prije nego uzmete AZOLAR tablete ako imate:

povišen šećer u krvi (karakteriziran simptomima poput pretjerane žeđi, obilnog mokrenja,

povećanog apetita i osjećaja slabosti) ili šećernu bolest u obiteljskoj povijesti bolesti

H A L M E D

15-09-2016

O D O B R E N O

napadaje

nevoljne, nepravilne mišićne pokrete, osobito na licu

krvožilne bolesti, krvožilne bolesti u obiteljskoj povijesti bolesti, moždani udar ili „mali“

moždani udar, poremećen krvni tlak

krvne ugruške ili krvne ugruške u obiteljskoj povijesti bolesti, jer su antipsihotici povezani s

razvojem krvnih ugrušaka

ako ste u prošlosti imali problema s prekomjernim kockanjem.

Ako primijetite povećanje tjelesne težine, pojavu neuobičajenih pokreta, izrazitu pospanost koja

Vas ometa u obavljanju svakodnevnih aktivnosti, poteškoće s gutanjem ili alergijske simptome,

molimo obavijestite o tome svog liječnika.

Ako ste starija osoba i bolujete od demencije (gubitka pamćenja i drugih mentalnih sposobnosti),

Vi ili Vaš skrbnik/član obitelji morate obavijestiti liječnika ako ste preboljeli moždani udar ili

„mali“ moždani udar.

Odmah obavijestite svog liječnika ako imate misli o samoozljeđivanju ili osjećate da biste si

mogli nauditi. Samoubilačke misli i ponašanja prijavljena su tijekom liječenja ovim lijekom.

Odmah obavijestite svog liječnika ako bolujete od ukočenosti ili nesavitljivost mišića s visokom

tjelesnom temperaturom, znojenjem, promijenjenim mentalnim statusom ili jako ubrzanim ili

nepravilnim otkucajima srca.

Djeca i adolescenti

AZOLAR tablete nisu namijenjene za primjenu u djece i adolescenata mlađih od 13 godina.

Ako se nešto od gore navedenog odnosi na Vas ili pak niste sigurni, javite se svom liječniku.

Drugi lijekovi i AZOLAR tablete

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

bilo koje druge lijekove. Ovo se odnosi i na lijekove koje ste nabavili bez recepta te na biljne

lijekove i homeopatske pripravke.

Lijekovi za snižavanje krvnog tlaka:

AZOLAR tablete mogu pojačati učinak lijekova koji se koriste za snižavanje krvnog tlaka.

Obavezno obavijestite svog liječnika ako uzimate lijek za kontrolu krvnog tlaka.

Ako uzimate AZOLAR tablete s nekim drugim lijekovima, možda će biti potrebno promijeniti

dozu AZOLAR tableta koju uzimate.

U slučaju da uzimate sljedeće lijekove, osobito je važno da o tome obavijestite svog liječnika:

lijekove za ispravljanje srčanog ritma

antidepresive ili biljne lijekove za liječenje depresije i tjeskobe

lijekove za liječenje gljivičnih bolesti

određene lijekove za liječenje infekcije HIV-om

antikonvulzive za liječenje epilepsije.

Lijekovi koji povećavaju razinu serotonina:

Triptani, tramadol, triptofan, SSRI (kao paroksetin i fluoksetin), triciklički antidepresivi (kao

klomipramin, amitriptilin), petidin, gospina trava i venlafaksin. Ovi lijekovi povećavaju rizik od

nuspojava. Ako primijetite bilo kakav neobičan simptom dok uzimate neki od ovih lijekova

istodobno s AZOLAR tabletama, obavezno se javite svom liječniku.

H A L M E D

15-09-2016

O D O B R E N O

AZOLAR tablete s hranom, pićem i alkoholom

AZOLAR tablete mogu se uzimati neovisno o obrocima.

Za vrijeme liječenja AZOLAR tabletama moraju se izbjegavajti alkoholna pića.

Trudnoća i dojenje

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

svom liječniku za savjet prije nego uzmete ovaj lijek.

Ako ste trudni, ne smijete uzimati AZOLAR tablete

, osim ako ste o tome razgovarali s

liječnikom.

