Leonis 10 mg tablete

Glavna informacija

  • Trgovački naziv:
  • Leonis 10 mg tablete
  • Doziranje:
  • 10 mg
  • Farmaceutski oblik:
  • tableta
  • Sastav:
  • Urbroj: svaka 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:
  • Genera d.d., Rakov Potok, Republika Hrvatska

Dokument

Lokalizacija

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

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 30 tableta u blisteru, u kutiji [HR-H-974897880-01]; 60 tableta u blisteru, u kutiji [HR-H-974897880-02] Urbroj: 381-12-01/70-17-08

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-974897880
  • Datum autorizacije:
  • 03-11-2017
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za bolesnika

Leonis 5 mg tablete

Leonis 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 ponovno 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 Leonis i za što se koristi?

Što morate znati prije nego počnete uzimati Leonis?

Kako uzimati Leonis?

Moguće nuspojave

Kako čuvati Leonis?

Sadržaj pakiranja i druge informacije

1.

Što je Leonis i za što se koristi?

Leonis sadrži djelatnu tvar amlodipin, koji pripada skupini lijekova pod nazivom blokatori

kalcijevih kanala.

Leonis se koristi u liječenju visokog krvnog tlaka (hipertenzije) ili odreĎenih vrsta boli u prsima

(angina pektoris). Rijedak oblik angine naziva se Prinzmetalova ili varijantna angina.

U bolesnika s visokim krvnim tlakom, Leonis djeluje tako da opušta krvne žile, pa krv kroz njih

lakše protječe. U bolesnika s anginom pektoris, Leonis djeluje tako da poboljšava dotok krvi u

srčani mišić koji na taj način dobiva više kisika i time se sprječava pojava boli u prsima. Lijek ne

djeluje na trenutno ublažavanje boli uzrokovane anginom pektoris.

2.

Što morate znati prije nego počnete uzimati Leonis?

Nemojte uzimati Leonis:

• ako ste alergični na amlodipin ili neki drugi sastojak ovog lijeka (naveden

u dijelu 6.), ili na neki drugi lijek iz skupine blokatora kalcijevih kanala. Alergijska

reakcija može se javiti kao osip, svrbež i crvenilo kože ili tegobe 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 Vašem liječniku ili ljekarniku prije nego uzmete Leonis.

Obavijestite svog liječnika ako bolujete ili ste bolovali od bilo kojeg od sljedećih stanja:

• ako ste nedavno imali srčani udar

H A L M E D

03 - 11 - 2017

O D O B R E N O

• ako imate zatajivanje srca

• ako imate jaki porast krvnog tlaka (hipertenzivnu krizu)

• ako imate bolest jetre

• ako ste starije životne dobi i trebate povisiti dozu

Djeca i adolescenti

Amlodipin se nije ispitivao u djece mlaĎe od 6 godina. Amlodipin se smije koristiti samo za

liječenje visokog krvnog tlaka (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 Leonis

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

koje druge lijekove.

Leonis može utjecati na druge lijekove ili drugi lijekovi mogu utjecati na Leonis, 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)

• takrolimus (upotrebljava se za kontrolu imunološkog odgovora Vašeg tijela, što

omogućuje Vašem tijelu da prihvati transplantirani organ)

• klaritromicin (za infekcije uzrokovane bakterijama)

• simvastatin (lijek za snižavanje kolesterola)

• ciklosporin (imunosupresiv)

Ako već uzimate druge lijekove za snižavanje krvnog tlaka, Leonis može uzrokovati dodatno

sniženje krvnog tlaka.

Leonis s hranom i pićem

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

mogu uzrokovati porast vrijednosti djelatne tvari amlodipina u krvi, što može izazvati pojačano

djelovanje Leonis na snižavanje krvnog tlaka.

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.

Trudnoća

Nije utvrĎena sigurnost primjene amlodipina u trudnica. Ako mislite da ste trudni ili planirate

trudnoću, recite to Vašem liječniku prije uzimanja Leonisa.

Dojenje

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

svom liječniku prije uzimanja Leonisa.

Upravljanje vozilima i strojevima

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

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

se odmah obratite liječniku.

H A L M E D

03 - 11 - 2017

O D O B R E N O

3.

Kako uzimati Leonis?

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 Leonisa jedanput na dan. Doza se može povisiti na 10 mg jedanput

na dan.

Lijek možete uzimati prije ili nakon obroka i pića. Tabletu morate uzeti svaki dan u isto vrijeme s

čašom vode. Nemojte uzimati Leonis sa sokom od grejpa.

Primjena u djece i adolescenata

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

preporučena doza je 5 mg na dan. Doza od 2,5 mg ne može se postići Leonis 5 mg tabletom, jer ove

tablete nisu predviĎene za lomljenje na dva jednaka dijela.

Vrlo je važno redovito uzimati tablete, stoga nemojte čekati da popijete i zadnju tabletu iz kutije prije

nego posjetite liječnika.

