Larona 15 mg želučanootporne

Glavna informacija

  • Trgovački naziv:
  • Larona 15 mg želučanootporne kapsule
  • Doziranje:
  • 15 mg
  • Farmaceutski oblik:
  • želučanootporna kapsula, tvrda
  • Sastav:
  • Urbroj: jedna kapsula sadrži 15 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 15 mg želučanootporne kapsule
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 28 kapsula u bočici, u kutiji [HR-H-321273562-01]; 28 kapsula u blisteru, u kutiji [HR-H-321273562-02] Urbroj: 381-12-01/30-17-07

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-321273562
  • 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:

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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.

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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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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.

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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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Evaluation of confirmatory data following the Article 12 MRL review for pyraclostrobin

Evaluation of confirmatory data following the Article 12 MRL review for pyraclostrobin

Published on: Thu, 15 Nov 2018 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for pyraclostrobin in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residues trials supporting the existing use of pyraclostrobin on table grapes authorised in southern EU Member States and an analytical method for analysing residues of pyraclostrobin in ...

Europe - EFSA - European Food Safety Authority Publications

7-11-2018

Kadesh Incorporation Issues Voluntary Nationwide Recall of Puriton Eye Relief Drops Due to Non-Sterile Production Conditions

Kadesh Incorporation Issues Voluntary Nationwide Recall of Puriton Eye Relief Drops Due to Non-Sterile Production Conditions

Kadesh, Inc. of Garden Grove, CA is voluntarily recalling all lots of Puriton Eye Relief Drops, 0.5 oz. (15ml) bottle, UPC 7 36972 1679 0, to the consumer level. During a recent FDA inspection, investigators observed that ophthalmic drugs, which are required to be sterile, are manufactured without necessary production controls and conditions to assure sterility.

FDA - U.S. Food and Drug Administration

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

17-10-2018

Faribault Foods, Inc. Announces Voluntary Recall of a Limited Quantity of S&W Brand White Beans Due to the Presence of Undeclared (Sulfites)

Faribault Foods, Inc. Announces Voluntary Recall of a Limited Quantity of S&W Brand White Beans Due to the Presence of Undeclared (Sulfites)

Faribault Foods, Inc. of Faribault, MN is recalling its 15 ounce S&W White Beans because it contains undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

17-10-2018

Enforcement Report for the Week of October 17, 2018

Enforcement Report for the Week of October 17, 2018

Recently Updated Records for the Week of October 17, 2018 Last Modified Date: Monday, October 15, 2018

FDA - U.S. Food and Drug Administration

16-10-2018

October 15, 2018: Leader of Fraudulent Prescription Conspiracy Sentenced to Six Years in Prison

October 15, 2018: Leader of Fraudulent Prescription Conspiracy Sentenced to Six Years in Prison

October 15, 2018: Leader of Fraudulent Prescription Conspiracy Sentenced to Six Years in Prison

FDA - U.S. Food and Drug Administration

16-10-2018

October 15, 2018: Four Men and Seven Companies Indicted for Billion-Dollar Telemedicine Fraud Conspiracy, Telemedicine Company and CEO Plead Guilty in Two Fraud Schemes

October 15, 2018: Four Men and Seven Companies Indicted for Billion-Dollar Telemedicine Fraud Conspiracy, Telemedicine Company and CEO Plead Guilty in Two Fraud Schemes

October 15, 2018: Four Men and Seven Companies Indicted for Billion-Dollar Telemedicine Fraud Conspiracy, Telemedicine Company and CEO Plead Guilty in Two Fraud Schemes

FDA - U.S. Food and Drug Administration

16-10-2018

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum, which are well‐defined and distinguishable tree fungal pathogens of the family Cronartiaceae. In 2018, these species were moved from the genus Endocronartium to the genus Cronartium. These pathogens are not known to be present in the EU and are regulated in Council Directive 2...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Published on: Mon, 15 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant, BASF SE, submitted an application to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance mepiquat in cotton seeds. The data submitted in support of the application were found to be sufficient to derive a MRL proposal for cotton seeds and the previously derived MRL proposals for animal commodities were found to be stil...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Published on: Mon, 15 Oct 2018 00:00:00 +0200 A rapid qualitative assessment has been done by performing a theoretical analysis on the transmission of low pathogenic avian influenza (LPAI) via fresh meat from poultry reared or kept in captivity for the production of meat (raw poultry meat) or raw table eggs. A predetermined transmission pathway followed a number of steps from a commercial or non‐commercial poultry establishment within the EU exposed to LPAI virus (LPAIV) to the onward virus transmission...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Melampsora farlowii

