NUTRAPLUS

Genel Bilgiler

  • Ticaret Unvanı:
  • NUTRAPLUS %10 60 GR KREM
  • INN (International Adı):
  • UREA
  • Reçete türü:
  • Normal
  • İçin kullanmak:
  • İnsanlar
  • İlaç türü:
  • allopatik ilaç

Belgeler

Yerelleştirme

  • Bulunduğu ülkeler::
  • NUTRAPLUS %10 60 GR KREM
    Türkiye
  • Dil:
  • Türkçe

Terapötik bilgiler

  • Terapötik alanı:
  • mevcut formları

Diğer bilgiler

Durum

  • Kaynak:
  • TİTCK - TÜRKİYE İLAÇ VE TIBBİ CİHAZ KURUMU - Türkiye
  • Yetkilendirme durumu:
  • Aktif
  • Yetkilendirme numarası:
  • 8699586352638
  • Yetkilendirme tarihi:
  • 05-04-2016
  • Son Güncelleme:
  • 24-05-2018

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

KULLANMA TALİMATI

NUTRAPLUSKREM%10

Ciltüzerine uygulanır.

Etkinmadde:Her1gramkrem100mgÜre(Karbamid)içerir.

Yardımcımaddeler:Gliserol monostearat,Oktil palmitat,Miristil laktat

Mineralyağ,PromulgenD(Stearilalkolve setearet-20içermektedir)

Propilen glikol, Propilparahidroksibenzoat(E216), Metilparahidroksibenzoat(E218)

Safsu

BuKULLANMATALİMATINIdikkatliceokuyunuz, çünküsiziniçinönemli

bilgileriçermektedir.

Bu ilaçsizin reçetesizolaraktemin edip birdoktoryardımıalmadan eczacınızın

tavsiyesiilehafifbirhastalığıtedavietmenizicindir. Buna karşın, yinede

NURTAPLUS’dan en iyisonuçlarıalabilmenizicin dikkatlikullanmanız

gerekmektedir.

Bu kullanma talimatınısaklayınız. Daha sonra tekrarokumaya ihtiyaç

duyabilirsiniz.

Eğerilavesorularınızolursa, lütfen doktorunuza veyaeczacınıza danışınız.

Bu ilaçkişiselolaraksizin için reçeteedilmistir, başkalarına vermeyiniz.

Bu ilacınkullanımısırasında, doktora veya hastaneyegittiğinizde

doktorunuza bu ilacıkullandığınızısöyleyiniz.

Bu talimatta yazılanlaraaynen uyunuz. İlaçhakkında sizeönerilen dozun

dışındayüksek veya düşükdozkullanmayınız.

BuKullanma Talimatında:

1.NUTRAPLUSnedirveneiçin kullanılır?

2.NUTRAPLUS ’ıkullanmadanöncedikkatedilmesigerekenler

3.NUTRAPLUS nasılkullanılır?

4. Olasıyanetkilernelerdir?

5.NUTRAPLUS ’ınsaklanması

Başlıklarıyeralmaktadır.

1

1.NUTRAPLUSnedirveneiçin kullanılır?

NUTRAPLUS, deriüzerinesürülerek kullanılan birüründür.

YumuşatıcılarveKoruyucularolarakadlandırılanbirilaçgrubunadahildir.

Etkin maddeolarak1 gramında100mg üreihtivaeder.

NUTRAPLUS,kutuda, ağzıplastikburgulukapaklakapatılmış,60g

kremlaminetüpte kullanımasunulmaktadır.

NUTRAPLUS;iktiyozis (balıkpulugörünümündekikurucilthastalığı),

kseroderma/kserozis(kurucilt),atopikegzama,asteotikegzamagibi

kronikleşmişkuruciltdurumlarınıneşlikettiğiderihastalıklarınıntedavisinde

kullanılır.

NUTRAPLUS; aynızamanda,topikalkortikosteroidtedavisinde,aralıklı

tedaviyöntemindekortikosteroitlerle birliktekullanılır.

Derininenüst tabakasındaki(stratumkorneum)suyunazalmasısonucundaderi

kurur.Butabaka kuruduğunda,pullanma,çatlamavekaşıntıgörülebilir.

