Amonex 10 mg tablete

Glavna informacija

  • Trgovački naziv:
  • Amonex 10 mg tablete
  • Doziranje:
  • 10 mg
  • Farmaceutski oblik:
  • tableta
  • Sastav:
  • Urbroj: 1 tableta sadrži 10 mg amlodipina u obliku amlodipinbesilata
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Belupo lijekovi i kozmetika d.d., Koprivnica, Republika Hrvatska

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Amonex 10 mg tablete
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 30 tableta u blisteru, u kutiji [HR-H-502519569-01]; 60 tableta u blisteru, u kutiji [HR-H-502519569-02]; 90 tableta u blisteru, u kutiji [HR-H-502519569-03] Urbroj: 381-12-01/30-16-06

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-502519569
  • Datum autorizacije:
  • 31-05-2016
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za bolesnika

AMONEX 5 mg tablete

AMONEX

10 mg tablete

amlodipin

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

podatke.

Sačuvajte ovu uputu. Možda ćete je trebati ponovo pročitati.

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

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

znakovi bolesti jednaki Vašima.

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

svaku moguću nuspojavu koja nije navedena u ovoj uputi, vidjeti dio 4.

Što se nalazi u ovoj uputi:

Što je AMONEX i za što se koristi?

Što morate znati prije nego počnete uzimati AMONEX?

Kako uzimati AMONEX?

Moguće nuspojave

Kako čuvati AMONEX?

Sadržaj pakiranja i druge informacije

1.

Što je AMONEX i za što se koristi?

AMONEX sadrži djelatnu tvar amlodipin, koja spada u skupinu lijekova koji se nazivaju antagonisti

kalcija.

Vaš se lijek koristi za liječenje visokog krvnog tlaka (hipertenzije) ili za liječenje određenog tipa boli u

prsištu

koja

naziva

angina

pektoris.

Rijedak

oblik

angine

pektoris

naziva

Prinzmetalova

varijantna angina.

U bolesnika s visokim krvnim tlakom ovaj lijek djeluje tako da opušta krvne žile i tako omogućava lakši

protok krvi kroz njih. U bolesnika s anginom pektoris AMONEX djeluje tako da poboljšava opskrbu

srčanog mišića krvlju, na taj način dovodeći više kisika u srce, što sprječava pojavu boli u prsištu. Vaš

lijek neće odmah ublažiti bol u prsištu izazvanu anginom pektoris.

2.

Što morate znati prije nego počnete uzimati AMONEX?

Nemojte uzimati AMONEX:

ako ste alergični (preosjetljivi) na amlodipin ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu

6.), ili na druge antagoniste kalcija. Alergija se može očitovati u obliku svrbeža, crvenila kože ili

tegoba pri disanju.

ako imate jako niski tlak (hipotenziju)

ako imate suženje aortnog srčanog zaliska (stenozu aorte) ili kardiogeni šok (stanje u kojem srce ne

može opskrbiti tijelo s dovoljno krvi)

ako bolujete od zatajivanja srca nakon srčanog udara.

Upozorenja i mjere opreza

Obratite se svom liječniku ili ljekarniku prije nego uzmete AMONEX.

Obavijestite svoga liječnika ako imate ili ste imali bilo koje od navedenih stanja:

nedavni srčani udar

H A L M E D

31-05-2016

O D O B R E N O

zatajivanje srca

jaki porast krvnog tlaka (hipertenzivnu krizu)

bolest jetre

starije ste životne dobi i trebate povisiti dozu.

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

Djeca i adolescenti

AMONEX se nije ispitivao u djece mlađe od 6 godina. Ovaj lijek se smije koristiti samo za liječenje

hipertenzije u djece i adolescenata u dobi od 6 do 17 godina (vidjeti dio 3).

Za dodatne informacije obratite se svom liječniku.

Drugi lijekovi i AMONEX

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

druge lijekove.

AMONEX može utjecati na druge lijekove, ili drugi lijekovi mogu utjecati na AMONEX, kao što su:

ketokonazol, itrakonazol (lijekovi za liječenje infekcija gljivicama)

ritonavir, indinavir, nelfinavir (tzv. inhibitori proteaze koji se koriste u liječenju HIV-a)

rifampicin, eritromicin, klaritromicin (antibiotici)

gospina trava (

Hypericum perforatum

verapamil, diltiazem (lijekovi za srce)

dantrolen (infuzija koja se koristi kod velikih odstupanja tjelesne temperature)

simvastatin (lijek za snižavanje kolesterola)

takrolimus (upotrebljava se za kontrolu imunološkog odgovora vašeg tijela, što omogućuje Vašem

tijelu da prihvati transplantirani organ)

ciklosporin (imunosupresiv).

