16504 results
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Orphan designation: Lactobacillus acidophilus and Bifidobacterium bifidum for: Prevention of necrotising enterocolitis
Date of designation: 16/01/2014, Positive, Last updated: 23/01/2014Lactobacillus acidophilus and Bifidobacterium bifidum … Italy, for Lactobacillus acidophilus and Bifidobacterium bifidum … expected to work? Lactobacillus acidophilus and Bifidobacterium bifidum … -
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Human medicine European public assessment report (EPAR): Sunitinib Accord
sunitinib, Gastrointestinal Stromal Tumors; Carcinoma, Renal Cell; Neuroendocrine Tumors
Date of authorisation: 11/02/2021,
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, Revision: 1, Authorised, Last updated: 14/12/2021
Sunitinib Accord Cancer Neoplasms Neoplasms … Sunitinib Accord is a medicine used … tissues of these organs. Sunitinib Accord is used in patients … -
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Human medicine European public assessment report (EPAR): Sutent
sunitinib, Gastrointestinal Stromal Tumors; Carcinoma, Renal Cell; Neuroendocrine Tumors
Date of authorisation: 19/07/2006, Revision: 39, Authorised, Last updated: 13/08/2021contains the active substance sunitinib. It is available as capsules … active substance in Sutent, sunitinib, is a protein kinase inhibitor … or contact your doctor or pharmacist. List item … -
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Opinion/decision on a Paediatric investigation plan (PIP): Sutent, sunitinib
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000342-PIP01-08-M07, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 07/05/2018, Last updated: 27/11/2018, Compliance check: V, 29/06/2018name Sutent Active substance sunitinib Therapeutic area Oncology … EMEA-000342-PIP01-08-M07 Pharmaceutical form(s) Capsule, hard Condition(s … Sutent Sutent sunitinib sunitinib sunitinib … -
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Human medicine European public assessment report (EPAR): Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen)
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 30/06/2015,, Revision: 15, Authorised, Last updated: 12/01/2023
Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) Schizophrenia Spectrum and … Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) … market exclusivity under pharmaceutical legislation (typically 10 … -
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Withdrawn application: Topotecan SUN
topotecan, date of withdrawal: 03/01/2011, Initial authorisation, Last updated: 23/02/2011Topotecan SUN: Withdrawn application … Overview On 3 January 2011, Sun Pharmaceutical Industries Europe B.V. officially … authorisation for Topotecan SUN for the treatment metastatic … -
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Withdrawn application: Repaglinide Sun
repaglinide, date of withdrawal: 25/03/2010, Initial authorisation, Last updated: 15/05/2010Repaglinide Sun: Withdrawn application … Overview On 23 March 2010, Sun Pharmaceutical Industries Europe B.V. officially … authorisation for Repaglinide Sun for the treatment of type … -
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Withdrawn application: Sutent
sunitinib, date of withdrawal: 26/06/2018, Post-authorisation, Last updated: 17/08/2018authorisation for Sutent (sunitinib) On 26 June 2018, Pfizer … contains the active substance sunitinib. Further information on … active substance in Sutent, sunitinib, is a protein kinase inhibitor … -
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Withdrawn application: Docetaxel SUN
docetaxel, date of withdrawal: 06/06/2016, Initial authorisation, Last updated: 29/09/2016Docetaxel SUN: Withdrawn application … market exclusivity under pharmaceutical legislation (typically 10 … substance(s) it contains. The pharmaceutical legislation defines the … -
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Withdrawn application: Doxorubicin SUN
doxorubicin, date of withdrawal: 20/07/2011, Initial authorisation, Last updated: 26/09/2011Doxorubicin SUN: Withdrawn application … market exclusivity under pharmaceutical legislation (typically 10 … substance(s) it contains. The pharmaceutical legislation defines the … -
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Orphan designation: lonapegsomatropin for: Treatment of growth hormone deficiency
Date of designation: 17/10/2019, Positive, Last updated: 17/02/2022European Commission to Ascendis Pharma Endocrinology Division A/S … Lonapegsomatropin Ascendis Pharma since 11 January 2022. Expand … Lonapegsomatropin Ascendis Pharma) Skytrofa (previously Lonapegsomatropin … -
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Human medicine European public assessment report (EPAR): Skytrofa (previously Lonapegsomatropin Ascendis Pharma)
Lonapegsomatropin, Growth and Development
Date of authorisation: 11/01/2022,, 
, Revision: 3, Authorised, Last updated: 31/01/2023
Lonapegsomatropin Ascendis Pharma) Growth and Development … Lonapegsomatropin Ascendis Pharma is a medicine that is used … Lonapegsomatropin Ascendis Pharma was designated an ‘ A medicine … -
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Summary of opinion: Sitagliptin / Metformin hydrochloride Sun
sitagliptin, metformin hydrochloride, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023Metformin hydrochloride Sun: Pending EC decision … physiological functions by exerting a pharmacological, immunological or metabolic … Sitagliptin/Metformin hydrochloride Sun, intended for the treatment … -