Pest categorisation of Melampsora farlowii

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Melampsora farlowii, a well‐defined and distinguishable fungus of the family Melampsoraceae. M. farlowii is the causal agent of a leaf and twig rust of hemlocks (Tsuga spp.) in eastern North America. The pathogen is regulated in Council Directive 2000/29/EC (Annex IAI) as a harmful organism whose introduction into the EU is banned. M. farlowii ...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Published on: Mon, 15 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in United Kingdom to evaluate the confirmatory data that were identified for teflubenzuron in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new metabolism study on leafy crops, a study investigating the nature of residues under standard hydrolytic conditions and a validated ...

Europe - EFSA - European Food Safety Authority Publications

3-10-2018

Sportminister Bruno Bruins brengt verrassingsbezoek aan Talent TeamNL in Buenos Aires

Sportminister Bruno Bruins brengt verrassingsbezoek aan Talent TeamNL in Buenos Aires

Van 6 tot 18 oktober wordt in Buenos Aires, Argentinië, de derde editie van de Jeugd Olympische Spelen gehouden. Toptalenten uit 206 landen tussen de 15 en 18 jaar oud doen hieraan mee. Talent TeamNL bestaat uit 41 sporters die uitkomen in  19 disciplines. Minister voor Sport Bruno Bruins bracht vandaag een verrassingsbezoek aan de Nederlandse ploeg. Hij bezocht het Olympisch Dorp waar de talenten onder leiding van Chef de Mission Mark Huizinga zich voorbereiden op de Spelen die zaterdag beginnen. 

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

28-9-2018

EpiPen and EpiPen Jr auto-injectors may stick in their carrier tube

EpiPen and EpiPen Jr auto-injectors may stick in their carrier tube

Pfizer Canada has advised Health Canada that, in a very small number of cases, some EpiPen (0.3 mg) and EpiPen Jr (0.15 mg) auto-injector devices may not slide out of their carrier tube easily, or at all. This could delay or prevent emergency treatment, possibly leading to patient disability or death.

Health Canada

28-9-2018

Avian influenza overview May – August 2018

Avian influenza overview May – August 2018

Published on: Thu, 27 Sep 2018 00:00:00 +0200 Between 16 May and 15 August 2018, three highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments and three HPAI A(H5N6) outbreaks in wild birds were reported in Europe. Three low pathogenic avian influenza (LPAI) outbreaks were reported in three Member States. Few HPAI and LPAI bird cases have been detected in this period of the year, in accordance with the seasonal expected pattern of LPAI and HPAI. There is no evidence to date ...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Published on: Tue, 25 Sep 2018 00:00:00 +0200 Abstract Following a notification from Sorghum Zrt., submitted to the European Commission under Article 14 of Regulation (EU) 2015/2283 to place on the market syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country (TF), and in line with Article 15(2) of that Regulation, EFSA was asked by the European Commission whether there are duly reasoned safety objections to the placing on the market of the TF within the European Union. The ap...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Published on: Thu, 16 Aug 2018 00:00:00 +0200 4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the avai...

Europe - EFSA - European Food Safety Authority Publications

16-8-2018

August 15, 2018: Florida Man Pleads Guilty to Scheme to Market Dietary Supplements

August 15, 2018: Florida Man Pleads Guilty to Scheme to Market Dietary Supplements

August 15, 2018: Florida Man Pleads Guilty to Scheme to Market Dietary Supplements

FDA - U.S. Food and Drug Administration

15-8-2018

Enforcement Report for the Week of August 15, 2018

Enforcement Report for the Week of August 15, 2018

Recently Updated Records for the Week of August 15, 2018 Last Modified Date: Monday, August 13, 2018

FDA - U.S. Food and Drug Administration

14-8-2018

Minister-president Rutte bij herdenking capitulatie Japan

Minister-president Rutte bij herdenking capitulatie Japan

Minister-president Rutte neemt woensdagmiddag 15 augustus 2018 deel aan de herdenking van de capitulatie van Japan op 15 augustus 1945. De herdenking vindt plaats bij het Indisch Monument in Den Haag.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