Sljedeći simptomi se mogu javiti u novorođenčadi majki koje su uzimale AZOLAR tablete u

posljednjem tromjesečju (posljednja tri mjeseca trudnoće): tresavica, ukočenost i/ili slabost

mišića, pospanost, uznemirenost, tegobe s disanjem i poteškoće s hranjenjem. Ako se kod Vašeg

djeteta razvije bilo koji od ovih simptoma, javite se svom liječniku.

Ako uzimate AZOLAR tablete, ne smijete dojiti.

Upravljanje vozilima i strojevima

Nemojte voziti niti koristiti bilo kakve alate ili strojeve prije nego što znate kako AZOLAR

tablete utječu na Vas.

AZOLAR tablete sadrže laktozu

AZOLAR tablete sadrže pomoćnu tvar laktozu hidrat. Ako Vam je liječnik rekao da ne podnosite

neke šećere, savjetujte se s liječnikom prije uzimanja ovog lijeka.

3. KAKO UZIMATI AZOLAR TABLETE

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

Vašim liječnikom ili ljekarnikom ako niste sigurni.

Preporučena doza za odrasle je 15 mg jedanput dnevno.

Međutim, liječnik Vam može

propisati manju ili veću dozu, koja smije iznositi najviše 30 mg jedanput dnevno.

Primjena u djece i adolescenata

Liječenje

aripiprazolom

može

započeti

nižom

jačinom

lijeka

obliku

oralne

otopine

(tekućine) drugog proizvođača. U nastavku liječenja doza se može postupno povećavati do

preporučene doze za adolescente od 10 mg jedanput dnevno

. Međutim, liječnik Vam može

propisati manju ili veću dozu, koja smije iznositi najviše 30 mg jedanput dnevno.

Ako imate dojam da je učinak AZOLAR tableta prejak ili preslab, obratite se svom liječniku ili

ljekarniku.

Pokušajte uzimati AZOLAR tablete svaki dan u isto vrijeme.

Nije važno uzimate li ih s hranom ili ne (vidjeti dio

AZOLAR tablete s hranom, pićem i

alkoholom

AZOLAR 10 mg tablete

Tableta ima razdjelni urez koji omogućava lomljenje tablete na dva dijela pri čemu se

osigurava da svaka polovica tablete sadrži 5 mg. U dogovoru s Vašim liječnikom, progutajte

polovicu ili cijelu tabletu s čašom vode, jedanput na dan.

H A L M E D

15-09-2016

O D O B R E N O

AZOLAR 15 mg tablete i AZOLAR 30 mg tablete

Uvijek progutajte cijelu tabletu s čašom vode, jedanput na dan.

Čak

osjećate

bolje,

nemojte mijenjati dozu niti prekidati svakodnevno uzimanje

AZOLAR tableta bez prethodnog savjetovanja s liječnikom.

Ako uzmete više AZOLAR tableta nego što ste trebali

Ukoliko ste slučajno uzeli više AZOLAR tableta nego što Vam je liječnik propisao (ili ako je

druga osoba popila Vaše AZOLAR tablete), odmah se javite najbližoj hitnoj medicinskoj službi

ili obavijestite svojeg liječnika. Uzmite preostale tablete ili uputu o lijeku sa sobom kako bi

zdravstveni djelatnici kojima ste se obratili točno znali koji ste lijek uzeli.

Ako ste zaboravili uzeti AZOLAR tablete

Ukoliko zaboravite uzeti dozu lijeka, uzmite ju čim se sjetite. Nemojte uzeti dvostruku dozu

kako biste nadoknadili zaboravljenu dozu.

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

ljekarniku.

4. MOGUĆE NUSPOJAVE

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

Česte nuspojave (javljaju se u najviše 1 na 10 bolesnika):

nekontrolirano trzanje mišića ili trzajni pokreti, glavobolja, umor, mučnina, povraćanje,

neugodan osjećaj u želucu, zatvor, pojačano stvaranje sline, ošamućenost, poteškoće sa

spavanjem, nemir, osjećaj tjeskobe, pospanost, tresavica i zamagljen vid.

