LIFTA 5 MG 28 FILM TABLET

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  • cialis

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  • Kaynak:
  • TİTCK - TÜRKİYE İLAÇ VE TIBBİ CİHAZ KURUMU - Türkiye
  • Yetkilendirme durumu:
  • Aktif
  • Yetkilendirme numarası:
  • 8699514093367
  • Yetkilendirme tarihi:
  • 20-01-2015
  • Son Güncelleme:
  • 25-05-2018

Hasta Bilgi broşürü: Ürün Özellikleri Özeti - kompozisyon, endikasyonlar, yan etkiler, dozaj, etkileşimleri, advers reaksiyonlar, gebelik, laktasyon

KIsA

ORfrN

silcisi

nngnni

rmni

On0r0x.l,ot

I,iffa

mgfilm

tablet

xlr,iuttr

xlrult.l,rtr

nilp$lu

Etkin

madde:

film

tablet

2.5 mg

tadalafil

igerir.

Yardrmcr

maddeler:

Laktoz

grantil

278.21mgltablet

Sodyum

lauril

siilfat

mg/tablet

Kroskarmeloz

sodyum

mg/tablet

Yardrmcr

maddeler

igin

6.1'e

bakmz.

FARMASOTT

f,'ORM

Filmtablet

Sarrmsr

beyazrenkte

ve badem

geklinde,

yliztinde

"2Y2"

isarctibuhuran

film

tablet

KLiNIK

Oznr,r,txr,rn

Terapdtik

endikasyonlar

Erektil

disfonksiyonun

tedavisinde

endikedir.

LiFTA'nrn

etkili

olabilmesi

igin

cinsel

uyanrun

olmasr

gereklidir.

LIFTA

kadrnlarda

kullamm

igin

endike

de$ildir.

4.2.Pozoloii

uygulama

gekli

Pozoloji/uygulame

s*h$

stresi

Yetigkin

erkeklerde

kullammr

iligki

Oncesi

L[FTA'mn

datra

kullanrmrna

(Orne[in,

haftada

kez).ihtiyag

duyan

hastalardq

hastamn

tercihine

hekimin

de[erlendirmesine

ba$r

olarak

LIFTA

tabletlerin

giinde

kullamldr[r

rejimi

uygun

olarak

deSerlendirilebilir.

hastalarda

dnerilen

doz,

giin

yaklaqrk

saatte

alrnan,

gilnde

mg'hk

tablettir.

Etkinligin

yetersiz

oldupu

durumda,

grkrlabilecek

maksimum

giinde

mg'hk

tablettir.

Giinluk

rejimin

siirekli

kullamm

uygunlu[u,

periyodik

olarak

telaar

delerlendirilmelidir.

Uygulama

gekli:

Tabletler

aprz

yoluyla

ahnrr.

6zel

popf,lasyonlara

ititkin

bffiIer:

B6brek/Karaciler

yetmezli[i:

Hafif

orta

giddetli

b0brek

fonksiyon

boalklu[u

olan

hastalardadozayarlamasr

yaprlmasrna

getek

yoktur.

$iddetli

bObrek

fonksiyon

bozuklu[u

olan

hastalarda,

g0nde

siirekli

(gtnlfik

rejimin

stirekli

larllamlmasr)

tadalafil kullamlmasr

Onerilmez

(bkz.

b0l0m

5.2).

Karaciper fonksiyon bozuklupu olan

hastalarda

glinde

tek doz

kullanrmr

araqtrnlmamrgtrr.

nedenle,

eler iiriln

regete

edilirse,

hastaya

ilacr

regete eden

hekim

taraflndan detayh

bireysel

yarar/risk

de[erlendirmesi

yaprlmahdrr (bkz.

bOlum

5.2).

Diyebet:

Diyabetli

hastalarda

ayarlamasr

yapilmasrna

gerek

yoktur.

Pediyatrik

poptlasyon:

Ltr'TA

yaqrn

altrndaki

kigilerde

kullamlmamahdrr.

Geriyatrik

poptlesyon:

Yagh

erkeklerde

ayarlamasr

yaprlmasrna

gerek

yoktur.

4.3.

Kontrendikasyonlar

Etkin

madde

veya

yardrmcr

maddelerden

herhangi

birine

kargr

agrn

duyarlilr[r

olan

hastalarda

kontrendikedir.

Klinik

gahgmalarda

tadalafilin,

nitraflann hipotansif etkiterini

arhr&B

g6steritni$tir.

durumun

nitatlann

tadalafilin

nirik

oksit/cGMP

yolag

tizerindeki kombine

etkilerinin

sonucu

oldupu

dilgtlnUlmektedir.

nedenle,

herhangi

formda

organik

nitat

alan hastalara

LiFTA'mn

birlikte

uygulanmasr

kontrendikedir

Okz.

b6liim

4.5).

LIFTA'rn

da datril oldu$u

erektil

disfonksiyon

tedavisi

igin

kultamlmakta olan

bilegikler,

cinsel

aktivitenin

0nerilmediEi

kilp

hastahg olan

erkeklerde

kullamlmamahdrr.

Hekimler,

daha

Onceden

kardiyovaskitler

hastah[r

olan

kigilerde,

cinsel

aktivitenin

olugturdu[u

potansiyel

kardiyak

riskleri

dntinde

bulundurmahdrlar.

ASaBda

belirtilen

kardiyovaskiiler

hastahg olan

hasta

gruplan

klinik

gahgmalara

dahil

edilmemiglerdir

nedenle

hastalarda

tadalafil

kullanmt

konfrendikedir:

giin

iginde

miyokard

infarktiisii

gegirmig

hastalar,

stabil

olmayan

anginasr

olan

cinsel birlegme srasrnda

angina

geligen

hastatar,

aydaNew

York

Heart

Association

srruflandrmasrna

g6re

"Srilf

2"

yadadaha

kalp

yetmezli[i

olan hastalar,

kontrol

edilemeyen

arimrileri,

hipotansiyonu

(<

90/50

mm Hg),

kontrol

edilemeyen

hipertansiyonu olan

hastalar,

son 6 ay

iginde inme

gegirmig

olan

hastalar.

Non-arteritik anterior

iskemik

optik

n6ropati

(NAIOI$

nedeniyle

g6zlinde

g6rme

kaybr

olan

hastalarda,

epizodrur daha

6nce

PDE5

inhibit6m

manrziyeti

iligkisi

olsun

olmasrn,

LIFTA

kontrendikedir

Okz.

b0lflm

4.4).

4.4.

&rllkullanrm

uyanlan

dnlemleri

Erektil

disfonksiyonu

teghis

etnek

alunda

yatan potansiyel

sebepleri

tespit

etnek

igin,

farmakolojik tedavi

diigiiniilmeden 6nce,

hastamn

medikal

gegmigi

incelenmeli

fizik

muayene

yaprlmahdr.

Cinsel

aktivite

ba[lantrh

olarak

belirli

kardiyak

risk

s6z konusu

oldu$undan,

erektil

disfonksiyona

y0nelik

herhangi

tedavi

baglatrlmadan

6nce

hekimler,

hastalannrn

kardiyovasktiler

durumlanm

Oniinde

bulundtrmahdrlar.

Tadalafil,

basrncrnda

hafif

gegici

dUgtiglere

sebep

olabilen

vazodilatOr

Ozelliklere

sahip

olup

Okz.

b6ltm

5.1),

nitratlann

hipotansif

etkisini

artrrmaktadrr

Okz.

ffiltm

4.3).

Beraberinde

antihipertansif

ilaglar

kullanan

hastalarda,

tadalafil kan

basrncrndaki

diigmeyi

indtlkleyebilir.

Tadalafil

g0nltik

tedavi

baglatrlrken,

antihipertansif

tedavisinin

olas

ayarlamasrna

uygun

klinik

6rem

verilmelidir

Miyokard

infarktiis0, ani

kardiyak

Oliim,

stabil

olmayan

angina

pektoris,

ventikiiler aritni,

inme,

gegici

iskemik

ataklar,

giis

a[nsr,

palpitasyonlar

ta$ikardi

grbi

ciddi

kardiyovaskiiler

olaylar,

pazarlama

sonrasr

klinik

gahgmalar

srasrnda

rapor

edilmigtir.

olaylann

rapor

edildili

hastalann

gopunlulu

datra

Onceden

mevcut

kardiyovasktiler

risk

faktorlerine

sahiptir.

Ancak,

otaylann

do[rudan

risk

faktOrlerine,

LiFTA'ya,

cinsel

aktiviteye

veya

bunlann

di[er

faktOrlerin

kombinasyonuna

ba$r

olup

olmah[rru

kesin

olarak

tespit

ehek

mtlmklln

de[ildir.

LIFTA

di[er

PDE5

inhibitorlerinin

kullammr

iligkili

olarak

g6rsel

kusurlar ve

NAION

vakalan bildirilmigtir.

