THEO DUR RETARD

Informació principal

  • Denominació comercial:
  • THEO DUR RETARD 100 mg 40 comprimidos lib control
  • formulario farmacéutico:
  • Comprimidos retard
  • Vía de administración:
  • Oral
  • Utilitza per:
  • Humans
  • Tipo de medicina:
  • medicament al·lopàtic

Documents

Localització

  • Disponible en:
  • THEO DUR RETARD 100 mg 40 comprimidos lib control
    Andorra
  • Idioma:
  • català

Altres dades

Estat

  • Font:
  • CedimCat - Centre d'Informació de Medicaments de Catalunya
  • Número d'autorització:
  • 656693
  • última actualització:
  • 08-06-2018

Prospecte: composició, indicacions, interacció, posologia, embaràs, lactància, reaccions adverses

THEO DUR RETARD 100 mg 40 comprimidos

lib control

teofilina

Indicacions

Medicament que relaxa les vies respirat

ries (BRONCODILATADOR) i alleuja la dificultat per

respirar produ

da per l'asma i altres malalties respirat

ries (ANTIASM

TIC).

Consideracions

Prengui els comprimits sencers, sense partir ni mastegar, empassant-los amb ajuda d'un got d'aigua.

s millor que prengui aquest medicament amb l'est

mac buit (1 hora abans dels menjars o 2 hores

despr

s), per

si t

sties d'est

mac, pot prendre'l amb els menjars.

Segueixi estrictament la pauta indicada pel seu metge pel que fa a dosi i freq

眉猫

ncia d'administraci

Tot i trobar-se millor, NO deixi de prendre aquest medicament durant el temps indicat pel seu metge.

Si vost

fuma, comen

a a fer-ho o deixa de fumar, comuniqui-li-ho al seu metge perqu

猫 茅

possible que hagi de modificar-li la dosi d'aquest medicament.

Mentre prengui aquest medicament procuri NO prendre grans quantitats de begudes amb cafe

na (caf

, te, refrescs de cola).

Aquest medicament modifica l'acci

d'altres f

rmacs, NO prengui altres medicaments sense consultar

abans al seu metge o farmac

utic.

Aquest medicament pot causar somnol

ncia i disminuir els seus reflexos, per aix

s'aconsella que

vagi amb compte en conduir o en manipular maquin

ria perillosa.

Per tal de controlar l'efecte d'aquest medicament pot ser necessari que li facin an

lisi de sang;

important que no oblidi anar al metge els dies que li hagin indicat.

Informi immediatament el seu metge si est

embarassada o creu que pot estar-ho, aix

com si qued

s embarassada durant el tractament.

Avisi al seu metge si t

algun fill a qui estigui alletant.

Efectes adversos

Aquest medicament pot produir mol

sties gastrointestinals (n

usees, v

mits, etc.), mal de cap,

tremolors, canvis en el ritme del cor, nerviosisme i insomni.

Si qualsevol d'aquests s

mptomes persisteix o

s molest, comuniqui-li-ho al seu metge.

Si not

s qualsevol altre s

mptoma que creu que pot ser causat per aquest medicament, digui-li-ho al

seu metge.

Posologia

Prengui 1 comprimit cada 12 hores.

VIA ORAL.

18-4-2019

Systematic review on health outcomes related to the age of introduction of complementary food

Systematic review on health outcomes related to the age of introduction of complementary food

Published on: Wed, 17 Apr 2019 In 2016, the European Commission gave EFSA a mandate to update its 2009 opinion on the appropriate age for introduction of complementary feeding of infants. In order to retrieve data on health outcomes related to the age of introduction of complementary food, a systematic literature review will be conducted by EFSA. This report presents the preparatory work that is performed by Pallas, with advice of Wageningen University, for the systematic literature review. It provides ...

