8347 results
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Opinion/decision on a Paediatric investigation plan (PIP): Solithromycin
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Infectious diseases
PIP number: EMEA-001581-PIP02-16, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Capsule, hard, Powder for concentrate for solution for infusion, Powder for oral suspension
Decision date: 28/04/2016, Last updated: 20/04/2018, Compliance check: XKey facts Solithromycin Infectious diseasesP/0120/2016EMEA-001581-PIP02-16 … Powder for concentrate for solution for infusion Powder for oral … granting of a waiver for solithromycin (EMEA-001581-PIP02-16) PDF … -
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Opinion/decision on a Paediatric investigation plan (PIP): Solifenacin (succinate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-000573-PIP02-13-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral suspension, Film-coated tablet
Decision date: 05/06/2015, Last updated: 06/07/2015, Compliance check: V, 16/12/2016Vesicare and associated names Solifenacin (succinate) Uro-nephrologyP/0115/2015EMEA-000573-PIP02-13-M03 … paediatric investigation plan for solifenacin (succinate) (Vesicare and … paediatric investigation plan for solifenacin (succinate) (Vesicare and … -
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Opinion/decision on a Paediatric investigation plan (PIP): Solifenacin (succinate), Mirabegron
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Uro-nephrology
PIP number: EMEA-001528-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Modified-release film-coated tablet
Decision date: 19/12/2013, Last updated: 05/02/2014, Compliance check: XKey facts Solifenacin (succinate) Mirabegron Uro-nephrologyP/0319/2013EMEA-001528-PIP01-13 … product specific waiver for solifenacin (succinate) / mirabegron … product specific waiver for solifenacin (succinate) / mirabegron … -
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Orphan designation: Soluble yeast beta-1,3/1,6- glucan for: Prevention of oral mucositis in head and neck cancer patients undergoing radiation therapy
Date of designation: 16/06/2005, Positive, Last updated: 07/04/2011Soluble yeast beta-1,3/1,6- glucan … opinion on orphan designation Soluble yeast beta-1,3/1,6- glucan … Pharmacon ASA, Norway, for soluble yeast beta-1,3/1,6- glucan … -
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Orphan designation: Oxygen, sodium chloride solution 0.9% for: Treatment of amyotrophic lateral sclerosis
Date of designation: 11/10/2022, Positive, Last updated: 24/01/2023Oxygen, sodium chloride solution 0.9 … Oxygen, sodium chloride solution 0.9 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Soluble yeast beta-1,3/1,6-glucan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology-Gynaecology-Fertility-Metabolism
PIP number: Soluble yeast beta-1,3/1,6-glucan, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Cutaneous solution
Decision date: 03/11/2009, Last updated: 23/12/2009, Compliance check: XSoluble yeast beta-1,3/1,6-glucan En … Soluble yeast beta-1,3/1,6-glucan … product specific waiver for soluble yeast beta-1,3/1,6-glucan … -
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Orphan designation: Soluble recombinant human fibroblast growth factor receptor 3 for: Treatment of achondroplasia
Date of designation: 27/02/2017, Withdrawn, Last updated: 24/03/2023Soluble recombinant human fibroblast … opinion on orphan designation Soluble recombinant human fibroblast … TherAchon SAS, France, for soluble recombinant human fibroblast … -
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Orphan designation: Recombinant human soluble Fc-gamma receptor II b for: Treatment of idiopathic thrombocytopenic purpura
Date of designation: 02/08/2007, Withdrawn, Last updated: 16/10/2019Recombinant human soluble Fc-gamma receptor II b … Recombinant human soluble Fc-gamma receptor II b … -
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Referral: Prontax 5 mg/ml pour-on solution for cattle
doramectin, associated names: Dectomax 5 mg/ml pour-on Solution for cattle, Article 33
Status: European Commission final decision, opinion/position date: 08/02/2012, EC decision date: 25/05/2012, Last updated: 05/07/2012Prontax 5 mg/ml pour-on solution for cattle … Overview Prontax 5 mg/ml pour-on solution for cattle (and associated … of Prontax 5 mg/ml pour-on solution for cattle and associated … -
