Acipan S 20 mg želučanootporne

Glavna informacija

  • Trgovački naziv:
  • Acipan S 20 mg želučanootporne tablete
  • Doziranje:
  • 20 mg
  • Farmaceutski oblik:
  • želučanootporna tableta
  • Sastav:
  • Urbroj: jedna želučanootporna tableta sadrži 20 mg pantoprazola u obliku pantoprazolnatrij seskvihidrata
  • Tip recepta:
  • bez recepta, u ljekarni
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Lek Pharmaceuticals d.d., Ljubljana, Slovenija

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Acipan S 20 mg želučanootporne tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 7 tableta u blisteru, u kutiji [HR-H-979842986-01]; 14 tableta u blisteru, u kutiji [HR-H-979842986-02] Urbroj: 381-12-01/38-17-04

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-979842986
  • Datum autorizacije:
  • 29-12-2017
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku: sastav, indikacije, doziranje, nuspojave, interakcija, trudnoća, dojenje

Uputa o lijeku: Informacije za bolesnika

Acipan

S 20 mg želučanootporne tablete

pantoprazol

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

podatke.

Uvijek uzmite ovaj lijek točno onako kako je opisano u ovoj uputi ili kako su Vam rekli Vaš liječnik

ili ljekarnik.

Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.

Ako trebate dodatne informacije ili savjet, obratite se Vašem ljekarniku.

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.

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

2 tjedna.

Što se nalazi u ovoj uputi:

1. Što je Acipan

S i za što se koristi?

2. Što morate znati prije nego počnete uzimati Acipan

3. Kako uzimati Acipan

4. Moguće nuspojave

5. Kako čuvati Acipan

6. Sadržaj pakiranja i druge informacije

1. Što je Acipan S i za što se koristi?

Acipan S sadrži djelatnu tvar pantoprazol, koja blokira "pumpu" koja proizvodi želučanu kiselinu.

Stoga smanjuje sadržaj kiseline u Vašem želucu.

Acipan S se koristi za kratkotrajno liječenje simptoma refluksa (npr. žgaravica, vraćanje kiseline iz

želuca) u odraslih.

Refluks je povrat kiseline iz želuca u jednjak (kroz jednjak hrana prolazi u želudac), koji može

postati upaljen i bolan. To može uzrokovati simptome kao što su osjećaj pečenja u prsnom košu koji

se penje do grla (žgaravica) i kiseli okus u ustima (vraćanje kiseline iz želuca u usta).

Olakšanje simptoma refluksa kiseline ili žgaravice možete osjetiti već nakon jednog dana liječenja

Acipan S tabletama, ali ovaj lijek nije namijenjen trenutnom olakšanju simptoma. Možda će biti

potrebno uzimati tablete 2 – 3 uzastopna dana da bi se postiglo olakšanje simptoma.

Ne smijete uzimati Acipan S tablete dulje od 4 tjedna bez savjetovanja s liječnikom.

Obavezno se obratite Vašem liječniku ako se ne osjećate bolje ili ako se osjećate lošije nakon 2

tjedna.

2. Što morate znati prije nego počnete uzimati Acipan S?

Nemojte uzimati Acipan

S:

ako ste alergični (preosjetljivi) na pantoprazol ili neki drugi sastojak ovog lijeka (naveden u

dijelu 6.)

ako uzimate inhibitore HIV proteaze kao što su atazanavir i nelfinavir (za liječenje infekcije

HIV-om). Pogledajte „Ostali lijekovi i Acipan S“

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O D O B R E N O

Upozorenja i mjere opreza

Obratite se Vašem liječniku ili ljekarniku prije nego uzmete Acipan S:

ako liječite žgaravicu ili probavne smetnje neprekidno tijekom 4 ili više tjedana

ako ste stariji od 55 godina i svakodnevno uzimate lijekove za lošu probavu koji se izdaju bez

recepta

ako ste stariji od 55 godina i imate bilo kakve nove ili nedavno promijenjene simptome refluksa

ako ste imali čir na želucu ili operaciju želuca

ako imate probleme s jetrom ili žuticu (žutilo kože ili očiju)

ako redovno posjećujete liječnika zbog neke ozbiljne bolesti ili stanja

ako ste naručeni na endoskopiju ili C-urea izdisajni test

ako ste ikad imali kožnu reakciju nakon terapije s lijekom sličnim lijeku Acipan S koji smanjuje

želučanu kiselinu

morate napraviti određenu krvnu pretragu (kromogranin A).

istodobno

pantoprazolom uzimate

inhibitore HIV proteaze

što su atazanavir i

nelfinavir (za liječenje infekcije HIV-om), posavjetujte se s liječnikom.

Ne uzimajte ovaj lijek dulje od 4 tjedna bez savjetovanja s liječnikom. Ako simptomi refluksa

(žgaravica ili vraćanje kiseline iz želuca u usta) potraju dulje od 2 tjedna posavjetujte se s liječnikom,

koji će odlučiti o potrebi za dugotrajnim uzimanjem ovog lijeka.

