Diuver 10 mg tablete

Glavna informacija

  • Trgovački naziv:
  • Diuver 10 mg tablete
  • Doziranje:
  • 10 mg
  • Farmaceutski oblik:
  • tableta
  • Sastav:
  • Urbroj: jedna tableta sadrži 10 mg torasemida
  • Tip recepta:
  • na recept, u ljekarni ponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Pliva Hrvatska d.o.o., Zagreb, Republika Hrvatska

Dokument

Lokalizacija

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

Terapeutski informacija

  • Proizvod sažetak:
  • Urbroj: 381-12-01/70-15-09

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-414026946
  • Datum autorizacije:
  • 20-03-2015
  • Zadnje ažuriranje:
  • 04-06-2018

Uputu o lijeku

Uputa o lijeku: Informacija za korisnika

Diuver 5 mg tablete

Diuver 10 mg tablete

torasemid

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 lijek je 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 su Diuver tablete i za što se koriste

2. Što morate znati prije nego počnete uzimati Diuver tablete

3. Kako uzimati Diuver tablete

4. Moguće nuspojave

5. Kako čuvati Diuver tablete

6. Sadržaj pakiranja i druge informacije

1.

Što su Diuver tablete i za što se koriste

Djelatna tvar Diuver tableta je torasemid. Pripadaju skupini lijekova pod nazivom „diuretici“ koji

povećavaju izlučivanje mokraće iz organizma („lijekovi za mokrenje“).

Diuver 5 mg tablete upotrebljavaju se za liječenje povišenog krvnog tlaka (hipertenzije)

Diuver 5 mg i 10 mg tablete upotrebljavaju se za liječenje prekomjernog nakupljanja tekućine u

organizmu (edema).

2.

Što morate znati prije nego počnete uzimati Diuver tablete

Nemojte uzimati Diuver tablete:

ako ste alergični (preosjetljivi) na djelatnu tvar ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)

ako ste alergični (preosjetljivi) na slične lijekove pod nazivom „sulfonilureje“ koji se koriste za

liječenje dijabetesa (visoka razina šećera u krvi). Ti lijekovi uključuju klorpropamid, glibenklamid,

glipizid i tolbutamid

ako imate tegobe s bubrezima (zatajenje bubrega s izrazito smanjenim mokrenjem (anurija))

ako bolujete od bubrežne bolesti uzrokovane lijekovima koji oštećuju bubrege

ako imate tegobe s jetrom

ako imate smanjen volumen krvi u krvotoku (hipovolemija)

ako imate nizak krvni tlak (hipotenzija)

ako imate nepravilne otkucaje srca (srčana aritmija)

ako imate giht ili visoke razine mokraćne kiseline u krvi

ako uzimate aminoglikozidne ili cefalosporinske antibiotike (za liječenje infekcija), uključujući

streptomicin, gentamicin, cefaleksin i ceftriakson (vidjeti dio „Drugi lijekovi i Diuver tablete“)

ako ste trudni ili dojite (vidjeti dio „Trudnoća i dojenje“).

Upozorenja i mjere opreza

Obratite se svom liječniku ili ljekarniku prije nego uzmete Diuver tablete:

ako imate nisku razinu kalija ili natrija u krvi

H A L M E D

20 - 03 - 2015

O D O B R E N O

ako imate smetnje mokrenja

ako imate šećernu bolest (dijabetes)

ako imate poremećaj acido-bazne ravnoteže

Djeca i adolescenti

Diuver tablete ne smiju uzimati djeca mlađa od 12 godina.

Drugi lijekovi i Diuver tablete

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

druge lijekove.

Kod kombinacije s drugim lijekovima može doći do njihovog međudjelovanja (interakcija), stoga će

možda trebati prilagoditi dozu Diuver tableta prema potrebama.