Hastalarq

g6rme

bozuklu$u

durumunda

LIFTA

kullanmayr

brakmalan

derhal

hekime

damgmalan

tavsiye

edilmelidir

Okz.

bOliim

4.3).

Arfinrg

tadalafil

manrziyeti

(EAA),

krsrth

klinik

deneyim

klerensi diyaliz

dilzeltememe

olasrhg

nedeniyle,

giddetli

bObrek

yefinezliSi

olan

hastalarda

LIFTA'rn

e0nlUk

kullammr

0nerilmez.

A[rr

karaci[er

yetnezli[i

olan

hastalarda

(Child-Pugh

Srmf

LiFTA'mn

uygulamasrmn

giivenliligi

ilgili

srmrh

klinik

veri

mevcuttur. Gtlnde

uygulamasr,

karaciper

yetnezli[i

olan

hastalarda

araqhnlmamrghr.

E[er

hastalara

LIFTA

regete

edilirse,

hastaya

ilacr

regete eden

hekim

tarafindan

detayh

bireysel

yarar/risk

de[erlendirmesi

yaprlmahdr.

saat

yadadalra

fazla

siiren ereksiyon

yapyan

hastalar

derhal

trbbi

yardm

almahdrlar.

E[er

priapiznr

derhal

tedavi

edilmezse,

penil

dokuda

hasar

meydana

gelebilir

kaftcr

iktidarsdtk

sonuglanabilir.

Penisinde

anatomik

deformasyon

bulunan

(angillasyorq

kavemozal

fibroz

Peyronie

hastahg

gibi)

priapizme

neden

olabilecek

dunrmu

olan

(orak

hiicre

anemisi,

multipl

miyelom

losemi

gibi)

hastalarda,

LIFTA'rn

da datril

oldu$u,

erektil

disfonksiyon

tedavisine

y6nelik

bilegikler dikkatle

kullamlmahdr.

Erektil

disfonksiyon

de[erlendirmesi

potansiyel

altta

yatan

nedenlerin

tespitini

ve uygun

trbbi

de$erlendirme

sonra$ uygun tedavinin

belirlenmesini

kapsamahdr.

Pelvik

cerratri

veya

sinir

koruyucu

olmayan

radikal

prostatektomi

gegiren

hastalarda

LIFTA'rn

etkili

olup

olmadrlr

bilinmemektedir.

Alfar

blokorleri

alan

hastalara

zamanh olarak

LIFTA

verilmesi

bazr

hastalarda

semptomatik

hipotansiyona

neden

olabilmektedir

(bkz.

b6l[m

4.5).

Tadalafil

doksazosin

kombinasyonu

6nerilmemektedir.

Potent

CYP3A4

inhibitdrleri

(ritonavir,

sakinavir,

ketokonazol,

itakonazol

eritomisin)

kullanan

hastalara,

ilaglar

birlikte

kullanl&lrnda

tadalafil

manrziyetinde

artr$

(EAA)

g6zlendi[inden,

LIFTA

regetelendirilirken

dikkatli

olunmahdrr

Okzb0ltln

4.5).

LIFTA'rn

di[er

PDE5

inhibitOrleri

erektil

disfonksiyonun

diger tedavileriyle

birlikte

kullammrnda

glivenlilik

etkilili$

gahgrlmamrgtr.

Hastalar;

tIFTA?yr

tilr

kombinasyonlarla

almamalan

igin

bilgilendirilmelidir.

nedenle,

tltr

kombinasyonlar

6nerilmemektedir.

LIFTA

laktoz

igermektedir.

Nadir

kalrtrmsal

galaktoz

intolerans,

Lapplaktazyetnezli[i

yada

glnkoz-galakozmalabsorpsiyon

problemi

olan

hastalann bu

ilacr

kullanmamalan

gerekir.

trbbi

tirtin

fihn

tablette

lmmol

mg)'dan

az sodyum

ihtiva

eder,

yani

igerdi[i

dozu nedeniyle

herhangi

uyany

gerektirmez.

Pazarlama

sonrast

deneyimde,

retinal

okliizyonu

seyrek olarak

bildirilmigtir.

Tadalafil

retinal

oklilzyonu

arasrndaki

nedensellik

iliqkisi

ara$tmlmamrgtr.

Doktorlanru

Ozellikle

ya$h,

viskozitesi

arfimg

hastalarda

retinal

okltlzyonu

riskinin

daha

y0ksek

olduSuna

dild@t

etneleri

gerekir.

4.5.Di!er

hbbi

flrfinler

etkilegimlerve

diler

etkilegim

gekilleri

Etkilegim

gahgmalan

agalrda

belirtildiEi

Sibi

ve/veya

tadalafille

birlikte

gergekleqtirilmigtir.

tadalafil

dozunun

kullamldr$

etkilegim

gahgmalarmda,

y0ksek

dodarda

klinik

olarak

iligkili

etkilegimler

tamamen

harig

brrakrlamamaktadr.

Di$er maddelerin

todalafrl

tEerhdeki

etkileri

Tadalafil

temel olarak

CYP3A4

tarafindan

metabolize

edilir.

Segici

CYP3A4

inhibit6rii

olan ketokonazol

(giinde

200 mg), tek

bagrna

tadalafil

elde

edilen

Crao

deEerlerine

kryasla,

tadalafil

maruziyetini

(EAA)

kat ve

Cn,rks't

oramnda

artrmtgtr.

Ketokonazol

(giinde

mg), tek

bagrna

tadalafil

elde edilen

Cmar,s

deEerlerine

kryasla,

tadalafil

mg) manrziyetini

(EAA)

kat ve Cr.ro't

o/o22

oranrnda

artrmrghr.

CYP3A4,

CYP2C9,

CYP2Clg

CYP2D6

inhibit6rii

olan

proteaz

inhibit6rii ritonavir

(gllnde

kez 200

mg),

C.a.s

deEerinde

bir deligim

olmaksum, tadalafil

manrziyetini

(EAA)

artrmrgtr.

ne kadar spesifik

etkilegimler

gahgrlmamr$sa

sakinavir

gibi

di[er

proteaz

inhibitorleri

eritromisin,

klaritomisiru

itrakonazol

greyfurt

suyu

gibi

diper

CYP3A4

inhibitOrleri

birlikte

uygulanrrken,

bunlann tadalafilin

plaznra

konsantrasyonunu

artrmasr

beklendi[inden

dikkatli olunmahdr

(bkz.

bOltitn

4.4).

Sonug

olaralq

bdltim

4.8'de

listelenen istenmeyen

etkilerin

insidansr

artabilmektedir.

Tadalafilin

dispozisyonundq

tagryrcrlann

(0rnegiq

p-glikoprotein)

rollerinin

oldupu

bilinmemektedir.

nedenle tagryrcrlann

inhibisyonu

aracrhsr

ilag

etkilegimlerinin

g6riilme

olasrhpr

vardr.

CYP3A4

indtlkleyicisi

olan

rifampisin,

bagrna

tadalafille

elde edilen

delerlerine

kryasla,

tadalafilin

F.A,,Atr*

%88 azalffirgtr.

azalan

manrziyetin tadalafilin

etkilili[ini

azalfilt

tattmin

edilebilir;

ancak

azalaun

etkilililin

derecesi

bilinmemektedir.

Fenobarbital,

fenitoin

karbamazepin

gibi

di[er

CYP3A4

indtlkleyicileri

tadalafilin

plama

konsantrasyonlanm

dtlgiirebilmektedir.

Tadalatilin

diSer

nbbi tiriinler

ilzerindeki

etkileri

Klinik

gal$malarda,

tadalafilin

ve 20

mg), nitratlann

hipotansif

etkilerini

artrd{r

gOsterilmigtir.

Bu

nedenle,

herhangi

bir

formda organik

nitat

alan

hastalara

LIFTA

uygulanmasr

kontendikedir

Okz.

b0lUm

4.3).

150

denegin, 7

efln

boyunca

gllnde

20

mgdozda

tadalafil

ve

defigik

zamanlarda

0.4

mg

dil

altr

nitrogliserin

al&g

bir

klinik

gahgmamn

sonuglanna

gOre,

ilag

etkilegimi 24

sattenuzun

stirede sonlanmrg

ve

son

tadalafil

dozundan

48

saat sonra

artrk tespit

edilemez

bir

dtlzeye

gelmigtir.

Bu

nedenle

herhangi

bir

LIFTA

doztr

regete

edilmig

ve

ya$auu

tehdit

eden

bir

durumda

nitat

uygulanmasrnrn

trbbi

olarak

gerekli

g6rilldii[U

bir

hastada,

nitat

uygulamasr

yaprlmadan

6nce

en

son

LFTA

dozundan en az

48

saat

gegmig

olmasr

gereklili$

dikkate ahnmahdrr.

