Larona 30 mg želučanootporne

Glavna informacija

  • Trgovački naziv:
  • Larona 30 mg želučanootporne kapsule
  • Doziranje:
  • 30 mg
  • Farmaceutski oblik:
  • želučanootporna 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:
  • Jadran Galenski laboratorij d.d., Rijeka, Republika Hrvatska

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Larona 30 mg želučanootporne kapsule
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 28 kapsula u bočici, u kutiji [HR-H-895950686-01]; 28 kapsula u blisteru, u kutiji [HR-H-895950686-02] Urbroj: 381-12-01/30-17-05

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-895950686
  • Datum autorizacije:
  • 08-11-2017
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za korisnika

Larona 15 mg ţeluĉanootporne kapsule

Larona 30 mg ţeluĉanootporne kapsule

lanzoprazol

Paţljivo proĉitajte cijelu uputu prije nego poĉnete uzimati ovaj lijek jer sadrţi Vama vaţne

podatke.

Sačuvajte ovu uputu. Možda ćete je trebati ponovo pročitati.

Ako imate dodatnih pitanja, obratite se Vašem 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 Vašeg liječnika ili

ljekarnika. To uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi.

Pogledajte dio 4.

Što se nalazi u ovoj uputi:

Što je Larona i za što se koristi?

Što morate znati prije nego počnete uzimati Laronu?

Kako uzimati Laronu?

Moguće nuspojave

Kako čuvati Laronu?

Sadržaj pakiranja i druge informacije

1.

ŠTO JE LARONA I ZA ŠTO SE KORISTI?

Djelatna tvar u Laroni je lanzoprazol. Pripada skupini lijekova koji se zovu inhibitori protonske

pumpe, a djeluju tako što smanjuju proizvodnju želučane kiseline.

Vaš liječnik Vam može propisati Laronu za sljedeće indikacije u odraslih:

liječenje čira (vrijeda) na dvanaesniku i želucu,

liječenje upale jednjaka (refluksni ezofagitis),

sprječavanje upale jednjaka (refluksnog ezofagitisa),

liječenje žgaravice i vraćanja kiselog sadržaja u jednjak,

liječenje infekcija uzrokovanih bakterijom Helicobacter pylori u kombinaciji s

antibiotskim liječenjem,

liječenje ili sprječavanje čira (vrijeda) na dvanaesniku ili želucu u bolesnika kojima je

potrebno trajno liječenje nesteroidnim protuupalnim lijekovima (NSAIL; skupina

lijekova koji se koriste za liječenje bolova ili upale),

liječenje Zollinger-Ellisonovog sindroma

Možda Vam je Vaš liječnik propisao Laronu za drugu indikaciju ili s dozom koja se razlikuje od

onoga što je napisano u ovoj uputi. Molimo slijedite upute Vašeg liječnika za uzimanje ovog

lijeka.

Obavezno se obratite Vašem liječniku ako se ne osjećate bolje ili ako se osjećate lošije nakon 14

dana.

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08 - 11 - 2017

O D O B R E N O

2.

ŠTO MORATE ZNATI PRIJE NEGO POĈNETE UZIMATI LARONU?

Nemojte uzimati Laronu:

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

Upozorenja i mjere opreza

Obratite se Vašem liječniku ili ljekarniku prije nego uzmete Laronu.

Molimo recite svom liječniku ako imate ozbiljnu bolest jetre. Liječnik će možda trebati

prilagoditi Vašu dozu.

Vaš liječnik može napraviti ili je već napravio dodatnu pretragu koja se zove endoskopija, kako

bi postavio dijagnozu Vaše bolesti i/ili isključio malignu bolest.

Ukoliko tijekom liječenja Laronom nastupi proljev, odmah obavijestite Vašeg liječnika, jer je

Larona povezana s malim povećanjem učestalosti infektivnog proljeva.

Ako Vam je liječnik propisao Laronu uz druge lijekove (antibiotike) namijenjene za liječenje

Helicobacter pylori infekcije, ili zajedno s protuupalnim lijekovima za liječenje bolova ili

reumatske bolesti: molimo Vas da takoĎer pažljivo pročitate i upute tih lijekova.

Uzimanje inhibitora protonske pumpe kao što je Larona, osobito tijekom vremenskog perioda

duljeg od godinu dana, može blago povećati Vaš rizik od prijeloma kuka, zapešća ili kralježnice.

