1686 results
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Human medicine European public assessment report (EPAR): Ziagen
abacavir, HIV Infections
Date of authorisation: 08/07/1999, Revision: 43, Authorised, Last updated: 24/03/2021abacavir … Human Use (CHMP) Ziagen (abacavir sulfate) Procedure No … Protocol 1052 for Ziagen (Abacavir pharmacokinetics during chronic … -
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Human medicine European public assessment report (EPAR): Kivexa
abacavir, lamivudine, HIV Infections
Date of authorisation: 16/12/2004, Revision: 34, Authorised, Last updated: 08/09/2021abacavir / lamivudine … combination containing 600 mg abacavir and 300 mg lamivudine through … Kivexa, which contains 600 mg abacavir and 300 mg lamivudine in … -
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Opinion/decision on a Paediatric investigation plan (PIP): Triumeq, dolutegravir, abacavir, lamivudine (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001219-PIP01-11-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Dispersible tablet
Decision date: 17/03/2021, Last updated: 23/11/2021, Compliance check: XActive substance dolutegravir abacavir lamivudine Therapeutic area … plan for dolutegravir / abacavir / lamivudine (Triumeq), (EMEA-001219-PIP01-11-M05 … plan for dolutegravir / abacavir / lamivudine (Triumeq), (EMEA-001219-PIP01-11-M05 … -
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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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, Authorised, Last updated: 06/04/2021
Sunitinib Accord Cancer Neoplasms Neoplasms … Sunitinib Accord … EMA/18013/2021 EMEA/H/C/005419 Sunitinib Accord sunitinib) An overview of Sunitinib Accord and why it is authorised … -
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Human medicine European public assessment report (EPAR): Triumeq (updated)
dolutegravir sodium, lamivudine, abacavir (as sulfate), HIV Infections
Date of authorisation: 31/08/2014, Revision: 23, Authorised, Last updated: 25/11/2021Authorised abacavir sulfate / dolutegravir sodium … substances : dolutegravir, abacavir and lamivudine. How is Triumeq … of an allergic reaction to abacavir, so they should not take Triumeq … -
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Human medicine European public assessment report (EPAR): Trizivir
abacavir (as sulfate), lamivudine, zidovudine, HIV Infections
Date of authorisation: 27/12/2000, Revision: 39, Authorised, Last updated: 08/09/2021abacavir (as sulfate) / lamivudine … tablet contains 300 mg of abacavir (as sulfate), 150 mg lamivudine … replaces the three components (abacavir, lamivudine and zidovudine … -
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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: 13/08/2021sunitinib … Sutent; INN-sunitinib 30 Churchill Place … for the public Sutent sunitinib This is a summary of the … -
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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 … Sutent Sutent sunitinib sunitinib sunitinib … -
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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 … application for Docetaxel Sun (docetaxel) On 6 June … docetaxel) On 6 June 2016, Sun Pharmaceutical Industries … -
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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 … Topotecan SUN: Withdrawal of the marketing … application for Topotecan SUN (topotecan) On 3 January … -
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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 … Repaglinide Sun: Withdrawal of the marketing … application for Repaglinide Sun (repaglinide) On 23 March … -
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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 … application for Doxorubicin SUN (doxorubicin) On 20 Jul … doxorubicin) On 20 Jul 2011, Sun Pharmaceutical Industries … -
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Opinion/decision on a Paediatric investigation plan (PIP): abacavir, lamivudine, efavirenz
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-002114-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 30/06/2017, Last updated: 25/07/2017, Compliance check: XKey facts abacavir lamivudine efavirenz Infectious … product-specific waiver for abacavir / lamivudine / efavirenz … product specific waiver for abacavir / lamivudine / efavirenz … -
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Summary of opinion: Sitagliptin SUN
sitagliptin fumarate, opinion date: 14/10/2021, Positive, Last updated: 15/10/2021Sitagliptin SUN: Pending EC decision … authorisation) Sitagliptin SUN sitagliptin fumarate On … medicinal product Sitagliptin SUN, intended for the treatment … -
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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: 4, Authorised, Last updated: 26/10/2021
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): Levetiracetam Sun
levetiracetam, Epilepsy
Date of authorisation: 14/12/2011,, Revision: 16, Authorised, Last updated: 03/09/2021
Levetiracetam Sun Nervous System Diseases Central … EPAR) for Levetiracetam Sun. It explains how the The committee … of use for Levetiracetam Sun. What is Levetiracetam Sun and what is it used for … -
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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 … Bortezomib Sun … Bortezomib SUN, INN-bortezomib 30 … -
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Human medicine European public assessment report (EPAR): Temozolomide Sun
temozolomide, Glioma; Glioblastoma
Date of authorisation: 13/07/2011,, Revision: 17, Authorised, Last updated: 25/05/2021
Temozolomide Sun Cancer Neuroectodermal … Temozolomide Sun … Temozolomide SUN, INN-temozolomide … -
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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 … authorisation for Capecitabine SUN has been withdrawn at the … Summary documents Capecitabine SUN : EPAR - Summary for the … -
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Human medicine European public assessment report (EPAR): Atosiban SUN
atosiban (as acetate), Premature Birth
Date of authorisation: 31/07/2013,, Revision: 8, Authorised, Last updated: 11/11/2020
Atosiban SUN Obstetric Labor, Premature Obstetric … report (EPAR) for Atosiban SUN. It explains how the Agency … advice on how to use Atosiban SUN. For practical information … -
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News: Public Statement on Ziagen (Abacavir) - Abacavir hypersensitivity cases following an interruption of therapy
Last updated: 14/08/2000Public Statement on Ziagen (Abacavir Abacavir hypersensitivity cases following … prescribing or taking Ziagen (abacavir)1. The European Agency's … reactions associated with Ziagen (abacavir). Hypersensitivity reactions … -
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Sunset-clause monitoring: questions and answers
Last updated: 01/01/2016Sunset-clause monitoring: questions and … holders (MAHs) may have on sunset-clause monitoring. It provides an …
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Press release: Further data needed to determine risk of heart attack with abacavir
Last updated: 02/04/2008risk of heart attack with abacavir … risk of heart attack with abacavir … risk of heart attack with abacavir The European Medicines … -
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News: Public Statement on Ziagen (Abacavir) - Important safety Information on Hypersensitivity Reactions and Respiratory Symptoms
Last updated: 24/01/2000Public Statement on Ziagen (Abacavir) - Important safety Information … contains the active substance abacavir sulfate. Ziagen® is marketed … hypersensitivity reaction to abacavir that included respiratory …