Uzimanje lijeka Acipan S tijekom duljih razdoblja može izazvati dodatne rizike, kao što su:

smanjenje apsorpcije vitamina B12 i pomanjkanje vitamina B12 ako su vam tjelesne zalihe

vitamina B12 već smanjene.

prijelom kuka, zapešća ili kralježnice, posebno ako već bolujete od osteoporoze ili ako

uzimate kortikosteroide (koji mogu povećati rizik od osteoporoze).

smanjenje razine magnezija u krvi (potencijalni simptomi: umor, nevoljne kontrakcije mišića,

dezorijentacija, konvulzije, omaglica, ubrzana srčana frekvencija). Niske razine magnezija

mogu izazvati i smanjenje razina kalija ili kalcija u krvi. Ako uzimate ovaj lijek dulje od 4

tjedna,

morate

posavjetovati

liječnikom.

Liječnik

može

odlučiti

obavljanje

redovitih krvnih pretraga radi praćenja vaše razine magnezija.

Odmah obavijestite Vašeg liječnika, prije ili nakon uzimanja ovog lijeka, ako primijetite neki od

sljedećih simptoma koji može biti znak druge, ozbiljnije bolesti:

nenamjeran gubitak težine (koji nije vezan uz dijetu ili program tjelovježbe)

povraćanje, osobito ako se ponavlja

povraćanje krvi, što možete primijetiti u obliku tamnih zrnaca veličine zrna kave

krv u stolici, koja može biti crna ili poput katrana

teškoće pri gutanju ili bol pri gutanju

bljedoća ili osjećaj slabosti (anemija)

bol u prsnom košu

bol u trbuhu

težak i/ili stalan proljev, jer je ovaj lijek povezan s malim povećanjem rizika od zaraznog

proljeva.

Vaš će liječnik odlučiti da li su potrebne neke pretrage.

Ukoliko idete na krvne pretrage, obavijestite liječnika da uzimate ovaj lijek.

Možete osjetiti olakšanje od simptoma refluksa kiseline ili žgaravice nakon samo jednog dana

liječenja Acipan S tabletama, ali ovaj lijek nije namijenjen trenutnom olakšanju simptoma. Ne

smijete ga uzimati kao preventivnu mjeru.

Ako duže vrijeme patite od žgaravice ili probavnih smetnji, redovito posjećujte liječnika.

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

je prije moguće, jer ćete možda morati prekinuti liječenje Acipan S tabletama. Sjetite se spomenuti i

bilo koje druge štetne učinke poput boli u zglobovima.

Djeca i adolescenti

Acipan S ne smiju koristiti djeca i mladi u dobi do 18 godina jer ne postoje podaci o sigurnosti

primjene u ovoj mlađoj dobnoj skupini.

Drugi lijekovi i Acipan S

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

koje druge lijekove.

Acipan S može zaustaviti djelovanje nekih drugih lijekova.

Naročito lijekova koji sadrže sljedeće djelatne tvari:

inhibitore HIV proteaze, kao što su atazanavir i nelfinavir (za liječenje infekcije HIV-om). Ne

smijete koristiti Acipan S ako uzimate inhibitore HIV proteaze. Pogledajte „Nemojte uzimati

Acipan S“.

ketokonazol (lijek za liječenje gljivičnih infekcija)

varfarin i fenprokumon (lijekovi za razrjeđivanje krvi i sprječavanje stvaranja ugrušaka). Možda

će biti potrebno napraviti dodatne krvne pretrage.

metotreksat (koristi se za liječenje reumatoidnog artritisa, psorijaze ili raka) – ako uzimate

metotreksat liječnik će Vam možda preporučiti da privremeno prekinete uzimati Acipan S jer

pantoprazol može povisiti razine metotreksata u krvi.

Nemojte uzimati Acipan S s drugim lijekovima koji ograničavaju stvaranje želučane kiseline, kao što

su drugi inhibitori protonske pumpe (omeprazol, lanzoprazol ili rabeprazol) ili H

antagonisti

(npr.ranitidin, famotidin).

Ako je potrebno, Acipan S možete uzimati s antacidima (lijekovi koji smanjuju kiselost u želucu kao

npr. megaldrat, alginatna kiselina, natrijev bikarbonat, aluminijev hidroksid, magnezijev karbonat ili

kombinacije navedenih).

Trudnoća i dojenje

Ne uzimajte ovaj lijek ako ste trudni ili dojite.

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

Ako se kod Vas pojave nuspojave poput omaglice ili poremećaja vida, ne smijete upravljati vozilima

niti raditi na strojevima.

Važne informacije o nekim sastojcima lijeka

Tablete Acipan S sadrže boju Ponceau 4R aluminium lake, koja može uzrokovati alergijske reakcije.

3. Kako uzimati Acipan S?

Uvijek uzmite ovaj lijek točno onako kako je opisano u ovoj uputi ili kako su Vam rekli Vaš liječnik

ili ljekarnik. Provjerite sa Vašim liječnikom ili ljekarnikom ako niste sigurni.

Preporučena

doza

jedna

tableta

dan.

Nemojte

prekoračiti

preporučenu

dozu

pantoprazola na dan.

Lijek treba uzimati najmanje 2 – 3 dana za redom. Prestanite uzimati Acipan S kad nastupi potpuno

povlačenje simptoma. Možete osjetiti olakšanje simptoma refluksa kiseline ili žgaravice već nakon

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O D O B R E N O

jednog dana liječenja s Acipan S tabletama, ali ovaj lijek nije namijenjen trenutnom olakšanju

simptoma.

Ukoliko se nakon 2 tjedna neprekidnog liječenja simptomi ne povuku, posavjetujte se s liječnikom.

Ne uzimajte tablete Acipan S duže od 4 tjedna, bez savjetovanja s liječnikom.

