Lopin 10 mg tablete

Glavna informacija

  • Trgovački naziv:
  • Lopin 10 mg tablete
  • Doziranje:
  • 10 mg
  • Farmaceutski oblik:
  • tableta
  • Sastav:
  • Urbroj: jedna tableta sadržava 10 mg amlodipina u obliku amlodipinbesilata
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • mibe GmbH Arzneimittel, Brehna, Njemačka

Dokument

Lokalizacija

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

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 30 tableta u blisteru, u kutiji [HR-H-053759540-01]; 60 tableta u blisteru, u kutiji [HR-H-053759540-02]; 90 tableta u blisteru, u kutiji [HR-H-053759540-03] Urbroj: 381-12-01/30-15-04

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-053759540
  • Datum autorizacije:
  • 23-11-2015
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacija za bolesnika

Lopin 5 mg tablete

Lopin

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 svom 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 liječnika ili ljekarnika. To uključuje i svaku

moguću nuspojavu koja nije navedena u ovoj uputi. Pogledajte dio 4.

Što se nalazi u ovoj uputi:

1. Što je Lopin i za što se koristi?

2. Što morate znati prije nego počnete uzimati Lopin ?

3. Kako uzimati Lopin?

4. Moguće nuspojave

5. Kako čuvati Lopin ?

6. Sadržaj pakiranja i druge informacije

1.

ŠTO JE LOPIN I ZA ŠTO SE KORISTI?

Lopin tablete sadržavaju 5 mg ili 10 mg amlodipina koji pripada skupini lijekova pod nazivom blokatori

kalcijevih kanala.

Lopin tablete koriste se u liječenju povišenog krvnog tlaka (hipertenzije) ili nekih vrsta boli u prsima

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

U bolesnika s povišenim krvnim tlakom Lopin tablete djeluju tako da opuštaju glatke mišiće u stijenkama

krvnih žila, pa krv kroz njih lakše protječe. U bolesnika s anginom pektoris Lopin tablete djeluju tako da

poboljšavaju 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 LOPIN?

Nemojte uzimati Lopin:

ako ste alergični (preosjetljivi) 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 aortalnog ušća (aortalnu stenozu) 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 Lopin:

ako ste nedavno imali srčani udar

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

H A L M E D

23 - 11 - 2015

O D O B R E N O

Djeca i adolescenti

Amlodipin se nije ispitivao u djece mlađe od 6 godina. Amlodipin 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 Lopin

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

druge lijekove.

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

ketokonazol, itrakonazol (lijekovi za liječenje infekcija gljivicama)

ritonavir, indinavir, nelfinavir (tzv. inhibitori protezae 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)

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

krvnog tlaka.

Lopin s hranom i pićem

Bolesnici koji uzimaju Lopin 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

Lopina na snižavanje krvnog tlaka.

Trudnoća, dojenje i plodnost

Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, 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 Lopina.

Dojenje

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

liječniku prije uzimanja Lopina.

Upravljanje vozilima i strojevima

Lopin 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.

3.

KAKO UZIMATI LOPIN?

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

liječnikom ili ljekarnikom ako niste sigurni.

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

dan.

Lijek možete uzimati prije ili nakon obroka i pića. Tabletu uzmite svaki dan u približno isto vrijeme, s

čašom vode. Nemojte uzimati Lopin sa sokom od grejpa.

H A L M E D

23 - 11 - 2015

O D O B R E N O

Primjena u djece i adolescenata

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

preporučena doza je 5 mg na dan.

Doza od 2,5 mg ne može se postići s Lopin 5 mg tabletom, jer ove tablete nisu predviđene za lomljenje na

dva jednaka dijela.

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

posjetite liječnika.

Ako uzmete više Lopina 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 Lopina, odmah potražite medicinsku pomoć.

Ako ste zaboravili uzeti Lopin

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 Lopin

Vaš liječnik će Vam savjetovati koliko dugo trebate uzimati Lopin tablete. Ako ih prestanete uzimati prije

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

U slučaju bilo kakvih 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 javiti kod svakoga.

Odmah

obavijestite svog liječnika ako iskusite bilo koju od dolje navedenih, vrlo rijetkih ozbiljnih

nuspojava.