Obavijestite svog liječnika ako bolujete od osteoporoze ili ako uzimate kortikosteroide (koji

mogu povećati rizik od osteoporoze).

Ako uzimate Laronu dugotrajno (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.

Posavjetujte se sa Vašim liječnikom prije uzimanja lanzoprazola:

ako imate niske razine vitamina B12 ili imate faktore rizika za niske razine vitamina B12 i

primate dugotrajno liječenje s lanzoprazolom. Kao kod svih lijekova koji smanjuju količinu

kiseline, lanzoprazol može dovesti do smanjene apsorpcije vitamina B12

ako trebate napraviti odreĎenu krvnu pretragu (kromogranin A)

ako ste ikada imali kožnu reakciju nakon terapije s lijekom sličnim Laroni koji smanjuje

želučanu kiselinu.

Ako dobijete osip na koži, posebice na područjima izloženima suncu obavijestite svojeg liječnika

što je prije moguće, jer ćete možda morati prekinuti liječenje Laronom. Sjetite se spomenuti i

bilo koje druge štetne učinke poput boli u zglobovima.

Drugi lijekovi i Larona

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

koje druge lijekove, uključujući lijekove koji ste kupili bez recepta.

Osobito je važno da obavijestite Vašeg liječnika ili ljekarnika ako uzimate lijekove koji

sadržavaju bilo koju od sljedećih djelatnih tvari jer Larona može utjecati na način djelovanja tih

lijekova:

H A L M E D

08 - 11 - 2017

O D O B R E N O

inhibitori HIV proteaze kao što su atazanavir i nelfinavir (za liječenje HIV-a),

metotreksat (za liječenje autoimunih bolesti i karcinoma),

ketokonazol, itrakonazol, rifampicin (za liječenje infekcija),

digoksin (za liječenje srčanih poteškoća),

varfarin (za liječenje krvnih ugrušaka),

teofilin (za liječenje astme),

takrolimus (za sprječavanje odbacivanja transplantata),

fluvoksamin (za liječenje depresije i drugih psihijatrijskih bolesti),

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

sukralfat (za liječenje čira/vrijeda),

kantarion (gospina trava/Hypericum perforatum; za liječenje blage depresije).

Larona s hranom i pićem

Kako biste od Vaših lijekova dobili najbolje rezultate, neophodno je uzeti Laronu najmanje 30

minuta prije jela.

Trudnoća i dojenje

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

Vašem liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.

Upravljanje vozilima i strojevima

Nuspojave kao što su omaglica, vrtoglavica, umor i poremećaji vida, ponekad se mogu javiti u

bolesnika koji uzimaju Laronu. Ako osjetite nuspojave poput ovih, morate biti oprezni jer Vaša

sposobnost reagiranja može biti smanjena.

Samo Vi možete procijeniti da li ste sposobni upravljati vozilom ili izvršavati druge zadatke koji

zahtijevaju povećanu koncentraciju. Zbog njihovih učinaka ili nuspojava, uzimanje lijekova je

jedan od faktora koji mogu smanjiti Vašu sposobnost sigurnog izvršavanja tih zadataka.

Opis ovih nuspojava možete pronaći u drugim dijelovima ove upute. Pročitajte sve informacije u

ovoj uputi zbog korisnih smjernica. Posavjetujte se sa Vašim liječnikom ili ljekarnikom ako u

nečemu niste sigurni.

Larona sadrţi saharozu

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

ovog lijeka.

3.

KAKO UZIMATI LARONU?

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

liječnikom ili ljekarnikom ako niste sigurni.

Larona kapsule trebate progutati cijele uz nešto tekućine. Ako Vam je teško progutati kapsule,

Vaš liječnik Vas može savjetovati o drugim načinima primjene lijeka. Nemojte drobiti ni žvakati

ove kapsule niti sadržaj kapsule jer će to onemogućiti njihovo djelovanje.

Ako uzimate ovaj lijek jednom dnevno, pokušajte ga uzimati u isto vrijeme svaki dan. Za

postizanje najboljih rezultata, uzmite ga ujutro.

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O D O B R E N O

Ukoliko ga uzimate dva puta dnevno, prvu dozu uzmite ujutro, a drugu navečer.

Doziranje Larone ovisi o Vašem stanju. Preporučene doze za odrasle navedene su niže u tekstu.

Vaš će Vam liječnik ponekad propisati drugačiju dozu i reći Vam koliko dugo će Vaše liječenje

trajati.

