601 results
Keyword Erlotinib Sandoz Remove keyword
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Human medicine European public assessment report (EPAR): Giotrif
afatinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 25/09/2013, Revision: 15, Authorised, Last updated: 21/06/2023another cancer medicine, erlotinib. What are the risks associated … another cancer medicine, erlotinib. What are the risks associated … -
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Human medicine European public assessment report (EPAR): Aybintio
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 19/08/2020,
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, Revision: 7, Authorised, Last updated: 11/04/2023
Aybintio, in combination with erlotinib, is indicated for first-line … Aybintio, in combination with erlotinib, is indicated for first-line … -
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Summary of opinion: Herwenda (new)
trastuzumab, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023action. medicinal product is Sandoz GmbH. Herwenda will be available … this medicinal product is Sandoz GmbH. Herwenda will be … -
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Human medicine European public assessment report (EPAR): Alymsys
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 26/03/2021,, , Revision: 6, Authorised, Last updated: 26/07/2023
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Human medicine European public assessment report (EPAR): Oyavas
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 26/03/2021,, , Revision: 5, Authorised, Last updated: 14/07/2023
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Human medicine European public assessment report (EPAR): Onbevzi
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 11/01/2021,, , Revision: 4, Authorised, Last updated: 11/04/2023
Onbevzi, in combination with erlotinib, is indicated for first-line … -
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Human medicine European public assessment report (EPAR): Abevmy
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 21/04/2021,, , Revision: 5, Authorised, Last updated: 15/12/2022
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Human medicine European public assessment report (EPAR): Ziextenzo (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 22/11/2018,, Revision: 8, Authorised, Last updated: 05/09/2023
Marketing-authorisation holder Sandoz GmbH Revision 8 Date of issue … -
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Human medicine European public assessment report (EPAR): Zarzio (updated)
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 06/02/2009,, Revision: 23, Authorised, Last updated: 18/09/2023
throughout the EU for Zarzio to Sandoz GmbH on 6 February 2009 … -
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Human medicine European public assessment report (EPAR): Halimatoz
adalimumab, Hidradenitis Suppurativa; Psoriasis; Arthritis, Juvenile Rheumatoid; Uveitis; Arthritis, Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic
Date of authorisation: 26/07/2018,, , Revision: 8, Withdrawn, Last updated: 29/01/2021
Marketing-authorisation holder Sandoz GmbH Revision 8 Date of issue … marketing authorisation holder, Sandoz GmbH, which notified the … -
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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: 11, Authorised, Last updated: 18/09/2023
Marketing-authorisation holder Sandoz GmbH Revision 11 Date of … -
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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: 13, Authorised, Last updated: 18/09/2023
Marketing-authorisation holder Sandoz GmbH Revision 13 Date of … this medicinal product is Sandoz GmbH. Riximyo will be available … -
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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: 13, Authorised, Last updated: 04/08/2023
Marketing-authorisation holder Sandoz GmbH Revision 13 Date of … this medicinal product is Sandoz GmbH. Erelzi will be available … -
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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: 11, Authorised, Last updated: 14/07/2023
Marketing-authorisation holder Sandoz GmbH Revision 11 Date of … -
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Withdrawn application: Dimherity
dimethyl fumarate, date of withdrawal: 22/02/2022, Initial authorisation, Last updated: 03/11/2022dimethyl fumarate Overview Sandoz GmbH withdrew its application … Dimherity (dimethyl fumarate) Sandoz GmbH withdrew its application … that, at this point of time, Sandoz GmbH has taken the decision … -
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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,, 
, 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): Hefiya (updated)
adalimumab, Spondylitis, Ankylosing; Hidradenitis Suppurativa; Psoriasis; Arthritis, Juvenile Rheumatoid; Uveitis
Date of authorisation: 26/07/2018,, Revision: 14, Authorised, Last updated: 20/09/2023
Marketing-authorisation holder Sandoz GmbH Revision 14 Date of … -
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Human medicine European public assessment report (EPAR): Hyrimoz (updated)
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: 13, Authorised, Last updated: 20/09/2023
Marketing-authorisation holder Sandoz GmbH Revision 13 Date of … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 May 2020
CHMP, Last updated: 29/05/2020Erlotinib Accord … -
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News: EMA promotes consistent development of bioequivalence studies through product-specific guidance
CHMP, Last updated: 15/11/2013emtricitabine/tenofovir disproxil; erlotinib; imatinib; memantine; miglustat … -
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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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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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Human medicine European public assessment report (EPAR): Tagrisso
osimertinib mesilate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 01/02/2016,
, Revision: 18, Authorised, Last updated: 11/08/2023
with other medicines (either erlotinib or gefitinib). Finally, in … with other medicines (either erlotinib or gefitinib). Finally … -
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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 …