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Human medicine European public assessment report (EPAR): Clopidogrel Viatris (previously Clopidogrel Taw Pharma)
clopidogrel besilate, Peripheral Vascular Diseases; Stroke; Myocardial Infarction
Date of authorisation: 16/10/2009,, Revision: 26, Authorised, Last updated: 03/08/2022
previously Clopidogrel Taw Pharma) Vascular Diseases Cardiovascular … or contact your doctor or pharmacist. How does Clopidogrel Viatris … Viatris Clopidogrel Mylan Pharma received a The approval to … -
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Opinion/decision on a Paediatric investigation plan (PIP): 2,6-Bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2,6-diamino-hexanoylamino)-2,6-diamino-hexanoic acid (diphenylmethyl)-amide, polysodium salt
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Other
PIP number: EMEA-001354-PIP01-12, Route(s) of administration: Vaginal use, Pharmaceutical form(s): Vaginal gel
Decision date: 26/02/2013, Last updated: 23/04/2013, Compliance check: X2,6-Bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2,6-diamino-hexanoylamino)-2,6-diamino-hexanoic … 2,6-bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2 … 2,6-Bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2,6-diamino-hexanoylamino)-2,6-diamino-hexanoic … -
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Withdrawn application: Clopidogrel Teva Pharma
clopidogrel, date of withdrawal: 22/04/2009, Initial authorisation, Last updated: 23/04/2009Clopidogrel Teva Pharma: Withdrawn application … Clopidogrel Teva Pharma: Withdrawal of the marketing … market exclusivity under pharmaceutical legislation (typically 10 … -
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Withdrawn application: Lacosamide Pain UCB Pharma
lacosamide, date of withdrawal: 25/09/2008, Initial authorisation, Last updated: 26/09/2008Lacosamide Pain UCB Pharma: Withdrawn application … for Lacosamide Pain UCB Pharma International non-proprietary … On 25 September 2008, UCB Pharma S.A. officially notified … -
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Human medicine European public assessment report (EPAR): Teriparatide Sun
teriparatide, Osteoporosis; Osteoporosis, Postmenopausal
Date of authorisation: 18/11/2022, Authorised, Last updated: 12/12/2022Teriparatide Sun Bone Diseases, Metabolic Bone … teriparatide Overview Teriparatide Sun is a medicine used to treat … steroid). Teriparatide Sun is a ‘ A medicine that … -
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Human medicine European public assessment report (EPAR): Bortezomib Sun
bortezomib, Multiple Myeloma
Date of authorisation: 22/07/2016,, Revision: 12, Authorised, Last updated: 09/09/2021
Bortezomib Sun Hemostatic Disorders Vascular … report (EPAR) for Bortezomib Sun. It explains how the Agency … on how to use Bortezomib Sun. For practical information … -
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Human medicine European public assessment report (EPAR): Temozolomide Sun
temozolomide, Glioma; Glioblastoma
Date of authorisation: 13/07/2011,, Revision: 19, Authorised, Last updated: 17/03/2022
Temozolomide Sun Cancer Neuroectodermal … report (EPAR) for Temozolomide Sun. It explains how the Committee … conditions of use for Temozolomide Sun. Expand section Collapse section … -
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Human medicine European public assessment report (EPAR): Levetiracetam Sun
levetiracetam, Epilepsy
Date of authorisation: 14/12/2011,, Revision: 17, Authorised, Last updated: 24/06/2022
Levetiracetam Sun Nervous System Diseases Central … EPAR) for Levetiracetam Sun. It explains how the Committee … of use for Levetiracetam Sun. Expand section Collapse section … -
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Human medicine European public assessment report (EPAR): Sunlenca
Lenacapavir sodium, HIV Infections
Date of authorisation: 17/08/2022,, Authorised, Last updated: 25/08/2022
Sunlenca Blood-Borne Infections Communicable … Sunlenca is used, together with other … deficiency syndrome (AIDS). Sunlenca is given when the virus is … -
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Human medicine European public assessment report (EPAR): Sunosi
solriamfetol hydrochloride, Narcolepsy; Sleep Apnea, Obstructive
Date of authorisation: 16/01/2020,, Revision: 7, Authorised, Last updated: 14/12/2022
Sunosi Nervous System Diseases Sleep … orised solriamfetol Overview Sunosi is a medicine used to improve … disturbed night-time sleep. Sunosi is used in patients with … -
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Human medicine European public assessment report (EPAR): Capecitabine SUN
capecitabine, Stomach Neoplasms; Breast Neoplasms; Colonic Neoplasms; Colorectal Neoplasms
Date of authorisation: 21/06/2013,, Revision: 3, Withdrawn, Last updated: 22/12/2016
Capecitabine SUN Stomach Neoplasms Breast … details Name Capecitabine SUN Agency product number EMEA/H/C/002050 … Marketing-authorisation holder Sun Pharmaceutical Industries Europe B.V. Revision … -
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Human medicine European public assessment report (EPAR): Ertapenem SUN
ertapenem sodium, Bacterial Infections
Date of authorisation: 15/07/2022,, Authorised, Last updated: 21/11/2022
Ertapenem SUN Bacterial Infections and … ertapenem Overview Ertapenem SUN is an antibiotic. It is used … diabetes patients. Ertapenem SUN is also used in adults to …