Diuver tablete mogu stupiti u interakcije sa slijedećim lijekovima:

srčani glikozidi - (za liječenje zatajenja srca)

glukokortikoidi – (za liječenje alergija, upala i kožnih bolesti)

antihipertenzivi –(za liječenje visokog tlaka)

antibakterijski lijekovi –(za liječenje bakterijskih infekcija)

litij – (za liječenje nekih psihijatrijskih bolesti)

kurare i teofilin – (mišićni relaksansi)

salicilati – (za liječenje temperature i bolova)

antidijabetici – (za liječenje šećerne bolesti (dijabetesa)

nesteroidni protuupalni antireumatici - (za liječenje boli, temperature i upale)

probenecid – (za liječenje gihta)

kolestiramin – (za liječenje povišenih masnoća).

Trudnoća i dojenje

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.

Diuver tablete se smiju upotrebljavati samo u slučajevima kad potencijalna dobit premašuje postojeći

rizik.

Diuver tablete se ne smiju uzimati tijekom trudnoće i dojenja.

Upravljanje vozilima i strojevima

Kao i kod drugih lijekova koji izazivaju promjene krvnog tlaka, i kod uzimanja Diuver tableta nemojte

upravljati motornim vozilima i strojevima ako osjećate omaglicu ili slične simptome.

Ostala upozorenja

Prilikom liječenja Diuver tabletama treba biti oprezan kod slijedećih patoloških stanja:

Patološka promjena acido-bazne ravnoteže

Istodobno liječenje litijem i nekim antibioticima (aminoglikozidi, cefalosporini).

Bubrežno zatajenje nastalo zbog toksičnog djelovanja drugih lijekova

Patološke promjene krvnih stanica (eritrociti, leukociti i trombociti)

Diuver tablete sadrže laktozu

Ako Vam je liječnik rekao da imate bolest nepodnošenja nekih šećera, prije nego što počnete uzimati ovaj

lijek posavjetujte se sa svojim liječnikom

3.

Kako uzimati Diuver tablete

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

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

H A L M E D

20 - 03 - 2015

O D O B R E N O

Odrasli i djeca starija od 12 godina

LIJEČENJE HIPERTENZIJE (VISOKI TLAK): Preporučena doza je 2,5 mg (1/2 tablete od 5 mg)

torasemida jednom dnevno. Prema potrebi doza se može povećati do 5 mg jednom dnevno. Lijek postiže

najveći učinak nakon otprilike 12 tjedana kontinuiranog liječenja.

EDEMI: Uobičajena doza je 5 mg jednom dnevno. Ako je potrebno, doza se postupno može povećavati

do 20 mg jednom dnevno. Maksimalna doza u pojedinačnim slučajevima može iznositi do 40 mg

torasemida na dan.

Starije osobe

Nije potrebno prilagođavanje doze.

Pedijatrijska populacija

Diuver tablete ne smiju uzimati djeca mlađa od 12 godina.

Oslabljena funkcija jetre i bubrega

Postoje ograničeni podaci o doziranju kod bolesnika s oslabljenom funkcijom jetre i bubrega. Potreban je

oprez kod bolesnika s oštećenom jetrom, zbog mogućnosti od povećanja koncentracija lijeka u krvi.

Način primjene

Tablete trebate uzimati ujutro, bez žvakanja s malom količinom vode.

Diuver tablete se uobičajeno koriste u dugotrajnom liječenju sve do nestanka edema.

Ako uzmete više Diuver tableta nego što ste trebali

Previše tableta odjedanput može vam naškoditi. U slučaju predoziranja odmah se javite svom liječniku

kako bi mogao poduzeti odgovarajuće mjere.

Ako ste zaboravili uzeti Diuver tablete

Ako ste zaboravili uzeti dozu Diuver tableta uzmite je čim se sjetite. Međutim ako je prošlo dosta

vremena i blizu je vrijeme za slijedeću dozu, propuštenu dozu ne uzimajte, a slijedeću dozu uzmite u

uobičajeno vrijeme.

Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu tabletu.

U slučaju bilo kakvih nejasnoća ili pitanja u vezi s primjenom Diuver tableta, obratite se svom liječniku

ili ljekarniku.

4.

Moguće nuspojave

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

primijetite bilo koju navedenu nuspojavu ili neku drugu nuspojavu koja nije ovdje navedena odmah se

obratite svom liječniku.