NUTRAPLUS ’ıniçerdiği“Üre”stratumkorneum’dadoğalolarakbulunan

birmaddedir.Cildinnemlenmesini sağlar.Su,stratumkorneum’daincebir

tabakahalinde,cildin doğalyağıolansebumiledetutulmaktadır.Böylece;

ciltyüzeyindensuyun buharlaşmasıyavaşlatılarakiritasyonazaltılır,cildin

elastikiyeti sağlanırvegörünümüiyileştirilir.

2.NUTRAPLUS ’ıkullanmadanöncedikkatedilmesigerekenler

NUTRAPLUS’ ıaşağıdakidurumlardaKULLANMAYINIZ

Eğer:

Üre’yeveyaNUTRAPLUS’ ınherhangibirbileşeninealerjinizveyaaşırı

duyarlılığınızvarise,

Yarave açıkyaravarisekullanmayınız.

Ciltiritasyonu açısındansistematikolarakaraştırılmadığıiçin,sütçocuklarında

kullanılmamalıdır.

2

NUTRAPLUS’ ıaşağıdakidurumlardaDİKKATLİKULLANINIZ

Eğer:

Deriüzerinebaşkabirilaçkullanıyorsanız,

Hamileysenizveyaemziriyorsanız

NUTRAPLUScildinizdetahrişyaparsaveyadurumunuzdaiyileşmeolmazsadoktorunuzla

konuşunuz.

Bu uyarılargeçmiştekiherhangibirdönemdedahiolsasiziniçingeçerliyselütfen

doktorunuza danışınız.

NUTRAPLUS’ ınyiyecekveiçecekilekullanılması:

NUTRAPLUS’ ınuygulamayöntemiaçısındanyiyecekveiçeceklerleetkileşimiyoktur.

Hamilelik

İlacıkullanmadanöncedoktorunuzaveyaeczacınıza danışınız.

Üre’ninhamilelerde kullanımınınceninezararlıolup olmadığıbilinmemektedir.

NUTRAPLUS kullanımınınhastayasağlayacağıyarar-zarardengesigöz

önündebulundurularakzorunluhaller dışındakullanılmamalıdır.

Tedaviniz sırasındahamileolduğunuzufarkedersenizhemendoktorunuzaveya

eczacınızadanışınız.

Emzirme

İlacıkullanmadanöncedoktorunuzaveyaeczacınıza danışınız.

Üre’nininsansütüyle atılıpatılmadığıbilinmemektedir.

Üre’ninsüt ile atılımıhayvanlarüzerindearaştırılmamıştır.

NUTRAPLUStedavisinindurdurulup,durdurulmayacağınailişkinkarar

verilirken fayda/zararoranıdikkatealınmalıdır.

Araçvemakinekullanımı

Cilt üzerinetopikal olarak uygulananNUTRAPLUSileilgiliolarakbukonudayapılmışbirçalışma

mevcutdeğildir.

3

NUTRAPLUS ’ıniçeriğindebulunanbazıyardımcımaddelerhakkında

önemlibilgiler

NUTRAPLUS ’ıniçeriğindebulunan,

Metilparahidroksibenzoat(E216 vePropilparahidroksibenzoat(E216) alerjik reaksiyonlara

sebebiyetverebilir.

Propilenglikol ciltteirritasyonasebepolabilir.

Stearilalkollokalderireaksiyonlarına(kontak dermatitgibi)sebebiyetverebilir.

Diğerilaçlarilebirliktekullanımı

NUTRAPLUS’ ınherhangibirilaçlaetkileşimdebulunduğunadairbirkanıtyoktur.

NUTRAPLUSderiüzerineuygulanan diğerilaçlarınderidengeçişiniarttırabilir.

Eğerreçeteliyadareçetesizherhangibirilacışuandakullanıyorsanızveyason

zamanlarda kullandınıziselütfendoktorunuzaveyaeczacınızabunlarhakkındabilgi

veriniz.

3. NUTRAPLUS nasılkullanılır?

Uygun kullanımvedoz/uygulamasıklığıiçintalimatlar:

Doktorunuzca başkatürlüönerilmediğitakdirdegünde1-2kezhastalıklıbölgeüzerine

sürülmek suretiylekullanılır.

Uygulamayoluvemetodu:

Deriüzerinesürülerek uygulanır.

Değişikyaşgrupları:

Çocuklardakullanımı:

Çocuklarda kullanımıincelenmemiştir.Sütçocuklarındakullanılmamalıdır.