Tabletu uzimajte prije obroka, svaki dan u isto vrijeme. Tabletu treba progutati cijelu s nešto vode.

Nemojte žvakati ili lomiti tabletu.

Ako uzmete više tableta Acipan S nego što ste trebali

Obavijestite liječnika ili ljekarnika ako ste uzeli više od preporučene doze. Ako je moguće, sa sobom

ponesite lijek i ovu Uputu.

Ako ste zaboravili uzeti Acipan S

Nemojte uzeti dvostruku dozu da biste nadoknadili propuštenu. Uzmite sljedeću redovitu dozu

sljedeći dan, u uobičajeno vrijeme.

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.

Odmah obavijestite Vašeg liječnika ili se uputite u najbližu bolnicu ako dobijete bilo koju od

sljedećih ozbiljnih nuspojava. Odmah prestanite uzimati lijek, a Uputu i/ili tablete ponesite sa

sobom.

Ozbiljne alergijske reakcije (rijetko: mogu se javiti u manje od 1 na 1000 osoba):

reakcije preosjetljivosti, tzv. anafilaktičke reakcije, anafilaktički šok i angioedem. Tipični

simptomi su: oticanje lica, usana, usta, jezika i/ili grla što može uzrokovati teškoće pri

gutanju ili disanju, koprivnjača (urtikarija), jaka omaglica s vrlo brzim lupanjem srca i

izrazitim znojenjem.

Ozbiljne kožne reakcije (nepoznata učestalost:

učestalost se ne može procijeniti iz

dostupnih podataka): osip s oticanjem, stvaranje mjehurića na koži ili ljuštenje kože,

gubljenje

kože

krvarenje

oko očiju,

nosa,

usta

genitalija,

brzo pogoršanje

općeg

zdravstvenog stanja, ili pojava osipa nakon izlaganja suncu.

Ostale ozbiljne reakcije (nepoznata učestalost: učestalost se ne može procijeniti iz

dostupnih podataka): žutilo kože i očiju (zbog teškog oštećenja jetre) ili problemi s

bubrezima kao što je bolno mokrenje i bol u donjem dijelu leđa s vrućicom.

Ostale nuspojave uključuju:

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

Dobroćudni polipi u želucu.

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

Glavobolja, omaglica, proljev, mučnina, povraćanje, nadutost i vjetrovi, zatvor, suha usta, bol i

nelagoda u trbuhu, osip na koži ili koprivnjača, svrbež, osjećaj slabosti, iscrpljenost ili loše opće

stanje, poremećaji sna, povišene vrijednosti jetrenih enzima u krvnim pretragama; prijelom kuka,

zapešća ili kralježnice.

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

Poremećaj ili potpuni nestanak osjeta okusa, poremećaji vida kao što je zamućen vid, bol u

zglobovima, bol u mišićima, promjene tjelesne težine, povišenje tjelesne temperature, oticanje udova,

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depresija,

povišene

vrijednosti

bilirubina

masnoća

krvi

(vidljivo

krvnim

pretragama),

povećanje dojki kod muškaraca, visoka vrućica i nagli pad broja cirkulirajućih granulocita u krvi

(vidljivo na krvnim pretragama).

Vrlo rijetko (mogu se javiti u manje od 1 na 10000 osoba)

Dezorijentiranost,

smanjen

broj

krvnih

pločica

što

može

uzrokovati

neuobičajena

krvarenja

stvaranje

modrica,

smanjen

broj

bijelih

krvnih

stanica

što

može

dovesti

češćih

infekcija,

istovremeno abnormalno smanjenje broja crvenih i bijelih krvnih stanica, te krvnih pločica (vidljivo

na krvnim pretragama).

Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka)

Halucinacije, smetenost (pogotovo u bolesnika koji su već imali te simptome), smanjenje razine

natrija u krvi, smanjenje razine magnezija u krvi, 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 čuvati Acipan S?

Lijek treba čuvati izvan pogleda i dohvata djece.

Lijek ne zahtijeva posebne uvjete čuvanja.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i na blisteru 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. Sadržaj pakiranja i dodatne informacije

Što Acipan S sadrži?

Djelatna tvar je pantoprazol. Jedna želučanootporna tableta sadrži 20 mg pantoprazola u obliku

pantoprazolnatrij seskvihidrata.

Pomoćne tvari:

Jezgra: kalcijev stearat; celuloza, mikrokristalična; krospovidon; hidroksipropilceluloza, vrste EXF;

natrijev karbonat, bezvodni; silicijev dioksid, koloidni, bezvodni.

Ovojnica: hipromeloza; željezov oksid, žuti (E172); makrogol 400; metakrilatna kiselina/etilakrilat

kopolimer (1:1); polisorbat 80, Ponceau 4R, aluminium lake (E124); quinoline yellow, aluminium

lake (E104); natrijev laurilsulfat; titanijev dioksid (E171); trietilcitrat.

Kako Acipan S izgleda i sadržaj pakiranja?

Acipan S želučanootporne tablete su žute, ovalne, obložene tablete približne dimenzije 8,9x4,6 mm..

Dostupne su u blister pakiranjima od 7 ili 14 tableta.

U prometu se ne moraju nalaziti sve veličine pakiranja.

