83 results
-
List item
Human medicine European public assessment report (EPAR): Olanzapine Glenmark
olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 03/12/2009,
, Revision: 15, Authorised, Last updated: 20/12/2022
Olanzapine Glenmark Schizophrenia Spectrum and … Olanzapine Glenmark … for the public Olanzapine Glenmark olanzapine This is a … -
List item
Human medicine European public assessment report (EPAR): Olanzapine Glenmark Europe
olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 03/12/2009,, Revision: 14, Authorised, Last updated: 20/12/2022
Olanzapine Glenmark Europe Schizophrenia Spectrum … Olanzapine Glenmark Europe … for the public Olanzapine Glenmark Europe Olanzapine This … -
List item
Human medicine European public assessment report (EPAR): Olazax
olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 11/12/2009,, Revision: 12, Authorised, Last updated: 31/07/2020
Marketing-authorisation holder Glenmark Pharmaceuticals s.r.o. … 11/12/2009 Contact address Glenmark Pharmaceuticals s.r.o. Hvezdova … -
List item
Human medicine European public assessment report (EPAR): Olazax Disperzi
olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 10/12/2009,, Revision: 12, Authorised, Last updated: 16/06/2020
Marketing-authorisation holder Glenmark Pharmaceuticals s.r.o. … 10/12/2009 Contact address Glenmark Pharmaceuticals s.r.o. Hvezdova … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Mometasone (furoate monohydrate), Olopatadine (hydrochloride) (GSP 301 NS)
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-002514-PIP01-18, Route(s) of administration: Intranasal use, Pharmaceutical form(s): Nasal spray, suspension
Decision date: 15/05/2019, Last updated: 21/09/2021, Compliance check: V, 27/03/2020rhino-conjunctivitis Intranasal use Glenmark Pharmaceuticals Europe Ltd … 1923202950 E-mail: PIP@glenmarkpharma.com P: decision agreeing … -
List item
National expert: Massimo Tempestilli, Italian Medicines Agency (updated)
- Declaration of interests - 39.2 KB | PDF
- Curriculum Vitae - 35.93 KB | PDF
-
List item
National expert: Arpad Szallasi, National Institute of Pharmacy and Nutrition (updated)
- Declaration of interests - 40.67 KB | PDF
- Curriculum Vitae - 25.61 KB | PDF
member Past 08-05- 2006 09-01- 2010 Glenmark Cross product related … -
List item
Human medicine European public assessment report (EPAR): Sustiva (updated)
efavirenz, HIV Infections
Date of authorisation: 28/05/1999, Revision: 48, Authorised, Last updated: 25/05/2023 -
List item
Human medicine European public assessment report (EPAR): Stocrin
efavirenz, HIV Infections
Date of authorisation: 28/05/1999, Revision: 49, Authorised, Last updated: 25/04/2023 -
List item
Human medicine European public assessment report (EPAR): Ritonavir Mylan (updated)
ritonavir, HIV Infections
Date of authorisation: 09/11/2017,, Revision: 14, Authorised, Last updated: 17/05/2023
-
List item
Human medicine European public assessment report (EPAR): Artesunate Amivas
artesunate, Malaria
Date of authorisation: 22/11/2021,
, 
, Revision: 1, Authorised, Last updated: 24/04/2023
-
List item
Human medicine European public assessment report (EPAR): Lamivudine/Zidovudine Teva
lamivudine, zidovudine, HIV Infections
Date of authorisation: 28/02/2011,, Revision: 16, Withdrawn, Last updated: 21/03/2023
-
List item
Human medicine European public assessment report (EPAR): Efavirenz Teva
efavirenz, HIV Infections
Date of authorisation: 09/01/2012,, Revision: 12, Authorised, Last updated: 03/03/2023
-
List item
Human medicine European public assessment report (EPAR): Paxlovid (updated)
nirmatrelvir, ritonavir, COVID-19 virus infection
Date of authorisation: 28/01/2022, Revision: 11, Authorised, Last updated: 03/05/2023 -
List item
Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Krka
efavirenz, emtricitabine, tenofovir disoproxil succinate, HIV Infections
Date of authorisation: 08/02/2018,, Revision: 9, Authorised, Last updated: 05/12/2022
-
List item
Human medicine European public assessment report (EPAR): Trizivir
abacavir (as sulfate), lamivudine, zidovudine, HIV Infections
Date of authorisation: 27/12/2000, Revision: 42, Authorised, Last updated: 27/09/2022 -
List item
Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
efavirenz, emtricitabine, tenofovir disoproxil maleate, HIV Infections
Date of authorisation: 05/09/2017,, Revision: 13, Authorised, Last updated: 14/09/2022
-
List item
Human medicine European public assessment report (EPAR): Norvir
ritonavir, HIV Infections
Date of authorisation: 25/08/1996, Revision: 68, Authorised, Last updated: 18/10/2022 -
List item
Human medicine European public assessment report (EPAR): Juluca
dolutegravir sodium, rilpivirine hydrochloride, HIV Infections
Date of authorisation: 16/05/2018, Revision: 14, Authorised, Last updated: 02/02/2023 -
List item
Human medicine European public assessment report (EPAR): Combivir
lamivudine, zidovudine, HIV Infections
Date of authorisation: 18/03/1998, Revision: 37, Authorised, Last updated: 29/08/2022 -
List item
Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva
efavirenz, emtricitabine, tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 17/07/2017,, Revision: 8, Authorised, Last updated: 18/05/2022
-
List item
Human medicine European public assessment report (EPAR): Crixivan
indinavir sulfate ethanolate, HIV Infections
Date of authorisation: 04/10/1996, Revision: 39, Withdrawn, Last updated: 12/07/2022 -
List item
Human medicine European public assessment report (EPAR): Atripla
efavirenz, emtricitabine, tenofovir disoproxil fumarate, HIV Infections
Date of authorisation: 13/12/2007, Revision: 36, Withdrawn, Last updated: 21/01/2022 -
List item
National expert: Christophe Richez, European Medicines Agency (updated)
- Declaration of interests - 60.86 KB | PDF
- Curriculum Vitae - 29.16 KB | PDF
null Past 01-02- 2018 01-01- 2020 GLENMARK PHARMACEUTICALS Cross product … -
List item
Human medicine European public assessment report (EPAR): Grepid
clopidogrel (as besilate), Peripheral Vascular Diseases; Stroke; Myocardial Infarction
Date of authorisation: 27/07/2009,, Revision: 25, Authorised, Last updated: 27/07/2022