Lanzul 30 mg tvrde kapsule

Glavna informacija

  • Trgovački naziv:
  • Lanzul 30 mg tvrde kapsule
  • Doziranje:
  • 30 mg
  • Farmaceutski oblik:
  • kapsula, tvrda
  • Sastav:
  • Urbroj: jedna kapsula sadrži 30 mg lanzoprazola
  • 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:
  • Lanzul 30 mg tvrde kapsule
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 14 kapsula u blisteru, u kutiji [HR-H-768580684-01]; 28 kapsula u blisteru, u kutiji [HR-H-768580684-02] Urbroj: 381-12-01/70-16-09

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-768580684
  • Datum autorizacije:
  • 28-04-2016
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za bolesnika

Lanzul 30 mg tvrde kapsule

lanzoprazol

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

podatke.

Sačuvajte ovu uputu. Možda ćete je 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 Lanzul i za što se koristi?

Što morate znati prije nego počnete uzimati Lanzul?

Kako uzimati Lanzul?

Moguće nuspojave

Kako čuvati Lanzul?

Sadržaj pakiranja i druge informacije

1.

Što je Lanzul i za što se koristi?

Djelatna tvar u Lanzulu je lanzoprazol koji pripada skupini lijekova pod nazivom inhibitori protonske

pumpe. Inhibitori protonske pumpe smanjuju količinu kiseline koju stvara Vaš želudac.

Liječnik može propisati Lanzul za sljedeća stanja:

liječenje čira/vrijeda dvanaesnika i želuca,

liječenje upale jednjaka (refluksni ezofagitis),

prevencija upale jednjaka (refluksnog ezofagitisa),

liječenje žgaravice i vraćanja kiselog sadržaja u jednjak,

liječenje infekcija uzrokovanih bakterijom

Helicobacter pylori

kada se daje u kombinaciji s

antibiotskim liječenjem,

liječenje ili sprječavanje čira/vrijeda dvanaesnika ili želuca u bolesnika kojima je potrebno

trajno liječenje nesteroidnim protuupalnim lijekovima (NSAID). NSAID terapija se primjenjuje

za liječenje bolova ili upale,

liječenje Zollinger-Ellisonovog sindroma.

2.

Što morate znati prije nego počnete uzimati Lanzul?

Nemojte uzimati Lanzul

ako ste alergični na lanzoprazol ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6.),

ako uzimate lijek koji sadrži djelatnu tvar atazanavir (koristi se u liječenju HIV-a).

Upozorenja i mjere opreza

Obratite se svom liječniku ili ljekarniku prije nego uzmete Lanzul.

Recite svom liječniku ako imate tešku bolest jetre. Liječnik će možda trebati prilagoditi Vašu dozu.

Razgovarajte sa svojim liječnikom prije uzimanja Lanzula:

Ako ste ikada imali kožnu reakciju nakon terapije lijekom sličnim Lanzulu koji smanjuje

želučanu kiselinu.

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O D O B R E N O

Ako dobijete osip na koži, posebice na područjima izloženima suncu obavijestite svog liječnika što je

prije moguće, jer ćete možda morati prekinuti liječenje Lanzulom. Sjetite se spomenuti i bilo koje

druge štetne učinke poput boli u zglobovima.

Vaš liječnik je proveo ili će tek provesti dodatnu pretragu koja se zove endoskopija, kako bi postavio

dijagnozu bolesti i/ili isključio malignu bolest.

Ako tijekom liječenja Lanzulom nastupi proljev, odmah obavijestite svog liječnika, jer je Lanzul bio

povezan s malim povećanjem učestalosti infektivnog proljeva.

Ako Vam je liječnik propisao Lanzul pored drugih lijekova (antibiotika) namijenjenih za liječenje

Helicobacter pylori

infekcije ili zajedno s protuupalnim lijekovima za liječenje bolova ili reumatske

bolesti: molimo Vas da pozorno pročitate i upute tih lijekova.

Ako uzimate Lanzul tijekom duljeg vremenskog perioda (dulje od 1 godine) liječnik će Vas vjerojatno

držati pod redovitim nadzorom. Prilikom svake posjete liječniku obavezno prijavite sve nove i

izvanredne simptome i okolnosti.

