1907 results
Keyword Enalapril Sun Remove keyword
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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 … EMA/18013/2021 EMEA/H/C/005419 Sunitinib Accord sunitinib) An overview of Sunitinib Accord and why it is authorised … -
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Referral: Renitec
enalapril, Article 30 referrals
Status: European Commission final decision, opinion/position date: 19/09/2002, EC decision date: 21/05/2003, Last updated: 02/12/2003Commission final decision Overview Enalapril is a highly specific, competitive … the benefit/risk ratio of enalapril is considered to be favourable … Non-Proprietary Name (INN): enalapril: Background information an … -
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Opinion/decision on a Paediatric investigation plan (PIP): Enalapril (maleate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001706-PIP01-14-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form
Decision date: 17/03/2021, Last updated: 09/03/2023, Compliance check: V, 25/06/2021Key facts Enalapril (maleate) Cardiovascular … paediatric investigation plan for enalapril (maleate) (EMEA-001706-PIP01-14-M03 … paediatric investigation plan for enalapril (maleate) (EMEA-001706-PIP01-14-M03 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Enalapril (maleate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001241-PIP02-13-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 03/09/2014, Last updated: 29/09/2014, Compliance check: XKey facts Enalapril (maleate) Cardiovascular … paediatric investigation plan for enalapril (maleate) (EMEA-001241-PIP02-13-M01 … paediatric investigation plan for enalapril (maleate) (EMEA-001241-PIP02-13-M01 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Enalapril (maleate)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001516-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet for oral suspension, Orodispersible film
Decision date: 05/05/2014, Last updated: 06/06/2014, Compliance check: XKey facts Enalapril (maleate) Cardiovascular … the refusal of a waiver for enalapril (maleate) (EMEA-001516-PIP01-13 … the refusal of a waiver for enalapril (maleate) (EMEA-001516-PIP01-13 … -
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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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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 … Metformin hydrochloride Sun … Sitagliptin/Metformin hydrochloride Sun sitagliptin / metformin … -
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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): 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): Levetiracetam Sun
levetiracetam, Epilepsy
Date of authorisation: 14/12/2011,, Revision: 17, Authorised, Last updated: 24/06/2022
Levetiracetam Sun Nervous System Diseases Central … Levetiracetam Sun … EMEA/H/C/002051 Levetiracetam Sun (levetiracetam) An overview … -
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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 … EMA/624383/2022 EMEA/H/C/005638 Sunlenca (lenacapavir) An overview … -
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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 … Temozolomide Sun … Temozolomide SUN, INN-temozolomide … -
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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): 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 … Capecitabine SUN … statement Capecitabine SUN Withdrawal of the marketing … -
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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 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Sunvozertinib
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-003132-PIP01-21, Route(s) of administration: All routes of administration, Pharmaceutical form(s): All pharmaceutical forms
Decision date: 11/03/2022, Last updated: 20/04/2023, Compliance check: XKey facts Sunvozertinib OncologyP/0058/2022EMEA-003132-PIP01-21 … product-specific waiver for sunvozertinib (EMEA-003132-PIP01-21) PDF … product-specific waiver for sunvozertinib (EMEA-003132-PIP01-21) in … -
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Human medicine European public assessment report (EPAR): Sitagliptin SUN
sitagliptin fumarate, Diabetes Mellitus, Type 2
Date of authorisation: 09/12/2021,, Revision: 1, Authorised, Last updated: 27/10/2022
Sitagliptin SUN Endocrine System Diseases Diabetes … Sitagliptin SUN … EMEA/H/C/005741 Sitagliptin SUN (sitagliptin) An overview … -
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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: 9, Authorised, Last updated: 09/02/2022
Atosiban SUN Obstetric Labor, Premature Obstetric … Atosiban SUN … for the public Atosiban SUN atosiban This is a summary … -
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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 …