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O D O B R E N O

Nositelj odobrenja za stavljanje lijeka u promet i proizvoĎač

Nositelj odobrenja za stavljanje lijeka u promet

Sandoz d.o.o. Maksimirska 120, 10000 Zagreb

Proizvođač

Lek Pharmaceuticals d.d., Verovškova 57, Ljubljana, Slovenija

Način i mjesto izdavanja lijeka

Lijek se izdaje bez recepta, u ljekarni.

Ova uputa je posljednji put revidirana u prosincu 2017.

Sljedeće preporuke za promjenu životnih navika i prehrane mogu Vam pomoći u ublažavanju

žgaravice i simptoma povezanih sa želučanom kiselinom:

izbjegavajte obilne obroke

jedite polako

prestanite pušiti

smanjite konzumaciju alkohola i kofeina

smanjite prekomjernu tjelesnu težinu

izbjegavajte nositi usku odjeću ili remenje

izbjegavajte jesti barem tri sata prije spavanja

podignite uzglavlje kreveta (ako patite od noćnih simptoma)

smanjite unos hrane koja može izazvati žgaravicu. To može uključivati: čokoladu, paprenu

metvicu, zelenu metvicu, masnu i prženu hranu, kiselu hranu, začinjenu hranu, citrusno voće i

voćne sokove, rajčicu.

H A L M E D

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O D O B R E N O

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Safety and efficacy of eight compounds belonging to different chemical groups when used as flavourings for cats and dogs

Safety and efficacy of eight compounds belonging to different chemical groups when used as flavourings for cats and dogs

Published on: Tue, 19 Mar 2019 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 23 compounds belonging to different chemical groups. This opinion concerns eight out of the 23 compounds, which are currently authorised for use as flavours in food. The Panel concludes that the eight additives are safe for cats and dogs at the proposed use level: phenyl...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-3-2019

Safety and efficacy of 26 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters) when used as flavourings for all animal species and categories

Safety and efficacy of 26 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters) when used as flavourings for all animal species and categories

Published on: Tue, 19 Mar 2019 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 26 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters). They are all currently authorised as flavours in food. The FEEDAP Panel was unable to perform the assessment of non‐2(c...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-3-2019

Mylan Institutional LLC Initiates Voluntary Nationwide Recall of Levoleucovorin Injection Due to the Presence of Particulate Matter

Mylan Institutional LLC Initiates Voluntary Nationwide Recall of Levoleucovorin Injection Due to the Presence of Particulate Matter

Mylan Institutional LLC is conducting a voluntary nationwide recall of two lots (see table below) of Levoleucovorin Injection, 250 mg/25 mL to the consumer/user level. The lots were manufactured by Alidac Pharmaceuticals Limited and distributed by Mylan Institutional LLC.

FDA - U.S. Food and Drug Administration

16-3-2019

Efficacy of sodium formate as a technological feed additive (hygiene condition enhancer) for all animal species

Efficacy of sodium formate as a technological feed additive (hygiene condition enhancer) for all animal species

Published on: Fri, 15 Mar 2019 In 2015, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of formic acid, ammonium formate and sodium formate as feed hygiene agents for all animal species. In this opinion, two forms of the additive sodium formate, a solid form (specified to contain ≥ 98% sodium formate (w/w)) and a liquid form (specified to contain a minimum of 15% sodium formate, a maximum of 75% free formic acid and a maxim...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-3-2019

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient

Legacy Pharmaceutical Packaging, LLC is recalling 3 repackaged lots of Losartan Tablets USP 50mg to the consumer level. This recall was prompted due to Torrent Pharmaceuticals LTD issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).

FDA - U.S. Food and Drug Administration

16-3-2019

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmace

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmace

Earth City, MO, Legacy Pharmaceutical Packaging, LLC is recalling 40 repackaged lots of Losartan Tablets USP 25mg, 50mg, and 100mg to the consumer level. This recall was prompted due to Camber Pharmaceuticals, Inc. issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).

FDA - U.S. Food and Drug Administration

15-3-2019

Modification of the existing maximum residue level for fluopyram in broccoli

Modification of the existing maximum residue level for fluopyram in broccoli

Published on: Thu, 14 Mar 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer Hellas AG submitted a request to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance fluopyram in broccoli. The data submitted in support of the request were found to be sufficient to derive MRL proposals for broccoli. Adequate analytical methods for enforcement are available to control the residues of fluopyram on the commodit...

Europe - EFSA - European Food Safety Authority EFSA Journal

14-3-2019

Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive

Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive

Published on: Wed, 13 Mar 2019 The Scientific Panel on Food Additives and Flavouring (FAF) provides a scientific opinion on the safety evaluation of annatto E and an exposure assessment of the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive, taking into account new proposed uses and use levels. In 2016, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the safety of annatto extracts (E 160b) as a food additive....

Europe - EFSA - European Food Safety Authority EFSA Journal

14-3-2019

Safety evaluation of the food enzyme β‐glucanase, xylanase and cellulase from Mycothermus thermophiloides (strain NZYM‐ST)

Safety evaluation of the food enzyme β‐glucanase, xylanase and cellulase from Mycothermus thermophiloides (strain NZYM‐ST)

Published on: Fri, 08 Mar 2019 The food enzyme has three declared activities (endo‐1,3(4)‐β‐glucanase EC 3.2.1.6, endo‐1,4‐β‐xylanase EC 3.2.1.8 and cellulase (endo‐1,4‐β‐d‐glucanase EC 3.2.1.4)) and is produced with a non‐genetically modified Mycothermus thermophiloides strain by Novozymes A/S. It is intended to be used in baking and brewing processes. For the two intended uses, based on the maximum use levels recommended and individual data from the EFSA Comprehensive European Food Database, dietary e...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-3-2019

Hometown Food Company Recalls Two Production LOT Codes of Pillsbury® Unbleached All-Purpose 5lb Flour Due to Possible Health Risk

Hometown Food Company Recalls Two Production LOT Codes of Pillsbury® Unbleached All-Purpose 5lb Flour Due to Possible Health Risk

Please be advised the Hometown Food Company initiated a limited, voluntary retail-level recall on two specific lot codes of its Pillsbury® Unbleached All-Purpose 5 lb Flour (UPC 51500-22241) because it may be contaminated with Salmonella. Only Best If Used By Dates APR 19 2020 and APR 20 2020 are impacted.