Uzimanje inhibitora protonske pumpe kao što je Lanzul, osobito tijekom razdoblja duljeg od godine

dana, može povećati rizik od prijeloma kuka, ručnog zgloba ili kralježnice. Recite svom liječniku ako

imate osteoporozu ili ako uzimate kortikosteroide (koji mogu povećati rizik od osteoporoze).

Drugi lijekovi i Lanzul

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

druge lijekove.

Osobito je važno da obavijestite svog liječnika ako uzimate lijekove koji sadrže bilo koju od djelatnih

tvari navedenih u nastavku, jer Lanzul može utjecati na način djelovanja tih lijekova:

ketokonazol, itrakonazol, rifampicin (koriste se za liječenje infekcija),

digoksin (koristi se za liječenje srčanih poteškoća),

teofilin (koristi se za liječenje astme),

takrolimus (koristi se za sprječavanje odbacivanja transplantata),

fluvoksamin (koristi se za liječenje depresije i drugih psihičkih bolesti),

antacidi (koriste se za liječenje žgaravice i vraćanja kiselog sadržaja u jednjak),

sukralfat (koristi se za liječenje čira/vrijeda),

gospina trava (

Hypericum perforatum

) (koristi se za liječenje blage depresije).

Lanzul s hranom i pićem

Kako biste od svojih lijekova dobili najbolje rezultate, neophodno je uzeti Lanzul najmanje 30 minuta

prije jela.

Trudnoća i dojenje

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

liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.

Primjena lanzoprazola tijekom trudnoće se ne preporučuje. Također se ne preporučuje uzimanje

lanzoprazola tijekom dojenja.

Upravljanje vozilima i strojevima

Nuspojave kao što su omaglica, vrtoglavica, umor i poremećaji vida ponekad se javljaju u bolesnika

koji uzimaju Lanzul. Ako osjetite nuspojave poput ovih, morate biti oprezni jer sposobnost reagiranja

može biti smanjena.

Pročitajte sve informacije iz ove upute, radi korisnih smjernica.

Posavjetuje se sa svojim liječnikom, medicinskom sestrom ili ljekarnikom ako u nečemu niste sigurni.

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Lanzul sadrži saharozu

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

lijeka.

3.

Kako uzimati Lanzul?

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

liječnikom ili ljekarnikom ako niste sigurni.

Progutajte kapsulu u cijelosti uz čašu vode. Ako Vam gutanje kapsula predstavlja poteškoću, liječnik

Vam može savjetovati druge načine primjene Vašeg lijeka.

Nemojte drobiti ili žvakati ove kapsule ili sadržaj ispražnjene kapsule jer ćete tako spriječiti

primjereno djelovanje lijeka.

Ako uzimate Lanzul jednom dnevno, pokušajte ga uzimati u isto vrijeme svakoga dana. Najbolji

rezultati se mogu postići ako uzmete Lanzul odmah ujutro.

Ako uzimate Lanzul dva puta dnevno, prvu dozu trebate uzeti ujutro, a drugu dozu navečer.

Doza Lanzula ovisi o stanju bolesti. Niže su navedene uobičajene doze Lanzula za odrasle. Liječnik

ponekad može propisati drugačiju dozu i reći Vam koliko dugo će trajati liječenje.

Liječenje žgaravice i vraćanja kiselog sadržaja u jednjak:

jedna kapsula od 15 mg (u tom slučaju

su dostupne Lanzul S 15 mg želučanootporne kapsule) ili jedna kapsula od 30 mg tijekom 4 tjedna.

Ako simptomi i dalje traju, trebate se javiti svom liječniku. Ako olakšanje simptoma ne nastupi unutar

4 tjedna, obavijestite svog liječnika.

Liječenje čira/vrijeda dvanaesnika:

jedna kapsula od 30 mg svaki dan tijekom 2 tjedna.

Liječenje čira/vrijeda želuca:

jedna kapsula od 30 mg svaki dan tijekom 4 tjedna.

Liječenje upale jednjaka (refluksni ezofagitis):

jedna kapsula od 30 mg svaki dan tijekom 4 tjedna.