Manje česte nuspojave (javljaju se u najviše 1 na 100 bolesnika):

neke osobe mogu osjećati omaglicu, osobito pri ustajanju iz ležećeg ili sjedećeg položaja, ili

mogu osjetiti ubrzan rad srca. Neke osobe se mogu osjećati depresivno.

povišenje razine hormona prolaktina u krvi.

štucavica

Sljedeće nuspojave prijavljene su nakon stavljanja AZOLAR tableta u promet, ali nije

poznato kojom su se učestalošću javljale (učestalost se ne može odrediti iz dostupnih

podataka):

Promjene broja nekih krvnih stanica; nepravilni otkucaji srca, iznenadna neobjašnjiva smrt,

srčani udar; alergijska reakcija (npr. oteklina usta, jezika, lica i grla, svrbež, osip); povišen šećer

u krvi, početak ili pogoršanje šećerne bolesti, ketoacidoza (ketoni u krvi i mokraći) ili koma,

smanjena razina natrija u krvi; povećanje tjelesne težine, smanjenje tjelesne težine, anoreksija;

nervoza,

uznemirenost,

agresija,

osjećaj

tjeskobe,

prekomjerno

kockanje;

suicidalne

misli,

pokušaj

samoubojstva

samoubojstvo;

poremećaj

govora,

epileptički

napadi,

serotoninski

sindrom (reakcija koja

može

dovesti

osjećaja

velike

sreće, omamljenosti, nespretnosti,

nemira,

osjećaja

pijanstva,

vrućice,

znojenja

ukočenih

mišića),

kombinacija

vrućice,

ukočenosti mišića, ubrzanog disanja, znojenja, smanjene svijesti i iznenadnih promjena krvnog

tlaka i brzine otkucaja srca; nesvjestica, visoki krvni tlak, krvni ugrušci u venama osobito nogu

(simptomi uključuju oteklinu, bol i crvenilo noge), koji mogu putovati kroz krvne žile do pluća i

tamo prouzročiti bol u prsima i otežano disanje (

ako primijetite neki od navedenih simptoma,

odmah potražite liječničku pomoć

); grč mišića koji okružuju glasnice, slučajno udisanje hrane

uz rizik od razvoja upale pluća, poteškoće s gutanjem; upala gušterače; zatajenje jetre, upala

H A L M E D

15-09-2016

O D O B R E N O

jetre, žuta boja kože i bjeloočnica, abnormalne vrijednosti jetrenih pretraga, nelagoda u trbuhu i

želucu, proljev; kožni osip i osjetljivost na svjetlost, neobičan gubitak kose ili prorijeđenost kose,

pojačano znojenje; ukočenost ili grčevi, bol u mišićima, slabost; nemogućnost kontroliranja

mokrenja, poteškoće pri mokrenju; produljena i/ili bolna erekcija; poteškoće s kontroliranjem

osnovne tjelesne temperature ili pregrijavanje, bol u prsima i otekline ruku, gležnjeva ili stopala.

U starijih bolesnika s demencijom prijavljeno je više smrtnih slučajeva za vrijeme liječenja ovim

lijekom. Osim toga, prijavljeni su slučajevi moždanog udara ili „malog“ moždanog udara.

Dodatne nuspojave u djece i adolescenata

Adolescenti u dobi od 13 ili više godina imali su nuspojave slične učestalosti i vrste kao i odrasli

bolesnici, osim što su pospanost, nekontrolirano trzanje mišića ili trzajni pokreti, nemir i umor

bili vrlo česti (javljaju se u više od 1 na 10 bolesnika), dok su bol u gornjem dijelu trbuha, suha

usta,

ubrzani

otkucaji

srca,

povećanje

tjelesne

težine,

pojačan

apetit,

trzanje

mišića,

nekontrolirani pokreti udova i osjećaj omaglice, osobito pri ustajanju iz ležećeg ili sjedećeg

položaja, bili česti (javljaju se u najviše 1 na 100 bolesnika).