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Administrative guidance on submission of dossiers and assessment reports for the peer‐review of pesticide active substances

Administrative guidance on submission of dossiers and assessment reports for the peer‐review of pesticide active substances

Published on: Mon, 08 Apr 2019 This document provides guidance to applicants submitting dossiers for approval of pesticide active substances, and to Member States preparing assessment reports on active substances within the scope of Regulation (EC) No 1107/2009 and Commission Implementing Regulation (EU) No 844/2012 and its subsequent amendments. It describes the administrative requirements for the preparation and submission of the dossier to support an application for the approval, the amendment of ap...

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15-4-2019

Irbesartan Teva (Teva B.V.)

Irbesartan Teva (Teva B.V.)

Irbesartan Teva (Active substance: Irbesartan) - Referral - Commission Decision (2019)2975 of Mon, 15 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1471/C/1093/32

Europe -DG Health and Food Safety

15-4-2019

Versican Plus Pi/L4 (Zoetis Belgium S.A.)

Versican Plus Pi/L4 (Zoetis Belgium S.A.)

Versican Plus Pi/L4 (Active substance: Canine parainfluenza virus vaccine (live) and canine leptospirosis vaccine (inactivated)) - Centralised - Renewal - Commission Decision (2019)2964 of Mon, 15 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/3683/R/11

Europe -DG Health and Food Safety

12-4-2019

capecitabine

capecitabine

capecitabine (Active substance: capecitabine) - Centralised - Art 28 - (PSUR - Commission Decision (2019)2988 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/531/201804

Europe -DG Health and Food Safety

12-4-2019

EU/3/18/2038 (PPD Bulgaria EOOD)

EU/3/18/2038 (PPD Bulgaria EOOD)

EU/3/18/2038 (Active substance: Palovarotene) - Transfer of orphan designation - Commission Decision (2019)2940 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005020

Europe -DG Health and Food Safety

12-4-2019

EU/3/16/1665 (Diamond ROC EOOD)

EU/3/16/1665 (Diamond ROC EOOD)

EU/3/16/1665 (Active substance: Recombinant adeno-associated viral vector containing the human RPGR gene) - Transfer of orphan designation - Commission Decision (2019)2934 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005876

Europe -DG Health and Food Safety

12-4-2019

EU/3/15/1556 (Diamond ROC EOOD)

EU/3/15/1556 (Diamond ROC EOOD)

EU/3/15/1556 (Active substance: Recombinant adeno-associated viral vector containing human CNGA3 gene) - Transfer of orphan designation - Commission Decision (2019)2933 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005873

Europe -DG Health and Food Safety

12-4-2019

EU/3/13/1107 (Diamond ROC EOOD)

EU/3/13/1107 (Diamond ROC EOOD)

EU/3/13/1107 (Active substance: Recombinant adeno-associated viral vector containing the human retinoschisin gene) - Transfer of orphan designation - Commission Decision (2019)2932 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005875

Europe -DG Health and Food Safety

12-4-2019

EU/3/13/1099 (Diamond ROC EOOD)

EU/3/13/1099 (Diamond ROC EOOD)

EU/3/13/1099 (Active substance: Recombinant adeno-associated viral vector containing the human CNGB3 gene) - Transfer of orphan designation - Commission Decision (2019)2931 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005874

Europe -DG Health and Food Safety

12-4-2019

EU/3/07/440 (Diamond ROC EOOD)

EU/3/07/440 (Diamond ROC EOOD)

EU/3/07/440 (Active substance: Recombinant adeno-associated viral vector containing human alpha-1 antitrypsin gene) - Transfer of orphan designation - Commission Decision (2019)2930 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005871

Europe -DG Health and Food Safety

12-4-2019

EU/3/18/2124 (IntraBio Ireland Ltd)

EU/3/18/2124 (IntraBio Ireland Ltd)

EU/3/18/2124 (Active substance: Acetylleucine) - Transfer of orphan designation - Commission Decision (2019)2939 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005404

Europe -DG Health and Food Safety

12-4-2019

EU/3/18/2059 (IntraBio Ireland Ltd)

EU/3/18/2059 (IntraBio Ireland Ltd)