FDA - U.S. Food and Drug Administration

13-3-2019

Safety evaluation of the food enzyme triacylglycerol lipase from Aspergillus niger (strain LFS)

Safety evaluation of the food enzyme triacylglycerol lipase from Aspergillus niger (strain LFS)

Published on: Tue, 12 Mar 2019 The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3) is produced with a genetically modified Aspergillus niger strain LFS by DSM Food Specialties B.V.. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The triacylglycerol lipase food enzyme is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the fo...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-3-2019

Safety evaluation of the food enzyme glucose oxidase from Aspergillus niger (strain ZGL)

Safety evaluation of the food enzyme glucose oxidase from Aspergillus niger (strain ZGL)

Published on: Tue, 12 Mar 2019 The food enzyme glucose oxidase (β‐d‐glucose:oxygen 1‐oxidoreductase; EC 1.1.3.4) is produced with a genetically modified Aspergillus niger strain ZGL by DSM Food Specialties B.V.. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The glucose oxidase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme‐total orga...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-3-2019


Agenda - CAT agenda of the 20-22 February 2019 meeting

Agenda - CAT agenda of the 20-22 February 2019 meeting

Agenda - CAT agenda of the 20-22 February 2019 meeting

Europe - EMA - European Medicines Agency

9-3-2019

Safety evaluation of the food enzyme 4‐α‐glucanotransferase from Aeribacillus pallidus (strain AE‐SAS)

Safety evaluation of the food enzyme 4‐α‐glucanotransferase from Aeribacillus pallidus (strain AE‐SAS)

Published on: Fri, 08 Mar 2019 The food enzyme 4‐α‐glucanotransferase (1,4‐α‐d‐glucan:1,4‐α‐d‐glucan 4‐α‐d‐glycosyltransferase, EC 2.4.1.25) is produced with a non‐genetically modified Aeribacillus pallidus (previously identified as Geobacillus pallidus) strain from Amano Enzyme Inc. The food enzyme is intended to be used in baking processes and in starch processing for the production of modified dextrins. For baking processes, based on the maximum use levels recommended and individual data from the EFS...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-3-2019

Safety of ethyl lauroyl arginate (E 243) as a food additive in the light of the new information provided and the proposed extension of use

Safety of ethyl lauroyl arginate (E 243) as a food additive in the light of the new information provided and the proposed extension of use

Published on: Fri, 08 Mar 2019 The present scientific opinion deals with the evaluation of the safety of the food additive ethyl lauroyl arginate (E 243) in the light of a new interpretation of the available toxicological data and with respect to the proposed changes to the currently authorised conditions of use. Ethyl lauroyl arginate (E 243) is an already authorised food additive in the EU for use in heat‐treated meat products only, with some exceptions. The safety of ethyl lauroyl arginate (E 243) as...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-3-2019


Draft Colchicine tablet 0.5 mg and 1 mg product-specific bioequivalence guidance

Draft Colchicine tablet 0.5 mg and 1 mg product-specific bioequivalence guidance

Draft Colchicine tablet 0.5 mg and 1 mg product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

7-3-2019

American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

American Health Packaging is voluntarily recalling one lot of Valsartan Tablets, USP, 160 mg to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-Nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Resea...

FDA - U.S. Food and Drug Administration

7-3-2019

Re‐evaluation of Quillaia extract (E 999) as a food additive and safety of the proposed extension of use

Re‐evaluation of Quillaia extract (E 999) as a food additive and safety of the proposed extension of use

Published on: Wed, 06 Mar 2019 The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion on Quillaia extract (E 999) when used as a food additive and the evaluation of the safety of its proposed extension of use as a food additive in flavourings. The Scientific Committee for Food (SCF) in 1978 established an acceptable daily intake (ADI) of 0–5 mg spray‐dried extract/kg body weight (bw) per day for E 999. The Joint FAO/WHO Expert Committee on Food Additives ...