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 leđima, povezana s općim osjećajem

slabosti

Zabilježene su sljedeće česte nuspojave:

Česte nuspojave (javljaju se kod 1-10 osoba na 100 osoba koje uzimaju lijek):

glavobolja, omaglica, pospanost (osobito na početku liječenja)

lupanje srca koje osjetite (palpitacije), crvenilo lica

bolovi u trbuhu, mučnina

oticanje gležnjeva (edemi), umor

Ostale zabilježene nuspojave uključuju sljedeće:

Manje česte nuspojave (javljaju se kod 1-10 osoba na 1000 osoba koje uzimaju lijek):

promjene raspoloženja, tjeskoba, depresija, nesanica

drhtanje, poremećaj okusa, nesvjestica, slabost

osjećaj umrtvljenosti ili trnci u udovima, gubitak osjeta boli

H A L M E D

23 - 11 - 2015

O D O B R E N O

poremećaj vida, dvoslike, zvonjava u ušima

nizak krvni tlak

kihanje, curenje nosa uzrokovano upalom sluznice nosa (rinitis)

poremećaj u radu crijeva, proljev, zatvor, loša probava, suha usta, povraćanje

gubitak kose, pojačano znojenje, svrbež kože, mjestimično crvenilo kože, promjena boje kože

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

nemogućnost postizanja erekcije, povećanje ili napetost grudi u muškaraca

slabost, bol, osjećaj opće slabosti

bolovi u mišićima ili zglobovima, grčevi mišića, bolovi u leđima

povećanje ili smanjenje tjelesne težine

Rijetke nuspojave (javljaju se kod 1-10 na 10000 osoba koje uzimaju lijek)

smetenost

Vrlo rijetke nuspojave (javljaju se kod manje od 1 na 10000 osoba koje uzimaju lijek):

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

kašalj, oticanje desni

nadimanje u trbuhu (gastritis)

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

enzima koji mogu utjecati na neke pretrage

povišena mišićna napetost

upala krvnih žila, često povezana s kožnim osipom

osjetljivost na svjetlost

poremećaj koji obuhvaća ukočenost, drhtanje i/ili poremećaj pokreta

Prijavljivanje nuspojava

Ako primijetite bilo koju nuspojavu potrebno je obavijestiti liječnika ili ljekarnika. Ovo 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 LOPIN?

Lijek čuvajte izvan pogleda i dohvata djece.

Lopin tablete moraju se čuvati na temperaturi ispod 25

C, u originalnom pakiranju,

zaštićene

svjetlosti.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju. 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 Lopin sadrži

- Djelatna tvar je amlodipin u obliku amlodipinbesilata. Jedna Lopin tableta sadržava 5 mg ili 10

mg amlodipina u obliku amlodipinbesilata.

- Drugi sastojci (pomoćne tvari) su: kalcijev hidrogenfosfat dihidrat; celuloza, mikrokristalična; silicijev

dioksid, koloidni, bezvodni; natrijev škroboglikolat, vrste A; magnezijev stearat

H A L M E D

23 - 11 - 2015

O D O B R E N O

Kako Lopin izgleda i sadržaj pakiranja

Lopin 5 mg tablete su bijele do gotovo bijele, okrugle, bikonveksne tablete s oznakom 5 na jednoj strani

tablete.

Lopin 10 mg tablete su bijele do gotovo bijele, okrugle, bikonveksne tablete s oznakom 10 na jednoj

strani tablete.

Pakirane su po 30 (3x10), 60 (6x10) ili 90 (9x10) tableta u blisteru, u kutiji.

Nositelj odobrenja za stavljanje lijeka u promet

Farmal d.d., Branitelja domovinskog rata 8, 42230 Ludbreg

Proizvođač

Farmal d.d., Branitelja domovinskog rata 8, 42230 Ludbreg

mibe GmbH Arzneimittel, Münchener Strasse 15, 06796 Brehna, Njemačka

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni

Ova uputa je zadnji puta revidirana u studenom 2015.

H A L M E D

23 - 11 - 2015

O D O B R E N O

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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

30-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Cyprus and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Cyprus and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Cyprus alongside with another 4 countries has participated successfully in the Grant Agreement GP/EFSA/DATA/2016/01‐GA 02, entitled: “Strategic Partnership with Cyprus on Data Quality”. The project was co‐financed by EFSA, aiming to help both EFSA and data providers from Member States to possess data of high quality in a quantitatively manageable way. The main objective of the grant agreement was the establishment of the data governance, coordination and imp...

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

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