COLIRIO

Informació principal

  • Denominació comercial:
  • COLIRIO DE SUERO AUTÓLOGO (Fórmula Magistral)
  • formulario farmacéutico:
  • Colirio F.M.
  • Vía de administración:
  • Oftálmica
  • Utilitza per:
  • Humans
  • Tipo de medicina:
  • medicament al·lopàtic

Documents

Localització

  • Disponible en:
  • COLIRIO DE SUERO AUTÓLOGO (Fórmula Magistral)
    Andorra
  • Idioma:
  • català

Altres dades

Estat

  • Font:
  • CedimCat - Centre d'Informació de Medicaments de Catalunya
  • Número d'autorització:
  • 000121
  • última actualització:
  • 23-05-2018

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

COLIRIO DE SUERO AUTÓLOGO (Fórmula

Magistral)

suero autólogo

Indicacions

Medicament utilitzat per tractar determinades malalties de l'ull (OFTÀLMIC).

També s'utilitza per tractar la síndrome de l'ull sec i per afavorir el procés de cicatrització i formació de

col·lagen.

Consideracions

Aquest medicament NO es troba comercialitzat sinó que és una fórmula magistral que li elaborarà el

farmacèutic seguint la prescripció del metge.

Conservi aquest medicament a la nevera (mai en el congelador).

Ha de rebutjar el medicament 4 setmanes després de l'obertura de l'envàs.

Renti's les mans abans i després de cada aplicació.

En administrar aquest medicament eviti el contacte del comptagotes amb l'ull o els dits, d'aquesta manera

evitarà el risc de contaminació.

Per a administrar aquest col·liri, inclini el cap cap a enrere, baixi la parpella inferior i deixi caure les gotes

a l'ull. Tanqui l'ull i pressioni suaument la parpella amb el dit durant uns segons.

Si ha d'aplicar-se un altre col·liri, esperi uns minuts entre l'administració de l'un i l'altre.

Efectes adversos

Aquest medicament pot produir coïssor o picor a l'ull que desapareixerà passats uns minuts.

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

metge.

Posologia

Segueixi la pauta indicada pel seu metge.

VIA OFTÀLMICA.

9-4-2019


Orphan designation: Autologous adult live cultured osteoblasts, Treatment of non-traumatic osteonecrosis, 26/02/2019, Positive

Orphan designation: Autologous adult live cultured osteoblasts, Treatment of non-traumatic osteonecrosis, 26/02/2019, Positive

Orphan designation: Autologous adult live cultured osteoblasts, Treatment of non-traumatic osteonecrosis, 26/02/2019, Positive

Europe - EMA - European Medicines Agency

8-4-2019


Orphan designation: Autologous stromal vascular cell fraction from adipose tissue, Treatment of systemic sclerosis, 28/04/2016, Positive

Orphan designation: Autologous stromal vascular cell fraction from adipose tissue, Treatment of systemic sclerosis, 28/04/2016, Positive

Orphan designation: Autologous stromal vascular cell fraction from adipose tissue, Treatment of systemic sclerosis, 28/04/2016, Positive

Europe - EMA - European Medicines Agency

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


Summary of opinion: Zynteglo,autologous CD34+ cell enriched population that contains hematopoietic stem cells transduced with lentiglobin BB305 lentiviral vector encoding the beta-A-T87Q-globin gene,  28/03/2019,  Positive

Summary of opinion: Zynteglo,autologous CD34+ cell enriched population that contains hematopoietic stem cells transduced with lentiglobin BB305 lentiviral vector encoding the beta-A-T87Q-globin gene, 28/03/2019, Positive

Summary of opinion: Zynteglo,autologous CD34+ cell enriched population that contains hematopoietic stem cells transduced with lentiglobin BB305 lentiviral vector encoding the beta-A-T87Q-globin gene, 28/03/2019, Positive

Europe - EMA - European Medicines Agency

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

27-3-2019

EU/3/16/1643 (Clinical Network Services (NL) B.V.)