Europe - EFSA - European Food Safety Authority EFSA Journal

7-3-2019

Safety and efficacy of Robenz® 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening

Safety and efficacy of Robenz® 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening

Published on: Tue, 05 Mar 2019 Following a request from European Commission, the 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 Robenz® 66G (robenidine hydrochloride (HCl)) when used as a feed additive for chickens for fattening and turkeys for fattening. The coccidiostat Robenz®66G is considered safe for chickens for fattening at the highest proposed level of 36 mg robenidine HCl/kg complete feed with a ...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-3-2019

Morphine Sulfate Injection BP 30 mg in 1 mL ampoule

Morphine Sulfate Injection BP 30 mg in 1 mL ampoule

Safety advisory – Section 19A product not for epidural or intrathecal use

Therapeutic Goods Administration - Australia

5-3-2019

Opinion on the follow‐up of the re‐evaluation of sorbic acid (E200) and potassium sorbate (E202) as food additives

Opinion on the follow‐up of the re‐evaluation of sorbic acid (E200) and potassium sorbate (E202) as food additives

Published on: Fri, 01 Mar 2019 In this opinion, the EFSA Panel on Food Additives and Flavourings (FAF Panel) was requested by the European Commission to carry out a scientific evaluation of an extended one‐generation reproductive toxicity study (EOGRTS) to determine whether it would allow reconsideration of the temporary group acceptable daily intake (ADI) for sorbic acid (E 200) and potassium sorbate (E 202), established by the Panel on Food Additives and Nutrient Sources added to Food (ANS Panel) in 2...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Pest categorisation of Thrips palmi

Pest categorisation of Thrips palmi

Published on: Thu, 28 Feb 2019 The EFSA Panel on Plant Health (PLH) performed a pest categorisation of Thrips palmi(Thysanoptera: Thripidae), for the EU. T. palmi is listed in Annex IAI of 2000/29 EC. Using molecular methods, cryptic speciation has been shown although no new species from the group have been formally described. Here, we consider T. palmi sensu lato as a defined species native to southern Asia, which has spread to tropical and subtropical countries in Asia, the Pacific, North, Central and...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical

Camber Pharmaceuticals, Inc. is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. This recall was prompted due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

FDA - U.S. Food and Drug Administration

27-2-2019

Enforcement Report for the Week of February 27, 2019

Enforcement Report for the Week of February 27, 2019

Recently Updated Records for the Week of February 27, 2019 Last Modified Date: Wednesday, February 20, 2019

FDA - U.S. Food and Drug Administration

26-2-2019

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Published on: Mon, 25 Feb 2019 Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the product TYFER™ (ferric tyrosine chelate) as zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breeding. The additive is safe for chickens for fattening at the maximum expected level of 200 mg TYFER™/kg complete feed; this conclusion can be extended to chickens reared for laying/breedin...

Europe - EFSA - European Food Safety Authority EFSA Journal

25-2-2019

Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity

Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity

Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg to the consumer level due to the detection of trace amounts of an unexpected impurity (NDEA) found in finished product manufactured with active pharmaceutical ingredient made by Hetero Labs Limited.

FDA - U.S. Food and Drug Administration

25-2-2019

Xeljanz, Xeljanz XR (tofacitinib): Safety Communication - Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients

Xeljanz, Xeljanz XR (tofacitinib): Safety Communication - Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients

FDA is alerting the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (RA). FDA has not approved this 10 mg twice daily dose for RA; this dose is only approved in the dosing regimen for patients with ulcerative colitis

FDA - U.S. Food and Drug Administration

22-2-2019

February 20, 2019: Home Health Nurse Sentenced to Federal Prison for Tampering with Patients' Medication

February 20, 2019: Home Health Nurse Sentenced to Federal Prison for Tampering with Patients' Medication

February 20, 2019: Home Health Nurse Sentenced to Federal Prison for Tampering with Patients' Medication

FDA - U.S. Food and Drug Administration

22-2-2019

Enforcement Report for the Week of February 20, 2019

Enforcement Report for the Week of February 20, 2019

Recently Updated Records for the Week of February 20, 2019 Last Modified Date: Friday, February 22, 2019

FDA - U.S. Food and Drug Administration

21-2-2019

Annual report of the EFSA Scientific Network for Risk Assessment of GMOs for 2018

Annual report of the EFSA Scientific Network for Risk Assessment of GMOs for 2018

Published on: Wed, 20 Feb 2019 The EFSA Scientific Network for Risk Assessment of GMOs (the GMO Network) was established in accordance with EFSA's strategy for cooperation and networking with Member States. The goals of the GMO Network are to improve dialogue among members, build mutual understanding of risk assessment principles, enhance knowledge and confidence in the scientific assessment carried out in the EU, and increase the transparency of the process among Member States and EFSA. The annual repo...

Europe - EFSA - European Food Safety Authority EFSA Journal

14-2-2019

Modification of the existing maximum residue levels for mandipropamid in various crops

Modification of the existing maximum residue levels for mandipropamid in various crops

Published on: Wed, 13 Feb 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Syngenta Crop Protection B.V. and Agriculture and Horticulture Development Board (AHDB) submitted, respectively, a request to the competent national authorities in the Netherlands and United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance mandipropamid in various crops. The data submitted in support of the request were found to be sufficient to derive MRL propo...

Europe - EFSA - European Food Safety Authority EFSA Journal

4-2-2019

Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling

Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling

Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced that it’s wholly owned subsidiary, Dr Reddy’s Laboratories, Inc is continuing its voluntary nationwide recall of lot ABD807 of Levetiracetram in 0.54% Sodium Chloride Injection, 1,500 mg/100 mL (15 mg/mL) single-dose infusion bags to the hospital level in U.S.A.

FDA - U.S. Food and Drug Administration

30-1-2019

Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, Due to Higher Concentration of Ibuprofen

Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, Due to Higher Concentration of Ibuprofen

Monmouth Junction, NJ, Tris Pharma, Inc. is expanding the scope of its November 2018 recall by adding three (3) additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, to the retail (pharmacy) level. Some units from these batches have been found to have higher levels of Ibuprofen concentration.