Ako već uzimate druge lijekove za snižavanje krvnog tlaka, ovaj lijek može uzrokovati dodatno sniženje

krvnog tlaka.

AMONEX s hranom i pićem

Bolesnici koji uzimaju AMONEX ne smiju konzumirati sok od grejpa ili grejp. Sok od grejpa i grejp

mogu

uzrokovati

porast

vrijednosti

djelatne

tvari

amlodipina

krvi,

što

može

izazvati

pojačano

djelovanje ovog lijeka na snižavanje krvnog tlaka.

Trudnoća i dojenje

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

ili ljekarniku za savjet prije nego uzmete ovaj lijek.

Trudnoća

Nije utvrđena sigurnost primjene amlodipina u trudnica. Ako mislite da ste trudni ili planirate trudnoću,

recite to svom liječniku prije uzimanja ovog lijeka.

Dojenje

Nije poznato izlučuje li se amlodipin u majčino mlijeko. Ako dojite ili planirate dojiti, recite to svom

liječniku prije uzimanja ovog lijeka.

Upravljanje vozilima i strojevima

AMONEX može utjecati na Vašu sposobnost vožnje i upravljanja strojevima. Ako nakon uzimanja

tableta osjećate mučninu, omaglicu, umor ili glavobolju, nemojte voziti niti upravljati strojevima te se

odmah obratite liječniku.

H A L M E D

31-05-2016

O D O B R E N O

3.

Kako uzimati AMONEX?

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

liječnikom ili ljekarnikom ako niste sigurni.

Preporučena početna doza je 5 mg jedanput na dan. Doza se može povisiti na 10 mg jedanput na dan.

Lijek možete uzeti prije ili nakon obroka. Tabletu progutajte cijelu s vodom, redovito svaki dan u isto

vrijeme. Urez na tableti nije namijenjen za lomljenje.

Nemojte uzimati AMONEX tabletu sa sokom od

grejpa.

Primjena u djece i adolescenata

Za djecu i adolescente (u dobi od 6-17 godina) preporučena uobičajena početna doza je 2,5 mg na dan.

Najviša preporučena doza iznosi 5 mg na dan.

Doza od 2,5 mg amlodipina ne može se postići s primjenom AMONEX tableta.

Vrlo je važno da tablete uzimate redovito. Posjetite liječnika prije nego potrošite sve tablete.

Ako uzmete više AMONEX tableta nego što ste trebali

Uzimanje previše tableta može uzrokovati snižavanje ili čak opasno snižavanje krvnog tlaka. Možete

osjećati omaglicu, osjećaj gubitka svijesti, nesvjesticu ili slabost. U slučaju jakog pada krvnog tlaka,

može nastupiti šok. Koža Vam može postati hladna i znojna i možete izgubiti svijest. U slučaju da ste

uzeli previše AMONEX tableta, odmah potražite medicinsku pomoć.

Ako ste zaboravili uzeti AMONEX

Ne brinite. Ako ste zaboravili uzeti jednu tabletu, preskočite tu dozu. Sljedeću dozu uzmite u predviđeno

vrijeme. Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.

Ako prestanete uzimati AMONEX

Liječnik će Vas savjetovati koliko dugo trebate uzimati lijek. Bolest se može ponovo pojaviti ako lijek

prestanete uzimati prije nego što Vam je to preporučio liječnik.

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

liječniku ili ljekarniku.

4. Moguće nuspojave

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

Odmah

obavijestite svoga liječnika ako iskusite bilo koju od dolje navedenih nuspojava:

iznenadna pojava piskutavog disanja, bol u prsima, kratak dah, tegobe s disanjem

oticanje očnih kapaka, lica ili usana

oticanje jezika i grla koje uzrokuje poteškoće s disanjem

teške kožne reakcije koje uključuju intenzivni kožni osip, koprivnjaču, crvenilo po cijelom tijelu, jaki

svrbež, stvaranje mjehurića, guljenje i oticanje kože, upalu sluznice (Stevens-Johnsonov sindrom) ili

druge alergijske reakcije

srčani udar, nepravilni ritam srca

upala gušterače koja može uzrokovati jaku bol u trbuhu i leđima, povezana s općim osjećajem

slabosti.

