7350 results
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Human medicine European public assessment report (EPAR): Silapo
epoetin zeta, Anemia; Blood Transfusion, Autologous; Cancer; Kidney Failure, Chronic
Date of authorisation: 18/12/2007,
, Revision: 17, Authorised, Last updated: 25/11/2020
Marketing-authorisation holder Stada Arzneimittel AG Revision … 18/12/2007 Contact address Stadastrasse 2-18 D-61118 Bad Vilbel Germa … dossier The applicant STADA Arzneimittel AG submitted … -
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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: 29/09/2010Escitalopram Sandoz, Escitalopram Stada, Escitalopram Tiefenbacher … years for some medicines (e.g. different indications, contraindications … Escitalopram Sandoz, Escitalopram Stada, Escitalopram Tiefenbacher … -
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Human medicine European public assessment report (EPAR): Oyavas (updated)
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: 6, Authorised, Last updated: 09/11/2023
fallopian tube that carries the egg from the ovary to the womb … fallopian tube that carries the egg from the ovary to the womb … this medicinal product is STADA Arzneimittel AG. Oyavas … -
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Human medicine European public assessment report (EPAR): Kinpeygo
budesonide, micronised, Glomerulonephritis, IGA
Date of authorisation: 15/07/2022,, 
, 
, Revision: 5, Authorised, Last updated: 21/08/2023
Marketing-authorisation holder Stada Arzneimittel AG Revision … 15/07/2022 Contact address Stadastrasse 2-18 D-61118 Bad Vilbel Germa … -
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Summary of opinion: Uzpruvo (new)
ustekinumab, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023action. medicinal product is STADA Arzneimittel AG. Uzpruvo … this medicinal product is STADA Arzneimittel AG. Uzpruvo … -
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Human medicine European public assessment report (EPAR): Movymia
teriparatide, Osteoporosis
Date of authorisation: 11/01/2017,, Revision: 10, Authorised, Last updated: 20/01/2022
Marketing-authorisation holder STADA Arzneimittel AG Revision … 11/01/2017 Contact address Stadastrasse 2-18 Bad Vilbel Hessen 61118 … -
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Human medicine European public assessment report (EPAR): Hukyndra
adalimumab, Arthritis, Psoriatic; Arthritis, Juvenile Rheumatoid; Arthritis, Rheumatoid; Colitis, Ulcerative; Crohn Disease; Hidradenitis Suppurativa; Psoriasis; Spondylitis, Ankylosing; Uveitis
Date of authorisation: 15/11/2021,, Revision: 4, Authorised, Last updated: 09/03/2023
Marketing-authorisation holder Stada Arzneimittel AG Revision … 15/11/2021 Contact address Stadastrasse 2-18 D-61118 Bad Vilbel Germa … -
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Referral: Doxastad 4 mg
Doxazosin, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 28/06/2006, EC decision date: 11/10/2006, Last updated: 11/10/2006benign prostatic hyperplasia. Stada Artzneimittel submitted applications … prostatic hyperplasia. Stada Artzneimittel submitted applications … administration Estonia STADA Arzneimittel AG Stadastr. 2-18, 61118 Bad Vilbel Germany … -
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Human medicine European public assessment report (EPAR): Libmyris
adalimumab, Arthritis, Rheumatoid; Arthritis, Juvenile Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic; Psoriasis; Hidradenitis Suppurativa; Crohn Disease; Colitis, Ulcerative; Uveitis
Date of authorisation: 12/11/2021,, Revision: 1, Authorised, Last updated: 11/01/2023
Marketing-authorisation holder Stada Arzneimittel AG Revision … 12/11/2021 Contact address Stadastrasse 2-18 D-61118 Bad Vilbel Germa … -
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Orphan designation: Budesonide for: Treatment of primary IgA nephropathy
Date of designation: 18/11/2016, Positive, Last updated: 14/09/2022designation 18/11/2016 Sponsor STADA Arzneimittel AG Stadastrasse 2-18 Dortelweil 61118 Bad … Hassia Germany E-mail: info@stada.de … -
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Human medicine European public assessment report (EPAR): GONAL-f
follitropin alfa, Anovulation; Reproductive Techniques, Assisted; Infertility, Female; Hypogonadism
Date of authorisation: 20/10/1995, Revision: 26, Authorised, Last updated: 09/10/2023over) who do not produce eggs and do not respond to treatment … stimulates the ovaries to produce eggs); adult women who are undergoing … to produce more than one egg at a time; adult women with … -
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Human medicine European public assessment report (EPAR): Tarceva
erlotinib, Carcinoma, Non-Small-Cell Lung; Pancreatic Neoplasms
Date of authorisation: 19/09/2005, Revision: 32, Authorised, Last updated: 16/05/2023epidermal growth factor receptor (EGFR); patients with EGFR activating mutations whose … treat cancer); patients with EGFR activating mutations in whom … worked; patients without EGFR activating mutations in whom … -
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Human medicine European public assessment report (EPAR): Tagrisso (updated)
osimertinib mesilate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 01/02/2016,
, Revision: 19, Authorised, Last updated: 20/11/2023
gene for a protein called EGFR. • In patients whose cancer … confirm that the patient has an EGFR mutation. Tagrisso is available … It blocks the activity of EGFR, which normally controls growth … -