EU/3/18/2059 (Active substance: Acetylleucine) - Transfer of orphan designation - Commission Decision (2019)2938 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005399

Europe -DG Health and Food Safety

12-4-2019

EU/3/17/1949 (IntraBio Ireland Ltd)

EU/3/17/1949 (IntraBio Ireland Ltd)

EU/3/17/1949 (Active substance: Acetylleucine) - Transfer of orphan designation - Commission Decision (2019)2936 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005385

Europe -DG Health and Food Safety

12-4-2019

EU/3/17/1878 (IntraBio Ireland Ltd)

EU/3/17/1878 (IntraBio Ireland Ltd)

EU/3/17/1878 (Active substance: Ursodeoxycholic acid) - Transfer of orphan designation - Commission Decision (2019)2937 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005394

Europe -DG Health and Food Safety

12-4-2019

EU/3/17/1848 (IntraBio Ireland Ltd)

EU/3/17/1848 (IntraBio Ireland Ltd)

EU/3/17/1848 (Active substance: Acetylleucine) - Transfer of orphan designation - Commission Decision (2019)2935 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005357

Europe -DG Health and Food Safety

12-4-2019

EU/3/18/1977 (GW Pharma (International) B.V)

EU/3/18/1977 (GW Pharma (International) B.V)

EU/3/18/1977 (Active substance: Cannabidivarin) - Transfer of orphan designation - Commission Decision (2019)2929 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004768

Europe -DG Health and Food Safety

12-4-2019

EU/3/17/1959 (GW Pharma (International) B.V)

EU/3/17/1959 (GW Pharma (International) B.V)

EU/3/17/1959 (Active substance: Cannabidiol) - Transfer of orphan designation - Commission Decision (2019)2925 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004767

Europe -DG Health and Food Safety

12-4-2019

EU/3/17/1921 (GW Pharma (International) B.V)

EU/3/17/1921 (GW Pharma (International) B.V)

EU/3/17/1921 (Active substance: Cannabidivarin) - Transfer of orphan designation - Commission Decision (2019)2928 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004766

Europe -DG Health and Food Safety

12-4-2019

EU/3/17/1920 (GW Pharma (International) B.V)

EU/3/17/1920 (GW Pharma (International) B.V)

EU/3/17/1920 (Active substance: Cannabidiol) - Transfer of orphan designation - Commission Decision (2019)2927 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004765

Europe -DG Health and Food Safety

12-4-2019

EU/3/17/1855 (GW Pharma (International) B.V)

EU/3/17/1855 (GW Pharma (International) B.V)

EU/3/17/1855 (Active substance: Cannabidiol) - Transfer of orphan designation - Commission Decision (2019)2926 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004607

Europe -DG Health and Food Safety

12-4-2019

EU/3/16/1621 (GW Pharma (International) B.V)

EU/3/16/1621 (GW Pharma (International) B.V)

EU/3/16/1621 (Active substance: Delta-9-tetrahydrocannabinol and cannabidiol from extracts of the Cannabis sativa L. plant) - Transfer of orphan designation - Commission Decision (2019)2924 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004763

Europe -DG Health and Food Safety

12-4-2019

EU/3/14/1339 (GW Pharma (International) B.V)

EU/3/14/1339 (GW Pharma (International) B.V)

EU/3/14/1339 (Active substance: Cannabidiol) - Transfer of orphan designation - Commission Decision (2019)2923 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004708

Europe -DG Health and Food Safety

12-4-2019

EU/3/18/2126 (JVM Europe B.V.)

EU/3/18/2126 (JVM Europe B.V.)

EU/3/18/2126 (Active substance: Human glucagon-like peptide-2 analogue linked to a human immunoglobulin Fc fragment) - Transfer of orphan designation - Commission Decision (2019)2922 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005194

Europe -DG Health and Food Safety

12-4-2019

EU/3/18/2035 (JVM Europe B.V.)

EU/3/18/2035 (JVM Europe B.V.)