EU/3/16/1643 (Clinical Network Services (NL) B.V.)

EU/3/16/1643 (Active substance: Autologous stromal vascular cell fraction from adipose tissue) - Transfer of orphan designation - Commission Decision (2019)2405 of Wed, 27 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005318

Europe -DG Health and Food Safety

18-3-2019

EU/3/14/1247 (Diamond ROC EOOD)

EU/3/14/1247 (Diamond ROC EOOD)

EU/3/14/1247 (Active substance: Autologous dendritic cells pulsed with tumour antigen-derived synthetic peptides (MAGE-1, HER-2, AIM-2, TRP-2, gp-100, and interleukin-13 receptor alpha)) - Transfer of orphan designation - Commission Decision (2019)2146 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003818

Europe -DG Health and Food Safety

18-3-2019


Orphan designation: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human betaA-T87Q-globin gene, Treatment of beta thalassaemia intermedia and major, 24/01/2013, Positive

Orphan designation: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human betaA-T87Q-globin gene, Treatment of beta thalassaemia intermedia and major, 24/01/2013, Positive

Orphan designation: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human betaA-T87Q-globin gene, Treatment of beta thalassaemia intermedia and major, 24/01/2013, Positive

Europe - EMA - European Medicines Agency

18-3-2019


Orphan designation: Autologous Epstein-Barr virus specific T cells derived from peripheral blood mononuclear cells, expanded ex vivo-, Treatment of extranodal NK/T-cell lymphoma, nasal type, 14/07/2016, Positive

Orphan designation: Autologous Epstein-Barr virus specific T cells derived from peripheral blood mononuclear cells, expanded ex vivo-, Treatment of extranodal NK/T-cell lymphoma, nasal type, 14/07/2016, Positive

Orphan designation: Autologous Epstein-Barr virus specific T cells derived from peripheral blood mononuclear cells, expanded ex vivo-, Treatment of extranodal NK/T-cell lymphoma, nasal type, 14/07/2016, Positive

Europe - EMA - European Medicines Agency

15-3-2019

EU/3/19/2139 (Clinical Network Services (NL) B.V.)

EU/3/19/2139 (Clinical Network Services (NL) B.V.)

EU/3/19/2139 (Active substance: Autologous adult live cultured osteoblasts) - Transfer of orphan designation - Commission Decision (2019)2105 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004280

Europe -DG Health and Food Safety

4-3-2019


Orphan designation: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA, Treatment of adrenoleukodystrophy, 06/06/2012, Positive

Orphan designation: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA, Treatment of adrenoleukodystrophy, 06/06/2012, Positive

Orphan designation: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA, Treatment of adrenoleukodystrophy, 06/06/2012, Positive

Europe - EMA - European Medicines Agency

28-2-2019

EU/3/16/1696 (Clinical Network Services (NL) B.V.)

EU/3/16/1696 (Clinical Network Services (NL) B.V.)

EU/3/16/1696 (Active substance: Autologous Epstein-Barr virus specific T-cells derived from peripheral blood mononuclear cells, expanded ex vivo) - Transfer of orphan designation - Commission Decision (2019)1747 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004066

Europe -DG Health and Food Safety

28-2-2019

EU/3/16/1695 (Clinical Network Services (NL) B.V.)

EU/3/16/1695 (Clinical Network Services (NL) B.V.)

EU/3/16/1695 (Active substance: Autologous Epstein-Barr virus specific T-cells derived from peripheral blood mononuclear cells, expanded ex vivo) - Transfer of orphan designation - Commission Decision (2019)1746 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004064

Europe -DG Health and Food Safety

28-2-2019

EU/3/19/2139 (Clinical Network Services (UK) Ltd)

EU/3/19/2139 (Clinical Network Services (UK) Ltd)

EU/3/19/2139 (Active substance: Autologous adult live cultured osteoblasts) - Orphan designation - Commission Decision (2019)1731 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000001655

Europe -DG Health and Food Safety

25-2-2019

EU/3/12/1091 (bluebird bio (Netherlands) B.V.)