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

31-7-2018

ADM Animal Nutrition Recalls Mintrate® 36-15 Breed Right Cattle Tub - A specific lot of product may contain elevated levels of non-protein nitrogen, could harm cattle

ADM Animal Nutrition Recalls Mintrate® 36-15 Breed Right Cattle Tub - A specific lot of product may contain elevated levels of non-protein nitrogen, could harm cattle

ADM Animal Nutrition, a division of Archer Daniels Midland Company (NYSE: ADM), is recalling 200-pound tubs of Mintrate® 36-15 Breed Right Tub cattle feed, product number 54549AAA6H, because the product may contain elevated levels of non-protein nitrogen, which could be harmful to cattle. Excessive levels of non-protein nitrogen can be toxic to cattle and can cause muscle tremors (especially of face and ears), abdominal pain, bloat, frothy salivation, excessive urination, teeth grinding, incoordination, ...

FDA - U.S. Food and Drug Administration

18-7-2018

Blokhuis: jaarlijkse subsidie voor 113Zelfmoordpreventie omhoog naar 5,4 miljoen

Blokhuis: jaarlijkse subsidie voor 113Zelfmoordpreventie omhoog naar 5,4 miljoen

Staatssecretaris Paul Blokhuis (VWS) wil het aantal zelfmoorden en zelfmoordpogingen terugdringen. Om dat te bereiken geeft hij structureel 2 miljoen per jaar extra instellingssubsidie aan 113Zelfmoordpreventie. Het jaarlijkse budget van de organisatie gaat daarmee fors omhoog, van 3,4 miljoen naar 5,4 miljoen euro. Daarnaast zijn er extra middelen voor andere lopende activiteiten zoals de lokale aanpakken suïcidepreventie en onderzoek. In totaal is daar 15 miljoen mee gemoeid.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

17-7-2018

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

FDA - U.S. Food and Drug Administration

29-6-2018

Wish Bone Salad Dressing Issues Allergy Alert On Undeclared Milk and Egg in 15 oz. Wish-Bone House Italian Salad Dressing

Wish Bone Salad Dressing Issues Allergy Alert On Undeclared Milk and Egg in 15 oz. Wish-Bone House Italian Salad Dressing

Pinnacle Foods Inc. is voluntarily recalling a limited quantity of Wish Bone House Italian Salad Dressing 15 oz. with the health and safety of our consumers as our top priority. The recall was initiated after learning from a retail customer that a limited number of bottles were mislabeled. The product contains milk and egg, known allergens not declared on the bottle. People who have an allergy or severe sensitivity to milk or egg may run the risk of a serious or life-threatening allergic reaction if t...

FDA - U.S. Food and Drug Administration

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

15-11-2018

alitretinoin

alitretinoin

alitretinoin (Active substance: alitretinoin) - Centralised - Art 28 - (PSUR - Commission Decision (2018)7675 of Thu, 15 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/90/201801

Europe -DG Health and Food Safety

8-11-2018

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries.pic.twitter.com/WkDNnXqm

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries.pic.twitter.com/WkDNnXqm

There's only 1 week until the 2018 Patient Engagement Advisory Committee meeting. Join the @US_FDA on Nov 15 to discuss patient-generated health data from sources like social media, activity trackers, and patient-driven registries. pic.twitter.com/WkDNnXqmbw

FDA - U.S. Food and Drug Administration

31-10-2018

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Active substance: adalimumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7344 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4279/T/15

Europe -DG Health and Food Safety

22-10-2018

EU/3/16/1640 (Celgene Europe B.V.)

EU/3/16/1640 (Celgene Europe B.V.)

EU/3/16/1640 (Active substance: 2-methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol methanesulfonate) - Transfer of orphan designation - Commission Decision (2018)6989 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/253/15/T/01

Europe -DG Health and Food Safety

22-10-2018

EU/3/15/1495 (Ultragenyx Netherlands B.V.)

EU/3/15/1495 (Ultragenyx Netherlands B.V.)

EU/3/15/1495 (Active substance: Triheptanoin) - Transfer of orphan designation - Commission Decision (2018)6992 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/007/15/T/02

Europe -DG Health and Food Safety

22-10-2018

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Sirius Regulatory Consulting EU Limited)

EU/3/15/1532 (Active substance: Insulin human) - Transfer of orphan designation - Commission Decision (2018)6985 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

17-10-2018

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review.

Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD.  https:

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review. Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD. https:

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review. Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD. https://go.usa.gov/xPqku  pic.twitter.com/EYNZANlgr9

FDA - U.S. Food and Drug Administration

15-10-2018

Riximyo (Sandoz GmbH)

Riximyo (Sandoz GmbH)

Riximyo (Active substance: rituximab) - Centralised - Yearly update - Commission Decision (2018)6811 of Mon, 15 Oct 2018

Europe -DG Health and Food Safety

1-10-2018

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

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

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

Europe -DG Health and Food Safety

25-9-2018

Conducting clinical trials & preparing a submission for #FDA review?

Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more!  https://go.

Conducting clinical trials & preparing a submission for #FDA review? Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more! https://go.

Conducting clinical trials & preparing a submission for #FDA review? Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more! https://go.usa.gov/xPqku . pic.twitter.com/Ktqq9Slx0y

FDA - U.S. Food and Drug Administration

24-9-2018

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

FDA - U.S. Food and Drug Administration

18-8-2018

EU/3/16/1645 (Salzman Group Ltd)

EU/3/16/1645 (Salzman Group Ltd)

EU/3/16/1645 (Active substance: Cannabidiol) - Transfer of orphan designation - Commission Decision (2018)4806 of Sat, 18 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/248/15/T/01

Europe -DG Health and Food Safety

15-8-2018

EU/3/18/1994 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/1994 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/1994 (Active substance: Ivosidenib) - Transfer of orphan designation - Commission Decision (2018)5555 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/172/17/T/01

Europe -DG Health and Food Safety

15-8-2018

Orbactiv (Rempex London Ltd)

Orbactiv (Rempex London Ltd)

Orbactiv (Active substance: oritavancin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5556 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3785/T/20

Europe -DG Health and Food Safety

15-8-2018

Komboglyze (AstraZeneca AB)

Komboglyze (AstraZeneca AB)

Komboglyze (Active substance: saxagliptin / metformin) - Centralised - 2-Monthly update - Commission Decision (2018)5559 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2059/WS/1289

Europe -DG Health and Food Safety

15-8-2018

Ivabradine Zentiva (Zentiva, k.s.)

Ivabradine Zentiva (Zentiva, k.s.)

Ivabradine Zentiva (Active substance: ivabradine) - Centralised - Yearly update - Commission Decision (2018)5558 of Wed, 15 Aug 2018

Europe -DG Health and Food Safety

27-7-2018

EU/3/15/1473 (Celgene Europe B.V.)

EU/3/15/1473 (Celgene Europe B.V.)

EU/3/15/1473 (Active substance: Lenalidomide) - Transfer of orphan designation - Commission Decision (2018)5042 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/284/14/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/16/1635 (Leadiant GmbH)

EU/3/16/1635 (Leadiant GmbH)

EU/3/16/1635 (Active substance: N-acetyl-D-mannosamine monohydrate) - Transfer of orphan designation - Commission Decision (2018)5053 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/228/15/T/01

Europe -DG Health and Food Safety

10-7-2018

Corbilta (Orion Corporation)

Corbilta (Orion Corporation)

Corbilta (Active substance: levodopa / carbidopa / entacapone) - Centralised - Renewal - Commission Decision (2018)4468 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2785/R/15

Europe -DG Health and Food Safety

27-6-2018

EU/3/15/1606 (Bayer AG)

EU/3/15/1606 (Bayer AG)

EU/3/15/1606 (Active substance: (S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate) - Transfer of orphan designation - Commission Decision (2018)4094 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/184/15/T/02

Europe -DG Health and Food Safety

27-6-2018

EU/3/15/1460 (Eisai GmbH)

EU/3/15/1460 (Eisai GmbH)

EU/3/15/1460 (Active substance: Lenvatinib) - Transfer of orphan designation - Commission Decision (2018)4080 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/287/14/T/01

Europe -DG Health and Food Safety

27-6-2018

EU/3/15/1590 (Merck Europe B.V.)

EU/3/15/1590 (Merck Europe B.V.)

EU/3/15/1590 (Active substance: Recombinant human monoclonal IgG1 antibody against programmed death ligand-1) - Transfer of orphan designation - Commission Decision (2018)4088 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/150/15/T/02

Europe -DG Health and Food Safety