Bu

gibi

dtrurrlarda,

nihatlar

sadece

yakm

medikal

g6zetim

altrnda

ve

uygun

hemodinamik izleme ile

uygulanmahdrr.

Doksazosin

(gilnde

4

ve

8

mg) ve

tadalafilin

(giinde

5

mg ve 20 mg

tek

doz)

eg zamanh

uygulamasr,

bu alfa-blokOriln

kan

basrncr

dtlgtlmre

etkisini

anlamh bigimde

arhnr.

Bu

etki,

en

az

12

saat

devam

eder

ve

senkop

datril

semptomatik

olabilir. Bu

nedenle,

bu

kombinasyon

onerilmemektedir

(bkz.

bolum

4.4).

Krsrth

sayrdaki

sa[hkh

g6ntlll0de

yaprlan

etkilegim

gahgmalannda,

bu

etkiler

alfuzosin

ve

tamsulosin

ile

bildirilmemigir.

Ancalq alfa-blok6rlerle tedavi edilen

hastalarda

ve

Ozellikle

yaghlarda

tadalafil

kullamlrken dikkatli

olunmahdrr.

Tedaviler

en

dtlgiik

doz

ile

baglatlmalt

ve kademeli olarak

ayarlanmahdr.

Klinik

farmakoloji

gahgmalannda,

tadalafilin,

antihipertansif

bilegiklerin

hipotansif

etkilerini

arttrma

potansiyeli

aragtrnlmrgtu.

Bu

araqtrmada

kalsiyum kanal

blok6rleri

(amlodipin),

anjiotensin

dOntgtiirticti

enzim

(ACE)

intribitOrleri

(enalapril),

beta-adrenerjik

reseptOr

blok6rleri

(metoprolol),

tiyazid

diiiretikleri

(bendrofluazid)

ve

anjiotensin

II

resept0r

blok6rleri

(de!i$k

tip

ve

dozlarda,

tek

bagrna

veya

tiyazidler,

kalsiyum kanal

blok6rleri,

beta-blokOrler

ve/veya

alfa-blok6rler

ile

birlikte)

datril

olmak

tizere

temel antihipertansif

bilegikler

iizerinde

gahgrlmrgtr.

Tadalafilin

(20

mg

dozun

uygulandr[r

anjiyotensin

II

blok6rler

ve amlodipin

ile

yaprlan

gahgmalar

haricinde 10

mg)

yukanda

belirtilen

kategorilerle

klinik

olarak

anlamlt

higbir

etkilegimi

olmamrgr.

Bir di[er klinik

farmakoloji

gahpmasrnda

tadalafil

Q0

mg),4

farkh

srmf

antihipertansif

ilag

ile

kombine edilerek

gahgrlmrgr.

Birden fazla

antihipertansif

almakta

olan

ayakta

tedavi

edilebilen

hasalarda

kan

basrncr

deligimleriniq kan

basrncr

kontrolii ile bir

dereceye

kadar

ballantrh

oldu[u

g6r0tnthtUr.

Bu

bakmdaq

kan

basrnglan

iyi

kontol

edilmig

olan

hastalardq

aztlniaen

az

seviyede

ve

salhkh

gOniilliilerde

g6rtllene

benzer

seviyede

olmugtur.

Kan

basrnglan

kontol

edilmemig

olan

gOniilliilerde,

her ne kadar

dtisu$,

g6nllllillerin

buyuk

gopunlugunda

hipotansif

semptomlar

ile

ballantrh

olmasa

da

daha

fazla

olmugtur.

Eg zamanh

olarak antihipertansif

ilaglan

almakta

olan hastalada tadalafil 20

mg,

kan

basrncrnda

bir

dihilstl

indiikleyebilmektedir

ki

(alfa-blok6rler

haricinde

-

yukandaki

bOliime bakrmz),

bu

da

genelde,

gok

dthtlk

seviyededir

ve

klinik

olarak

0nemsizdir.

Faz

3

klinik

gahgma

verilerinin

analizi,

tadalafili

antihipertansif

ilaglar

ile

ya

da

tek

bagrna alan

hastalardaki

advers

etkiler

arasrnda

higbir

fark

olmadr$m

g6stermi$ir.

Ancak

hastalara,

.

{C.*l

u

I

antihipertansif

ilaqlarla

birlikte

tedavi

edildikleri

ztrnndn,

kan

basrncrnda

olasr

bir

dUgtg

olabilecepine

dair

uygun

klinik

tavsrye

verilmelidir.

Bir

klinik

famrakoloji

gahgmasrnd4

l0

mg

tadalafil,

segici olmayan

bir

fosfodiesteraz

inhibitOrii

olan

teofilin

ile uygulandrgnda

higbir farmakokinetik etkilegim

olmamrgtu.

G6rillen

tek

farmakodinamik etki,

nabrzdaki

k0q$k

artr$tr

(3.5

bpm).

Her

ne kadar

bu

etki

kiigUk olsa

da ve

bu

gaftgmada

klinik

olarak

anlamhh[r

olmasa

da,

her

iki

ilag

birlikte

kullamlrrken

bu

durumun

dikkate

ahnmasr

gerekir.

Tadalafilin" etinilestradiyoltin

oral

biyoyararlammrnda

bir

artrga

sebep

oldu[u

g6sterilmigtir.

Bunun

klinik

sonucu

kesin

otnamakla

birlikte

benzer

bir

arhgrn"

terbutalinin

oral

uygulamasryla

da

g6rlilmesi

beklenebilir.

Alkol

konsanfasyonlan

(ortalama

maksimum

kan

konsantasyonu %0.08),

tadalafil

(10

mg

veya2}

zamanh uygulamadan

etkilenmemigtir.

Buna ilaveten,

alkol

zamanh

uygulamadan

saat sonra

tadalafil

konsantasyonlannda

higbir de$gim

gOrtilmemigtir.

Alkol,

alkol

absorpsiyonunu

maksimize

edecek

gekilde

verilmigir

(gece

alkol

almmdan

saat

sonrasma

kadar

yemek

yemeden).

Tadalafil

mg), alkolitn

sebep

olduSu

ortalarna

basurcrndaki

dtigiisii artrrmamrgtr

(0.1

yaklalk

alrh[rndaki

erkekte,

o/A}'hkalkol'den

[votka]

ml),

fakat

bazr

gOntilltilerde,

postllrel

d6nmesi

ve ortostatik

hipotansiyon

giizlenmigtir.

Tadalafil

datn

dfl$tlk

alkol

dozlan

(0.6

g,/kg)

uygulan&[r

z:rma\

hipotansiyon

g6zlenmemiStir

ddnmesi,

bagrna

alkol

ahmrndaki

benzer

srkhkta

meydana

gelmigtir.

Alkoliitr,

kognitif

fonksiyonlar

tizerindeki

etkisi

tadalafil

artnamrytu.

Tadalafilin,

CYP450

izoformlan

tarafindan

metabolize

edilen

fibbi llriinlerin

klerensini

klinik

olarak

belirgin

anlamda

inhibe

etnesi

veya

indtiklemesi

beklenmemektedir.

Qahgmalar

tadalafilin,

CYP3A4,

CYPIA2,

CYP2D6,

CYP2EI,

CYP2C9 ve

CYP2CI9

dahil olmak

iizere

CYP450

izoformlanm

inhibe

etnedi[ini

indtiklemediErni

do[rulamrghr.

Tadalafil

ve20

mg),

S-varfarin

yadaR-varfarin

(CYP2C9

substratr)

manrziyeti

(EAA)

tizerinde

klinik

olarak

anlamh

higbir etkiye

sahip

olmadr$

gibi

varfarin tarafindan

inditklenen

protombin

siiresinde

de$gime

agmamtgfir.

Tadalafil

mg ve20

mg),

asetil

salisilik

asitten

kaynaklanan

kanama zamamndaki

vzdrnaya

etki

etnemigtir.

Antidiyabetik

bilegiklerle spesifik

etkilegim

gahgmalan

ytirtitiilmemigtir.

Ozel

popiilasyonlara

iligkin

bilgiler:

Pediyatrik

popf,lasyon:

LIFTA

pediyatik

hastalann

kullammr

igin

endike

de[ildir.

altrndaki

hastalann

giivenliligi

etkilili[ine

dair

veri

oluqturulmamrgttr.

4.6.Gebelik

laktasyon

Gebelik kategorisi:

LIFTA

kadrnlann

kullammr igin

endike

de[ildir.

Qocuk

doluma

potansiyeli

bulunan

kedmler

Dolum

kontrolf,

(Kontrasepsiyon)

Gebelik

$ophesi

veya

gebelik

oldugunda

hekim

bilgilendirilmelidir.

Gebelik

dUnemi

Tadalafilin

gebe

kadrnlar tizerinde

kullammrna

iligkin

krsrth

veri

mevcuttur.