Dugoročna prevencija refluksnog ezofagitisa:

jedna kapsula od 15 mg svaki dan. U tom slučaju su

dostupne Lanzul S 15 mg želučanootporne kapsule. Vaš liječnik može prilagoditi dozu na jednu

kapsulu od 30 mg svaki dan.

Liječenje infekcija izazvanih bakterijom Helicobacter pylori:

uobičajena doza iznosi jednu kapsulu

od 30 mg u kombinaciji s dva različita antibiotika ujutro i jednu kapsulu od 30 mg u kombinaciji s dva

različita antibiotika navečer. Lijekovi se u pravilu uzimaju svaki dan, tijekom 7 dana.

Preporučene kombinacije antibiotika su:

30 mg Lanzula zajedno s 250

500 mg klaritromicina i 1000 mg amoksicilina

30 mg Lanzula zajedno s 250 mg klaritromicina i 400

500 mg metronidazola

Ako se liječite zbog infekcije, budući da imate imate čir/vrijed, nije vjerojatno da će Vam se on vratiti

ako se infekcija uspješno izliječi. Kako bi lijek najbolje djelovao, uzmite ga u pravo vrijeme i ne

propuštajte uzeti dozu.

Liječenje čira/vrijeda dvanaesnika ili želuca u bolesnika kojima je potrebno trajno liječenje

nesteroidnim protuupalnim lijekovima (NSAID):

jedna kapsula od 30 mg svaki dan tijekom

4 tjedna.

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Prevencija čira/vrijeda dvanaesnika ili želuca u bolesnika kojima je potrebno trajno liječenje

nesteroidnim protuupalnim lijekovima (NSAID):

jedna kapsula od 15 mg svaki dan. U tom slučaju

su dostupne Lanzul S 15 mg želučanootporne kapsule. Liječnik može prilagoditi dozu na jednu

kapsulu od 30 mg svaki dan.

Zollinger-Ellisonov sindrom:

uobičajena doza iznosi dvije kapsule od 30 mg svaki dan na početku, a

u nastavku će Vaš liječnik odlučiti koja je doza najbolja za Vas ovisno o tome kakav je Vaš odgovor

na Lanzul.

Primjena u djece

Lanzul se ne smije davati djeci.

Ako uzmete više Lanzula nego što ste trebali

Ako ste uzeli više Lanzula nego što ste trebali, bez odlaganja zatražite savjet liječnika.

Ako ste zaboravili uzeti Lanzul

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

dozu. U tom slučaju preskočite propuštenu dozu i uzmite preostale kapsule u uobičajeno vrijeme.

Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.

Ako prestanete uzimati Lanzul

Nemojte prekinuti liječenje prerano, samo zato što su se Vaši simptomi poboljšali. Postoji mogućnost

da bolest još nije u potpunosti izliječena te se može ponovno vratiti ako ne dovršite liječenje.

U slučaju bilo kakvih nejasnoća ili 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 razviti u svakoga.

Ako primijetite neku od sljedećih nuspojava (učestalost pojavljivanja je navedena u zagradi), morate se

odmah javiti liječniku:

Manje česte (mogu se javiti u manje od 1 na 100 osoba):

angioedem; simptomi angioedema su oticanje lica, jezika ili ždrijela, otežano gutanje, osip i

otežano disanje

Vrlo rijetke (mogu se javiti u manje od 1 na 10 000 osoba):

teške reakcije preosjetljivosti uključujući šok; simptomi reakcije preosjetljivosti mogu

uključivati vrućicu, osip, otekline i ponekad pad krvnog tlaka

Stevens-Johnsonov sindrom; simptomi su vrlo teške kožne reakcije s crvenilom, stvaranjem

mjehura, teškom upalom i gubitkom kože

Lanzul može uzrokovati sniženje broja bijelih krvnih stanica (leukocita) te otpornost na

infekciju može biti smanjena. Ako se razvije infekcija sa simptomima kao što su vrućica i

ozbiljno pogoršanje općeg stanja ili vrućica sa simptomima lokalne infekcije poput bolova u

grlu/ždrijelu/ustima ili poteškoće s mokraćnim sustavom, obavezno bez odlaganja posjetite svog

liječnika. Provest će se pretraga krvi radi provjere mogućeg sniženja bijelih krvnih stanica

(agranulocitoza).