Ako uzmete više Leonis 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 tableta Leonis, odmah potražite medicinsku pomoć.

Ako ste zaboravili uzeti Leonis

Ne brinite. Ako ste zaboravili uzeti jednu tabletu, preskočite tu dozu. Iduću dozu uzmite u uobičajeno

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

Ako prestanete uzimati Leonis

Vaš liječnik će Vam savjetovati koliko dugo trebate uzimati ovaj lijek. Ako ga prestanete uzimati prije

nego Vam je liječnik to preporučio, simptomi bolesti mogu se vratiti.

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 ako iskusite bilo koju od dolje navedenih nuspojava nakon

uzimanja ovog lijeka:

• iznenadna pojava zviždanja u prsima, bol u prsima, kratak dah, poteškoće 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 leĎima, povezana s općim osjećajem

slabosti

Ostale zabilježene nuspojave uključuju sljedeće:

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

• oticanje (edem)

H A L M E D

03 - 11 - 2017

O D O B R E N O

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

• glavobolja (osobito na početku liječenja), omaglica, pospanost

• lupanje srca koje osjetite (palpitacije), crvenilo lica i osjećaj vrućine

• bolovi u trbuhu, mučnina

• poremećaj u radu crijeva, proljev, zatvor, loša probava

• umor, slabost

• poremećaj vida, dvoslike

• grčevi mišića

• oticanje zglobova

• kratkoća daha

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

• promjene raspoloženja, tjeskoba, depresija, nesanica

• drhtanje, poremećaj okusa, nesvjestica

• osjećaj umrtvljenosti ili trnci u udovima, gubitak osjeta boli

• zvonjenje u ušima

• nizak krvni tlak

• kihanje i/ili 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

• bolovi u mišićima ili zglobovima, bolovi u leĎima

• povećanje ili smanjenje tjelesne težine

• nenormalni otkucaji srca (prebrzi ili prespori)

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

• smetenost

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

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

neuobičajene pojave modrica ili lakog krvarenja (oštećenje crvenih krvnih stanica)

• povišene vrijednosti šećera u krvi (hiperglikemija)

• poremećaj živaca koji uzrokuje slabost, trnce ili umrtvljenost

• oticanje desni

• neuobičajeno nadimanje u trbuhu (gastritis)

• poremećaj funkcije jetre, upala jetre (hepatitis), žutilo kože (žutica), povećane vrijednosti

jetrenih enzima koji mogu utjecati na neke pretrage

• upala gušterače (pankreatitis)

• povišena mišićna napetost

• upala krvnih žila, često povezana s kožnim osipom

• osjetljivost na svjetlost

• poremećaj koji obuhvaća ukočenost, drhtanje i/ili poremećaj pokreta

• srčani udar

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

• drhtanje, kruto držanje, spori pokreti i neuravnotežen hod sa sitnim koracima (ekstrapiramidalni

sindrom)

Ukoliko Vam bilo koja nuspojava radi poteškoće ili ako traje dulje od jednog tjedna, trebate se

obratiti Vašem liječniku.

H A L M E D

03 - 11 - 2017

O D O B R E N O

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 Leonis?

Čuvati na temperaturi ispod 25°C.

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

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

oznake „Rok valjanosti“ ili otisnutog na blisteru. Rok valjanosti odnosi se na zadnji dan navedenog

mjeseca.

6.

Sadržaj pakiranja i druge informacije

Što Leonis sadrži?

Djelatna tvar je amlodipin. Svaka tableta Leonis 5 mg sadrži 5 mg amlodipina.

Svaka tableta Leonis 10 mg sadrži 10 mg amlodipina.

Pomoćne tvari su: mikrokristalična celuloza; natrijev škroboglikolat vrste A; dinatrijev hidroencitrat;

magnezijev stearat; umrežena karmelozanatrij; krospovidon

Kako Leonis izgleda i sadržaj pakiranja?

Leonis 5 mg i Leonis 10 mg tablete su pakirane po 30 (3x10) i 60 (6x10) tableta u PVC/PVdC//Al

blisteru, u kutiji. Dimenzije Leonis 5 mg tableta su 6,6 x 3,5 mm. Dimenzije Leonis 10 mg tableta su

8,5 x 4,5 mm.

Nositelj odobrenja za stavljanje lijeka u promet i proizvođač

Nositelj odobrenja:

Mylan Hrvatska d.o.o.,

Koranska 2

10000 Zagreb

Proizvođač:

Genera d.d

Svetonedeljska 2

Kalinovica, 10436 Rakov Potok

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je posljednji put revidirana u studenom 2017.

H A L M E D

03 - 11 - 2017

O D O B R E N O

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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

12-11-2018

Spinraza (Biogen Netherlands B.V.)

Spinraza (Biogen Netherlands B.V.)

Spinraza (Active substance: nusinersen) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7550 of Mon, 12 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4312/T/10

Europe -DG Health and Food Safety

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