17076 results
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Referral: Lansoprazol-ratiopharm 15 mg and 30 mg
Lansoprazole, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 15/09/2005, EC decision date: 21/02/2006, Last updated: 25/02/2006Lansoprazol-ratiopharm 15 mg and 30 mg … Lansoprazol-ratiopharm (15 mg and 30 mg) was previously granted to … Procedure was started on 16 September 2004. The Reference … -
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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: 28/10/2020Cabazitaxel Accord 20 mg/mL concentrate for solution … and mix-up with Jevtana (60 mg/1.5 mL) concentrate and solvent … Cabazitaxel Accord 20 mg/mL concentrate for solution … -
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Referral: Stresnil 40 mg/ml solution for injection for pigs and associated names, and generic products thereof
azaperone, Article 35
Status: European Commission final decision, opinion/position date: 16/07/2020, EC decision date: 12/10/2020, Last updated: 30/10/2020Stresnil 40 mg/ml solution for injection for … -
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Orphan designation: allogeneic peripheral blood mononuclear cells incubated ex-vivo with 16, 16-dimethyl prostaglandin E2, dexamethasone for: Treatment in haematopoietic stem cell transplantation
Date of designation: 18/11/2016, Withdrawn, Last updated: 10/08/2022EU/3/16/1774 … EU/3/16/1774: Orphan designation … cells incubated ex-vivo with 16, 16- dimethyl prostaglandin E2 … -
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Orphan designation: Allogeneic umbilical cord blood cells treated ex vivo with 16,16-dimethyl prostaglandin E2 for: Treatment of acute myeloid leukaemia
Date of designation: 13/05/2011, Withdrawn, Last updated: 30/08/2019cells treated ex vivo with 16,16-dimethyl prostaglandin E2 … cells treated ex vivo with 16,16-dimethyl prostaglandin E2 … -
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Referral: Lansoprazol AbZ-Pharma 15 mg and 30 mg
Lansoprazole, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 15/09/2005, EC decision date: 21/02/2006, Last updated: 25/02/2006Lansoprazol AbZ-Pharma 15 mg and 30 mg … Lansoprazol AbZ-Pharma (15 mg and 30 mg) was previously granted to … Procedure was started on 16 September 2004. The Reference … -
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Orphan designation: Allogeneic umbilical cord blood cells treated ex vivo with 16,16-dimethyl prostaglandin E2 for: Treatment of acute lymphoblastic leukaemia
Date of designation: 10/08/2015, Withdrawn, Last updated: 07/02/2017cells treated ex vivo with 16,16-dimethyl prostaglandin E2 Intended … EU/3/15/1546 Date of designation 10/08/2015 Sponsor … cells treated ex vivo with 16,16-dimethyl prostaglandin E2 for the … -
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Referral: Valbazen 100 mg/ml Total Spectrum Wormer oral suspension and associated names, including its generic/hybrid products
albendazole, Article 35
Status: European Commission final decision, opinion/position date: 05/11/2020, EC decision date: 18/01/2021, Last updated: 22/02/2021Valbazen 100 mg/ml Total Spectrum Wormer oral … for cattle for Valbazen 100 mg/ml Total Spectrum Wormer oral … www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 © European … -
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Direct healthcare professional communication (DHPC): Pazenir® (paclitaxel formulated as albumin bound nanoparticles) 5 mg/ml powder for dispersion for infusion: temporary supply shortage
Active substance: paclitaxel, DHPC type: Medicine shortage, Last updated: 25/01/2023albumin bound nanoparticles) 5 mg/ml powder for dispersion for … albumin bound nanoparticles) 5 mg/ml powder for dispersion for … www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 © European … -
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Human medicine European public assessment report (EPAR): Cervarix (updated)
human papillomavirus1 type 16 L1 protein, human papillomavirus type 18 L1 protein, Papillomavirus Infections; Uterine Cervical Dysplasia; Immunization
Date of authorisation: 20/09/2007, Revision: 39, Authorised, Last updated: 23/05/2023papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted … human papillomavirus (types 16 and 18). It is available … and anal cancers. HPV types 16 and 18 cause approximately … -
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Orphan designation: Allogeneic bone marrow stem cells treated ex vivo with 16,16-dimethyl prostaglandin E2 for: Treatment of acute myeloid leukaemia
Date of designation: 13/05/2011, Withdrawn, Last updated: 07/02/2017cells treated ex vivo with 16,16-dimethyl prostaglandin E2 … cells treated ex vivo with 16,16-dimethyl prostaglandin E2 for the … cells treated ex vivo with 16,16- dimethyl prostaglandin E2 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Pollen from Dactylis glomarata (16%), Festuca pratensis (16%), Lolium perenne (16%), Phleum pratense (16%), Poa pratensis (16%), Secale cereale (20%)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000869-PIP01-10, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oralmucosal drops
Decision date: 22/12/2010, Last updated: 24/01/2011, Compliance check: Xfrom Dactylis glomarata (16%), Festuca pratensis 16%), Lolium perenne 16%), Phleum pratense … from Dactylis glomarata (16%), Festuca pratensis 16%), Lolium perenne 16%), Phleum pratense … from Dactylis glomarata (16%), Festuca pratensis 16%), Lolium perenne 16%), Phleum pratense … -
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Referral: Lansoprazol CT-Arzneimittel 15 mg and 30 mg
