FER-IN-SOL

Informació principal

  • Denominació comercial:
  • FER-IN-SOL 30 ml
  • formulario farmacéutico:
  • Gotas
  • Vía de administración:
  • Oral
  • Utilitza per:
  • Humans
  • Tipo de medicina:
  • medicament al·lopàtic

Documents

Localització

  • Disponible en:
  • FER-IN-SOL 30 ml
    Andorra
  • Idioma:
  • català

Altres dades

Estat

  • Font:
  • CedimCat - Centre d'Informació de Medicaments de Catalunya
  • Número d'autorització:
  • 201483
  • última actualització:
  • 26-05-2018

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

FER-IN-SOL 30 ml

hierro ll, sulfato

Indicacions

Medicament que s'utilitza quan cal una aportació extra de vitamines i minerals (COMPLEX

MULTIVITAMÍNIC).

Consideracions

Prengui les gotes directament o dissoltes en mig got d'aigua.

És millor que prengui aquest medicament amb l'estómac buit (1 hora abans dels menjars o 2 hores

després), però si té molèsties d'estómac, pot prendre'l amb els menjars.

NO prengui aquest medicament amb llet, cafè o te.

Prengui aquest medicament amb suc de taronja per a millorar la seva absorció.

Segueixi estrictament la pauta indicada pel seu metge pel que fa a dosi i freqüència d'administració.

Aquest medicament triga algun temps a fer efecte, NO deixi de prendre'l encara que al principi no noti

milloria.

Avisi el seu metge si pateix intolerància a alguns sucres.

Avisi el seu metge si pateix o ha patit úlcera d'estómac o de duodè.

Aquest medicament modifica l'acció d'altres fàrmacs, NO prengui altres medicaments sense consultar

abans al seu metge o farmacèutic.

Si pren llet o derivats làctics (formatge, iogurt, etc.), prengui'ls, com a mínim, 2 hores abans o després

d'haver pres aquest medicament.

Alguns medicaments poden modificar l'eficàcia d'aquest fàrmac, es recomana separar l'administració 2

hores.

Efectes adversos

Aquest medicament pot produir molèsties gastrointestinals (nàusees, vòmits, etc.), cremor d'estómac,

dolor abdominal i una coloració negrosa de les femtes.

Si notés qualsevol altre símptoma que creu que pot ser causat per aquest medicament, digui-li-ho al seu

metge.

Posologia

Prengui 5 gotes cada dia.

És millor que prengui aquest medicament amb l'estómac buit.

VIA ORAL.

17-4-2019

Mondelēz Global LLC Conducts Voluntary Recall of Certain Chewy Chips Ahoy 13oz Due to Unexpected Solidified Ingredient in Product in the US

Mondelēz Global LLC Conducts Voluntary Recall of Certain Chewy Chips Ahoy 13oz Due to Unexpected Solidified Ingredient in Product in the US

Mondelēz Global LLC announced today a limited voluntary recall in the United States of certain Chewy Chips Ahoy 13oz cookies. This voluntary recall is being conducted because of the potential for certain product to contain an unexpected solidified ingredient. Some reports of potential adverse health effects have been received.

FDA - U.S. Food and Drug Administration

11-4-2019

Toxicity reference values (TRVs)

Toxicity reference values (TRVs)

As part of its missions and under the French National Environmental & Health Action Plan (2004-2008), the Agency began a national programme on TRVs in 2004 with the aim of building solid French expertise that could be shared by the various competent authorities in this area.

France - Agence Nationale du Médicament Vétérinaire

29-3-2019

Expanded Recall: Swing Paints, Ltd. recalls Klenk's Paint Thinner, Klenk's Sol-V, Klenk's Super Sol-V and Klenk's Mineral Spirits

Expanded Recall: Swing Paints, Ltd. recalls Klenk's Paint Thinner, Klenk's Sol-V, Klenk's Super Sol-V and Klenk's Mineral Spirits

The recalled products do not meet the child-resistant packaging requirements for consumer chemical products required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

12-4-2019


Orphan designation: Recombinant human minibody against complement component C5 fused with RGD-motif, Prevention of the ischaemia/reperfusion injury associated with solid organ transplantation, 20/01/2009, Withdrawn

Orphan designation: Recombinant human minibody against complement component C5 fused with RGD-motif, Prevention of the ischaemia/reperfusion injury associated with solid organ transplantation, 20/01/2009, Withdrawn

Orphan designation: Recombinant human minibody against complement component C5 fused with RGD-motif, Prevention of the ischaemia/reperfusion injury associated with solid organ transplantation, 20/01/2009, Withdrawn