EU/3/12/1091 (bluebird bio (Netherlands) B.V.)

EU/3/12/1091 (Active substance: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human betaA-T87Q-globin gene) - Transfer of orphan designation - Commission Decision (2019)1626 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003556

Europe -DG Health and Food Safety

25-2-2019

EU/3/12/1003 (bluebird bio (Netherlands) B.V.)

EU/3/12/1003 (bluebird bio (Netherlands) B.V.)

EU/3/12/1003 (Active substance: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA) - Transfer of orphan designation - Commission Decision (2019)1634 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003636

Europe -DG Health and Food Safety

25-2-2019


Orphan designation: Ex vivo fused normal allogeneic human myoblast with autologous human myoblast derived from Duchenne muscular dystrophy affected donor, Treatment of Duchenne muscular dystrophy, 19/11/2019, Positive

Orphan designation: Ex vivo fused normal allogeneic human myoblast with autologous human myoblast derived from Duchenne muscular dystrophy affected donor, Treatment of Duchenne muscular dystrophy, 19/11/2019, Positive

Orphan designation: Ex vivo fused normal allogeneic human myoblast with autologous human myoblast derived from Duchenne muscular dystrophy affected donor, Treatment of Duchenne muscular dystrophy, 19/11/2019, Positive

Europe - EMA - European Medicines Agency

22-2-2019


Orphan designation: Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor, Treatment of diffuse large B-cell lymphoma, 17/07/2017, Positive

Orphan designation: Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor, Treatment of diffuse large B-cell lymphoma, 17/07/2017, Positive

Orphan designation: Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor, Treatment of diffuse large B-cell lymphoma, 17/07/2017, Positive

Europe - EMA - European Medicines Agency

22-2-2019


Orphan designation: Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor, Treatment of follicular lymphoma, 25/05/2018, Positive

Orphan designation: Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor, Treatment of follicular lymphoma, 25/05/2018, Positive

Orphan designation: Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor, Treatment of follicular lymphoma, 25/05/2018, Positive

Europe - EMA - European Medicines Agency

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ hematopoietic stem cells transduced ex vivo with EFS lentiviral vector encoding for the human adenosine deaminase gene, decision type: , therapeutic area: , PIP number: P/0400/20

Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ hematopoietic stem cells transduced ex vivo with EFS lentiviral vector encoding for the human adenosine deaminase gene, decision type: , therapeutic area: , PIP number: P/0400/20

Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ hematopoietic stem cells transduced ex vivo with EFS lentiviral vector encoding for the human adenosine deaminase gene, decision type: , therapeutic area: , PIP number: P/0400/2018

Europe - EMA - European Medicines Agency

20-2-2019


Orphan designation: autologous human adipose perivascular stromal cells genetically modified to secrete soluble tumour necrosis factor-related apoptosis-inducing ligand, The treatment of pancreatic cancer, 19/11/2018, Positive

Orphan designation: autologous human adipose perivascular stromal cells genetically modified to secrete soluble tumour necrosis factor-related apoptosis-inducing ligand, The treatment of pancreatic cancer, 19/11/2018, Positive

Orphan designation: autologous human adipose perivascular stromal cells genetically modified to secrete soluble tumour necrosis factor-related apoptosis-inducing ligand, The treatment of pancreatic cancer, 19/11/2018, Positive

Europe - EMA - European Medicines Agency

18-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Holoclar,Ex-vivo expanded human autologous epithelium containing stem cells, decision type: , therapeutic area: , PIP number: P/0370/2018

Opinion/decision on a Paediatric investigation plan (PIP): Holoclar,Ex-vivo expanded human autologous epithelium containing stem cells, decision type: , therapeutic area: , PIP number: P/0370/2018

Opinion/decision on a Paediatric investigation plan (PIP): Holoclar,Ex-vivo expanded human autologous epithelium containing stem cells, decision type: , therapeutic area: , PIP number: P/0370/2018

Europe - EMA - European Medicines Agency

14-2-2019

EU/3/18/2018 (Celgene Europe B.V.)