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

glavobolja

omaglica

slabost, umor

probavne smetnje (bol u gornjem dijelu trbuha, gubitak apetita, mučnina, povraćanje, proljev i zatvor)

stanje

praćeno

povišenim

vrijednostima

krvi

(metabolička

alkaloza),

poremećaj

ravnoteže

tekućine i elektrolita u tijelu

grčenje mišića (spazam)

Manje česte ( mogu se javiti u do 1 na 100 bolesnika):

tegobe mokraćnog mjehura (zadržavanje mokraće)

smanjena količina kalija u krvi

povišena razina šećera u krvi

povećane vrijednosti jetrenih enzima

povećane vrijednosti mokraćne kiseline, šećera i masnoća u krvi

H A L M E D

20 - 03 - 2015

O D O B R E N O

Rijetko (mogu se javiti u do 1 na 1000 bolesnika):

trnci, bockanje, utrnulost, mravinjanje ili peckanje u rukama i nogama

zujanje/zvonjava u ušima, gubitak sluha

poremećaji krvnih pretraga kao posljedica poremećenog rada bubrega

Vrlo rijetko (mogu se javiti u do 1 na 10 000 bolesnika):

kožne reakcije preosjetljivosti praćene sa svrbežom i osipom

osjetljivost na svjetlo

Nepoznato (učestalost nuspojava ne može se procijeniti iz dostupnih podataka):

suha usta, upala gušterače

pojedinačni slučajevi smanjenja broja krvnih stanica (crvenih krvnih stanica odnosno eritrocita,

bijelih krvnih stanica odnosno leukocita te krvnih pločica odnosno trombocita)

poremećaj prokrvljenosti mozga (cerebralna ishemija)

stanje smetenosti

oštećenje vida

poremećaj

prokrvljenosti

srca

(srčani

infarkt,

angina

pectoris),

nesvjestica,

krvnog

tlaka

(hipotenzija)

začepljenje krvnih žila (embolija)

ozbiljne kožne reakcije (npr. Stevens-Johnsonov sindrom, toksična epidermalna nekroliza)

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:

Agencija za lijekove i medicinske proizvode (HALMED)

Odsjek za farmakovigilanciju

Roberta Frangeša Mihanovića 9

10 000 Zagreb

Republika Hrvatska

Fax: + 385 (0) 1 4884 119

Website: www.halmed.hr

e-mail: nuspojave@halmed.hr

Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka

5.

Kako čuvati Diuver tablete

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Lijek ne zahtjeva posebne uvjete čuvanja.

Diuver tablete se ne smiju upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju. Rok

valjanosti odnosi se na zadnji dan navedenog mjeseca.

6.

Sadržaj pakiranja i druge informacije

Što Diuver tablete sadrže

Djelatna tvar Diuver tableta je torasemid.

Jedna Diuver 5 mg tableta sadrži 5 mg torasemida.

Jedna Diuver 10 mg tableta sadrži 10 mg torasemida.

H A L M E D

20 - 03 - 2015

O D O B R E N O

U Diuver tabletama su sadržane i sljedeće pomoćne tvari: laktoza hidrat, kukuruzni škrob, natrijev

škroboglikolat,vrste A, silicijev dioksid, koloidni, bezvodni, magnezijev stearat.

Kako Diuver tablete izgledaju i sadržaj pakiranja

Diuver 5 mg tablete su bijele do gotovo bijele, okrugle, bikonveksne tablete, s razdjelnom crtom na jednoj

strani i utisnutom oznakom 915 na drugoj strani.

Diuver 10 mg tablete su bijele do gotovo bijele, okrugle, bikonveksne tablete, s razdjelnom crtom na jednoj

strani i utisnutom oznakom 916 na drugoj strani.

Diuver tablete su dostupan je u pakiranju od 20 i 30 tableta u blisteru, u kutiji

Nositelj odobrenja za stavljanje lijeka u promet i proizvođač :

PLIVA Hrvatska d.o.o.

Prilaz baruna Filipovića 25

10 000 Zagreb, Hrvatska

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni.

Ova uputa je zadnji puta revidirana u ožujku 2015.

H A L M E D

20 - 03 - 2015

O D O B R E N O

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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