Europe - EMA - European Medicines Agency

12-4-2019


Orphan designation: Recombinant human minibody against complement component C5, Treatment of primary membranoproliferative glomerulonephritis, 27/10/2011, Withdrawn

Orphan designation: Recombinant human minibody against complement component C5, Treatment of primary membranoproliferative glomerulonephritis, 27/10/2011, Withdrawn

Orphan designation: Recombinant human minibody against complement component C5, Treatment of primary membranoproliferative glomerulonephritis, 27/10/2011, Withdrawn

Europe - EMA - European Medicines Agency

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

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/3/16/1628 (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/3/14/1284 (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

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

1-4-2019

Sialanar (Proveca Pharma Limited)

Sialanar (Proveca Pharma Limited)

Sialanar (Active substance: glycopyrronium bromide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2593 of Mon, 01 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/3883/T/09

Europe -DG Health and Food Safety

1-4-2019

EU/3/18/2000 (Amicus Therapeutics Europe Limited)

EU/3/18/2000 (Amicus Therapeutics Europe Limited)

EU/3/18/2000 (Active substance: Recombinant human acid alpha-glucosidase) - Transfer of orphan designation - Commission Decision (2019)2423 of Mon, 01 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004425

Europe -DG Health and Food Safety

1-4-2019

EU/3/13/1232 (Amicus Therapeutics Europe Limited)

EU/3/13/1232 (Amicus Therapeutics Europe Limited)

EU/3/13/1232 (Active substance: Allantoin) - Transfer of orphan designation - Commission Decision (2019)2422 of Mon, 01 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004625

Europe -DG Health and Food Safety

1-4-2019

EU/3/06/368 (Amicus Therapeutics Europe Limited)

EU/3/06/368 (Amicus Therapeutics Europe Limited)

EU/3/06/368 (Active substance: 1-deoxygalactonojirimycin hydrochloride) - Transfer of orphan designation - Commission Decision (2019)2421 of Mon, 01 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004426

Europe -DG Health and Food Safety

1-4-2019

EU/3/14/1379 (Maxia Strategies-Europe Limited)

EU/3/14/1379 (Maxia Strategies-Europe Limited)

EU/3/14/1379 (Active substance: Dantrolene sodium) - Transfer of orphan designation - Commission Decision (2019)2410 of Mon, 01 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004589

Europe -DG Health and Food Safety

1-4-2019

Galafold (Amicus Therapeutics Europe Limited)

Galafold (Amicus Therapeutics Europe Limited)

Galafold (Active substance: migalastat) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2580 of Mon, 01 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/004059/T/0020

Europe -DG Health and Food Safety

29-3-2019

Nerlynx (Puma Biotechnology B.V.)

Nerlynx (Puma Biotechnology B.V.)

Nerlynx (Active substance: neratinib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2579 of Fri, 29 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4030/T/01

Europe -DG Health and Food Safety

29-3-2019

EU/3/18/2102 (TherAchon SAS)

EU/3/18/2102 (TherAchon SAS)

EU/3/18/2102 (Active substance: Apraglutide) - Transfer of orphan designation - Commission Decision (2019)2415 of Fri, 29 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004473

Europe -DG Health and Food Safety

29-3-2019

EU/3/14/1280 (Orchard Therapeutics (Europe) Limited)

EU/3/14/1280 (Orchard Therapeutics (Europe) Limited)

EU/3/14/1280 (Active substance: Autologous CD34+ cells transduced with a lentiviral vector containing the human SGSH gene) - Transfer of orphan designation - Commission Decision (2019)2432 of Fri, 29 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003985

Europe -DG Health and Food Safety

29-3-2019

EU/3/13/1134 (Orchard Therapeutics (Netherlands) B.V.)

EU/3/13/1134 (Orchard Therapeutics (Netherlands) B.V.)

EU/3/13/1134 (Active substance: Autologous CD34+ cells transduced with a lentiviral vector containing the human ADA gene) - Transfer of orphan designation - Commission Decision (2019)2431 of Fri, 29 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003982

Europe -DG Health and Food Safety

29-3-2019

EU/3/07/446 (Orchard Therapeutics (Netherlands) B.V.)

EU/3/07/446 (Orchard Therapeutics (Netherlands) B.V.)

EU/3/07/446 (Active substance: Autologous CD34+ cells transfected with lentiviral vector containing the human arylsulfatase A cDNA) - Transfer of orphan designation - Commission Decision (2019)2430 of Fri, 29 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003632

Europe -DG Health and Food Safety

29-3-2019

Coagadex (BPL Bioproducts Laboratory GmbH)

Coagadex (BPL Bioproducts Laboratory GmbH)

Coagadex (Active substance: human coagulation factor X) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2577 of Fri, 29 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/3855/T/14

Europe -DG Health and Food Safety

28-3-2019

EU/3/10/804 (Pharma Gateway AB)

EU/3/10/804 (Pharma Gateway AB)

EU/3/10/804 (Active substance: Methylthioninium) - Transfer of orphan designation - Commission Decision (2019)2416 of Thu, 28 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005100

Europe -DG Health and Food Safety

28-3-2019

EU/3/15/1467 (Holostem Terapie Avanzate S.r.l.)