EU/3/18/2035 (Active substance: Efpegsomatropin) - Transfer of orphan designation - Commission Decision (2019)2921 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005050

Europe -DG Health and Food Safety

12-4-2019

EU/3/18/2022 (JVM Europe B.V.)

EU/3/18/2022 (JVM Europe B.V.)

EU/3/18/2022 (Active substance: Glucagon analogue linked to a human immunoglobulin Fc fragment) - Transfer of orphan designation - Commission Decision 2920 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005277

Europe -DG Health and Food Safety

12-4-2019


Referral: Estradiol-containing (0.01% w/w) medicinal products for topical use,  estradiol, associated names: Linoladiol,Linoladiol N,Linoladiol Estradiol,Estradiol Wolff,Montadiol, Article 31 referrals, Procedure started

Referral: Estradiol-containing (0.01% w/w) medicinal products for topical use,  estradiol, associated names: Linoladiol,Linoladiol N,Linoladiol Estradiol,Estradiol Wolff,Montadiol, Article 31 referrals, Procedure started

Referral: Estradiol-containing (0.01% w/w) medicinal products for topical use,  estradiol, associated names: Linoladiol,Linoladiol N,Linoladiol Estradiol,Estradiol Wolff,Montadiol, Article 31 referrals, Procedure started

Europe - EMA - European Medicines Agency

12-4-2019


Referral: Lemtrada,  alemtuzumab, Article 20 procedures, Procedure started

Referral: Lemtrada,  alemtuzumab, Article 20 procedures, Procedure started

Referral: Lemtrada,  alemtuzumab, Article 20 procedures, Procedure started

Europe - EMA - European Medicines Agency

10-4-2019

Versican Plus DHPPi/L4R (Zoetis Belgium S.A.)

Versican Plus DHPPi/L4R (Zoetis Belgium S.A.)

Versican Plus DHPPi/L4R (Active substance: Canine distemper, canine adenovirus, canine parvovirus and canine parainfluenza virus vaccine (live) and canine leptospirosis and rabies vaccine (inactivated)) - Centralised - Renewal - Commission Decision (2019)2850 of Wed, 10 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/2759/R/14

Europe -DG Health and Food Safety

10-4-2019

Versican Plus L4 (Zoetis Belgium S.A.)

Versican Plus L4 (Zoetis Belgium S.A.)

Versican Plus L4 (Active substance: Canine leptospirosis vaccine (inactivated)) - Centralised - Renewal - Commission Decision (2019)2848 of Wed, 10 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/3680/R/07

Europe -DG Health and Food Safety

10-4-2019

Versican Plus DHPPi/L4 (Zoetis Belgium S.A.)

Versican Plus DHPPi/L4 (Zoetis Belgium S.A.)

Versican Plus DHPPi/L4 (Active substance: Canine distemper, canine adenovirus, canine parvovirus and canine parainfluenza virus vaccine (live) and canine leptospirosis vaccine (inactivated)) - Centralised - Renewal - Commission Decision (2019)2849 of Wed, 10 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/3678/R/13

Europe -DG Health and Food Safety

10-4-2019

M-M-RVAXPRO (MSD VACCINS)

M-M-RVAXPRO (MSD VACCINS)

M-M-RVAXPRO (Active substance: Measles, Mumps and Rubella Vaccine (Live)) - PSUSA - Modification - Commission Decision (2019)2812 of Wed, 10 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/00001937/201805

Europe -DG Health and Food Safety

10-4-2019

DuoResp Spiromax (Teva Pharma B.V.)

DuoResp Spiromax (Teva Pharma B.V.)

DuoResp Spiromax (Active substance: budesonide / formoterol) - Centralised - Renewal - Commission Decision (2019)2810 of Wed, 10 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/002348/R/0027

Europe -DG Health and Food Safety

10-4-2019

BiResp Spiromax (Teva Pharma B.V.)

BiResp Spiromax (Teva Pharma B.V.)