Hayvanlar

tlzerinde

yaprlan

gahgmalar

gebelik,

embriyonaUfetal

geligfurS

doStrm

veya do$um

sonrasl

geligim

ltzerindeki

direkt

veya endirekt

z*r:wb

etkileri

gOstermemektedir

(bkz.

b6lttm

5.3).

Tedbir

amagh

olarak

gebelik

stiresince

LIFTA'nrn

kullammrndan

kagrmlmasr

0nerilir.

Laktasyon

ddnemi

Tadalafilin anne

siitiine

gegip

gegmedigi

bilinmemektedir.

Hayvanlara

iligkin

mevcut

farmakodinamil/toksikolojik

veriler tadalafilin

siite

gegti[ini

g6stermektedir.

Qocu[a

anne

siit0yle

gegme

riski

Onlenemez.Emnrme

ddnemi boyunca

LIFTA

kullamlmamahdr.

Oreme

yetene[i/Fertilite

Erkek

digi

srganlarda

yaprlan

gahgmalarda

fertilite

tizerinde

herhangi

bozukluk

g6zlenmemigtir.

Gtinde

25 mgkg

datra

fazlatadalafil

dozunun 6-12 ay

boyunca

verildi$i

kOpeklerde

($inlilk

dozla elde

edilen

insan

EAA'rurun

katl

13.7

18.6

katll

manrziyet

ile)

spermatogenezde

azalmayla sonuglanan

seminifer

ttibtil

epitelinde

de$igiklikler

olmugttr

Okz.

b6liim

5.3).

GUnlUk

olarak

uygulanan

20 mg

tadalafil

dozunun

insanlarda

spermatogenez

tizerindeki

potansifl

etkisini

deperlendirmek amacryla

yiirlitlllen

gahgmalar

sonucunda

sperm

sayrsr

konsantasyonunda

klinik

olarak anlamh

du$th

bulunmam$tr

Okz.

bdliim

5.1).

4;7.

Arag

makine

kullanrmr fizerindeki

etkiler

Arag ve makine

kullammr iizerindeki etkiler

igin

gahqma

yaprlmamrghr.

ne kadar

klinik

gahgmalann

plasebo

tadalafil

kollanndaki

d6nmesi

vakalannrn

srkh[r

benzer

olsa

da, hastalar,

drag

da makine

kullanrmrndan

Once

LiFTA'ya

nasrl

tepki

verdiklerinin

farknda olmahdrlar.

4.8.

lstenmeyen

etkiler

a-Gflvenlik

profil6zeti

yaygrn

bildirilen

istenmeyen

etkiler

a[nsr,

dispepsi,

a[nsr

miyalji

olup

tadalafil

dozunun

artrnlmasryla

insidans

artar.

Bildirilen

istenmeyen

etkiler

gegici

genelde

hafif

orta

giddetli

olmugtur.

iizerindeki

hastalarda

istenmeyen

etki

verileri

srmrhdrr.

b- Advers reaksiyonlenn

listelenmig 6zeti

Agalrdq

erektil

disfonksiyonun

yaprlan

plasebo

kontoll0

klinik

gahgmalannda

iligki

Oncesi

kullamlan

LIFTA

veya

gtinltik

tedavi edilen

hastalarda

raporlanan

istenmeyen

etkiler

listelenmektedir.

AgaSrdaki

veriler aym

zamanda,

LIFTA

kullanan

hastalarda

pazarlama

sonrasrnda

raporlanan

istenmeyen

etkileri

kapsamaldadtr.

Aga$da

listelenen

istenmeyen

etkiler,

MedDRA

sistem-organ

srmfina

g6.re

ve mutlak

srkhk

olarak

verilmigtir.

yaygrn

E1/10);

yaygm

(>l/100

<l/10);

yaygm

olmayan

(21/1.000

<1/100);

seyrek

(>l/10.000

<l/1.000);

seyrek

(<l/10.000),

bilinmiyor

(eldeki

verilerden hareketle

tahmin edilemiyor).

Baggrkhk

sistemi

bozukluklan

Yaygrn

olmayan

Agrn duyarhhk

reaksiyonlan

Sinir

sistemi

bozukluklan

yaygrn

a[nst

Yaygn

olmayan

dAnmesi

Seyrit

inmel

(hemorajik

olaylan

igeren),

senkop,

gegici

iskemik

ataklarr,

migren3

n6betler,

gegici

amnezi

hastahklan

Yaygrn

olmayan

Bulamk

gdrme,

g6zAe

hissi

Seyrek

G6rme

alam

bozuklupu,

kapaklannda

gigme,

konjuktival

hiperemi

non-arteritik

anterior

iskemik

optik

n0ropati

(NAION)',

retinal

vaskiiler

okltizyon3

Kulakve

kulak

hastahklan

Seyrek

i$nne

kaybf

Kardiyak

hastahkla/

Yaygn

olmayan

Tagikardi,

palpitasyonlar

Seyret

MiyomrA

infa*miU,

olmayan

angina

pektoris3,

ventiktiler

adhi3

Vaskfiler

hastahklar

Yaygrn

Ytizkzankl{t

Yaygrn

olmayan: Hipotansiyon

(antihipertansif

bilegikler

almalda

olan

hastalara

tadalafil

verildi[inde

datra

yaygrn

bildirilmigtir),

hipertansiyon

Solunum,

g6E[s

mediastinal

hastahklar

Yaygrn

Nazal

konjesyon

Yaygrn

olmayan:

Dispne

Seyrek

Epistaksis

Gastrointestinal

hastahklar

Yaygrn

Dispepsi

Yaygn

olmayan

Abdominal

a!n,

gasto-Ozofageal

reflii

Deri

deri

altr doku

hastahklan

Yaygrn olmayan

Ddkiintii,

hiperhidroz

(terleme)

Seyret<

Urtiker,

Stevens-Johnson

sendromu3,

eksfolyatif

dermatif

Kas-iskelet

bozukluklan

doku

kemik hastahklan

Yaygn'

a$nsr,

miyalji,

ekstemitelerde

olaylann

rapor

edildigi

hastalann

gotunluf,u

daha Onceden

mevcut

kardiyovask0ler risk

faktOrlerine sahiptir.

(bkz.

bolum 4.a).

lgitmede

ani azalma veya

kayp,

tadalafil dahil olmak

0zere

tllm

PDE5

inhibit0rlerinin kullamldr$

pazarlama

sonrasl

klinik

aragurmalann

aanda

bildirilmigtir.

Pazarlama sonralu

g0zlemdg

plasebo-kontollll

gahgmalarda gOrlllmeyen

bazt advers

olaylar

raporlanmrytlr

Oreme

sistemive

meme

bozukluklan

Seyek

Uzamrg

ereksiyon,

priapiznr

Genel

bozukluklar

uygulama

b6lgesine

ititkin

hastahklar

Yaygrn

olmayan

G6$tls a$nsrr

Seyrlk

Yuzde

0dem3,

kardiyak

olumr'3

Segili advers

reaksiyonlann

agrklamasr

Plasebo

kryaslandrErndq

giinde

tadalafil

tedavi edilen

hastalarda

anormallikleri,

Oncelikle sinlis bradikardisi

bildiriLne srkhlr

biraz

datra

ytiksek

olmugtur.

EKG anormalliklerinin

go[unlupu

istenmeyen

etkiler

iligkili

de[ildir.

$Opheli

advers

reaksivonlann

raporlanmasr

Rtrhsaflandrrma

sonrasl

giipheli

ilag

advers

reaksiyonlann

raporlanmasr

b0y0k

6nem

ta$maktadr.

Raporlama

yaprlmasr,

ilacrn

yarar/risk

dengesinin

stlrekli

olarak

izlennresine

olanak

sallar.

SaSlft

mesle[i

mensuplanrun herhangi

gtipheli

advers

reaksiyonu

Tiirkiye

Farmakovijilans

Merkezi

(TUFAM)'ne

bildirmeleri

gerekmektedir

(u/$Ary.titck.gov.t;

posta:tufam@titck.gov.tr;

tel:0

800 314

00 08; faks:

0 312218

35 99)

4.9.Iloz

rgrmr

tedavisi

Salhkh

g6niilltllere

mg'a kadar

tek doz

ve hastalara

mg'a kadar

goklu

giinltik

dodar

verilmigtir.

Advers

olaylar,

dti$iik

dozlarda

gOriilenlerle

benzerdir.Doz

aqrmrndq

gerektili

gekilde

standart

destekleyici

Onlemler

ahnmahdr.

Hemodiyalizin

tadalafil

eliminasyonuna

katkrsr

ihmal

edilebilir

diDeydedir.

X'ARMAKOLOJiK

oZnlliXr,rn

5.1.