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Orphan designation: dry extract from birch bark (DER 5-10 : 1), extraction solvent n-heptane 95% (w/w) (birch bark extract) for: Treatment of epidermolysis bullosa
Date of designation: 23/02/2011, Positive, Last updated: 04/07/2022DER 5-10 : 1), extraction solvent n-heptane 95% (w/w) (birch … DER 0.1-0.2:1), extraction solvent n-heptane 95% (V/V) for the … DER 0.1-0.2:1), extraction solvent n-heptane 95% (V/V) for … -
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Human medicine European public assessment report (EPAR): Filsuvez
dry extract from birch bark (DER 5-10 : 1), extraction solvent n-heptane 95% (w/w), Epidermolysis Bullosa Dystrophica; Epidermolysis Bullosa, Junctional
Date of authorisation: 21/06/2022,
, Revision: 1, Authorised, Last updated: 23/01/2023
oleanolic acid. Extraction solvent: n-Heptane. For the full … DER 5-10 : 1), extraction solvent n-heptane 95% (w/w … -
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Referral: Prontax 10 mg/ml solution for injection for cattle, sheep and pigs
doramectin, associated names: Dectomax 10 mg/ml solution for injection for cattle sheep and pigs, Article 33
Status: European Commission final decision, opinion/position date: 08/02/2012, EC decision date: 25/05/2012, Last updated: 05/07/2012Prontax 10 mg/ml solution for injection for cattle … Overview Prontax 10 mg/ml solution for injection for cattle … profile of Prontax 10 mg/ml solution for injection for cattle … -
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Opinion/decision on a Paediatric investigation plan (PIP): Human immunoglobulin (Ig) G4-variant monoclonal antibody that binds and neutralizes soluble human interleukin (IL-) 33
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Dermatology
PIP number: EMEA-002464-PIP01-18, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 16/08/2019, Last updated: 20/11/2019, Compliance check: Xthat binds and neutralizes soluble human interleukin (IL-) 33 … EMEA-002464-PIP01-18 Pharmaceutical form(s) Solution for injection Condition(s … that binds and neutralizes soluble human interleukin (IL-) 33 … -
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Orphan designation: 3,5-diamino-6-chloro-N-(N-(4-(4-(2-(hexyl((2S,3R,4R,5R)-2,3,4,5,6-pentahydroxyhexyl)amino)ethoxy)phenyl)butyl)-carbamimidoyl)pyrazine-2-carboxamide, Sodium chloride solution 4.2% (w/v) for: Treatment of primary ciliary dyskinesia
Date of designation: 16/11/2020, Positive, Last updated: 07/03/2023carboxamide, Sodium chloride solution 4.2% (w/v … 3,5-diamino-6-chloro-N-(N-(4-(4-(2-(hexyl((2S,3R,4R,5R)-2,3,4,5,6- pentahydroxyhexyl)amino)ethoxy)phenyl)butyl)-carbamimidoyl)pyrazine-2- carboxamide, sodium chloride solution 4.2% (w/v) for the treatment … 3,5-diamino-6-chloro-N-(N-(4-(4-(2-(hexyl((2S,3R,4R,5R)-2,3,4,5,6- pentahydroxyhexyl)amino)ethoxy)phenyl)butyl)-carbamimidoyl)pyrazine-2-carboxamide, sodium chloride solution 4.2% (w/v) (also known as … -
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Veterinary medicine European public assessment report (EPAR): Locatim (previously Serinucoli)
Bovine concentrated lactoserum containing specific immunoglobulins G against E. coli F5 (K99) adhesin, Calves, neonatal less than 12 hrs of age
Date of authorisation: 29/03/1999, Revision: 15, Authorised, Last updated: 20/10/2021Authorised Locatim, oral solution for neonatal calves less … prescription. Locatim is an oral solution produced from colostrum (first … and package size: Oral solution >2.8log10 /ml bovine concentrated … -
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Opinion/decision on a Paediatric investigation plan (PIP): Soluble human T cell receptor (TCR) directed against the glycoprotein 100 (gp100) melanoma antigen, linked to the single-chain variable fragment (ScFv) domain of the anti-cluster of differentiation 3 (CD3) antibody
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002197-PIP01-17, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 01/12/2017, Last updated: 07/03/2018, Compliance check: XKey facts Soluble human T cell receptor (TCR … OncologyEMEA-002197-PIP01-17EMEA-002197-PIP01-17 Concentrate for solution for infusion Treatment of … product specific waiver for soluble human T cell receptor (TCR … -