EU/3/18/2018 (Celgene Europe B.V.)

EU/3/18/2018 (Active substance: Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor) - Transfer of orphan designation - Commission Decision (2019)1350 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003327

Europe -DG Health and Food Safety

14-2-2019

EU/3/17/1890 (Celgene Europe B.V.)

EU/3/17/1890 (Celgene Europe B.V.)

EU/3/17/1890 (Active substance: Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor) - Transfer of orphan designation - Commission Decision (2019)1349 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003329

Europe -DG Health and Food Safety

29-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ATP-binding cassette, sub-family D (ALD), member 1 (ABCD1) from cDNA, decision type: , therapeuti

Opinion/decision on a Paediatric investigation plan (PIP): autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ATP-binding cassette, sub-family D (ALD), member 1 (ABCD1) from cDNA, decision type: , therapeuti

Opinion/decision on a Paediatric investigation plan (PIP): autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ATP-binding cassette, sub-family D (ALD), member 1 (ABCD1) from cDNA, decision type: , therapeutic area: , PIP number: P/0290/2018

Europe - EMA - European Medicines Agency

18-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Autologous dendritic cells pulsed with allogeneic tumour cell lysate, decision type: , therapeutic area: , PIP number: P/0334/2018

Opinion/decision on a Paediatric investigation plan (PIP): Autologous dendritic cells pulsed with allogeneic tumour cell lysate, decision type: , therapeutic area: , PIP number: P/0334/2018

Opinion/decision on a Paediatric investigation plan (PIP): Autologous dendritic cells pulsed with allogeneic tumour cell lysate, decision type: , therapeutic area: , PIP number: P/0334/2018

Europe - EMA - European Medicines Agency

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3- zeta chimeric antigen receptor, decision type: , therapeutic area: , PIP number: P/0232/2018

Opinion/decision on a Paediatric investigation plan (PIP): Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3- zeta chimeric antigen receptor, decision type: , therapeutic area: , PIP number: P/0232/2018

Opinion/decision on a Paediatric investigation plan (PIP): Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3- zeta chimeric antigen receptor, decision type: , therapeutic area: , PIP number: P/0232/2018

Europe - EMA - European Medicines Agency

17-1-2019

Holoclar (Chiesi Farmaceutici S.p.A.)

Holoclar (Chiesi Farmaceutici S.p.A.)

Holoclar (Active substance: Ex vivo expanded autologous human corneal epithelial cells containing stem cells) - Centralised - Annual renewal - Commission Decision (2019)272 of Thu, 17 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2450/R/21

Europe -DG Health and Food Safety

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Autologous cartilage derived cultured chondrocytes, decision type: , therapeutic area: , PIP number: P/0282/2018

Opinion/decision on a Paediatric investigation plan (PIP): Autologous cartilage derived cultured chondrocytes, decision type: , therapeutic area: , PIP number: P/0282/2018

Opinion/decision on a Paediatric investigation plan (PIP): Autologous cartilage derived cultured chondrocytes, decision type: , therapeutic area: , PIP number: P/0282/2018

Europe - EMA - European Medicines Agency

11-1-2019


Orphan designation: Autologous skeletal myoblasts expanded ex vivo, Treatment of oculopharyngeal muscular dystrophy, 13/04/2018, Negative

Orphan designation: Autologous skeletal myoblasts expanded ex vivo, Treatment of oculopharyngeal muscular dystrophy, 13/04/2018, Negative

Orphan designation: Autologous skeletal myoblasts expanded ex vivo, Treatment of oculopharyngeal muscular dystrophy, 13/04/2018, Negative

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA, Treatment of mucopolysaccharidosis type I, 26/10/2018, Positive

Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA, Treatment of mucopolysaccharidosis type I, 26/10/2018, Positive

Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA, Treatment of mucopolysaccharidosis type I, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

7-1-2019


Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous mesenchymal stem cells isolated from bone marrow

Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous mesenchymal stem cells isolated from bone marrow

Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous mesenchymal stem cells isolated from bone marrow

Europe - EMA - European Medicines Agency

7-1-2019


Scientific recommendation on classification of advanced therapy medicines: In vitro cultured autologous mesenchymal stem cells isolated from bone marrow

Scientific recommendation on classification of advanced therapy medicines: In vitro cultured autologous mesenchymal stem cells isolated from bone marrow

Scientific recommendation on classification of advanced therapy medicines: In vitro cultured autologous mesenchymal stem cells isolated from bone marrow

Europe - EMA - European Medicines Agency

19-12-2018


Orphan designation: autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor, Treatment of glioma, 24/08/2018, Positive

Orphan designation: autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor, Treatment of glioma, 24/08/2018, Positive

Orphan designation: autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor, Treatment of glioma, 24/08/2018, Positive

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Mesenchymal stem cells isolated from autologous bone marrow

Scientific recommendation on classification of advanced therapy medicinal products: Mesenchymal stem cells isolated from autologous bone marrow

Scientific recommendation on classification of advanced therapy medicinal products: Mesenchymal stem cells isolated from autologous bone marrow

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous melanocytes

Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous melanocytes

Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous melanocytes

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous muscle-derived stem cells

Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous muscle-derived stem cells

Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous muscle-derived stem cells

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Human autologous keratinocytes

Scientific recommendation on classification of advanced therapy medicinal products: Human autologous keratinocytes

Scientific recommendation on classification of advanced therapy medicinal products: Human autologous keratinocytes

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Viable human autologous skin fibroblasts

Scientific recommendation on classification of advanced therapy medicinal products: Viable human autologous skin fibroblasts

Scientific recommendation on classification of advanced therapy medicinal products: Viable human autologous skin fibroblasts

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous chondrocytes

Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous chondrocytes

Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous chondrocytes

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Autologous cultured adipose derived mesenchymal stem cells

Scientific recommendation on classification of advanced therapy medicinal products: Autologous cultured adipose derived mesenchymal stem cells

Scientific recommendation on classification of advanced therapy medicinal products: Autologous cultured adipose derived mesenchymal stem cells

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Autologous cultured fibroblasts

Scientific recommendation on classification of advanced therapy medicinal products: Autologous cultured fibroblasts

Scientific recommendation on classification of advanced therapy medicinal products: Autologous cultured fibroblasts

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Concentrate of autologous bone marrow-derived mononuclear cells (BM-MNC)

Scientific recommendation on classification of advanced therapy medicinal products: Concentrate of autologous bone marrow-derived mononuclear cells (BM-MNC)

Scientific recommendation on classification of advanced therapy medicinal products: Concentrate of autologous bone marrow-derived mononuclear cells (BM-MNC)

Europe - EMA - European Medicines Agency

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Autologous suspension of blood-derived endothelial and hematopoietic stem/progenitor cells

Scientific recommendation on classification of advanced therapy medicinal products: Autologous suspension of blood-derived endothelial and hematopoietic stem/progenitor cells

Scientific recommendation on classification of advanced therapy medicinal products: Autologous suspension of blood-derived endothelial and hematopoietic stem/progenitor cells

Europe - EMA - European Medicines Agency

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Autologous anti-BCMA (B-cell maturation antigen) chimeric antigen receptor (CAR) T-cells

Scientific recommendation on classification of advanced therapy medicinal products: Autologous anti-BCMA (B-cell maturation antigen) chimeric antigen receptor (CAR) T-cells

Scientific recommendation on classification of advanced therapy medicinal products: Autologous anti-BCMA (B-cell maturation antigen) chimeric antigen receptor (CAR) T-cells

Europe - EMA - European Medicines Agency

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Autologous fibroblasts expanded in vitro

Scientific recommendation on classification of advanced therapy medicinal products: Autologous fibroblasts expanded in vitro

Scientific recommendation on classification of advanced therapy medicinal products: Autologous fibroblasts expanded in vitro