Farmakodinamik

6zellikler

Farmakoterap0tik

grup:

Erektil

disfonksiyonda

kullamlan ilaglar.

kodu

G04BE08

Etki

mekaniznasr

Tadalafil,

siklik

guanozin

monofosfat

(cGMP)'a

spesifik

fosfodiesteraz

(PDE5)'in

segici

geri-d6niigiimlii

inhibitOrudiir.

Cinsel

uyan,

lokal

nitik

oksit

sahmrna sebep

olduEunda,

tadalafilin PDE5

inhibisyonu,

korpus kavernozumda

cGMP

seviyelerinde

artrga

neden

oltn.

kaslann

gevgemesi

penil

dokuya

dolmasr, dolayrsryla

ereksiyon

sonuglarur.

Cinsel

uyan olmadr[r

zaman

tadalafilin

higbir

etkisi

yoktur.

Farmakodinamik

dzellikler

In-vitro

gahgmalar,

tadalafilin, PDE5'in segici

inhibitOrii

olduSunu

g6stermigtir.

PDE5,

korpus kavernozum

dilz

kasrnda, damarlara

organlara

dtlz

kaslarda,

gizgili

kaslarda,

tombositlerde,

b6breklerde, akci$erde

ve beyincikte

bulunan

enzimdir.

Tadalafil,

PDE5

tizerinde

diler

fosfodiesterazlara

g6re

datra

etkilidir.

Tadalafilin PDE5 iizerine etkisi,

kalp,

beyirt

damarlan,

karaci[er

ve difer

organlarda

bulunan

PDEI,

PDE2

PDBI

erzimlerine

kryasla

10,000 kattan

daha

fazladr.

Tadalafilin

PDE5 lDerine

etkisi,

kalp ve kan

damarlannda

buluran

enzim

olan

PDE3'ten

10,000

kattan

datra

fazladrr. PDE3'e

kryaslq

PDES'in

segicilili

Onemlidir

gtinkti

PDE3,

kardiyak konfraktilite

ilgili

enzimdir.

Buna

ilave

olarak

tadalafilin

PDE5

iizerine etkisi,

retinada

bulunan

fototransdtiksiyondan sorumlu

olan

enzim olan

PDE6'dan

yaklagrk

datra

fazladrr.

Tadalafil

zamand4

PDE5

tizerine

PDET'den PDE10'a kadar olan enzimlerden

yaklaSrk

10,000

kattan

d*afazlaetkilidir.

Klinik

etkililik

giivenlilik

1054

hastayla

yaprlan

iligki

Oncesi

kullamlan

tadalafile

yamt

periyodunun

aragtml&[t

klinik

gahgmamn

sonuglanna

gOre;

tadalafilin

baganh

cinsel

iligki ve

ereksiyon

saSlayrcr

etkisi,

plaseboya

gOre

anlamh

olaralq doz ahmrndan

sonra

erken

dakika

iginde

baglamg

saat

boyunca devam

etnigtir.

Plasebo

alan

gOntilltilerle

kryaslandr$nda tadatafil

uygulanan

sa[hkh

g6niilltllerin

srrt

iistii

yatar

pozisyonda

Olgiilen

sistolik

diyastolik

kan basrnglannda

(ortalama

maksimum

azalma

srasryla

1.6/0.8

ayakta

dlgtilen

sistolik

diyastolik

basrnglannda

(ortalama

maksimum

azalma

srrasryla

0.214.6

belirgin

fark

olmazken,

nahzAa da

anlamh

de[igim

olmamrgtr.

Tadalafilin

g6rme

iizerindeki etkilerinin

incelendi[i

gahgmada,

Famsworth-Munsell

100-

testi

kullamlarak

renk

aynmrnda

(mavi/yegil)

bozukluk

olmadrfr

saptanmrgtr.

bulgu,

tadalafilin

PDES'e kryasla

PDE6'ya afinitesinin

dii$tik

olmasr

uyumludur.

klinik

gahsmalarda,

renk

g6rme

defigiklikleri

ilgili

raporlar

seyrektir

(<

%0.1).

Giinltlk

olarak uygulanan

tadalafil

ayhk

gahgma)

mg'rn

ayhk

ayhk

ohnak ilzere

gahgma)

spermatogenez

tizerindeki

potansiyel

etkisini

de[erlendirmek

amacryl4

erkekler iizerinde

iig ayn

gahgma

yUrlltlllmU$tiir.

gahgmalann

ikisinde, tadalafil

tedavisi

iligkili

olarak

sperm

sayrsr

konsantasyonunda

klinik

olarak

anlamh olmayan

dilgtigler

g6zlenmigtir.

etkiler, motilite,

morfoloji

folik0l

stimtile edici

hormonlar

gibi

diger

parametelerdeki

de[igimler

iligkili

defildir.

Gilnde

kez ahnan

2.5,5

dozlardaki tadalafil,

farkh

yaglardaki

(yal

aralr[t:21-82)

etnik

kOkenden

gelen

farkh

ciddiyette

Oafif,

orta

giddetli)

etiyolojide erektil

disfonksiyona

sahip 853

hastailn katrldr[r

klinik

gaftgmada

degerlendirilmigtir.

Genel

poptlasyonda

gergeklegtirilmig

olan

primer

etkililik

gahgmasrnda,

hasta

bagrna

baganlt

cinsel birlegme

girigimi

ortalamasr

57 iken,

plaseboda

31'dir

ve bu

oran

plaseboda

Yo37'ye

kryasla

LIFTA 5

mg'da

LIFTA

mg'da

%50 olmuqhr.

Diyabete

sekonder

erektil

disfonksiyon

hastalannrn

oldugu

gahgmad4

hasta

igin

baganh

cinsel

birlegme

gtri$mi

ortalamasr

plaseboda

o/o28'e

kryasla

LiFTA

mg ve 2.5 mg'da

srasryla

o/o4l

7o46

olmugtur.

gahgmada

hastalann

go[unlugu,

datra

Onceden

iligki

iincesi

kullanlan

PDE5

inhibitorleri

tedaviye

cevap

vermiglerdir.

Daha 6nce

PDE5 inhibitOrii

kullannams

hastahk datra

sonraki

gahgmada

hastalar

giinde

tek doz

LiFTA

plaseboya

randomize

edilmigtir.

Hasta

ba$rna

baqanh

cinsel

grri$m

ortalamasr

plaseboda

LIFTA

Smg'da

%68 olarak bulunmuqtur.

Spinal

kord

hasanna sekonder

erektil disfonksiyonlu

186 hasta

(142

tadalafil,

plasebo)

yaprlan

haftalft

gahgmada

hasta

bagrna

baganh

cinsel

birlegme

guigimi

ortalamast

plaseboda

o/ol7

ikery

tadatafil

veya2O

tedavi edilen

hastalarda

tadalafil

erektil

fonksiyonu

7o48

oramnda anlamh

derecede

iyilegtirmigtir

(iligki

Oncesi

esnek

doz).

5.2.

Farmakokinetik dzellikler

Genel6zellikler

Emilim:

Tadalafil,

oral

uygulamadan sonra

hrzla

emilir ve

g6zlenen

maksimum ortalama

plazrna

konsantrasyonuna

(C**r)

ilag

ahndrktan ortalama

saat

sonra

ulagrln.

Oral

ilag almt

sonrasmda

tadalafilin mutlak biyoyararlammr

tespit

edilmemigtir.

Tadalafilin emilim

hrzve

miktan,

yiyeceklerden

etkilenmez; dolayrsryla

tifte

karnna

ahnabilir.

ilag

zarnanuun

(sabatr

daakprn)

emilim

hraya

miktan

iizerinde

klinik

olarak anlamh

etkisi

yoktur.

DaErhm:

Ortalama

daErhm

hacmi

tadalafilin

dokulara

daprldrfrm

g0sterecek

gekilde yaklagrk

litredir.

Terapotik

konsantasyonlardq

plazmadaki

tadalafilin

yo94'U,

proteinlere

ba[hdr.

Protein

ba[lamasr,

bobrek

fonksiyonu

bozuklu[undan

etkilenmemektedir.

Sa[hkh

g6niilltllerin

semeninde

uygulanan

dozun % 0.0005'inden azt

gOriinmiigttir.

Biyotransformasyon

Tadalafil

esas

olarak, sitokrom

P450

(CYP)

izoformu

tarafindan

metabolize edilir.

Dolaqrma

katrlan

temel

metaboliti

metilkatekol

glulconittir.

metabolit, PDE5 iizerinde

tadalafilden

13,000

daln

etkilidir.

Dolayrsrylq

tespit

edilen

metabolit

konsantrasyonlannda

klinik

olarak

aktif

olmasr beklenmez.

Eliminasyon:

Sa$rkh

gtiniilltilerde

tadalafil igin

ortalama

oral

klerens 2.5

L/sa ve

ortalama

Omtir

17.5

saattir.

