1313 results
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National expert: Gitte Larsen, Danish Medicines Agency (updated)
- Declaration of interests - 79.79 KB | PDF
- Curriculum Vitae - 16.98 KB | PDF
Gitte Larsen … Gitte Larsen … Vitae PERSONAL INFORMATION Gitte Larsen WORK EXPERIENCE February … -
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National expert: Gitte Bach-Breitling, Danish Medicines Agency (updated)
- Declaration of interests - 79.8 KB | PDF
- Curriculum Vitae - 16.37 KB | PDF
Gitte Bach-Breitling … Gitte Bach-Breitling … Vitae PERSONAL INFORMATION Gitte Bach-Breitling WORK EXPERIENCE March … -
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Referral: Lipitor
atorvastatin, associated names: Atorvastatin, Atorvastatina Nostrum, Atorvastatina Parke-Davis, Atorvastatina Pharmacia, Cardyl, Edovin, Liprimar, Orbeos, Prevencor, Sortis, Tahor, Texzor, Torvast, Totalip, Xarator, Zarator, Article 30 referrals
Status: European Commission final decision, opinion/position date: 23/09/2010, EC decision date: 13/12/2010, Last updated: 10/04/2012trade names: Atorvastatin, Atorvastatina Nostrum Atorvastatina Parke-Davis Atorvastatina Pharmacia, Cardyl, Edovin … trade names: Atorvastatin, Atorvastatina Nostrum Atorvastatina Parke-Davis Atorvastatina Pharmacia, Cardyl, Edovin … -
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Human medicine European public assessment report (EPAR): Zometa
zoledronic acid, zoledronic acid monohydrate, Cancer; Fractures, Bone
Date of authorisation: 20/03/2001, Revision: 36, Authorised, Last updated: 09/07/2021breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … any fractures or any spinal compression. Zometa has also been compared … breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … -
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Human medicine European public assessment report (EPAR): Zoledronic Acid Accord
zoledronic acid monohydrate, Hypercalcemia; Fractures, Bone; Cancer
Date of authorisation: 16/01/2014,
, Revision: 9, Authorised, Last updated: 24/01/2022
breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … -
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Human medicine European public assessment report (EPAR): Zoledronic acid medac
zoledronic acid monohydrate, Fractures, Bone; Cancer
Date of authorisation: 03/08/2012,, Revision: 13, Authorised, Last updated: 20/11/2020
breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … -
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Human medicine European public assessment report (EPAR): Zoledronic acid Mylan
zoledronic acid, Fractures, Bone
Date of authorisation: 23/08/2012,, Revision: 13, Authorised, Last updated: 24/06/2022
breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … -
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Human medicine European public assessment report (EPAR): Zoledronic acid Actavis
zoledronic acid monohydrate, Fractures, Bone
Date of authorisation: 20/04/2012,, Revision: 14, Authorised, Last updated: 05/01/2022
breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … pathological fractures, spinal compression, radiation or surgery to … -
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Human medicine European public assessment report (EPAR): Zoledronic Acid Hospira
zoledronic acid monohydrate, Hypercalcemia
Date of authorisation: 19/11/2012,, Revision: 18, Authorised, Last updated: 09/11/2021
breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … -
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Human medicine European public assessment report (EPAR): Zoledronic acid Teva
zoledronic acid, Fractures, Bone; Cancer
Date of authorisation: 16/08/2012,, Revision: 14, Authorised, Last updated: 11/10/2021
breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders … pathological fractures, spinal compression, radiation or surgery to … -
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Human medicine European public assessment report (EPAR): VeraSeal
human fibrinogen, human thrombin, Hemostasis, Surgical
Date of authorisation: 10/11/2017, Revision: 7, Authorised, Last updated: 12/01/2023worked better than manual compression, with 76% of patients having … compared with 23% after manual compression (13 out of 57). In a second … intermittent application of compresses, swabs, use of suction devices … -
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Human medicine European public assessment report (EPAR): Evicel (updated)
human fibrinogen, human thrombin, Hemostasis, Surgical
Date of authorisation: 05/10/2008, Revision: 17, Authorised, Last updated: 21/03/2023compared Evicel with manual compression (applying direct pressure … received Evicel or manual compression. The second study compared … patients treated with manual compression (28 out of 72). During abdominal … -
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Referral: Sortis