Europe - EMA - European Medicines Agency

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Autologous concentrated bone marrow

Scientific recommendation on classification of advanced therapy medicinal products: Autologous concentrated bone marrow

Scientific recommendation on classification of advanced therapy medicinal products: Autologous concentrated bone marrow

Europe - EMA - European Medicines Agency

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Autologous ex vivo expanded regulatory T lymphocytes with the cell marker profile of CD3+, CD4+, CD25high, CD127-, FoxP3+

Scientific recommendation on classification of advanced therapy medicinal products: Autologous ex vivo expanded regulatory T lymphocytes with the cell marker profile of CD3+, CD4+, CD25high, CD127-, FoxP3+

Scientific recommendation on classification of advanced therapy medicinal products: Autologous ex vivo expanded regulatory T lymphocytes with the cell marker profile of CD3+, CD4+, CD25high, CD127-, FoxP3+

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Spherox,spheroids of human autologous matrix-associated chondrocytes, decision type: , therapeutic area: , PIP number: P/0161/2018

Opinion/decision on a Paediatric investigation plan (PIP): Spherox,spheroids of human autologous matrix-associated chondrocytes, decision type: , therapeutic area: , PIP number: P/0161/2018

Opinion/decision on a Paediatric investigation plan (PIP): Spherox,spheroids of human autologous matrix-associated chondrocytes, decision type: , therapeutic area: , PIP number: P/0161/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with lentiviral vector that encodes for the human ARSA cDNA sequence (GSK2696274), decision type: , therapeutic area:

Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with lentiviral vector that encodes for the human ARSA cDNA sequence (GSK2696274), decision type: , therapeutic area:

Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with lentiviral vector that encodes for the human ARSA cDNA sequence (GSK2696274), decision type: , therapeutic area: , PIP number: P/0212/2018

Europe - EMA - European Medicines Agency

21-11-2018

EU/3/18/2085 (Rigenerand S.r.l.)

EU/3/18/2085 (Rigenerand S.r.l.)

EU/3/18/2085 (Active substance: Autologous human adipose perivascular stromal cells genetically modified to secrete soluble tumour necrosis factor-related apoptosis-inducing ligand) - Orphan designation - Commission Decision (2018)7794 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/110/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2089 (Dystrogen Therapeutics S.A.)

EU/3/18/2089 (Dystrogen Therapeutics S.A.)

EU/3/18/2089 (Active substance: Ex vivo fused normal allogeneic human myoblast with autologous human myoblast derived from Duchenne muscular dystrophy affected donor) - Orphan designation - Commission Decision (2018)7798 of Wed, 21 Nov 2018

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1863 (Celgene Europe B.V.)

EU/3/17/1863 (Celgene Europe B.V.)

EU/3/17/1863 (Active substance: Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human B cell maturation antigen with 4-1BB and CD3-zeta intracellular signalling domains) - Transfer of orphan designation - Commission Decision (2018)7574 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/270/16/02

Europe -DG Health and Food Safety

6-11-2018

Communication to stakeholders: Autologous human cells and tissues (HCT) products

Communication to stakeholders: Autologous human cells and tissues (HCT) products

Important information about potential impact of regulation changes that came in force on 1 July 2018

Therapeutic Goods Administration - Australia

30-10-2018

EU/3/18/2073 (Fondazione Telethon)

EU/3/18/2073 (Fondazione Telethon)

EU/3/18/2073 (Active substance: Autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA) - Orphan designation - Commission Decision (2018)7274 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/113/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Pharma Gateway AB)

EU/3/18/2061 (Active substance: Autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor) - Orphan designation - Commission Decision (2018)5739 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/049/18

Europe -DG Health and Food Safety

27-8-2018

Strimvelis (Orchard Therapeutics (Netherlands) B.V.)

Strimvelis (Orchard Therapeutics (Netherlands) B.V.)

Strimvelis (Active substance: autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5703 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3854/T/14

Europe -DG Health and Food Safety