Yaşlılardakullanımı:

NUTRAPLUS’in yaşlılardakullanımıincelenmemiştir.

Özelkullanımdurumları:

Özel kullanımıyoktur.

EğerNUTRAPLUS’ınetkisininçokgüçlüyadaçokzayıfolduğunadairbir

izleniminizvar isedoktorunuzlaya da eczacınızlakonuşunuz.

4

KullanmanızgerekendendahafazlaNUTRAPLUSkullandıysanız:

TopikalolarakfazlamiktardaNUTRAPLUS uygulamasıderidetahrişyapabilir,

fakatbunun dışındariskteşkiletmez.KazaileNUTRAPLUS’ınfazlamiktarda

yutulursa,midebarsak tahrişi(midebulantısıvekusma)beklenebilir.Belirtilereyönelik

vedestekleyicitedaviyapılmalıdır.AğızdanBüyükmiktardasütveyasualımıyardımcı

olabilir.

EğerNUTRAPLUS’ıkullanmayıunutursanız:

Unutulan dozlarıdengelemekiçinçiftdozuygulamayınız.

NUTRAPLUSiletedavi sonlandırıldığındakioluşabileceketkiler:

Bulunmamaktadır.

4- Olasıyanetkiler nelerdir?

Tümilaçlargibi,NUTRAPLUS’ ıniçeriğindebulunanmaddelereduyarlıolan

kişilerdeyanetkilerolabilir.

Aşağıdakilerdenherhangibirinifark ederseniz, doktorunuzasöyleyiniz:

Kaşıntı

Kızarıklık

Pullanma

Tahriş

Yanma

Ödem

BunlarNUTRAPLUS ’ın hafifyanetkileridirveçok seyrekgörülür.Buyan etkilerhassas, sulantılı

veyaçatlaklarolanderiye uygulandığındaoluşabilir.Tedaviyihemen kesipdoktorunuzadanışınız.

5

Yanetkileri nraporlanması

KullanmaT alimatındayeralanveyaalmayan herhangibiryan etkimeydanagelmesidurumunda

hekiminiz,eczacınızveyahemşirenizilekonuşunuz.Ayrıcakarşılaştığınızyanetkileri

www.titck.gov.tr sitesindeyeralan “İlaçEtkiBildirimi”ikonunu tıklayarakyada

08003140008numaralıyanetkibildirimhattınıarayarakTürkiyeFarmakovijilansMerkezi

(TÜFAM)‘ne bildiriniz.Meydanagelenyanetkileribildirerekkullanmaktaolduğunuzilacın

güvenliğihakkındadahafazlabilgiedinilmesinekatkısağlamışolacaksınız.

Eğerbukullanmatalimatındabahsigeçmeyenherhangibiryanetkiilekarşılaşırsanız

doktorunuzuveya eczacınızıbilgilendiriniz.

5-NUTRAPLUS’ ınsaklanması

NUTRAPLUS ’ıçocukların göremeyeceği,erişemeyeceğiyerlerde ve

ambalajındasaklayınız.

°C’nin altındakiodasıcaklığındasaklayınız.

Sonkullanmatarihiyleuyumluolarak kullanınız.

AmbalajındakisonkullanmatarihindensonraNUTRAPLUS’ıkullanmayınız.

RuhsatSahibi: AshfieldSağlıkHizmetleriTic.Ltd.Şti

BüyükdereCad. YapıKrediPlazaB Blok

Kat12/D-29 Leventİstanbul

Üretici : LaboratoiresGaldermaZoneIndustrielle

Montdesir74540 Alby-Sur-CheranFransa

Bukullanmatalimatı……/……/……tarihindeonaylanmıştır.

6

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Europe -DG Health and Food Safety

26-11-2018

Levetiracetam Hospira (Pfizer Europe MA EEIG)

Levetiracetam Hospira (Pfizer Europe MA EEIG)

Levetiracetam Hospira (Active substance: levetiracetam) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7985 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2783/T/19

Europe -DG Health and Food Safety

26-11-2018

Alunbrig (Takeda Pharma A/S)

Alunbrig (Takeda Pharma A/S)

Alunbrig (Active substance: brigatinib) - Centralised - Authorisation - Commission Decision (2018)7976 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4248/

Europe -DG Health and Food Safety

26-11-2018

Ranexa (Menarini International Operations Luxembourg S.A.)