Prijavljivanje nuspojava

primijetite

bilo

koju

nuspojavu,

potrebno

obavijestiti

liječnika

ljekarnika.

uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi. Nuspojave možete prijaviti

izravno

putem

nacionalnog

sustava

prijavu

nuspojava

navedenog

Dodatku

Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.

5. KAKO ČUVATI AZOLAR TABLETE

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

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

Rok valjanosti odnosi se na zadnji dan navedenog mjeseca.

Lijek ne zahtjeva posebne uvjete 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 AZOLAR tablete sadrže

Djelatna tvar je aripiprazol.

AZOLAR 10 mg tablete: jedna tableta sadrži 10 mg aripiprazola.

AZOLAR 15 mg tablete: jedna tableta sadrži 15 mg aripiprazola.

AZOLAR 30 mg tablete: jedna tableta sadrži 30 mg aripiprazola.

Pomoćne

tvari

laktoza

hidrat;

kukuruzni

škrob;

celuloza,

mikrokristalična;

hidroksipropilceluloza; magnezijev stearat.

AZOLAR 10 mg i 30 mg tablete sadrže i boju željezov oksid, crveni (E172).

AZOLAR 15 mg tablete sadrže i boju željezov oksid, žuti (E172).

Kako AZOLAR tablete izgledaju i sadržaj pakiranja

AZOLAR 10 mg tableta je pravokutna, bikonveksna, svijetlo ružičasta tableta s razdjelnim

urezom na jednoj strani. Tableta ima razdjelni urez koji omogućava lomljenje tablete na dva

dijela pri čemu se osigurava da svaka polovica tablete sadrži 5 mg.

H A L M E D

15-09-2016

O D O B R E N O

AZOLAR 15 mg tableta je okrugla, ravna, svijetlo žuta tableta.

AZOLAR 30 mg tableta je okrugla, bikonveksna, svijetlo ružičasta tableta.

30 (5x6) tableta u oPA/Al/PVC//Al blisteru, u kutiji.

Ime i adresa nositelja odobrenja za stavljanje gotovog lijeka u promet

BELUPO lijekovi i kozmetika d.d.

Ulica Danica 5

48 000 Koprivnica, Hrvatska

Ime i adresa proizvođača lijeka

BELUPO lijekovi i kozmetika d.d.

Ulica Danica 5

48 000 Koprivnica, Hrvatska

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u svibnju 2016.

H A L M E D

15-09-2016

O D O B R E N O

15-11-2018

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Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

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Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The product Bergazym® P100 contains a xylanase which is produced by a non‐genetically modified strain of Trichoderma reesei. The additive is available in a coated granular form and it is intended to be used as a zootechnical additive (functional group: digestibility enhancers) for chickens for fattening, and weaned piglets at the dose of 1,500 EPU/kg feed. The production strain and the additive were fully characterised in a previous assessment of the Panel o...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Guidance on the scientific requirements for health claims related to muscle function and physical performance

Guidance on the scientific requirements for health claims related to muscle function and physical performance

Published on: Tue, 30 Oct 2018 00:00:00 +0100 EFSA has asked the Panel on Nutrition, Novel Foods and Food Allergens (NDA) to update the guidance on the scientific requirements for health claims related to physical performance published in 2012. The update takes into account the experience gained by the NDA Panel with the evaluation of additional health claim applications, changes introduced to the general scientific guidance for stakeholders for health claims applications and information collected from ...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Peer review of the pesticide risk assessment of the active substance methiocarb

Peer review of the pesticide risk assessment of the active substance methiocarb

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State the United Kingdom and co‐rapporteur Member State Germany for the pesticide active substance methiocarb 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 use...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of a strain of Lactobacillus hilgardii and of Lactobacillus buchneri when used as a technological additive intended to improve ensiling at a proposed application rate of 3.0 x 108 colony forming units (CFU)/kg fresh material. The two bacterial species are considered by EFS...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

P. East Trading Corp. Issues Alert on Undeclared Sulfites In Fruits Du Sud Golden Seedless Raisins

P. East Trading Corp. Issues Alert on Undeclared Sulfites In Fruits Du Sud Golden Seedless Raisins

P. EAST TRADING CORP. of Bronx, NY is recalling Fruits Du Sud Golden Seedless Raisins (Lot No. FDS T499/18) 30 lbs Box, because they contain undeclared SULFITES. People who have a severe sensitivity to sulfites run the risk of serious or life-threatening reactions if they consume these products.