FDA - U.S. Food and Drug Administration

26-1-2019

Safety assessment of the substance poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) for use in food contact materials

Safety assessment of the substance poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) for use in food contact materials

Published on: Fri, 25 Jan 2019 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) (PHBH), CAS No 147398‐31‐0 and food contact material (FCM) substance No 1059. This biodegradable copolymer is produced by fermentation of palm oil using a genetically modified microorganism (Cupriavidus necator). Overall migration was up to 5.4 mg/kg. Oligomers are hydroxyl‐terminated or with crotyl‐ and hexenyl end‐...

Europe - EFSA - European Food Safety Authority EFSA Journal

24-1-2019

General Mills Recalls Five Pound Bags of Gold Medal Unbleached Flour

General Mills Recalls Five Pound Bags of Gold Medal Unbleached Flour

General Mills announced today a voluntary national recall of five-pound bags of its Gold Medal Unbleached Flour with a better if used by date of April 20, 2020. The recall is being issued for the potential presence of Salmonella which was discovered during sampling of the five-pound bag product.

FDA - U.S. Food and Drug Administration

23-1-2019

Safety evaluation of the food enzyme lysophospholipase from Trichoderma reesei (strain RF7206)

Safety evaluation of the food enzyme lysophospholipase from Trichoderma reesei (strain RF7206)

Published on: Tue, 22 Jan 2019 The food enzyme lysophospholipase (EC 3.1.1.5) is produced with the genetically modified Trichoderma reesei strain RF7206 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The lysophospholipase food enzyme is intended to be used in starch processing for the production of glucose syrups. Residual amounts of total organic solids (TOS) are removed by the ...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-3-2019

EU/3/13/1154 (Diamond ROC EOOD)

EU/3/13/1154 (Diamond ROC EOOD)

EU/3/13/1154 (Active substance: Fosbretabulin tromethamine) - Transfer of orphan designation - Commission Decision (2019)2145 of Wed, 20 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003817

Europe -DG Health and Food Safety

13-3-2019

Cresemba (Basilea Pharmaceutica Deutschland GmbH)

Cresemba (Basilea Pharmaceutica Deutschland GmbH)

Cresemba (Active substance: isavuconazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2069 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2734/T/20

Europe -DG Health and Food Safety

8-3-2019

Public submissions on scheduling matters referred to the ACMS #25, ACCS #23 and Joint ACMS-ACCS #20 meetings held in November 2018

Public submissions on scheduling matters referred to the ACMS #25, ACCS #23 and Joint ACMS-ACCS #20 meetings held in November 2018

Public submissions on scheduling matters referred to ACMS/ACCS meetings held in November 2018

Therapeutic Goods Administration - Australia

6-3-2019


Orphan designation: Avacopan, Treatment of C3 glomerulopathy, 20/06/2017, Positive

Orphan designation: Avacopan, Treatment of C3 glomerulopathy, 20/06/2017, Positive

Orphan designation: Avacopan, Treatment of C3 glomerulopathy, 20/06/2017, Positive

Europe - EMA - European Medicines Agency

20-2-2019


Orphan designation: Rufinamide, Treatment of Lennox-Gastaut syndrome, 20/10/2004, Expired

Orphan designation: Rufinamide, Treatment of Lennox-Gastaut syndrome, 20/10/2004, Expired

Orphan designation: Rufinamide, Treatment of Lennox-Gastaut syndrome, 20/10/2004, Expired

Europe - EMA - European Medicines Agency

20-2-2019

Rizmoic (Shionogi B.V.)

Rizmoic (Shionogi B.V.)

Rizmoic (Active substance: naldemedine) - Centralised - Authorisation - Commission Decision (2019)1520 of Wed, 20 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4256

Europe -DG Health and Food Safety

20-2-2019

Tobramycin PARI (PARI Pharma GmbH)

Tobramycin PARI (PARI Pharma GmbH)

Tobramycin PARI (Active substance: tobramycin) - Centralised - Authorisation - Commission Decision (2019)1504 of Wed, 20 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/5086

Europe -DG Health and Food Safety

20-2-2019

Miglustat Dipharma (Dipharma B.V.)

Miglustat Dipharma (Dipharma B.V.)

Miglustat Dipharma (Active substance: miglustat) - Centralised - Authorisation - Commission Decision (2019)1512 of Wed, 20 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/004904/0000

Europe -DG Health and Food Safety

20-2-2019

Advagraf (Astellas Pharma Europe B.V.)

Advagraf (Astellas Pharma Europe B.V.)

Advagraf (Active substance: Tacrolimus) - PSUSA - Modification - Commission Decision (2019)1513 of Wed, 20 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/00002839/201803

Europe -DG Health and Food Safety

20-2-2019

Vantobra (PARI Pharma GmbH)

Vantobra (PARI Pharma GmbH)

Vantobra (Active substance: Tobramycin) - Centralised - Withdrawal - Commission Decision (2019)1511 of Wed, 20 Feb 2019

Europe -DG Health and Food Safety

20-2-2019

Silgard (Merck Sharp and Dohme Limited)

Silgard (Merck Sharp and Dohme Limited)

Silgard (Active substance: Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)) - Centralised - Withdrawal - Commission Decision (2019)1516 of Wed, 20 Feb 2019

Europe -DG Health and Food Safety

20-2-2019

Lusutrombopag Shionogi (Shionogi B.V.)

Lusutrombopag Shionogi (Shionogi B.V.)