Zabilježene su niže navedene

vrlo česte nuspojave

. Ako Vam bilo koja od nuspojava zadaje probleme, ili

ukoliko

traje dulje od tjedan dana

obratite se svome liječniku.

Vrlo česte

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

oticanje (edem).

H A L M E D

31-05-2016

O D O B R E N O

Zabilježene su niže navedene

česte nuspojave

. Ako Vam bilo koja od nuspojava zadaje probleme, ili

ukoliko

traje dulje od tjedan dana

obratite se svome liječniku.

Česte nuspojave

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

glavobolja(osobito na početku liječenja), omaglica, pospanost

osjećaj lupanja srca (palpitacije), crvenilo lica i osjećaj vrućine

bol u trbuhu, mučnina

poremećaj u radu crijeva, proljev, zatvor, loša probava

umor,slabost

poremećaji vida, dvoslike

grčevi u mišićima, oticanje zglobova

kratkoća daha.

Druge zabilježene nuspojave navedene su u sljedećem popisu. Ako bilo koja od njih postane ozbiljna, ili

ako uočite neku nuspojavu koja nije navedena u ovoj uputi, molimo Vas da o tome obavijestite svoga

liječnika ili ljekarnika.

Manje česte nuspojave

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

promjene raspoloženja, tjeskoba, depresija, nesanica

drhtanje, poremećaj okusa, gubitak svijesti

osjećaj umrtvljenosti ili trnci u udovima, gubitak osjeta boli

zvonjenje u ušima

niski krvni tlak

kihanje/curenje nosa uzrokovano upalom sluznice nosa (rinitis)

kašalj

suha usta, povraćanje

ispadanje kose, pojačano znojenje, svrbež kože, mjestimično crvenilo kože, promjena boje kože, osip,

koprivnjača

poremećaj mokrenja, povećan nagon za noćno mokrenje, povećana učestalost mokrenja

nemogućnost postizanja erekcije, povećanje ili napetost grudi u muškaraca

bol u prsima, bol, osjećaj opće slabosti

bol u mišićima ili zglobovima, bol u leđima

povećanje ili smanjenje tjelesne težine

nenormalni otkucaji srca (prebrzi ili prespori).

Rijetke nuspojave

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

smetenost.

Vrlo rijetke nuspojave

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

ozbiljne alergijske reakcije

smanjeni broj bijelih krvnih stanica, smanjeni broj trombocita što može dovesti do neuobičajene

pojave modrica ili lakog krvarenja (oštećenje crvenih krvnih stanica)

povišena razina šećera u krvi (hiperglikemija)

poremećaj živaca koji uzrokuje slabost, trnce, umrtvljenost

oticanje desni

neuobičajeno nadimanje (gastritis)

poremećaj funkcije jetre, upala jetre (hepatitis), žuta boja kože (žutica), povišenje razine jetrenih

enzima koji mogu utjecati na neke pretrage

upala gušterače (pankreatitis)

povišena mišićna napetost

upala krvnih žila, često povezana s kožnim osipom

preosjetljivost kože na sunčevu svijetlost

poremećaj koji obuhvaća ukočenost, drhtanje i/ili poremećaj pokreta

srčani udar.

Nepoznato

(učestalost se ne može procijeniti iz dostupnih podataka):

drhtanje, kruto držanje, lice poput maske, spori pokreti i neuravnotežen hod sa sitnim koracima.

H A L M E D

31-05-2016

O D O B R E N O

Prijavljivanje nuspojava

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika. Ovo uključuje i svaku

moguću

nuspojavu

koja

nije

navedena

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 AMONEX?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Čuvati na temperaturi ispod 25

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji. Rok valjanosti odnosi

se na zadnji dan navedenog mjeseca.

Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad. Pitajte svog ljekarnika kako baciti

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

6.

Sadržaj pakiranja i druge informacije

Što AMONEX sadrži?

Djelatna tvar je amlodipin.

Jedna tableta sadrži 5 mg, odnosno 10 mg amlodipina u obliku amlodipinbesilata.

Pomoćne tvari su: mikrokristalična celuloza; bezvodni kalcijev hidrogenfosfat; natrijev škroboglikolat,

vrsta A; magnezijev stearat.

Kako AMONEX tableta izgleda i sadržaj pakiranja?

AMONEX 5 mg tablete: bijela, okrugla tableta, promjera oko 7 mm, s razdjelnim urezom na jednoj strani

i otisnutom oznakom „5“ na drugoj strani.