Tadalafil

esas

olarak

inaktif

metabolitler

halinde,

biiylik dlgtde

fegesle

(dozun

yaklayk

6l'i)

daha

oranda

idrarla

(dozun

yaklagrk

36'sr)

atrlmaktadr.

DoIrusalhl/doFusal

olmayan dunrm:

Sa[lrklr

gOniiltiilerde

tadalafil farmakokineti[i,

zaman

yOniinden

lineerdir. 2.5

ila20

mg doz

arah[rnda

maruziyet

(EAA),

oranfisal olarak

artnalctadn. Giinde

uygulamasrndan

sonraki

giin

iginde kararh dtrrum

plazma

konsantrasyonlanna

ulagiltr.

Erektil

disfonksiyonu

olan

hastalarda,

poptilasyon

yaklagrmr

belirlenen

farmakokinetik,

erektil disfonksiyonu

olmayan

gOntilltllerdeki

farmakokinetik

benzerdir.

Hastalardaki

karakteristik

dzellikler

Ya$hlar:

Sa[hkh

yagh

goniilltilerde (65

ve iizeri)

tadalafilin oral

klerensi,

19-45

arasrndaki

sa[lrklr

g0ntilltilere

g6re

datra

d0;tik

olmug ve bu,

tadalafil

maruziyetinde

(EAA)

o/o2l'l*bir

arhgla

sonuglanmrgtr.

Yaga

ba$r

olarak ortaya

grkan

bu etki,

klinik

olarak anlamh

de[ildir

herhangi

doz ayarlamasr

gerektirmemektedir.

B6brek

yetrrediEi:

Tek-doz tadalafil

(5-20

kullamlarak

gergeklegtirilen

klinik

farmakoloji

galrymalannda,

hafif

(kreatinin

klerensi

mVdak)

veya orta ciddiyette

(kreatinin

klerensi

mydak)

bdbrek

boztrklu[u

bulunan

g0niilltllerde

son-agama bObrek

hastah$

olan

diyalize

giren

gdntllliilerde

tadalafil

manrziyeti

(EAA), yaklayk

kaUna

grkmrgtr.

Hemodiyaliz

hastalannda

C.rro

deperleri,

sa[lrkh

g6nUlltllerinkinden

o/Al

daha

fazla

olmugtur.

Hemodiyalizin tadalafil

eliminasyonuna

katkrsr

ihmal

edilebilir

dilzeydedir.

IGraciEer

yetnezliEi:

Hafif

ve orta

derecede

karaci[er bozuklu[u

olan

hastalarda

(Child-Pugh

Srmf

tadalafil

manrziyeti

(EAA),

sa$rkh

g6nillltilere

mg'hk

uygulandrEmdaki

benzerdir.

$iddetli

karaci[er

yetnezli[i

bulunan hastalarda

(Child-Pugh

Srmf C),

LIFTA'rn

giivenlili$

ilgili

krsrth

klinik

veri

mevcuttur.

Karaci[er

boztrkluSu

olan

hastalara

giinde

tadalafil

uygulamasr

ilgili

mevcut

veri

bulunmamaktadrr.

E[er LIFTA,

gilnde

doz ahnmak

lizere

regete edilmigse,

hastaya

ilacr

regete

eden

hekim

tarafindan

detayh

yarar/risk

de[erlendirmesi

yaprlmahdrr.

Diyabetli

hastalar:

Diyabetli

hasalarda

tadalafil

manrziyeti

(EAA),

sa$rkh

gOn0lltllerin

deEerlerinden

yaklaqrk

o/ol9

dabadiigtiktiir.

fark" doz

ayarlamasr

yaprlmasuu gerektirmemektedir.

5.3.

Klinik

dncesi

gflvenlilik

verileri

Klinik

olmayan

veriler,

gflvenlilik

farmakolojisi,

tekrarlanan

doz toksisitesi,

genotoksisite,

karsinojenik

potansiyel

tireme

toksisitesi

gahgmalanna

dayah

olarak

insanlara

y6nelik

6zel

tehlike

ortaya

koymamaktadr.

Gilnde

1000

mg/kg'

kadar

olan tadalafil

dozlannda

ilaq

uygulanmr$

olan

srgan

farelerde,

teratojenisite, embriyotoksisite

veya

fdtotoksisiteye

dair

higbir

kant

bulunmamaktadr.

Srganlar

iizerinde

yaprlmrg

olan

prenatal

postnatal

geligirme

gahgmasrnda,

higbir etkinin

gOzlenmedi[i

gtinde

mg/kg

olmugtur.

Gebe

srganda,

dozdaki

hesaplanmrg serbest

ilaq igin

EAA,

insanlar

igin 20

dozunda

g6riilen

EAA'run

yaklalk

katr

kadardr.

Erkek

digi

srganlarda

higbir

fertilite

bozuklupu

gOrtllmemigtir.

6-12 ay

boyrncq

giinde

2lmgkg

(tek

20 mg'hk

verilen

insanlardaki maruziyetin

enaz3

katr

fazla manrziyefle

[3.7-18.6

arahEr]

sonuglanacak

gekilde)

tlzeri

dozltda

tadalafil verilen

kOpeklerin

bazrlannda

spermatogenezAe

azalmayla

sonuglanan

seminifer

tiibill

epitelinde

regresyon

meydana

gelmiqtir

Okz.

b6liim

5.1).

X'ARMASottr

oZnLr,irO,rn

6.1.

Yardrmcr

maddelerin

listesi

Sodyln

lauril siilfat

Lal<toz

graniil

Hidroksipropil

seltiloz

(LHl

Ikoskarmeloz

sodyum

Mikrokristalin

seliiloz

(PHl

Magnezyum

stearat

Saf su

Aquarius

Prime

BAT314059

Yellow

Aquarius

Prime

BAT3I4059

Yellow

bilegimi

hidroksipropil metilselilloz,

titanyum

dioksit,

talh

demiroksit,

tiasetin.

Gegimsizlikler

Gegerli

de$[.

6.3.

6mr[

24 ay

6.4.

Saklamaya

y6nelik

6zel

tedbirler

Nemden

korumak

igin

orijinal

ambalajrnda saklanmahdrr.

25oC'nin

altrndaki

srcakh$nda

saklayrruz.

6.5.

Ambalajm

niteli$ve

igerifi

Karton

kutuda,

PVC/PVDC/AI

folyo

anrbalajlarda

film

tablet.

6.6.

Begeri

hbbi

firtnden

arta kelan maddelerin

imhasr

difer

6zel

6nlemler

Kullamlmamrg olan

tirlinler

yada

atrk

materyaller

"Trbbi

atrklann

kontoltl

yOnefrnelili"

"Ambalaj

Ambalaj

Atrklannrn

Kontrolii

Y6netnelikleri'ne uygun

olarak

imha

edilmelidir.

RT'HSAT

SAIfrBi

ibrahim llag

San.

Tic. A.$.

Reqitpaga

Matr.

Eski Biiyiikdere

Cad.

No:4

34467

Maslak

Sanyer

/ iSTANBUL

0212366

02122762020

RTIIISAT NT'MARASI

20141319

9.ILK

RT,HSAT

rlniNil

RUHSAT

YENILEME

I,lnINT

nrhsat

tarihi

17.04.2014

Ruhsat

yenileme

tarihi

KOB'ON

ynMr,nmlln

rARiril

13-12-2018

The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2017

The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2017

Published on: Wed, 12 Dec 2018 This report of the European Food Safety Authority and the European Centre for Disease Prevention and Control presents the results of zoonoses monitoring activities carried out in 2017 in 37 European countries (28 Member States (MS) and nine non-MS). Campylobacteriosis was the commonest reported zoonosis and its EU trend for confirmed human cases increasing since 2008 stabilised during 2013–2017. The decreasing EU trend for confirmed human salmonellosis cases since 2008 end...

Europe - EFSA - European Food Safety Authority Publications

11-12-2018

THAN YOU tablets

THAN YOU tablets

THAN YOU tablets pose a serious risk to your health and should not be taken.

Therapeutic Goods Administration - Australia

8-12-2018

Annual assessment of Echinococcus multilocularis surveillance reports submitted in 2018 in the context of Commission Regulation (EU) No 1152/2011

Annual assessment of Echinococcus multilocularis surveillance reports submitted in 2018 in the context of Commission Regulation (EU) No 1152/2011

Published on: Fri, 07 Dec 2018 This report is part of the `Echinococcus multilocularis surveillance’ scientific reports which are presented annually by EFSA to the European Commission and are intended to assess the sampling strategy, data collection and detection methods used by Finland, Ireland, Malta, the United Kingdom (UK) and Norway in their respective surveillance programmes. The surveillance programmes of these five countries were evaluated by checking the information submitted by each of them an...

Europe - EFSA - European Food Safety Authority Publications

4-12-2018

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

– Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths), 51 lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochloroth...