BiResp Spiromax (Active substance: budesonide / formoterol) - Centralised - Renewal - Commission Decision (2019)2811 of Wed, 10 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/003890/R/0027

Europe -DG Health and Food Safety

10-4-2019

Capecitabine medac (medac Gesellschaft fUr klinische SpezialprAparate mbH)

Capecitabine medac (medac Gesellschaft fUr klinische SpezialprAparate mbH)

Capecitabine medac (Active substance: capecitabine) - PSUSA - Modification - Commission Decision (2019)2817 of Wed, 10 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/00000531/201804

Europe -DG Health and Food Safety

9-4-2019


Orphan designation: Humanised IGg1 monoclonal antibody targeting human transferrin receptor conjugated to human iduronate-2-sulfatase, Treatment of mucopolysaccharidosis type II (Hunter’s syndrome), 26/02/2019, Positive

Orphan designation: Humanised IGg1 monoclonal antibody targeting human transferrin receptor conjugated to human iduronate-2-sulfatase, Treatment of mucopolysaccharidosis type II (Hunter’s syndrome), 26/02/2019, Positive

Orphan designation: Humanised IGg1 monoclonal antibody targeting human transferrin receptor conjugated to human iduronate-2-sulfatase, Treatment of mucopolysaccharidosis type II (Hunter’s syndrome), 26/02/2019, Positive

Europe - EMA - European Medicines Agency

4-4-2019

Deltyba (Otsuka Novel Products GmbH)

Deltyba (Otsuka Novel Products GmbH)

Deltyba (Active substance: delamanid) - Centralised - Annual renewal - Commission Decision (2019)2687 of Thu, 04 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/002552/R/0033

Europe -DG Health and Food Safety

4-4-2019

Kromeya (Fresenius Kabi Deutschland GmbH)

Kromeya (Fresenius Kabi Deutschland GmbH)

Kromeya (Active substance: adalimumab) - Centralised - Authorisation - Commission Decision (2019)2688 of Thu, 04 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/005158/0000

Europe -DG Health and Food Safety

4-4-2019

Betmiga (Astellas Pharma Europe B.V.)

Betmiga (Astellas Pharma Europe B.V.)

Betmiga (Active substance: mirabegron) - PSUSA - Modification - Commission Decision (2019)2689 of Thu, 04 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/00010031/201806

Europe -DG Health and Food Safety

4-4-2019

Vizimpro (Pfizer Europe MA EEIG)

Vizimpro (Pfizer Europe MA EEIG)

Vizimpro (Active substance: dacomitinib) - Centralised - Authorisation - Commission Decision (2019)2693 of Thu, 04 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4779

Europe -DG Health and Food Safety

4-4-2019

Idacio (Fresenius Kabi Deutschland GmbH)

Idacio (Fresenius Kabi Deutschland GmbH)

Idacio (Active substance: adalimumab) - Centralised - Authorisation - Commission Decision C(2019) 2699 of Thu, 04 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/004475/0000

Europe -DG Health and Food Safety

4-4-2019

Sylvant (Janssen-Cilag International NV)

Sylvant (Janssen-Cilag International NV)

Sylvant (Active substance: siltuximab) - Centralised - Renewal - Commission Decision (2019)2713 of Thu, 04 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/3708/R/0029

Europe -DG Health and Food Safety

4-4-2019

Gazyvaro (Roche Registration GmbH)

Gazyvaro (Roche Registration GmbH)

Gazyvaro (Active substance: obinutuzumab) - Centralised - Renewal - Commission Decision (2019)2712 of Thu, 04 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2799/R/0031

Europe -DG Health and Food Safety

3-4-2019

EU/3/17/1842 (EUDRAC GmbH)

EU/3/17/1842 (EUDRAC GmbH)

EU/3/17/1842 (Active substance: Recombinant human club cell 10 KDa protein) - Transfer of orphan designation - Commission Decision (2019)2668 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004449

Europe -DG Health and Food Safety

3-4-2019

EU/3/19/2150 (Real Regulatory Limited)