30 (1x30) tableta u PVC/Al blisteru, u kutiji.

60 (2x30) tableta u PVC/Al blisteru, u kutiji.

90 (3x30) tableta u PVC/Al blisteru, u kutiji.

AMONEX 10 mg: bijela, okrugla tableta, promjera oko 7 mm, s razdjelnim urezom na jednoj strani i

otisnutom oznakom „10“ na drugoj strani.

30 (1x30) tableta u PVC/Al blisteru, u kutiji.

60 (2x30) tableta u PVC/Al blisteru, u kutiji.

90 (3x30) tableta u PVC/Al blisteru, u kutiji.

Na tržištu se ne moraju nalaziti sve veličine pakiranja.

Nositelj odobrenja za stavljanje lijeka u promet i proizvođač

BELUPO lijekovi i kozmetika d.d.

Ulica Danica 5

48 000 Koprivnica

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u svibnju 2016.

H A L M E D

31-05-2016

O D O B R E N O

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FDA - U.S. Food and Drug Administration

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

1-9-2018

Spodoptera frugiperda partial risk assessment

Spodoptera frugiperda partial risk assessment

Published on: Fri, 31 Aug 2018 00:00:00 +0200 EFSA was asked for a partial risk assessment of Spodoptera frugiperda for the territory of the EU focussing on the main pathways for entry, factors affecting establishment, risk reduction options and pest management. As a polyphagous pest, five commodity pathways were examined in detail. Aggregating across these and other pathways, we estimate that tens of thousands to over a million individual larvae could enter the EU annually on host commodities. Instigat...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on a draft protocol for the Scientific Opinion on free sugars from all dietary sources, prepared by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel), supported by the ad‐hoc Working Group on Sugars. The draft protocol was endorsed by the Panel for public consultation at its plenary meeti...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 10 Aug 2018 00:00:00 +0200 This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process General Plastic (EU register No RECYC153), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes orig...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 In June 2016, EFSA received a mandate from the national food competent authorities of five European countries (Denmark, Finland, Iceland, Norway and Sweden) to provide a dietary reference value (DRV) for sugars, with particular attention to added sugars. A draft protocol was developed with the aim of defining as much as possible beforehand the strategy that will be applied for collecting data, appraising the relevant evidence, and analysing and integrating t...

Europe - EFSA - European Food Safety Authority Publications

22-8-2018

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food, Inc. of Portland, OR is expanding its voluntary recall to include an additional quantity of Rad Cat Raw Diet across all varieties with Best By dates of 10/19/18 through 12/3/19 because it has the potential to be contaminated with Listeria monocytogenes. Radagast Pet Food is conducting this voluntary recall out of an abundance of caution because of its strong commitment to food safety and quality.

FDA - U.S. Food and Drug Administration

10-8-2018

Enforcement Report for the Week of July 25, 2018

Enforcement Report for the Week of July 25, 2018

Recently Updated Records for the Week of July 25, 2018 Last Modified Date: Friday, August 10, 2018

FDA - U.S. Food and Drug Administration

18-7-2018

Orphan designation:  Recombinant humanised anti-human interleukin-1 beta monoclonal antibody,  for the: Treatment of Behçet’s disease

Orphan designation: Recombinant humanised anti-human interleukin-1 beta monoclonal antibody, for the: Treatment of Behçet’s disease

On 1 October 2010, orphan designation (EU/3/10/796) was granted by the European Commission to XOMA Ireland Ltd, Ireland, for recombinant humanised anti-human interleukin-1 beta monoclonal antibody for the treatment of Behçet’s disease.

Europe - EMA - European Medicines Agency

23-10-2018

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Active substance: Pegylated recombinant human interleukin-10) - Transfer of orphan designation - Commission Decision (2018)6994 of Tue, 23 Oct 2018

Europe -DG Health and Food Safety

22-10-2018

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Active substance: Sildenafil citrate) - Transfer of orphan designation - Commission Decision (2018)6993 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/068/10/T/01

Europe -DG Health and Food Safety

19-10-2018

Recocam (Bimeda Animal Health Limited)

Recocam (Bimeda Animal Health Limited)

Recocam (Active substance: Meloxicam) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6954 of Fri, 19 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2247/T/10

Europe -DG Health and Food Safety

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety

19-9-2018

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Active substance: olaratumab) - Centralised - Annual renewal - Commission Decision (2018)6105 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4216/R/10