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Human medicine European public assessment report (EPAR): Ximluci
ranibizumab, Wet Macular Degeneration; Macular Edema; Diabetic Retinopathy; Diabetes Complications
Date of authorisation: 09/11/2022,, , Revision: 1, Authorised, Last updated: 20/06/2023
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Human medicine European public assessment report (EPAR): Rybrevant
amivantamab, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 09/12/2021,, , Revision: 3, Authorised, Last updated: 22/09/2023
epidermal growth factor receptor (EGFR), and are known as ‘activating … are known as ‘activating EGFR exon 20 insertion mutations’ … Rybrevant work? In NSCLC cells, EGFR is often overactive, causing … -
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Human medicine European public assessment report (EPAR): Ovaleap
follitropin alfa, Anovulation
Date of authorisation: 27/09/2013,, Revision: 10, Authorised, Last updated: 18/08/2023
women who do not produce eggs and do not respond to treatment … stimulates the ovaries to produce eggs); women who are undergoing … to produce more than one egg at a time; women with severe … -
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Veterinary medicine European public assessment report (EPAR): Vectormune ND
cell-associated live recombinant turkey herpes virus (rHVT/ND) expressing the fusion protein of Newcastle diseases virus D-26 lentogenic strain, Chicken; Embryonated eggs
Date of authorisation: 08/09/2015, Revision: 7, Authorised, Last updated: 06/09/2021watery diarrhoea and reduced egg production. MD is a herpesvirus … directly into 18-day-old eggs containing embryos (unhatched … layers (chickens bred for egg production). For MD protection … -
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Human medicine European public assessment report (EPAR): Iressa
gefitinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 24/06/2009, Revision: 16, Authorised, Last updated: 17/07/2023epidermal-growth-factor receptor (EGFR). How is Iressa used? Treatment … of cancer cells, such as EGFR on the surface of non-small-cell-lung-cancer … non-small-cell-lung-cancer cells. EGFR is involved in the growth … -
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Human medicine European public assessment report (EPAR): Orgalutran
ganirelix, Reproductive Techniques, Assisted; Ovulation Induction; Infertility, Female
Date of authorisation: 16/05/2000, Revision: 24, Authorised, Last updated: 04/04/2023ovulation (early release of eggs from the ovary) in women … so that they produce more eggs). In premature ovulation, the … ovulation, the ovaries release eggs that may be immature and … -
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Veterinary medicine European public assessment report (EPAR): MS-H Vaccine
Mycoplasma synoviae strain MS-H, Chicken
Date of authorisation: 14/06/2011, Revision: 6, Authorised, Last updated: 03/06/2021with poor quality of the eggshell. MS-H Vaccine is used … chickens intended to produce eggs for broilers (for meat) and … for meat) and layers (for egg production) to reduce the … -
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Human medicine European public assessment report (EPAR): Gefitinib Mylan
gefitinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 27/09/2018,
, Revision: 6, Authorised, Last updated: 27/07/2023
epidermal growth factor receptor (EGFR). Gefitinib Mylan contains … of cancer cells, such as EGFR on the surface of non-small … non-small cell lung cancer cells. EGFR is involved in the growth … -
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Veterinary medicine European public assessment report (EPAR): Innovax-ND-IBD
Cell-associated live recombinant turkey herpesvirus (strain HVP360), expressing the fusion protein of ND virus and the VP2 protein of IBD virus, Chicken; Embryonated chicken eggs
Date of authorisation: 22/08/2017, Revision: 5, Authorised, Last updated: 04/11/2021watery diarrhoea and reduced egg production. IBD, also known … into 18-19-day-old chicken eggs containing embryos (unhatched … of vaccination of chicken eggs: for ND, 92% of chickens from … -
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Human medicine European public assessment report (EPAR): Vizimpro
dacomitinib monohydrate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 02/04/2019,, Revision: 2, Authorised, Last updated: 21/07/2021
epidermal growth factor receptor (EGFR). Vizimpro contains the active … presence of mutations in the EGFR gene should be confirmed … It blocks the activity of EGFR, which normally controls growth … -
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Veterinary medicine European public assessment report (EPAR): Vaxxitek HVT+IBD
Recombinant turkey herpesvirus, strain vhvt013-69, live, Embryonated eggs; Chicken
Date of authorisation: 09/08/2002, Revision: 17, Authorised, Last updated: 07/01/2022injected into chickens and into eggs where chicks are developing … chickens and chicks in the egg without presenting any apparent … chickens and chicks in the egg against Infectious Bursal … -
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Human medicine European public assessment report (EPAR): Ganirelix Gedeon Richter
ganirelix acetate, Reproductive Techniques, Assisted; Ovulation Induction; Infertility, Female
Date of authorisation: 15/07/2022,, Authorised, Last updated: 20/07/2022
ovulation (early release of eggs from the ovary) in women … so that they produce more eggs). Ganirelix Gedeon Richter … in the ovary that hold the eggs) to allow …