527 results
Keyword Indapamide Sandoz Remove keyword
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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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Human medicine European public assessment report (EPAR): Hycamtin (updated)
topotecan, Ovarian Neoplasms; Uterine Cervical Neoplasms; Small Cell Lung Carcinoma
Date of authorisation: 12/11/1996, Revision: 39, Authorised, Last updated: 04/12/2023 -
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Human medicine European public assessment report (EPAR): Riximyo (updated)
rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Microscopic Polyangiitis; Wegener Granulomatosis
Date of authorisation: 15/06/2017,
, Revision: 14, Authorised, Last updated: 29/11/2023
this medicinal product is Sandoz GmbH. Riximyo will be available … -
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Human medicine European public assessment report (EPAR): Rixathon (updated)
rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Leukemia, Lymphocytic, Chronic, B-Cell; Wegener Granulomatosis; Microscopic Polyangiitis; Pemphigus
Date of authorisation: 15/06/2017,, Revision: 12, Authorised, Last updated: 29/11/2023
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Human medicine European public assessment report (EPAR): Binocrit (updated)
epoetin alfa, Anemia; Kidney Failure, Chronic
Date of authorisation: 28/08/2007,, Revision: 22, Authorised, Last updated: 21/11/2023
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Human medicine European public assessment report (EPAR): Tyruko (updated)
natalizumab, Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis
Date of authorisation: 22/09/2023,
, , Revision: 1, Authorised, Last updated: 20/11/2023
Marketing-authorisation holder Sandoz GmbH Revision 1 Date of issue … -
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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: 22, Authorised, Last updated: 20/09/2023
Marketing-authorisation holder Sandoz GmbH Revision 22 Date of … patients. Omnitrope (MAH: Sandoz), Zomacton and associated names … -
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National expert: Javier Gisbert, European Medicines Agency (updated)
- Declaration of interests - 41.48 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): 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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Referral: Valtrex
valaciclovir, associated names: Zelitrex, Talavir, Valaciclovir Allen, Valherpes, Article 30 referrals
Status: European Commission final decision, opinion/position date: 22/04/2010, EC decision date: 13/07/2010, Last updated: 25/03/2014Valaciclovir GSK, Valaciclovir Sandoz, Valaciclovir Winthrop, Valavir … Valaciclovir GSK, Valaciclovir Sandoz, Valaciclovir Winthrop, Valavir … -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use,22-25 September 2008
CHMP, Last updated: 25/09/2008concerned are: Budesonide Sandoz 32/64 μg nasal spray (budesonide … spray (budesonide), from Sandoz Pharmaceutical GmbH, indicated … should be included. Loratadine Sandoz 10, 10 mg tablets (loratadine … -
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Opinion/decision on a Paediatric investigation plan (PIP): abacavir, lamivudine, efavirenz
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-002114-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 30/06/2017, Last updated: 25/07/2017, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ramipril, amlodipine (as besylate)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-003070-PIP01-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 03/12/2021, Last updated: 14/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Acetylcysteine, paracetamol, phenylephrine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases; Oto-rhino-laryngology
PIP number: EMEA-003091-PIP01-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Granules for oral solution
Decision date: 31/12/2021, Last updated: 14/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Azelastine (hydrochloride), Mometasone furoate
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oto-rhino-laryngology
PIP number: EMEA-003122-PIP01-21, Route(s) of administration: Nasal use, Pharmaceutical form(s): Nasal spray suspension
Decision date: 10/08/2022, Last updated: 29/08/2023, Compliance check: X -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 July 2012
CHMP, Last updated: 20/07/2012Farmaceuticos, Lda Mometasone Furoate Sandoz mometasone furoate Sandoz B.V … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 June 2015
CHMP, Last updated: 26/06/2015Aripiprazole Sandoz … -
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National expert: Lucija Kusar, Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (updated)
- Declaration of interests - 10.76 KB | PDF
- Curriculum Vitae - 25.27 KB | PDF
Slovenia 3. Employer: Lek d.d., Sandoz/Novartis • Start date: 2010 • … -
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National expert: Loreto Carmona, European Medicines Agency (updated)
- Declaration of interests - 12.63 KB | PDF
- Curriculum Vitae - 47.03 KB | PDF
Nordisk Pharma, Pfizer, Sandoz, Sanofi, Cross product related … -
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National expert: Martin Walter, Austrian Agency for Health and Food Safety (updated)
- Declaration of interests - 39.2 KB | PDF
- Curriculum Vitae - 29.63 KB | PDF
Austria 5. Employer: Novartis (Sandoz) • Start date: 08.2010 • … Austria 6. Employer: Novartis (Sandoz) • Start date: 07.2009 • … Austria 7. Employer: Novartis (Sandoz) • Start date: 07.2008 • … -
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Referral: Cefuroximaxetil
cefuroxime (as axetil), Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 26/04/2007, EC decision date: 22/08/2007, Last updated: 24/09/2007children above 12 years of age. Sandoz B.V. submitted applications … above 12 years of age. Sandoz B.V. submitted applications … administration The Netherlands Sandoz B.V. Veluwezoom 22 1327 … -
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Referral: Ceftriaxone Tyrol Pharma
Ceftriaxone, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 01/06/2006, EC decision date: 21/08/2006, Last updated: 30/08/2006additional anaerobic coverage. Sandoz GmbH submitted applications … additional anaerobic coverage. Sandoz GmbH submitted applications … administration Germany Sandoz GmbH Biochemiestrasse 10 … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2015
CHMP, Last updated: 24/07/2015Pemetrexed Sandoz … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 September 2013
CHMP, Last updated: 20/09/2013Levodopa/Carbidopa/Entacapone Sandoz, …