EU/3/15/1467 (Holostem Terapie Avanzate S.r.l.)

EU/3/15/1467 (Active substance: Ex-vivo-expanded autologous human keratinocytes containing epidermal stem cells transduced with a COL17A1-encoding retroviral vector) - Transfer of orphan designation - Commission Decision (2019)2414 of Thu, 28 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004602

Europe -DG Health and Food Safety

28-3-2019

EU/3/15/1466 (Holostem Terapie Avanzate S.r.l.)

EU/3/15/1466 (Holostem Terapie Avanzate S.r.l.)

EU/3/15/1466 (Active substance: Ex-vivo-expanded autologous human keratinocytes containing epidermal stem cells transduced with a COL7A1-encoding retroviral vector) - Transfer of orphan designation - Commission Decision (2019)2413 of Thu, 28 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004603

Europe -DG Health and Food Safety

28-3-2019

EU/3/15/1465 (Holostem Terapie Avanzate S.r.l.)

EU/3/15/1465 (Holostem Terapie Avanzate S.r.l.)

EU/3/15/1465 (Active substance: Ex-vivo-expanded autologous human keratinocytes containing epidermal stem cells transduced with a LAMB3-encoding retroviral vector) - Transfer of orphan designation - Commission Decision (2019)2412 of Thu, 28 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004545

Europe -DG Health and Food Safety

28-3-2019

EU/3/13/1217 (SFL Regulatory Services GmbH)

EU/3/13/1217 (SFL Regulatory Services GmbH)

EU/3/13/1217 (Active substance: (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5-tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride) - Transfer of orphan designation - Commission Decision (2019)2428 of Thu, 28 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004699

Europe -DG Health and Food Safety

28-3-2019

EU/3/13/1216 (SFL Regulatory Services GmbH)

EU/3/13/1216 (SFL Regulatory Services GmbH)

EU/3/13/1216 (Active substance: (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5-tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride) - Transfer of orphan designation - Commission Decision (2019)2427 of Thu, 28 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004691

Europe -DG Health and Food Safety

28-3-2019

EU/3/13/1215 (SFL Regulatory Services GmbH)

EU/3/13/1215 (SFL Regulatory Services GmbH)

EU/3/13/1215 (Active substance: (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5-tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride) - Transfer of orphan designation - Commission Decision (2019)2426 of Thu, 28 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004666

Europe -DG Health and Food Safety

28-3-2019

EU/3/13/1214 (SFL Regulatory Services GmbH)

EU/3/13/1214 (SFL Regulatory Services GmbH)

EU/3/13/1214 (Active substance: (4R,5R)-1-[[4-[[4-[3,3-dibutyl-7-(dimethylamino)-2,3,4,5-tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl]phenoxy]methyl]phenyl]methyl]-4-aza-1-azoniabicyclo[2.2.2]octane chloride) - Transfer of orphan designation - Commission Decision (2019)2425 of Thu, 28 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004351

Europe -DG Health and Food Safety

28-3-2019

EU/3/10/807 (Pharma Gateway AB)

EU/3/10/807 (Pharma Gateway AB)

EU/3/10/807 (Active substance: Methylthioninium) - Transfer of orphan designation - Commission Decision (2019)2419 of Thu, 28 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004926

Europe -DG Health and Food Safety

28-3-2019

EU/3/10/806 (Pharma Gateway AB)

EU/3/10/806 (Pharma Gateway AB)

EU/3/10/806 (Active substance: Methylthioninium) - Transfer of orphan designation - Commission Decision (2019)2418 of Thu, 28 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005102

Europe -DG Health and Food Safety

28-3-2019

EU/3/10/805 (Pharma Gateway AB)

EU/3/10/805 (Pharma Gateway AB)

EU/3/10/805 (Active substance: Methylthioninium) - Transfer of orphan designation - Commission Decision (2019)2417 of Thu, 28 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005087

Europe -DG Health and Food Safety

28-3-2019

EU/3/17/1910 (FGK Representative Service GmbH)

EU/3/17/1910 (FGK Representative Service GmbH)

EU/3/17/1910 (Active substance: Sirolimus) - Transfer of orphan designation - Commission Decision (2019)2404 of Thu, 28 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005428

Europe -DG Health and Food Safety