Ranexa (Menarini International Operations Luxembourg S.A.)

Ranexa (Active substance: ranolazine) - PSUSA - Modification - Commission Decision (2018)7980 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/805/PSUSA/2611/201801

Europe -DG Health and Food Safety

26-11-2018

Mirvaso (Galderma International)

Mirvaso (Galderma International)

Mirvaso (Active substance: brimonidine) - Centralised - Renewal - Commission Decision (2018)7977 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2642/R/21

Europe -DG Health and Food Safety

26-11-2018

Efient (Daiichi Sankyo Europe GmbH)

Efient (Daiichi Sankyo Europe GmbH)

Efient (Active substance: prasugrel) - PSUSA - Modification - Commission Decision (2018)7978 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2499/201802

Europe -DG Health and Food Safety

26-11-2018

Poteligeo (Kyowa Kirin Holdings B.V.)

Poteligeo (Kyowa Kirin Holdings B.V.)

Poteligeo (Active substance: Mogamulizumab) - Centralised - Authorisation - Commission Decision (2018) 7975 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4232

Europe -DG Health and Food Safety

26-11-2018

Ixiaro (Valneva Austria GmbH)

Ixiaro (Valneva Austria GmbH)

Ixiaro (Active substance: Japanese Encephalitis vaccine (inactivated, adsorbed)) - Centralised - Renewal - Commission Decision (2018)7979 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/963/R/91

Europe -DG Health and Food Safety

23-11-2018

Orfadin (Swedish Orphan Biovitrum International AB)

Orfadin (Swedish Orphan Biovitrum International AB)

Orfadin (Active substance: Nitisinone) - PSUSA - Modification - Commission Decision (2018)7890 of Fri, 23 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2169/201802

Europe -DG Health and Food Safety

22-11-2018

Fulphila (Mylan S.A.S.)

Fulphila (Mylan S.A.S.)

Fulphila (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)7880 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4915

Europe -DG Health and Food Safety

22-11-2018

Emtricitabine/Tenofovir disoproxil Krka (Krka d. d., Novo mesto)

Emtricitabine/Tenofovir disoproxil Krka (Krka d. d., Novo mesto)

Emtricitabine/Tenofovir disoproxil Krka (Active substance: emtricitabine / tenofovir disoproxil) - Centralised - 2-Monthly update - Commission Decision (2018)7884 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4215/IB/10G

Europe -DG Health and Food Safety

22-11-2018

Incruse Ellipta (GlaxoSmithKline (Ireland) Limited)

Incruse Ellipta (GlaxoSmithKline (Ireland) Limited)

Incruse Ellipta (Active substance: umeclidinium bromide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7876 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2809/T/22

Europe -DG Health and Food Safety

22-11-2018

Buvidal (Camurus AB)

Buvidal (Camurus AB)

Buvidal (Active substance: buprenorphine) - Centralised - Authorisation - Commission Decision (2018)7879 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4651

Europe -DG Health and Food Safety

22-11-2018

Pelmeg (Cinfa Biotech S.L.)

Pelmeg (Cinfa Biotech S.L.)

Pelmeg (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)7894 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4700

Europe -DG Health and Food Safety

22-11-2018

Ozurdex (Allergan Pharmaceuticals Ireland)

Ozurdex (Allergan Pharmaceuticals Ireland)

Ozurdex (Active substance: dexamethasone) - PSUSA - Modification - Commission Decision (2018)7886 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1140/PSUSA/985/201801

Europe -DG Health and Food Safety

22-11-2018

Brintellix (H. Lundbeck A/S)

Brintellix (H. Lundbeck A/S)

Brintellix (Active substance: vortioxetine) - Centralised - Renewal - Commission Decision (2018)7896 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2717/R/19

Europe -DG Health and Food Safety

22-11-2018

Levetiracetam Hospira (Hospira UK Limited)

Levetiracetam Hospira (Hospira UK Limited)

Levetiracetam Hospira (Active substance: levetiracetam) - Centralised - Renewal - Commission Decision (2018)7895 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2783/R/18

Europe -DG Health and Food Safety

22-11-2018

NovoSeven (Novo Nordisk A/S)

NovoSeven (Novo Nordisk A/S)