atorvastatin, associated names: Lipitor, Zarator, Orbeos, Tahor, Liprimar, Atorvastatin, Atorvastatina, Edovin, Obradon, Xarator, Torvast, Totalip, Texzor, Cardyl, Prevencor, Article 29 paediatrics
Status: European Commission final decision, opinion/position date: 18/03/2010, EC decision date: 01/07/2010, Last updated: 27/04/2011Tahor Liprimar Atorvastatin Atorvastatina Edovin Obradon Xarator Torvast … -
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Referral: Sortis
atorvastatin, associated names: Lipitor, Zarator, Orbeos, Tahor, Liprimar, Atorvastatin, Atorvastatina, Edovin, Obradon, Xarator, Torvast, Totalip, Texzor, Cardyl, Prevencor, Article 29 paediatrics
Status: European Commission final decision, opinion/position date: 18/03/2010, EC decision date: 01/07/2010, Last updated: 27/04/2011Tahor Liprimar Atorvastatin Atorvastatina Edovin Obradon Xarator Torvast … -
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Referral: Sortis
atorvastatin, associated names: Lipitor, Zarator, Orbeos, Tahor, Liprimar, Atorvastatin, Atorvastatina, Edovin, Obradon, Xarator, Torvast, Totalip, Texzor, Cardyl, Prevencor, Article 29 paediatrics
Status: European Commission final decision, opinion/position date: 18/03/2010, EC decision date: 01/07/2010, Last updated: 27/04/2011Tahor Liprimar Atorvastatin Atorvastatina Edovin Obradon Xarator Torvast … -
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Human medicine European public assessment report (EPAR): Camcevi
leuprorelin mesilate, Prostatic Neoplasms
Date of authorisation: 24/05/2022, Authorised, Last updated: 20/06/2022patients with spinal cord compression or those whose cancer has … patients with spinal cord compression or those whose cancer has … -
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Human medicine European public assessment report (EPAR): Xgeva
denosumab, Fractures, Bone; Neoplasm Metastasis
Date of authorisation: 13/07/2011, Revision: 23, Authorised, Last updated: 21/07/2022breaks in the bone), spinal compression (pressure on the spinal cord … breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), or complications … -
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Human medicine European public assessment report (EPAR): Cholib
fenofibrate, simvastatin, Dyslipidemias
Date of authorisation: 26/08/2013, Revision: 13, Authorised, Last updated: 13/08/2021 -
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Veterinary medicine European public assessment report (EPAR): Purevax RC
attenuated feline rhinotracheitis herpesvirus (FHV F2 strain), inactivated feline calicivirosis antigens (FCV 431 and G1 strains), Cats
Date of authorisation: 23/02/2005, Revision: 16, Authorised, Last updated: 29/03/2022 -
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Veterinary medicine European public assessment report (EPAR): Arti-Cell Forte
chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells, Horses
Date of authorisation: 29/03/2019, Revision: 5, Authorised, Last updated: 25/10/2021 -
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Veterinary medicine European public assessment report (EPAR): Kriptazen
halofuginone, Calves, newborn
Date of authorisation: 08/02/2019,, Revision: 2, Authorised, Last updated: 20/10/2021
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Orphan designation: Modified recombinant human C-type natriuretic peptide (Vosoritide) for: Treatment of achondroplasia
Date of designation: 24/01/2013, Positive, Last updated: 09/09/2021bowed legs, ear problems, compression of the spinal cord, as well … length, to correct spinal compression or to correct bowed legs … bowed legs, ear problems, compression of the spinal cord, as well … -
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Human medicine European public assessment report (EPAR): IntronA
interferon alfa-2b, Carcinoid Tumor; Leukemia, Hairy Cell; Lymphoma, Follicular; Hepatitis B, Chronic; Hepatitis C, Chronic; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Melanoma; Multiple Myeloma
Date of authorisation: 09/03/2000, Revision: 34, Withdrawn, Last updated: 15/12/2022major organ obstruction or compression syndrome, orbital or epidural … -
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Orphan designation: C-type natriuretic peptide conjugated to multi-arm polyethylene glycol carrier through a cleavable linker for: Treatment of achondroplasia
Date of designation: 27/07/2020, Positive, Last updated: 19/11/2020bowed legs, ear problems, compression of the spinal cord, as well … -
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Press release: Novartis withdraws its application to extend the marketing authorisation for Zometa
CHMP, Last updated: 20/11/2007pathological fractures, spinal compression, radiation or surgery to bone … pathological fractures, spinal compression, radiation or surgery to …