EU/3/19/2150 (Real Regulatory Limited)

EU/3/19/2150 (Active substance: Codon-optimised human cystic fibrosis transmembrane conductance regulator messenger ribonucleic acid complexed with lipid-based nanoparticles) - Orphan designation - Commission Decision (2019)2666 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002333

Europe -DG Health and Food Safety

3-4-2019

EU/3/19/2146 (Taiho Pharma Europe Limited)

EU/3/19/2146 (Taiho Pharma Europe Limited)

EU/3/19/2146 (Active substance: 1-[(3S)-3-{4-amino-3-[(3,5-dimethoxyphenyl)ethynyl]-1H-pyrazolo[3,4-d]pyrimidin-1-yl}pyrrolidin-1-yl]-2-propen-1-one) - Orphan designation - Commission Decision (2019)2662 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002457

Europe -DG Health and Food Safety

3-4-2019

EU/3/16/1628 (New B Innovation Biopharmaceutical (Ireland) Limited)

EU/3/16/1628 (New B Innovation Biopharmaceutical (Ireland) Limited)

EU/3/16/1628 (Active substance: Diaspirin cross-linked haemoglobin) - Transfer of orphan designation - Commission Decision (2019)2673 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003473

Europe -DG Health and Food Safety

3-4-2019

EU/3/14/1378 (New B Innovation Biopharmaceutical (Ireland) Limited)

EU/3/14/1378 (New B Innovation Biopharmaceutical (Ireland) Limited)

EU/3/14/1378 (Active substance: Diaspirin cross-linked haemoglobin) - Transfer of orphan designation - Commission Decision (2019)2672 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003420

Europe -DG Health and Food Safety

3-4-2019

EU/3/15/1520 (GW Pharma (International) B.V)

EU/3/15/1520 (GW Pharma (International) B.V)

EU/3/15/1520 (Active substance: Cannabidiol) - Transfer of orphan designation - Commission Decision (2019)2674 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004600

Europe -DG Health and Food Safety

3-4-2019

EU/3/19/2151 (Voisin Consulting S.A.R.L.)

EU/3/19/2151 (Voisin Consulting S.A.R.L.)

EU/3/19/2151 (Active substance: Marzeptacog alfa (activated)) - Orphan designation - Commission Decision (2019)2667 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002304

Europe -DG Health and Food Safety

3-4-2019

EU/3/19/2149 (Brainvectis)

EU/3/19/2149 (Brainvectis)

EU/3/19/2149 (Active substance: Adeno-associated viral vector serotype rh10 containing the human cholesterol 24-hydroxylase gene) - Orphan designation - Commission Decision (2019)2665 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002264

Europe -DG Health and Food Safety

3-4-2019

EU/3/19/2148 (Takeda Pharma A/S)

EU/3/19/2148 (Takeda Pharma A/S)

EU/3/19/2148 (Active substance: 4-hydroxy-6-{2-[4-(trifluoromethyl)phenyl]ethyl}pyridazin-3(2H)-one) - Orphan designation - Commission Decision (2019)2664 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002821

Europe -DG Health and Food Safety

3-4-2019

EU/3/19/2147 (Gilead Sciences Ireland UC)

EU/3/19/2147 (Gilead Sciences Ireland UC)

EU/3/19/2147 (Active substance: 2-[3-(2-chloro-4-{[5-cyclopropyl-3-(2,6-dichlorophenyl)-1,2-oxazol-4-yl]methoxy}phenyl)-3-hydroxyazetidin-1-yl]pyridine-4-carboxylic acid-2-amino-2-(hydroxymethyl)propane-1,3-diol (1/1)) - Orphan designation - Commission Decision (2019)2663 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002498

Europe -DG Health and Food Safety

3-4-2019

EU/3/14/1284 (Basilea Pharmaceutica Deutschland GmbH)

EU/3/14/1284 (Basilea Pharmaceutica Deutschland GmbH)