Lusutrombopag Shionogi (Active substance: lusutrombopag) - Centralised - Authorisation - Commission Decision (2019)1507 of Wed, 20 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4720

Europe -DG Health and Food Safety

20-2-2019

ATryn (Laboratoire franCais du Fractionnement et des Biotechnologies)

ATryn (Laboratoire franCais du Fractionnement et des Biotechnologies)

ATryn (Active substance: antithrombin alfa) - Centralised - Annual reassessment - Commission Decision (2019)1509 of Wed, 20 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/587/S/35

Europe -DG Health and Food Safety

20-2-2019

Zelboraf (Roche Registration GmbH)

Zelboraf (Roche Registration GmbH)

Zelboraf (Active substance: vemurafenib) - Centralised - Yearly update - Commission Decision (2019)1506 of Wed, 20 Feb 2019

Europe -DG Health and Food Safety

20-2-2019

Pixuvri (CTI Life Sciences Deutschland GmbH)

Pixuvri (CTI Life Sciences Deutschland GmbH)

Pixuvri (Active substance: pixantrone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1510 of Wed, 20 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/002055/T/0045

Europe -DG Health and Food Safety

20-2-2019

Zyprexa (Eli Lilly Nederland B.V.)

Zyprexa (Eli Lilly Nederland B.V.)

Zyprexa (Active substance: Olanzapine) - Centralised - Yearly update - Commission Decision (2019)1515 of Wed, 20 Feb 2019

Europe -DG Health and Food Safety

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ hematopoietic stem cells transduced ex vivo with EFS lentiviral vector encoding for the human adenosine deaminase gene, decision type: , therapeutic area: , PIP number: P/0400/20

Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ hematopoietic stem cells transduced ex vivo with EFS lentiviral vector encoding for the human adenosine deaminase gene, decision type: , therapeutic area: , PIP number: P/0400/20

Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ hematopoietic stem cells transduced ex vivo with EFS lentiviral vector encoding for the human adenosine deaminase gene, decision type: , therapeutic area: , PIP number: P/0400/2018

Europe - EMA - European Medicines Agency

13-2-2019


Orphan designation: Adeno-associated viral vector serotype LK03 encoding human ornithine transcarbamylase, Treatment of ornithine transcarbamylase deficiency, 20/03/2017, Positive

Orphan designation: Adeno-associated viral vector serotype LK03 encoding human ornithine transcarbamylase, Treatment of ornithine transcarbamylase deficiency, 20/03/2017, Positive

Orphan designation: Adeno-associated viral vector serotype LK03 encoding human ornithine transcarbamylase, Treatment of ornithine transcarbamylase deficiency, 20/03/2017, Positive

Europe - EMA - European Medicines Agency

4-2-2019

Feraccru (Norgine B.V.)

Feraccru (Norgine B.V.)

Feraccru (Active substance: ferric maltol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)857 of Mon, 04 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2733/T/20

Europe -DG Health and Food Safety

1-2-2019

Diotop 75 mg / 20 mg modified-release capsules, hard and associated names

Diotop 75 mg / 20 mg modified-release capsules, hard and associated names

Diotop 75 mg / 20 mg modified-release capsules, hard and associated names (Active substance: diclofenac/omeprazole) - Community Referrals - Art 29 - Commission Decision (2019)845 of Fri, 01 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/A-29(4)/1474

Europe -DG Health and Food Safety

1-2-2019


Withdrawn application: Cavoley, pegfilgrastim, Date of withdrawal: 20/12/2018, Initial authorisation

Withdrawn application: Cavoley, pegfilgrastim, Date of withdrawal: 20/12/2018, Initial authorisation

Withdrawn application: Cavoley, pegfilgrastim, Date of withdrawal: 20/12/2018, Initial authorisation

Europe - EMA - European Medicines Agency

1-2-2019


Withdrawn application: Efgratin, pegfilgrastim, Date of withdrawal: 20/12/2019, Initial authorisation

Withdrawn application: Efgratin, pegfilgrastim, Date of withdrawal: 20/12/2019, Initial authorisation

Withdrawn application: Efgratin, pegfilgrastim, Date of withdrawal: 20/12/2019, Initial authorisation

Europe - EMA - European Medicines Agency

1-2-2019


Referral: Lartruvo, olaratumab, Article 20 procedures, 31/01/2019

Referral: Lartruvo, olaratumab, Article 20 procedures, 31/01/2019

Referral: Lartruvo, olaratumab, Article 20 procedures, 31/01/2019

Europe - EMA - European Medicines Agency

23-1-2019


Orphan designation: Allogeneic ex-vivo-expanded umbilical cord blood-derived haematopoietic CD34+ progenitor cells and allogeneic non-expanded umbilical cord blood-derived haematopoietic mature myeloid and lymphoid cells, Treatment in haematopoietic stem

Orphan designation: Allogeneic ex-vivo-expanded umbilical cord blood-derived haematopoietic CD34+ progenitor cells and allogeneic non-expanded umbilical cord blood-derived haematopoietic mature myeloid and lymphoid cells, Treatment in haematopoietic stem

Orphan designation: Allogeneic ex-vivo-expanded umbilical cord blood-derived haematopoietic CD34+ progenitor cells and allogeneic non-expanded umbilical cord blood-derived haematopoietic mature myeloid and lymphoid cells, Treatment in haematopoietic stem cell transplantation, 20/03/2017, Positive

Europe - EMA - European Medicines Agency