FDA - U.S. Food and Drug Administration

11-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

25-9-2018

Voluntary Recall on Harris Teeter Low Fat Cookies & Cream Frozen Yogurt Due to Undeclared Peanut Product

Voluntary Recall on Harris Teeter Low Fat Cookies & Cream Frozen Yogurt Due to Undeclared Peanut Product

Harris Teeter is notifying shoppers of a voluntarily recall of Harris Teeter Low Fat Frozen Yogurt Cookies & Cream 1.5 qt laminated cartons, UPC 0 72036 98182 0, with all SELL BY DATES up to 07/30/19 due to undeclared peanut product.

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

31-8-2018

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

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

Published on: Thu, 30 Aug 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 Germany for the pesticide active substance 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 cype...

Europe - EFSA - European Food Safety Authority Publications

10-8-2018

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Ma...

FDA - U.S. Food and Drug Administration

6-8-2018

G & C Raw, LLC Recalls Pat's Cat Turkey, and Ground Lamb Pet Food, because of Possible Listeria Monocytogenes Health Risk

G & C Raw, LLC Recalls Pat's Cat Turkey, and Ground Lamb Pet Food, because of Possible Listeria Monocytogenes Health Risk

G & C Raw, of Versailles, OH is recalling 30 1-lb containers of Pat's Cat Turkey Cat Food and 40 2-lb containers of Ground Lamb Dog Food because it has the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes can cause serious and sometimes fatal infections in animals eating the products.

FDA - U.S. Food and Drug Administration

31-7-2018

July 30, 2018: Two People Guilty of Distributing Tramadol Pills

July 30, 2018: Two People Guilty of Distributing Tramadol Pills

July 30, 2018: Two People Guilty of Distributing Tramadol Pills

FDA - U.S. Food and Drug Administration

17-7-2018

Blokhuis kondigt grootschalige extra vaccinatie aan: Ruim half miljoen kinderen krijgen oproep

Blokhuis kondigt grootschalige extra vaccinatie aan: Ruim half miljoen kinderen krijgen oproep

Volgend jaar worden zo’n 650.000 kinderen extra opgeroepen om zich te laten inenten tegen de zeer ernstige infectieziekte meningokokken. Het gaat om kinderen die zijn geboren na 1 januari 2001 en voor mei 2004. Dat laat staatssecretaris Paul Blokhuis (VWS) weten in een brief aan de Tweede Kamer. Reden voor deze maatregel is dat in de afgelopen jaren een stijging te zien is van het aantal mensen dat de infectie meningokokken type W oploopt. Met deze extra vaccinatieronde moet die groei worden ingedamd. He...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

30-10-2018

EU/3/14/1250 (Akcea Therapeutics UK Ltd)

EU/3/14/1250 (Akcea Therapeutics UK Ltd)

EU/3/14/1250 (Active substance: Phosphorothioate oligonucleotide targeted to transthyretin) - Transfer of orphan designation - Commission Decision (2018)7282 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/098/13/T/01

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Active substance: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant) - Orphan designation - Commission Decision (2018)7281 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/127/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Active substance: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII) - Orphan designation - Commission Decision (2018)7280 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/104/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2078 (Sellas Life Sciences Limited)

EU/3/18/2078 (Sellas Life Sciences Limited)

EU/3/18/2078 (Active substance: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG) - Orphan designation - Commission Decision (2018)7279 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/091/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2077 (Worphmed Srl)

EU/3/18/2077 (Worphmed Srl)

EU/3/18/2077 (Active substance: Melatonin) - Orphan designation - Commission Decision (2018)7278 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/077/18

Europe -DG Health and Food Safety

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

30-10-2018

EU/3/18/2075 (Consorcio Centro de InvestigaciOn BiomEdica en Red M.P.)

EU/3/18/2075 (Consorcio Centro de InvestigaciOn BiomEdica en Red M.P.)