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Opinion/decision on a Paediatric investigation plan (PIP): Optaflu, Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains: A/Solomon Islands/3/2006 (H1N1)-like strain (A/Solomon Islands/3/2006, IVR-145); A/Wisconsin/67/2005 (H3N2)-like strain (A/Wisconsin/67/2005, NYMC X161B); B/Malaysia/2506/2004-like strain (B/Malaysia/2506/2004)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000124-PIP01-07-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection in pre-filled syringe
Decision date: 28/09/2012, Last updated: 27/02/2019, Compliance check: Xthe following strains: A/Solomon Islands/3/2006 (H1N1)-like … Islands/3/2006 (H1N1)-like strain (A/Solomon Islands/3/2006, IVR-145); A/Wisconsin/67/2005 … the following strains: A/Solomon Islands/3/2006 (H1N1)-like … -
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Referral: Cobactan IV 4.5% powder and solvent for solution for injection and its associated names
cefquinome, associated names: Cobactan, Cobactan Vet., Cobactan 4.5%, Cobactan IV IM 4.5%, Cobactan IV 4.5% A.U.V., Cephaguard IV IM 4.5%, Article 33
Status: European Commission final decision, opinion/position date: 17/05/2006, EC decision date: 21/08/2006, Last updated: 12/08/2014Cobactan IV 4.5% powder and solvent for solution for injection and its associated … associated names are a powder and solvent for solution for injection. Cobactan IV … Cobactan IV 4.5% powder and solvent for solution for injection and its associated … -
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Direct healthcare professional communication (DHPC): Briviact® (In Italy: Nubriveo®) (brivaracetam 10Mg/ml) Oral solution: Bottles with narrow neck diameter
Active substance: Brivaracetam, DHPC type: Quality defect, Last updated: 20/12/2021brivaracetam 10Mg/ml) Oral solution: Bottles with narrow neck … brivaracetam 10Mg/ml) Oral solution: Bottles with narrow neck … BRIVARACETAM 10MG/ML) ORAL SOLUTION: BOTTLES WITH NARROW NECK … -
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Direct healthcare professional communication (DHPC): Cabazitaxel Accord 20 mg/mL concentrate for solution for infusion: Risk of medication errors and mix-up with Jevtana (60 mg/1.5 mL) concentrate and solvent for solution for infusion
Active substance: cabazitaxel, DHPC type: Medication error, Last updated: 28/10/202020 mg/mL concentrate for solution for infusion: Risk of medication … mg/1.5 mL) concentrate and solvent for solution for infusion Prostatic Neoplasms … 20 mg/mL concentrate for solution for infusion: Risk of medication … -
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Direct healthcare professional communication (DHPC): Ecalta 100mg powder for concentrate for solution for infusion (anidulafungin) - Solution for infusion must no longer be frozen
Active substance: anidulafungin, DHPC type: Quality defect, Last updated: 14/02/2020powder for concentrate for solution for infusion (anidulafungin … infusion (anidulafungin) - Solution for infusion must no longer … powder for concentrate for solution for infusion (anidulafungin … -
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Press release: Hydroxyethyl starch solutions: CMDh introduces new measures to protect patients
CMDh, Last updated: 29/06/2018Hydroxyethyl starch solutions: CMDh introduces new measures … hydroxyethyl starch (HES) solutions for infusion should remain … with these medicines. HES solutions for infusion are used to … -
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Referral: Soludox
doxycycline hyclate, Article 13
Status: European Commission final decision, opinion/position date: 12/06/2013, EC decision date: 12/08/2013, Last updated: 24/09/2013Soludox … Commission final decision Overview Soludox 500-mg/g powder for use in … chickens to six days for Soludox 500-mg/g powder for use in … -
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Referral: Solacyl
Article 33
Status: European Commission final decision, opinion/position date: 13/02/2008, EC decision date: 17/04/2008, Last updated: 07/12/2011Solacyl … Commission final decision Overview Solacyl 100 % powder for oral solution for calves and pigs is indicated … to reach an agreement for Solacyl 100% powder for oral solution and the matter was referred … -
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Referral: Ifosfamide solutions
ifosfamide, associated names: Ifosfamide Eg, Ifo-Cell, Ifo-Cell N, Ifo-Cell N 2000, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/04/2021, EC decision date: 21/06/2021, Last updated: 19/07/2021Ifosfamide solutions … Benefits of ifosfamide solutions continue to outweigh risks … Benefits of ifosfamide solutions continue to outweigh risks …