506 results
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Human medicine European public assessment report (EPAR): Hycamtin
topotecan, Ovarian Neoplasms; Uterine Cervical Neoplasms; Small Cell Lung Carcinoma
Date of authorisation: 12/11/1996, Revision: 38, Authorised, Last updated: 16/01/2023Marketing-authorisation holder Sandoz Pharmaceuticals d.d. Revision … -
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Human medicine European public assessment report (EPAR): Atriance
nelarabine, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 22/08/2007,
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, Revision: 26, Authorised, Last updated: 16/01/2023
Marketing-authorisation holder Sandoz Pharmaceuticals d.d. Revision … -
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Human medicine European public assessment report (EPAR): Riximyo
rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Microscopic Polyangiitis; Wegener Granulomatosis
Date of authorisation: 15/06/2017,
, Revision: 11, Authorised, Last updated: 31/08/2022
Marketing-authorisation holder Sandoz GmbH Revision 11 Date of … this medicinal product is Sandoz GmbH. Riximyo will be available … -
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Human medicine European public assessment report (EPAR): Rixathon
rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Leukemia, Lymphocytic, Chronic, B-Cell; Wegener Granulomatosis; Microscopic Polyangiitis; Pemphigus
Date of authorisation: 15/06/2017,, Revision: 9, Authorised, Last updated: 31/08/2022
Marketing-authorisation holder Sandoz GmbH Revision 9 Date of issue … -
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Referral: Famvir
famciclovir, associated names: Famciclovir-Sandoz, Famciclovir-SB, Famciclovir-SB Zoster, Famvir Zoster and Oravir, Article 30 referrals
Status: European Commission final decision, opinion/position date: 22/04/2010, EC decision date: 27/07/2010, Last updated: 09/09/2011trade names: Famciclovir-Sandoz, Famciclovir-SB, Famciclovir-SB … trade names: Famciclovir-Sandoz, Famciclovir-SB, Famciclovir-SB … -
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Human medicine European public assessment report (EPAR): Binocrit
epoetin alfa, Anemia; Kidney Failure, Chronic
Date of authorisation: 28/08/2007,, Revision: 20, Authorised, Last updated: 31/10/2019
Marketing-authorisation holder Sandoz GmbH Revision 20 Date of … -
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National expert: Christopher Jarvis, European Medicines Agency (updated)
- Declaration of interests - 39.3 KB | PDF
- Curriculum Vitae - 27.24 KB | PDF
Nucleoside Analogues with Aciclovir. 4th Annual Skin Network Meeting … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 April 2015
CHMP, Last updated: 24/04/2015Pregabalin Sandoz … -
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Human medicine European public assessment report (EPAR): Zessly
infliximab, Arthritis, Psoriatic; Psoriasis; Crohn Disease; Arthritis, Rheumatoid; Colitis, Ulcerative; Spondylitis, Ankylosing
Date of authorisation: 18/05/2018,, Revision: 10, Authorised, Last updated: 12/12/2022
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Opinion/decision on a Paediatric investigation plan (PIP): amlodipine, hydrochlorothiazide, Ramipril
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002906-PIP01-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 19/03/2021, Last updated: 09/11/2021, Compliance check: Xof hypertension Oral use Sandoz GmbH E-mail: caroline.kleinjan@sandoz.com … application submitted by Sandoz GmbH on 23 October 2020 under … decision is addressed to Sandoz GmbH, Biochemiestrasse 10 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe, Rosuvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-003039-PIP01-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 19/11/2021, Last updated: 20/02/2023, Compliance check: Xhypercholesterolaemia Oral use Sandoz s.r.o. Tel.: +31 365241710 … application submitted by Sandoz s.r.o. on 1 June 2021 under … decision is addressed to Sandoz s.r.o., Na Pankráci 1724/129 … -
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Referral: Escitalopram
escitalopram, Article 30 referrals
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 18/02/2010, Last updated: 29/09/2010Ratiopharm, Escitalopram Sandoz, Escitalopram Stada, Escitalopram … Ratiopharm Nederland B.V., Sandoz B.V. and Winthrop Arzneimittel … Ratiopharm, Escitalopram Sandoz, Escitalopram Stada, Escitalopram … -
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Opinion/decision on a Paediatric investigation plan (PIP): clopidogrel hydrogen sulfate, Acetylsalicylic acid
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001257-PIP01-11, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 25/04/2012, Last updated: 24/05/2012, Compliance check: XContact for public enquiries Sandoz BV The Netherlands Phone … application submitted by Sandoz BV on 2 December 2011 under … decision is addressed to Sandoz BV, Veluwezoom 22, 1327 AH … -
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Opinion/decision on a Paediatric investigation plan (PIP): atorvastatin, Ezetimibe