EU/3/18/2075 (Active substance: Gefitinib) - Orphan designation - Commission Decision (2018)7276 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/090/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2074 (PhaRA bvba)

EU/3/18/2074 (PhaRA bvba)

EU/3/18/2074 (Active substance: Avapritinib) - Orphan designation - Commission Decision (2018)7275 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/079/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2073 (Fondazione Telethon)

EU/3/18/2073 (Fondazione Telethon)

EU/3/18/2073 (Active substance: Autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA) - Orphan designation - Commission Decision (2018)7274 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/113/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Active substance: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile) - Orphan designation - Commission Decision (2018)7272 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/125/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (Active substance: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate) - Orphan designation - Commission Decision (2018)7273 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/102/18

Europe -DG Health and Food Safety

30-9-2018

Roteas (Daiichi Sankyo Europe GmbH)

Roteas (Daiichi Sankyo Europe GmbH)

Roteas (Active substance: edoxaban) - PSUSA - Modification - Commission Decision (2018)5089 of Sun, 30 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10387/201710

Europe -DG Health and Food Safety

17-9-2018

Reminder: the FDA is accepting applications through Sept. 30, 2018, for the #FDAInnovationChallenge for devices to help combat #opioid addiction.   Submissions will be evaluated based on the feasibility, potential public health impact and novelty of the c

Reminder: the FDA is accepting applications through Sept. 30, 2018, for the #FDAInnovationChallenge for devices to help combat #opioid addiction. Submissions will be evaluated based on the feasibility, potential public health impact and novelty of the c

Reminder: the FDA is accepting applications through Sept. 30, 2018, for the #FDAInnovationChallenge for devices to help combat #opioid addiction. Submissions will be evaluated based on the feasibility, potential public health impact and novelty of the concept.

FDA - U.S. Food and Drug Administration

30-8-2018

Steglatro (Merck Sharp and Dohme B.V.)

Steglatro (Merck Sharp and Dohme B.V.)

Steglatro (Active substance: ertugliflozin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5789 of Thu, 30 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4315/T/2

Europe -DG Health and Food Safety

30-8-2018

Fluenz Tetra (AstraZeneca AB)

Fluenz Tetra (AstraZeneca AB)

Fluenz Tetra (Active substance: influenza vaccine (live attenuated, nasal)) - Centralised - Variation - Commission Decision (2018)5815 of Thu, 30 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2617/II/82

Europe -DG Health and Food Safety

3-8-2018

Scandonest and associated names

Scandonest and associated names

Scandonest and associated names (Active substance: mepivacaine) - Community Referrals - Art 30 - Commission Decision (2018)5380 of Fri, 03 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-30/1455

Europe -DG Health and Food Safety

1-8-2018

Bridion (Merck Sharp and Dohme B.V.)

Bridion (Merck Sharp and Dohme B.V.)

Bridion (Active substance: sugammadex) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5213 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/885/T/30

Europe -DG Health and Food Safety

30-7-2018

Nityr (Cycle Pharmaceuticals Ltd)

Nityr (Cycle Pharmaceuticals Ltd)

Nityr (Active substance: nitisinone) - Centralised - Authorisation - Commission Decision (2018)5446 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4582

Europe -DG Health and Food Safety

30-7-2018

Esmya (Gedeon Richter Plc.)

Esmya (Gedeon Richter Plc.)

Esmya (Active substance: ulipristal) - Referral - Commission Decision (2018)5101 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2041/A-20

Europe -DG Health and Food Safety

30-7-2018

Aimovig (Novartis Europharm Limited)

Aimovig (Novartis Europharm Limited)

Aimovig (Active substance: erenumab) - Centralised - Authorisation - Commission Decision (2018)5102 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4447

Europe -DG Health and Food Safety

30-7-2018

Besponsa (Pfizer Europe MA EEIG)

Besponsa (Pfizer Europe MA EEIG)

Besponsa (Active substance: inotuzumab ozogamicin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5104 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4119/T/7

Europe -DG Health and Food Safety

30-7-2018

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Active substance: ertugliflozin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5103 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4314/T/2

Europe -DG Health and Food Safety

30-7-2018

Invokana (Janssen-Cilag International NV)