FDA - U.S. Food and Drug Administration

4-12-2018

FDA Approves Pexion for Treating Noise Aversion in Dogs

FDA Approves Pexion for Treating Noise Aversion in Dogs

The U.S. Food and Drug Administration announced today that its Center for Veterinary Medicine has approved Pexion (imepitoin tablets) to treat noise aversion in dogs. Dogs with noise aversion are sensitive to loud noises such as fireworks, street/traffic noises, and gun shots.

FDA - U.S. Food and Drug Administration

3-12-2018

November 28, 2018: Former Vice President of Insys Pharmaceuticals Pleads Guilty to Racketeering Scheme

November 28, 2018: Former Vice President of Insys Pharmaceuticals Pleads Guilty to Racketeering Scheme

November 28, 2018: Former Vice President of Insys Pharmaceuticals Pleads Guilty to Racketeering Scheme

FDA - U.S. Food and Drug Administration

30-11-2018

The European Union summary report on surveillance for the presence of transmissible spongiform encephalopathies (TSEs) in 2017

The European Union summary report on surveillance for the presence of transmissible spongiform encephalopathies (TSEs) in 2017

Published on: Thu, 29 Nov 2018 This report presents the results of surveillance on transmissible spongiform encephalopathies (TSEs) in bovine animals, sheep, goats, cervids and other animal species, as well as genotyping in sheep, carried out in 2017 in the European Union (EU) according to Regulation (EC) 999/2001, and in Iceland, Norway and Switzerland. In total, 1,312,714 cattle were tested by the 28 EU Member States (MSs) which is a decrease of 3% compared with 2016; 18,526 were tested by the three n...

Europe - EFSA - European Food Safety Authority Publications

29-11-2018

FDA approves first treatment for Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder

FDA approves first treatment for Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder

FDA approved Firdapse (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. LEMS is a rare autoimmune disorder. This is the first FDA approval of a treatment for LEMS.

FDA - U.S. Food and Drug Administration

28-11-2018

FDA approves treatment for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a certain genetic mutation

FDA approves treatment for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a certain genetic mutation

The FDA approved Xospata (gilteritinib) tablets for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

FDA - U.S. Food and Drug Administration

28-11-2018

Enforcement Report for the Week of November 28, 2018

Enforcement Report for the Week of November 28, 2018

Recently Updated Records for the Week of November 28, 2018 Last Modified Date: Tuesday, November 27, 2018

FDA - U.S. Food and Drug Administration

28-11-2018

Information Update - Mylan-Valsartan medications voluntarily recalled as a precaution due to an impurity

Information Update - Mylan-Valsartan medications voluntarily recalled as a precaution due to an impurity

Mylan Pharmaceuticals ULC is voluntarily recalling four lots of Mylan-Valsartan tablets (40 mg, 80 mg, 160 mg and 320 mg strength) after testing found low levels of an impurity, N-nitrosodiethylamine (NDEA).

Health Canada

27-11-2018

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets That Are Within Expiry

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets That Are Within Expiry

Teva Pharmaceuticals has initiated a voluntary recall in the United States, to the patient level, of all lots of Amlodipine / Valsartan combination tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination tablets (see table below) due to an impurity detected above specification limits in an active pharmaceutical ingredient (API) manufactured by Mylan India. The impurity found in Mylan’s valsartan API is known as N-nitroso-diethylamine (NDEA), which has been classified as a probable human carc...

FDA - U.S. Food and Drug Administration

23-11-2018

ACT-Candesartan 4mg tablets (2018-11-23)

ACT-Candesartan 4mg tablets (2018-11-23)

Health Canada

22-11-2018

Foreign Product Alert: Black Ant King tablets, Gold Viagra 9800mg capsules, LIPRO Dietary capsules, Stree Overlord Strong tablets (pills), Vegetal Vigra capsules, ViaGro 500mg Male Enhancement capsules

Foreign Product Alert: Black Ant King tablets, Gold Viagra 9800mg capsules, LIPRO Dietary capsules, Stree Overlord Strong tablets (pills), Vegetal Vigra capsules, ViaGro 500mg Male Enhancement capsules

These foreign health products have been found by regulators in other countries to contain undeclared drug ingredients.

Health Canada

21-11-2018

FDA approves new treatment for patients with acute myeloid leukemia

FDA approves new treatment for patients with acute myeloid leukemia

The FDA approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are 75 years of age or older or who have other chronic health conditions or diseases (comorbidities) that may preclude the use of intensive chemotherapy.

FDA - U.S. Food and Drug Administration

21-11-2018

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. ...

FDA - U.S. Food and Drug Administration

9-11-2018

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz Inc. Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. This impurity, which is a substance that occurs naturally in ...

FDA - U.S. Food and Drug Administration

7-11-2018

Several store-brand pain or sinus relief tablets recalled because consumers may be unable to access important safety information

Several store-brand pain or sinus relief tablets recalled because consumers may be unable to access important safety information

Vita Health Products is voluntarily recalling several store-brand (Care, Exact, Life, and Pharmasave) over-the-counter drugs used for pain or sinus relief because of a labelling issue. Consumers may be unable to peel open the wrap-around label on the bottle to access the warning statements, or the label may not peel off completely, which may make it difficult to read some of the important safety information.

Health Canada

3-11-2018

Janssen Issues Voluntary Nationwide Recall for one lot of ORTHO-NOVUM 1/35 and two lots of ORTHO-NOVUM 7/7/7 Due to Incorrect Veridate Dispenser Instructions

Janssen Issues Voluntary Nationwide Recall for one lot of ORTHO-NOVUM 1/35 and two lots of ORTHO-NOVUM 7/7/7 Due to Incorrect Veridate Dispenser Instructions

Janssen Pharmaceuticals, Inc. has initiated a voluntary recall of one lot of ORTHO-NOVUM 1/35 (norethindrone / ethinyl estradiol) Tablets and two lots of ORTHO-NOVUM 7/7/7 (norethindrone / ethinyl estradiol) Tablets to the pharmacy level. The patient information provided inside affected packages of ORTHO-NOVUM does not include the appropriate instructions for the Veridate dispenser.

FDA - U.S. Food and Drug Administration

31-10-2018

Outcome of a public consultation on the draft guidance on the scientific requirements for health claims related to muscle function and physical performance

Outcome of a public consultation on the draft guidance on the scientific requirements for health claims related to muscle function and physical performance

Published on: Tue, 30 Oct 2018 00:00:00 +0100 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 guidance on the scientific requirements for health claims related to muscle function and physical performance, prepared by the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), supported by the Working Group on Claims. The draft guidance was endorsed by the Panel for public consultation ...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP  75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP 75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level. These products are being recalled due to the presence of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Irbesartan, USP manufactured by Aurobindo Pharma Limited. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a...

FDA - U.S. Food and Drug Administration

29-10-2018

Big Penis U.S.A tablets

Big Penis U.S.A tablets

Big Penis U.S.A tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

25-10-2018

BLL Enterprises Inc. recalls Fluid Film Rust & Corrosion Protection Aerosol

BLL Enterprises Inc. recalls Fluid Film Rust & Corrosion Protection Aerosol

The recalled products do not have proper hazard labelling required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

8-10-2018

Glyceryl trinitrate tablets (Anginine and Lycinate)

Glyceryl trinitrate tablets (Anginine and Lycinate)

Update 3 - continuing medicine shortage

Therapeutic Goods Administration - Australia

5-10-2018

Consumer Alert: Sprout Creek Farm “Margie” Cheese Batch Recalled

Consumer Alert: Sprout Creek Farm “Margie” Cheese Batch Recalled

Today the New York State Department of Agriculture and Markets alerted consumers to a pasteurization problem with one of Sprout Creek Farm's pasteurized cow's milk cheeses, "Margie," made on 8/28/2018. Sprout Creek Farm is located in Poughkeepsie, NY. The reason for the recall is the air temperature at the start and end of the pasteurization process is required to be above 150deg F per the Grade "A" Pasteurized Milk Ordinance; the batch in question did not meet that standard. The recall pertains only to...

FDA - U.S. Food and Drug Administration

28-9-2018

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo International plc (NASDAQ: ENDP) today announced that one of its operating companies, Endo Pharmaceuticals Inc., is voluntarily recalling two lots of Robaxin® (methocarbamol tablets, USP) 750mg Tablets 100 Count Bottle pack to the consumer level. The products have been found to have incorrect daily dosing information on the label due to a labeling error which misstates the daily dose as "two to four tablets four times daily" rather than the correct dosage of "two tablets three times daily." (see pic...

FDA - U.S. Food and Drug Administration

11-9-2018

Marvelon 28 birth control pills: Packages do not contain day-of-the-week stickers

Marvelon 28 birth control pills: Packages do not contain day-of-the-week stickers

Health Canada is informing Canadians that packages of certain lots of Marvelon 28 do not include day-of-the-week stickers. The stickers are meant to be applied on the blister pack containing the pills. The stickers indicate the first day of the week when the medication is started, and the weekdays that the pills should be taken. The stickers may be used by women to help them remember if they took their daily pill on a given day. Without these stickers, there may be an increased chance of missing a dose.

