514 results
Keyword Indapamide Sandoz Remove keyword
-
List item
Opinion/decision on a Paediatric investigation plan (PIP): atorvastatin (calcium trihydrate), Indapamide, perindopril arginine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002395-PIP01-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 08/10/2018, Last updated: 29/01/2019, Compliance check: Xatorvastatin (calcium trihydrate) Indapamide perindopril arginine Therapeutic … statin (calcium trihydrate) Indapamide perindopril arginine … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Acetylsalicylic acid, indapamide (hemihydrate), perindopril tert-butylamine, rosuvastatin calcium
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002366-PIP01-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 12/09/2018, Last updated: 18/01/2019, Compliance check: Xsubstance Acetylsalicylic acid indapamide (hemihydrate) perindopril … Acetylsalicylic acid indapamide (hemihydrate) perindopril … -
List item
Referral: Methylphenidate Sandoz
methylphenidate hydrochloride, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 25/07/2013, EC decision date: 09/10/2013, Last updated: 05/12/2013Methylphenidate Sandoz … medicine Methylphenidate Sandoz. The Agency's Committee for … benefits of Methylphenidate Sandoz outweigh its risks, and the … -
List item
Referral: Budesonide Sandoz
budesonide, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 20/02/2009, EC decision date: 07/05/2009, Last updated: 25/06/2009Budesonide Sandoz … of the medicine Budesonide Sandoz. The Agency's Committee for … the benefits of Budesonide Sandoz outweigh its risks, and the … -
List item
Referral: Calcium Sandoz
Calcium lactate gluconate, Calcium carbonate, Article 30 referrals
Status: European Commission final decision, opinion/position date: 21/04/2005, EC decision date: 09/08/2005, Last updated: 09/08/2005Calcium Sandoz … medicinal product Calcium Sandoz Effervescent tablets, 500/1000 … benefit/risk ratio of Calcium Sandoz Effervescent tablets, 500/1000 … -
List item
Referral: Mometasone Furoate Sandoz
mometasone furoate, associated names: Mometasone Sandoz, Mometasone Sandoz 50, Mometasone Furoato Sandoz 50, Mommox, Nasometi, Fumomo 50, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/07/2012, EC decision date: 08/10/2012, Last updated: 24/01/2013Mometasone Furoate Sandoz … medicine Mometasone Furoate Sandoz. The Agency's Committee for … benefits of Mometasone Furoate Sandoz outweigh its risks, and that … -
List item
Referral: Loratadine Sandoz 10
loratadine, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 29/05/2009, EC decision date: 06/08/2009, Last updated: 12/12/2009Loratadine Sandoz 10 … of the medicine Loratadine Sandoz 10. The Agency's Committee … the benefits of Loratadine Sandoz 10 do not outweigh its risks … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 April 2015
CHMP, Last updated: 24/04/2015Pregabalin Sandoz … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 …