Invokana (Janssen-Cilag International NV)

Invokana (Active substance: canagliflozin) - Centralised - Renewal - Commission Decision (2018)5105 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2649/R/37

Europe -DG Health and Food Safety

30-7-2018

NovoEight (Novo Nordisk A/S)

NovoEight (Novo Nordisk A/S)

NovoEight (Active substance: turoctocog alfa) - Centralised - 2-Monthly update - Commission Decision (2018)5093 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2719/II/23

Europe -DG Health and Food Safety

30-7-2018

Hyrimoz (Sandoz GmbH)

Hyrimoz (Sandoz GmbH)

Hyrimoz (Active substance: adalimumab) - Centralised - Authorisation - Commission Decision (2018)5097 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4320

Europe -DG Health and Food Safety

30-7-2018

Halimatoz (Sandoz GmbH)

Halimatoz (Sandoz GmbH)

Halimatoz (Active substance: adalimumab) - Centralised - Authorisation - Commission Decision (2018)5098 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4866

Europe -DG Health and Food Safety

30-7-2018

Rasagiline ratiopharm (Teva B.V.)

Rasagiline ratiopharm (Teva B.V.)

Rasagiline ratiopharm (Active substance: rasagiline) - Centralised - Yearly update - Commission Decision (2018)5108 of Mon, 30 Jul 2018

Europe -DG Health and Food Safety

30-7-2018

Hefiya (Sandoz GmbH)

Hefiya (Sandoz GmbH)

Hefiya (Active substance: adalimumab) - Centralised - Authorisation - Commission Decision (2018)5099 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4865

Europe -DG Health and Food Safety

30-7-2018

Alsitek (AB Science)

Alsitek (AB Science)

Alsitek (Active substance: masitinib) - Refusal of authorisation - Commission Decision (2018)5109 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4398

Europe -DG Health and Food Safety

30-7-2018

UBAC (Laboratorios Hipra, S.A.)

UBAC (Laboratorios Hipra, S.A.)

UBAC (Active substance: Streptococcus uberis vaccine (inactivated)) - Centralised - Authorisation - Commission Decision (2018)5152 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4595

Europe -DG Health and Food Safety

30-7-2018

Apoquel (Zoetis Belgium S.A.)

Apoquel (Zoetis Belgium S.A.)

Apoquel (Active substance: Oclacitinib maleate) - Centralised - Renewal - Commission Decision (2018)5153 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2688/R/13

Europe -DG Health and Food Safety

30-7-2018

Ofev (Boehringer Ingelheim International GmbH)

Ofev (Boehringer Ingelheim International GmbH)

Ofev (Active substance: Nintedanib) - PSUSA - Modification - Commission Decision (2018)5115 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10319/201710

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

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

30-7-2018

Trazimera (Pfizer Europe MA EEIG)

Trazimera (Pfizer Europe MA EEIG)

Trazimera (Active substance: trastuzumab) - Centralised - Authorisation - Commission Decision (2018)5095 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4463

Europe -DG Health and Food Safety

30-7-2018

RXULTI (Otsuka Pharmaceutical Europe Ltd)

RXULTI (Otsuka Pharmaceutical Europe Ltd)

RXULTI (Active substance: brexpiprazole) - Centralised - Authorisation - Commission Decision (2018)5088 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3841

Europe -DG Health and Food Safety

24-7-2018

ACV meeting statement, Meeting 8, 30 May 2018

ACV meeting statement, Meeting 8, 30 May 2018

Advisory Committee on Vaccines meeting statement

Therapeutic Goods Administration - Australia

11-7-2018

Vantavo (Merck Sharp and Dohme B.V.)

Vantavo (Merck Sharp and Dohme B.V.)

Vantavo (Active substance: alendronic acid / colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4511 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1180/T/30

Europe -DG Health and Food Safety

11-7-2018

Tovanor Breezhaler (Novartis Europharm Limited)

Tovanor Breezhaler (Novartis Europharm Limited)

Tovanor Breezhaler (Active substance: glycopyrronium bromide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4526 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2690/T/30

Europe -DG Health and Food Safety