NovoSeven (Active substance: Eptacog alfa (activated)) - Centralised - 2-Monthly update - Commission Decision (2018)7877 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000074/II/0104

Europe -DG Health and Food Safety

22-11-2018

Selincro (H. Lundbeck A/S)

Selincro (H. Lundbeck A/S)

Selincro (Active substance: nalmefene) - PSUSA - Modification - Commission Decision (2018)7889 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10120/201802

Europe -DG Health and Food Safety

22-11-2018

Neuraceq (Life Radiopharma Berlin GmbH)

Neuraceq (Life Radiopharma Berlin GmbH)

Neuraceq (Active substance: florbetaben (18F)) - Centralised - Renewal - Commission Decision (2018)7882 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2553/R/25

Europe -DG Health and Food Safety

22-11-2018

Vabomere (Rempex London Limited)

Vabomere (Rempex London Limited)

Vabomere (Active substance: meropenem/vaborbactam) - Centralised - Authorisation - Commission Decision (2018)7888 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4669/00

Europe -DG Health and Food Safety

22-11-2018

Apealea (Oasmia Pharmaceutical AB)

Apealea (Oasmia Pharmaceutical AB)

Apealea (Active substance: paclitaxel) - Centralised - Authorisation - Commission Decision (2018)7887 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4154/00

Europe -DG Health and Food Safety

22-11-2018

EU/3/17/1933 (Emerald Health Pharmaceuticals EspaNa, S.L.)

EU/3/17/1933 (Emerald Health Pharmaceuticals EspaNa, S.L.)

EU/3/17/1933 (Active substance: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione) - Transfer of orphan designation - Commission Decision (2018)7813 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000001966

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2081 (Pharma Gateway AB)

EU/3/18/2081 (Pharma Gateway AB)

EU/3/18/2081 (Active substance: 3-(3-(3,5-dimethyl-1H-pyrazol-4-yl)propoxy)-4-fluorobenzoic acid) - Orphan designation - Commission Decision (2018)7790 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/096/18

Europe -DG Health and Food Safety

21-11-2018

Rheumocam (Chanelle Pharmaceuticals Manufacturing Limited)

Rheumocam (Chanelle Pharmaceuticals Manufacturing Limited)

Rheumocam (Active substance: Meloxicam) - Centralised - Variation - Commission Decision (2018)7841 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/121/X/22

Europe -DG Health and Food Safety

21-11-2018

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (TMC Pharma (EU) Limited)

EU/3/15/1567 (Active substance: Recombinant human interleukin-3 truncated diphtheria toxin fusion protein) - Transfer of orphan designation - Commission Decision (2018)7816 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/064/15/T/02

Europe -DG Health and Food Safety

21-11-2018

EU/3/17/1962 (MWB Consulting S.A.R.L.)

EU/3/17/1962 (MWB Consulting S.A.R.L.)

EU/3/17/1962 (Active substance: Humanised Fc-engineered monoclonal antibody against CD19) - Transfer of orphan designation - Commission Decision (2018)7815 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/155/17/T/01

Europe -DG Health and Food Safety

21-11-2018

Osurnia (Elanco GmbH)

Osurnia (Elanco GmbH)

Osurnia (Active substance: terbinafine / florfenicol / betamethasone acetate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7842 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/003753/T/0010

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2102 (IQVIA RDS Ireland Limited)

EU/3/18/2102 (IQVIA RDS Ireland Limited)

EU/3/18/2102 (Active substance: Apraglutide) - Orphan designation - Commission Decision (2018)7812 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/115/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2101 (TMC Pharma Services Ltd)

EU/3/18/2101 (TMC Pharma Services Ltd)

EU/3/18/2101 (Active substance: Setmelanotide) - Orphan designation - Commission Decision (2018)7811 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/143/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2100 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/2100 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/2100 (Active substance: Propagermanium) - Orphan designation - Commission Decision (2018)7810 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/103/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2099 (Celgene Europe Limited)

EU/3/18/2099 (Celgene Europe Limited)

EU/3/18/2099 (Active substance: Lisocabtagene maraleucel) - Orphan designation - Commission Decision (2018)7809 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/124/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2098 (Bayer AG)

EU/3/18/2098 (Bayer AG)

EU/3/18/2098 (Active substance: Larotrectinib) - Orphan designation - Commission Decision (2018)7808 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/117/18

Europe -DG Health and Food Safety