EU/3/14/1284 (Active substance: Isavuconazonium sulfate) - Transfer of orphan designation - Commission Decision (2019)2670 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004336

Europe -DG Health and Food Safety

3-4-2019

EU/3/14/1276 (Basilea Pharmaceutica Deutschland GmbH)

EU/3/14/1276 (Basilea Pharmaceutica Deutschland GmbH)

EU/3/14/1276 (Active substance: Isavuconazonium sulfate) - Transfer of orphan designation - Commission Decision (2019)2669 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004334

Europe -DG Health and Food Safety

3-4-2019

EU/3/09/641 (Atlantic Healthcare Europe B.V.)

EU/3/09/641 (Atlantic Healthcare Europe B.V.)

EU/3/09/641 (Active substance: Alicaforsen) - Transfer of orphan designation - Commission Decision (2019)2671 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004618

Europe -DG Health and Food Safety

3-4-2019

EU/3/16/1721 (Araim Pharmaceuticals Europe Limited)

EU/3/16/1721 (Araim Pharmaceuticals Europe Limited)

EU/3/16/1721 (Active substance: L-Pyr-L-Glu-L-Gln-L-Leu-L-Glu-L-Arg-L-Ala-L-Leu-L-Asn-L-Ser-L-Ser) - Transfer of orphan designation - Commission Decision (2019)2676 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005497

Europe -DG Health and Food Safety

3-4-2019

EU/3/13/1191 (Araim Pharmaceuticals Europe Limited)

EU/3/13/1191 (Araim Pharmaceuticals Europe Limited)

EU/3/13/1191 (Active substance: L-Pyr-L-Glu-L-Gln-L-Leu-L-Glu-L-Arg-L-Ala-L-Leu-L-Asn-L-Ser-L-Ser) - Transfer of orphan designation - Commission Decision (2019)2675 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004909

Europe -DG Health and Food Safety

3-4-2019

EU/3/16/1648 (Tracon Pharma International Limited)

EU/3/16/1648 (Tracon Pharma International Limited)

EU/3/16/1648 (Active substance: Human/murine chimeric monoclonal antibody against endoglin) - Transfer of orphan designation - Commission Decision (2019)2677 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004633

Europe -DG Health and Food Safety

2-4-2019

Jylamvo (Therakind (Europe) Limited)

Jylamvo (Therakind (Europe) Limited)

Jylamvo (Active substance: methotrexate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2624 of Tue, 02 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/3756/T/7

Europe -DG Health and Food Safety

2-4-2019

EU/3/06/374 (Therakos Europe Limited)

EU/3/06/374 (Therakos Europe Limited)

EU/3/06/374 (Active substance: Methoxsalen) - Transfer of orphan designation - Commission Decision (2019)2420 of Tue, 02 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004676

Europe -DG Health and Food Safety

2-4-2019

EU/3/18/2036 (Regulis Consulting Europe Limited)

EU/3/18/2036 (Regulis Consulting Europe Limited)

EU/3/18/2036 (Active substance: L-cystine bis(N'-methylpiperazide)) - Transfer of orphan designation - Commission Decision (2019)2411 of Tue, 02 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004889

Europe -DG Health and Food Safety

2-4-2019

Arti-Cell Forte (Global Stem cell Technology (G.S.T.) NV)

Arti-Cell Forte (Global Stem cell Technology (G.S.T.) NV)

Arti-Cell Forte (Active substance: Chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells) - Centralised - Authorisation - Commission Decision (2019)2625 of Tue, 02 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/4727

Europe -DG Health and Food Safety

2-4-2019

EU/3/17/1868 (Diamond ROC EOOD)

EU/3/17/1868 (Diamond ROC EOOD)

EU/3/17/1868 (Active substance: N-[(1R)-1-phenylethyl]-6-{1H-pyrazolo[3,4-d]pyrimidin-4-yl}quinazolin-2-amine) - Transfer of orphan designation - Commission Decision (2019)2407 of Tue, 02 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004677

Europe -DG Health and Food Safety