Europe -DG Health and Food Safety

19-9-2018

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 5971 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4078/T/10

Europe -DG Health and Food Safety

10-9-2018

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Helsinn Birex Pharmaceuticals Ltd)

Akynzeo (Active substance: netupitant / palonosetron) - Centralised - Yearly update - Commission Decision (2018)5947 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

10-9-2018

Alkindi (Diurnal Limited)

Alkindi (Diurnal Limited)

Alkindi (Active substance: hydrocortisone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5945 of Mon, 10 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4416/T/03

Europe -DG Health and Food Safety

10-9-2018

Retacrit (Hospira UK Limited)

Retacrit (Hospira UK Limited)

Retacrit (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5946 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

10-9-2018

Silapo (STADA Arzneimittel AG)

Silapo (STADA Arzneimittel AG)

Silapo (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5944 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

4-9-2018

ACM meeting statement, Meeting 10, 2 August 2018

ACM meeting statement, Meeting 10, 2 August 2018

The Advisory Committee on Medicines meeting statement is now available

Therapeutic Goods Administration - Australia

22-8-2018

BTVPUR (Merial)

BTVPUR (Merial)

BTVPUR (Active substance: Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 4)) - Centralised - 2-Monthly update - Commission Decision (2018)5630 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2231/II/10

Europe -DG Health and Food Safety

10-8-2018

Torisel (Pfizer Europe MA EEIG)

Torisel (Pfizer Europe MA EEIG)

Torisel (Active substance: Temsirolimus) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5521 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/799/T/71

Europe -DG Health and Food Safety

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

Brinavess (Active substance: vernakalant hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5523 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1215/T/31

Europe -DG Health and Food Safety

10-8-2018

Lymphoseek (Norgine B.V.)

Lymphoseek (Norgine B.V.)

Lymphoseek (Active substance: tilmanocept) - Centralised - Yearly update - Commission Decision (2018)5520 of Fri, 10 Aug 2018

Europe -DG Health and Food Safety

10-8-2018

Sivextro (Merck Sharp and Dohme B.V.)

Sivextro (Merck Sharp and Dohme B.V.)

Sivextro (Active substance: tedizolid phosphate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5522 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2846/T/28

Europe -DG Health and Food Safety

10-8-2018

Cubicin (Merck Sharp and Dohme B.V.)

Cubicin (Merck Sharp and Dohme B.V.)

Cubicin (Active substance: Daptomycin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5519 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/637/T/69

Europe -DG Health and Food Safety

10-8-2018

Thalidomide Celgene (Celgene Europe B.V.)

Thalidomide Celgene (Celgene Europe B.V.)

Thalidomide Celgene (Active substance: Thalidomide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5524 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/823/T/57

Europe -DG Health and Food Safety

10-8-2018

CANCIDAS (Merck Sharp and Dohme B.V.)

CANCIDAS (Merck Sharp and Dohme B.V.)

CANCIDAS (Active substance: caspofungin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5517 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/379/T/67

Europe -DG Health and Food Safety

10-8-2018

Tesavel (Merck Sharp and Dohme B.V.)

Tesavel (Merck Sharp and Dohme B.V.)

Tesavel (Active substance: sitagliptin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5518 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/910/T/65

Europe -DG Health and Food Safety

10-8-2018

Januvia (Merck Sharp and Dohme B.V.)

Januvia (Merck Sharp and Dohme B.V.)

Januvia (Active substance: sitagliptin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4511 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/722/T/65

Europe -DG Health and Food Safety

10-8-2018

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Active substance: bortezomib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5515 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4207/T/10

Europe -DG Health and Food Safety

7-8-2018

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

FDA - U.S. Food and Drug Administration

7-8-2018

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Active substance: memantine) - Centralised - Renewal - Commission Decision (2018)5421 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2766/R/10

Europe -DG Health and Food Safety

30-7-2018

Zalmoxis (MolMed S.p.A.)

Zalmoxis (MolMed S.p.A.)

Zalmoxis (Active substance: Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (?LNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2)) - Centralised - Renewal - Commission Decision (2018)5118 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2801/R/10

Europe -DG Health and Food Safety

27-7-2018

EU/3/11/868 (Celgene Europe B.V.)

EU/3/11/868 (Celgene Europe B.V.)

EU/3/11/868 (Active substance: Lenalidomide) - Transfer of orphan designation - Commission Decision (2018)5045 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/160/10/T/01

Europe -DG Health and Food Safety