Lijeĉenje ţgaravice i vraćanja kiselog sadrţaja u jednjak: Preporučena doza je jedna kapsula

od 15 mg ili 30 mg dnevno tijekom 4 tjedna. Ako simptomi i dalje traju i olakšanje ne nastupi

unutar 4 tjedna, obavijestite svog liječnika.

Lijeĉenje ĉira (vrijeda) na dvanaesniku: Preporučena doza je jedna kapsula od 30 mg svaki

dan tijekom 2 tjedna.

Lijeĉenje ĉira (vrijeda) na ţelucu: Preporučena doza je jedna kapsula od 30 mg svaki dan

tijekom 4 tjedna.

Lijeĉenje upale jednjaka (refluksni ezofagitis): Preporučena doza je jedna kapsula od 30 mg

svaki dan tijekom 4 tjedna.

Dugotrajna prevencija refluksnog ezofagitisa: Preporučena doza je jedna kapsula od 15 mg

svaki dan. Liječnik Vam može prilagoditi dozu na jednu kapsulu od 30 mg svaki dan.

Lijeĉenje Helicobacter pylori infekcije: Preporučena doza je jedna kapsula od 30 mg u

kombinaciji s dva različita antibiotika ujutro i jedna kapsula od 30 mg u kombinaciji s dva

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

Preporučene kombinacije su:

- 30 mg Larone s 250-500 mg klaritromicina i 1000 mg amoksicilina;

- 30 mg Larone s 250 mg klaritromicina i 400-500 mg metronidazola.

Ukoliko infekciju liječite zato što imate čir (vrijed), nije vjerojatno da će Vam se on vratiti ako

se infekcija uspješno izliječi. Kako biste Vašem lijeku omogućili najbolje djelovanje, uzmite ga

u pravo vrijeme i ne propuštajte uzeti dozu.

Lijeĉenje ĉira (vrijeda) na dvanaesniku ili ţelucu u bolesnika kojima je potrebno trajno

lijeĉenje nesteroidnim protuupalnim lijekovima (NSAIL): Preporučena doza je jedna kapsula

od 30 mg svaki dan tijekom 4 tjedna.

Sprjeĉavanje nastanka ĉira (vrijeda) na dvanaesniku ili ţelucu u bolesnika kojima je

potrebno trajno NSAIL lijeĉenje: Preporučena doza je jedna kapsula od 15 mg svaki dan.

Liječnik Vam može prilagoditi dozu na jednu kapsulu od 30 mg svaki dan.

Lijeĉenje Zollinger-Ellisonovog sindroma: Preporučena početna doza su dvije kapsule od 30

mg svaki dan, a u nastavku, ovisno o tome kakav je Vaš odgovor na liječenje, doza za koju

Vaš liječnik odluči da je najbolja za Vas.

Primjena u djece

Larona se ne smije davati djeci.

Ako uzmete više Larone nego što ste trebali

Ako ste uzeli više Larona kapsula nego što ste trebali, o tome odmah obavijestite svog liječnika.

H A L M E D

08 - 11 - 2017

O D O B R E N O

Ako ste zaboravili uzeti Laronu

Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.

Ako ste zaboravili uzeti tabletu, uzmite ju čim se sjetite, osim ako je uskoro vrijeme za Vašu

sljedeću dozu. U tom slučaju preskočite propuštenu dozu i nastavite uzimati kapsule prema

uobičajenom rasporedu.

Ako prestanete uzimati Laronu

Nemojte prekinuti liječenje prerano, samo zbog toga što su se Vaši simptomi poboljšali. Vaša

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

Ako imate bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se Vašem liječniku ili

ljekarniku.

4.

MOGUĆE NUSPOJAVE

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

Niže su navedene nuspojave prema učestalosti:

Ĉeste (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 na koži, svrbež,

promjene u vrijednostima testova rada jetre,

umor

dobroćudni polipi u želucu

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

depresija,

bol u zglobovima ili mišićima,

zadržavanje tekućine ili oticanje (edem),

promjene u broju krvnih stanica.