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002852-PIP01-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/12/2020, Last updated: 22/09/2021, Compliance check: XContact for public enquiries Sandoz B.V. Email: caroline.kleinjan@sandoz.com … application submitted by Sandoz B.V. on 13 July 2020 under … decision is addressed to Sandoz B.V., Veluwezoom 22, 1327 … -
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Human medicine European public assessment report (EPAR): Ziextenzo
pegfilgrastim, Neutropenia
Date of authorisation: 22/11/2018,, , Revision: 5, Authorised, Last updated: 26/07/2022
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Press release: European Medicines Agency recommends precautionary recall of batches of clopidogrel-containing medicines from Acino Pharma GmbH
Last updated: 25/03/2010Ratiopharm GmbH and Clopidogrel Sandoz. The Marketing Authorisation … ratiopharm GmbH: EPAR Clopidogrel Sandoz: EPAR Questions and answers … Ratiopharm GmbH and Clopidogrel Sandoz. The Marketing Authorisation … -
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Orphan designation: Covalently closed DNA plasmids coding for cytomegalovirus phosphoprotein 65 and glycoprotein B genes for: Prevention of cytomegalovirus disease in patients with impaired cell-mediated immunity
Date of designation: 09/08/2012, Withdrawn, Last updated: 21/02/2019several antiviral medicines (aciclovir, ganciclovir, valaciclovir … -
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Human medicine European public assessment report (EPAR): Hefiya
adalimumab, Spondylitis, Ankylosing; Hidradenitis Suppurativa; Psoriasis; Arthritis, Juvenile Rheumatoid; Uveitis
Date of authorisation: 26/07/2018,, Revision: 12, Authorised, Last updated: 18/04/2023
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Human medicine European public assessment report (EPAR): Hyrimoz
adalimumab, Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis, Ankylosing; Uveitis; Hidradenitis Suppurativa; Colitis, Ulcerative; Arthritis, Juvenile Rheumatoid; Crohn Disease; Skin Diseases, Papulosquamous
Date of authorisation: 26/07/2018,, Revision: 11, Authorised, Last updated: 17/04/2023
Marketing-authorisation holder Sandoz GmbH Revision 11 Date of … -
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National expert: Maria Del Val Bermejo Sanz, The Spanish Agency Of Medicines And Medical Devices (updated)
- Declaration of interests - 41.53 KB | PDF
- Curriculum Vitae - 37.65 KB | PDF
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Human medicine European public assessment report (EPAR): Omnitrope
somatropin, Turner Syndrome; Prader-Willi Syndrome; Dwarfism, Pituitary
Date of authorisation: 12/04/2006,, Revision: 21, Authorised, Last updated: 23/01/2023
patients. Omnitrope (MAH: Sandoz), Zomacton and associated names … -
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Human medicine European public assessment report (EPAR): Aclasta
zoledronic acid, Osteoporosis; Osteitis Deformans; Osteoporosis, Postmenopausal
Date of authorisation: 15/04/2005, Revision: 31, Authorised, Last updated: 16/01/2023 -
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National expert: Javier Gisbert, European Medicines Agency (updated)
- Declaration of interests - 41.46 KB | PDF
- Curriculum Vitae - 35.61 KB | PDF
Takeda, Janssen, Roche, Sandoz, Celgene/Bristol Mye Cross … Takeda, Janssen, Roche, Sandoz, Celgene/Bristol Mye Several … Mylan, Takeda, Janssen, Roche, Sandoz, Celgene/Bristol Myers, Gilead/Galapagos … -
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Referral: Leuprorelin-containing depot medicinal products
leuprorelin, associated names: Daronda, Depo-Eligard, Eligard, Eligard Depot, Eligard Mensua, Eligard Semestral, Eligard Trimestral, Elityran 1 Month Depot (Dps), Elityran 3 Month Depot (Dps), Enanton Depot Dual, Enanton Depot Set, Enantone, Enantone L.P, Enantone Lp, Enantone Monats-Depot, Ginecrin Depot, Klebrocid 3-Monats-Depot, Klebrocid Depot Zweikammerspritze, Leptoprol, Lerin, Leugon, Leuprex 3, Leuprol, Leuprolin Ratiopharm, Leuprone 1-Monatsdepot, Leuprone 3-Monatsdepot, Leuprorelin 1-Month Depot Gp-Pharm, Leuprorelin Hexal, Leuprorelin Sandoz, Leuprorelina Gp-Pharm, Leupro-Sandoz 1-Monats-Depot, Leupro-Sandoz 3-Monats-Depot, Leuprorelina Trimestral Sandoz, Leuprostin, Leuproreline Sandoz, Lucrin, Lucrin Depot, Lucrin Pds Depot, Lucrin Pds Depot 1 Maand, Lucrin Pds Depot 3 Maanden, Lucrin Pds Depot 6 Maanden, Lupron Depo, Lutrate 1 Month Depot, Lutrate 3 Month Depot, Lutrate Depo, Lutrate Depot, Lutrate Depot Trimestral, Politrate, Politrate Depot, Procren Depot, Procren Depot Pds, Procrin Mensual, Procrin Semestral, Procrin Trimestral, Prostap 3 Dcs, Prostap 6 Dcs, Prostap Sr Dcs, Prostaplant, Sixantone, Trenantone, Trenantone-Gyn, Zeulide, Елигард, Лутрат Депо, Article 31 referrals
Status: CMDh final position, opinion/position date: 24/06/2020, Last updated: 31/07/2020 -
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Human medicine European public assessment report (EPAR): Erelzi
etanercept, Arthritis, Psoriatic; Psoriasis; Arthritis, Juvenile Rheumatoid; Arthritis, Rheumatoid; Spondylitis, Ankylosing
Date of authorisation: 23/06/2017,, , Revision: 12, Authorised, Last updated: 09/09/2022
Marketing-authorisation holder Sandoz GmbH Revision 12 Date of … this medicinal product is Sandoz GmbH. Erelzi will be available …