Health Canada

11-9-2018

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Botanicals and preparations derived from these are among the substances frequently added to foods and food supplements, yet the safety of many botanicals has not been systematically assessed. In the context of the EU‐FORA fellowship programme, the fellow performed an assessment on the safety of the botanical Gymnema sylvestre, in accordance with EFSA's guidance on the assessment of safety of botanicals. Although preparations of G. sylvestre are marketed as f...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of white willow (Salix alba) in food

Risk assessment of white willow (Salix alba) in food

Published on: Tue, 28 Aug 2018 00:00:00 +0200 This Technical Report contains a description of the activities within the work programme of the EU‐FORA Fellowship on the risk assessment of white willow in food. The bark of different varieties of willow has had a long history of medical use as a means to reduce fever and as a painkiller. Willow bark is also used in weight loss and sports performance food supplements. The labelling of these products usually does not mention any restrictions to the length of...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Novel foods could represent a sustainable alternative to traditional farming and conventional foodstuffs. Starting in 2018, Regulation (EU) 2283/2015 entered into force, laying down provisions for the approval of novel foods in Europe, including insects. This Approved Regulation establishes the requirements that enable Food Business Operators to bring new foods into the EU market, while ensuring high levels of food safety for European consumers. The present ...

Europe - EFSA - European Food Safety Authority Publications

7-9-2018

FDA approves new dosage strength of buprenorphine and naloxone sublingual film as maintenance treatment for opioid dependence

FDA approves new dosage strength of buprenorphine and naloxone sublingual film as maintenance treatment for opioid dependence

FDA approved Cassipa (buprenorphine and naloxone) sublingual film (applied under the tongue) for the maintenance treatment of opioid dependence.

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

31-8-2018

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

FDA is warning the public about a voluntary recall of one lot of montelukast sodium tablets made by Camber Pharmaceuticals due to incorrect drug in bottles

FDA - U.S. Food and Drug Administration

30-8-2018

August 28, 2018: Providence Nurse Sentenced for Tampering with Oxycodone

August 28, 2018: Providence Nurse Sentenced for Tampering with Oxycodone

August 28, 2018: Providence Nurse Sentenced for Tampering with Oxycodone

FDA - U.S. Food and Drug Administration

29-8-2018

Review of the existing maximum residue levels for sintofen according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for sintofen according to Article 12 of Regulation (EC) No 396/2005

Published on: Tue, 28 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance sintofen. To assess the occurrence of sintofen residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member ...

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

29-8-2018

Update of the tolerable upper intake level for vitamin D for infants

Update of the tolerable upper intake level for vitamin D for infants

Published on: Tue, 07 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 the draft Scientific Opinion on the update of the tolerable upper intake level for vitamin D for infants. This draft Scientific Opinion was prepared by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) and endorsed by the Panel for public consultation by written procedure on 9 April 20...

Europe - EFSA - European Food Safety Authority Publications

13-12-2018

voriconazole

voriconazole

voriconazole (Active substance: voriconazole) - Centralised - Art 28 - (PSUR - Commission Decision (2018)8915 of Thu, 13 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/3127/201802

Europe -DG Health and Food Safety

11-12-2018

Webinar recording: Medicine shortages reporting reforms, 28 November 2018

Webinar recording: Medicine shortages reporting reforms, 28 November 2018

An overview of mandatory medicine shortages reporting obligations for sponsors to be implemented on 1 January 2019

Therapeutic Goods Administration - Australia

28-11-2018

Docetaxel Zentiva (Zentiva k.s.)

Docetaxel Zentiva (Zentiva k.s.)

Docetaxel Zentiva (Active substance: Docetaxel) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8039 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/808/T/56

Europe -DG Health and Food Safety

28-11-2018

Econor (Elanco GmbH)

Econor (Elanco GmbH)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8038 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/42/T/54

Europe -DG Health and Food Safety

28-11-2018

Zeffix (GlaxoSmithKline (Ireland) Limited)

Zeffix (GlaxoSmithKline (Ireland) Limited)

Zeffix (Active substance: Lamivudine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8044 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/242/T/73

Europe -DG Health and Food Safety

28-11-2018

Orkambi (Vertex Pharmaceuticals (Ireland) Limited)

Orkambi (Vertex Pharmaceuticals (Ireland) Limited)

Orkambi (Active substance: Lumacaftor/Ivacaftor) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8042 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3954/T/39

Europe -DG Health and Food Safety

28-11-2018

Leflunomide ratiopharm (ratiopharm GmbH)

Leflunomide ratiopharm (ratiopharm GmbH)

Leflunomide ratiopharm (Active substance: leflunomide) - Centralised - Yearly update - Commission Decision (2018)8045 of Wed, 28 Nov 2018

Europe -DG Health and Food Safety

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

Europe -DG Health and Food Safety

28-11-2018

Darunavir Krka d.d. (Krka d. d., Novo mesto)

Darunavir Krka d.d. (Krka d. d., Novo mesto)

Darunavir Krka d.d. (Active substance: darunavir) - Centralised - 2-Monthly update - Commission Decision (2018)8046 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4891/IB/2/G

Europe -DG Health and Food Safety

28-11-2018

GILENYA (Novartis Europharm Limited)

GILENYA (Novartis Europharm Limited)

GILENYA (Active substance: Fingolimod) - Centralised - Variation - Commission Decision (2018)7969 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2202/X/44

Europe -DG Health and Food Safety

28-11-2018

Anoro Ellipta (Glaxo Group Ltd)

Anoro Ellipta (Glaxo Group Ltd)

Anoro Ellipta (Active substance: umeclidinium bromide / vilanterol trifenatate) - Centralised - Yearly update - Commission Decision (2018)8049 of Wed, 28 Nov 2018

Europe -DG Health and Food Safety

28-11-2018

Kalydeco (Vertex Pharmaceuticals (Ireland) Limited)

Kalydeco (Vertex Pharmaceuticals (Ireland) Limited)

Kalydeco (Active substance: ivacaftor) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8047 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2494/T/71

Europe -DG Health and Food Safety

15-11-2018

alitretinoin

alitretinoin

alitretinoin (Active substance: alitretinoin) - Centralised - Art 28 - (PSUR - Commission Decision (2018)7675 of Thu, 15 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/90/201801

Europe -DG Health and Food Safety

11-9-2018

 Minutes of the CHMP meeting 25-28 June 2018

Minutes of the CHMP meeting 25-28 June 2018

Europe - EMA - European Medicines Agency

11-9-2018

Imnovid (Celgene Europe B.V.)

Imnovid (Celgene Europe B.V.)

Imnovid (Active substance: Pomalidomide) - Centralised - Variation - Decision addressed to Member States - Commission Decision (2018)5970 of Tue, 11 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2682/R/28

Europe -DG Health and Food Safety

31-8-2018

Consultation: Referral of proposed amendments to the current Poisons Standard to the ACMS, Joint ACCS-ACMS or ACCS meeting, November 2018

Consultation: Referral of proposed amendments to the current Poisons Standard to the ACMS, Joint ACCS-ACMS or ACCS meeting, November 2018

Invitation to comment on proposed Poisons Standard amendments. Closing date: 28 September 2018

Therapeutic Goods Administration - Australia

28-8-2018

Abilify (Otsuka Pharmaceutical Netherlands B.V.)

Abilify (Otsuka Pharmaceutical Netherlands B.V.)

Abilify (Active substance: aripiprazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5681 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/471/T/131

Europe -DG Health and Food Safety

28-8-2018

Kalydeco (Vertex Pharmaceuticals (Europe) Limited)

Kalydeco (Vertex Pharmaceuticals (Europe) Limited)

Kalydeco (Active substance: ivacaftor) - PASS - Modification - Commission Decision (2018)5693 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2494/RSR/S/14

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2062 (IQVIA RDS Ireland Limited)

EU/3/18/2062 (IQVIA RDS Ireland Limited)

EU/3/18/2062 (Active substance: Bertilimumab) - Orphan designation - Commission Decision (2018)5740 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/098/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2066 (Incyte Biosciences Distribution B.V.)

EU/3/18/2066 (Incyte Biosciences Distribution B.V.)

EU/3/18/2066 (Active substance: Pemigatinib) - Orphan designation - Commission Decision (2018)5736 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/038/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2065 (SFL Regulatory Services GmbH)

EU/3/18/2065 (SFL Regulatory Services GmbH)

EU/3/18/2065 (Active substance: Obiltoxaximab) - Orphan designation - Commission Decision (2018)5735 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/080/18

Europe -DG Health and Food Safety