Nepoznate učestalosti (učestalost se ne može procijeniti iz dostupnih podataka):

ako uzimate lanzoprazol dulje od tri mjeseca, moguće je da se razina magnezija u krvi snizi.

Niska razina magnezija može se očitovati kao umor, nekontrolirano stezanje mišića,

dezorijentiranost, konvulzije, omaglica, ubrzan rad srca. Ako primijetite bilo koji od ovih

H A L M E D

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O D O B R E N O

simptoma, obavijestite odmah svog liječnika. Niska razina magnezija može izazvati i smanjenje

razine kalija ili kalcija u krvi. Vaš liječnik Vam može odrediti redovite krvne pretrage kako bi

se nadzirala razina magnezija u krvi.

osip, moguće praćen boli u zglobovima.

U nastavku su navedene ostale nuspojave prema učestalosti:

Česte (mogu se javiti u manje od 1 na 10 osoba):

glavobolja, omaglica,

proljev, zatvor, bolovi u trbuhu, mučnina ili povraćanje, vjetrovi, suhoća ili bol u ustima ili grlu,

osip kože, svrbež,

promjene u vrijednostima testova rada jetre,

umor.

Manje česte (mogu se javiti u manje od 1 na 100 osoba):

depresija,

bol u zglobovima ili mišićima

prijelom kuka, ručnog zgloba ili kralježnice,

zadržavanje tekućine ili oticanje,

promjene u broju krvnih stanica.

Rijetke (mogu se javiti u manje od 1 na 1000 osoba):

vrućica,

nemir, omamljenost, smetenost, halucinacije, nesanica, poremećaji vida, vrtoglavica,

poremećaj okusa, gubitak teka, upala jezika (glositis),

kožne reakcije kao što su osjećaj peckanja ili bockanja pod kožom, modrice, crvenilo kože i

pretjerano znojenje,

osjetljivost na svjetlo,

ispadanje kose,

osjećaj mravinjanja po koži (parestezije), drhtanje,

anemija (bljedilo),

poteškoće s bubrezima,

upala gušterače (pankreatitis),

upala jetre (može se očitovati kao žuta boja kože ili očiju),

rast dojki u muškaraca, impotencija,

kandidijaza (gljivična infekcija, može zahvatiti kožu ili sluznicu),

Vrlo rijetke (mogu se javiti u manje od 1 na 10 000 osoba):

upala sluznice usne šupljine (stomatitis),

upala sluznice crijeva (kolitis),

promjene u vrijednostima pretraga poput razine natrija, kolesterola i triglicerida,

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 prijave nuspojava: navedenog u Dodatku V.

Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.

5.

Kako čuvati Lanzul?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

H A L M E D

28-04-2016

O D O B R E N O

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.

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 Lanzul sadrži?

Djelatna tvar je lanzoprazol. Svaka tvrda kapsula sadrži 30 mg lanzoprazola.

Drugi sastojci su: šećerne kuglice; hidroksipropilceluloza; teški magnezijev subkarbonat;

saharoza; kukuruzni škrob; natrijev laurilsulfat; hipromeloza; metakrilatna kiselina/etilakrilat

kopolimer 1:1, 30 postotna raspršina; talk; makrogol 6000; titanijev dioksid (E171) u jezgri

kapsule i titanijev dioksid (E171) i želatina u ovojnici kapsuli.

Kako Lanzul izgleda i sadržaj pakiranja?

Tvrde kapsule: bijele kapsule punjene bijelim do svijetlo smeđim ili blago ružičasto obojenim

peletama.

Lanzul je dostupan u blisterima po 7 tvrdih kapsula, a svaka kutija sadrži ukupno 14 ili 28 tvrdih

kapsula.

Nositelj odobrenja za stavljanje lijeka u promet i proizvođač

Nositelj odobrenja:

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

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 travnju 2016.

H A L M E D

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O D O B R E N O

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Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

15-11-2018

Flixabi (Samsung Bioepis NL B.V.)

Flixabi (Samsung Bioepis NL B.V.)

Flixabi (Active substance: infliximab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7549 of Thu, 15 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4020/T/30

Europe -DG Health and Food Safety

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