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

- vrućica

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

promjene okusa, gubitak apetita, upala jezika (glositis),

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

pretjerano znojenje,

osjetljivost na svjetlo,

ispadanje kose,

osjećaj mravinjanja po koži (parestezije), drhtanje,

anemija (bljedilo kože i sluznica),

problemi s bubrezima,

upala gušterače (pankreatitis)

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

otok dojki u muškaraca, impotencija,

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O D O B R E N O

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

angioedem; Morate odmah posjetiti liječnika ako osjetite simptome angioedema, kao što su

otečeno lice, jezik ili ždrijelo, otežano gutanje, koprivnjača 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, oticanje i ponekad pad krvnog tlaka.

upala sluznice usne šupljine (stomatitis),

upala debelog crijeva (kolitis),

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

vrlo teške kožne reakcije s crvenilom, stvaranjem mjehura, teškom upalom i gubitkom

kože,

vrlo rijetko Larona može uzrokovati smanjenje broja bijelih krvnih stanica (leukocita) te

Vaša otpornost na infekciju može biti smanjena. Ukoliko se kod Vas razvije infekcija sa

simptomima kao što su vrućica i ozbiljno pogoršanje općeg stanja, ili vrućica sa

simptomima lokalne infekcije poput boli u grlu/ždrijelu/ustima ili problema s mokrenjem,

odmah se javite Vašem liječniku. Provest će se pretraga krvi radi provjere mogućeg

smanjenja broja bijelih krvnih stanica (stanje koje se zove agranulocitoza).

Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka)

ako uzimate Laronu dulje od 3 mjeseca, može doći do smanjenja razine magnezija u krvi.

Niske razine magnezija mogu se očitovati kao umor, nevoljno stezanje mišića,

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

simptoma, odmah obavijestite Vašeg liječnika. Niske razine magnezija mogu takoĎer

dovesti do smanjenja razine kalija ili kalcija u krvi. Vaš liječnik može odlučiti da je

potrebno provoditi redovite krvne pretrage kako bi se nadzirala razina magnezija u krvi.

kožni oblici lupusa ili osip povezan s lupusom

osip, moguće praćen boli u zglobovima.

Prijavljivanje nuspojava

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

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

izravno putem nacionalnog sustava za prijavu nuspojava:

navedenog u Dodatku V

Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.

5.

KAKO ĈUVATI LARONU?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Čuvati na temperaturi ispod 30°C.

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

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

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

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

6.

SADRŢAJ PAKIRANJA I DRUGE INFORMACIJE

Što Larona sadrţi?

- Djelatna tvar je lanzoprazol. 1 kapsula sadrži 15 mg, odnosno 30 mg lanzoprazola.

H A L M E D

08 - 11 - 2017

O D O B R E N O

- Drugi sastojci (pomoćne tvari) su: šećerne kuglice (saharoza i kukuruzni škrob); natrijev

škroboglikolat, vrsta A; natrijev laurilsulfat; povidon K-30; trinatrijev fosfat dodekahidrat;

hipromeloza (6 cP); trietilcitrat; titanijev dioksid (E171); talk; metakrilatna kiselina/etilakrilat

kopolimer 1:1, 30-postotna disperzija; kapsula: titanijev dioksid (E171); želatina; pročišćena

voda; tinta: šelak, propilenglikol, crni željezov oksid (E172).

Kako Larona izgleda i sadrţaj pakiranja?

Larona 15 mg želučanootporne kapsule: bijele neprozirne, tvrde, želatinske kapsule veličine 3, s

crnom oznakom “L” na kapici i brojem „15“ na tijelu kapsule. Sadržaj kapsula su kuglice bijele

do krem boje.

Larona 30 mg želučanootporne kapsule: bijele neprozirne, tvrde, želatinske kapsule veličine 1, s

crnom oznakom “L” na kapici i brojem „30“ na tijelu kapsule. Sadržaj kapsula su kuglice bijele

do krem boje.

Pakiranja sadrže 28 kapsula u plastičnoj bočici ili blisteru, u kutiji.

Nositelj odobrenja za stavljanje lijeka u promet i proizvoĊaĉ

JADRAN-GALENSKI LABORATORIJ d.d., Svilno 20, 51000 Rijeka

Naĉin i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u studenom 2017.

H A L M E D

08 - 11 - 2017

O D O B R E N O

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

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

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 Italy and co‐rapporteur Member State Bulgaria for the pesticide active substance dimethoate 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 dimetho...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

Published on: Tue, 30 Oct 2018 00:00:00 +0100 In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide an update of the reasoned opinion on the review of existing maximum residue levels (MRLs) for imazalil published on 5 September 2017, taking into account the additional information provided on the toxicity of the metabolites R014821, FK‐772 and FK‐284. EFSA did not derive MRL proposals from the post‐harvest uses reported on citrus fru...

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

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