Lansoprazole, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 15/09/2005, EC decision date: 21/02/2006, Last updated: 25/02/2006nsoprazol CT-Arzneimittel 15 mg and 30 mg … Lansoprazol CT-Arzneimittel 15 mg and 30 mg International Non-Proprietary … Lansoprazol CT-Arzneimittel (15 mg and 30 mg) was previously granted to … -
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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: 20/12/2021Nubriveo®) (brivaracetam 10Mg/ml) Oral solution: Bottles with … Nubriveo®) (brivaracetam 10Mg/ml) Oral solution: Bottles with … narrow neck diameter (PDF/161 KB … -
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Referral: Human papillomavirus vaccines - Cervarix, Gardasil, Gardasil 9, Silgard
bivalent HPV vaccine (types 16, 18), quadrivalent HPV vaccine (types 6, 11, 16, 18), 9-valent HPV vaccine (types 6, 11, 16, 18, 31, 33, 45, 52 and 58), associated names: Cervarix, Gardasil, Gardasil 9, Silgard, Article 20 procedures
Status: European Commission final decision, opinion/position date: 19/11/2015, EC decision date: 12/01/2016, Last updated: 20/01/2016types of HPV (types 6, 11, 16 and 18). Gardasil 9 (approved … of the virus (types 6, 11, 16, 18, 31, 33, 45, 52 and 58 … contains antigens for types 16 and 18 of the virus. Following … -
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Direct healthcare professional communication (DHPC): Eylea 40 mg/mL (aflibercept solution for intravitreal injection): Higher risk of intraocular pressure increase with the pre-filled syringe
Active substance: aflibercept, DHPC type: Adverse event, Last updated: 15/04/2021Eylea 40 mg/mL (aflibercept solution for … Eylea 40 mg/mL (aflibercept solution for … Communication EYLEA 40 mg/mL (aflibercept solution for … -
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Summary of opinion: Eurican L4
inactivated immunological veterinary medicinal product containing Leptospira interrogans, serogroup Canicola, serovar Canicola, strain 16070, L. interrogans, serogroup icterohaemorrhagiae, serovar icterohaemorrhagiae, strain 16069, L. interrogans, serogroup Grippotyphosa, serovar Grippotyphosa, strain Grippo Mal 1540, L. interrogans, serogroup Australis, serovar Bratislava, strain, opinion date: 15/02/2023, Positive, Last updated: 17/02/2023serovar Canicola, strain 16070, L. interrogans, serogroup … icterohaemorrhagiae, strain 16069, L. interrogans, serogroup … www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 © European … -
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Opinion/decision on a Paediatric investigation plan (PIP): Pollen from Dactylis glomarata (16%), Lolium perenne (16%), Phleum pratense (16%), Poa pratensis (16%), Anthoxhantum odoratum (16 %) and Secale cereale (20%)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000857-PIP01-10-M01, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oromucosal solution
Decision date: 27/11/2015, Last updated: 05/01/2021, Compliance check: Xfrom Dactylis glomarata (16%), Lolium perenne 16%), Phleum pratense 16%), Poa pratensis … from Dactylis glomarata (16%), Lolium perenne 16%), Phleum pratense 16%), Poa pratensis … -
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Acenocoumarol, tablet, 1 mg and 4 mg product-specific bioequivalence guidance
Last updated: 22/09/2021Acenocoumarol, tablet, 1 mg and 4 mg product-specific bioequivalence … Acenocoumarol, tablet, 1 mg and 4 mg product-specific bioequivalence … www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 © European …
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Opinion/decision on a Paediatric investigation plan (PIP): Pollen from Dactylis glomarata (8%), Lolium perenne (8%), Phleum pratense (8%), Poa pratensis (8%), Anthoxhantum odoratum (8%), Secale cereale (10%), Betula pendula (16.7%), Corylus avellana (16.6%) and Alnus glutinosa (16.6%)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000859-PIP01-10, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oral solution
Decision date: 22/12/2010, Last updated: 24/01/2011, Compliance check: Xcereale (10%), Betula pendula (16.7%), Corylus avellana 16.6%) and Alnus glutinosa 16.6%) Pneumology-allergologyP/301/2010EMEA-000859-PIP01-10 … 10%), Betula pendula (16,7%), Corylus avellana 16,6%) and Alnus glutinosa 16,6%) Invented name: Allerbio … -
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Referral: Suifertil 4-mg/ml oral solution for pigs and associated names
altrenogest, associated names: Synchroplan, Article 33
Status: European Commission final decision, opinion/position date: 18/07/2013, EC decision date: 02/10/2013, Last updated: 30/10/2013Suifertil 4-mg/ml oral solution for pigs and … decision Overview Suifertil 4-mg/ml oral solution for pigs contains … procedure for Suifertil 4-mg/ml oral solution for pigs and … -
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Press release: European Medicines Agency agrees to recall of Vimpat 15-mg/ml syrup
CHMP, Last updated: 22/07/2011agrees to recall of Vimpat 15-mg/ml syrup … to a recall of Vimpat 15 mg/ml syrup because of a quality … of an application for a 10-mg/ml syrup for Vimpat to continue … -
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Press release: European Medicines Agency recommends discontinuation of Vimpat 15-mg/ml syrup
CHMP, Last updated: 22/09/2011discontinuation of Vimpat 15-mg/ml syrup … recommended that Vimpat 15-mg/ml syrup should no longer be … voluntary recall of Vimpat 15-mg/ml syrup on 15 September 2011 … -
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Referral: Crestor 5 mg
rosuvastatin calcium, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 21/04/2005, EC decision date: 09/08/2005, Last updated: 09/08/2005Crestor 5 mg … Authorisation for Crestor (10 to 40 mg) was originally granted to … committed to apply for a 5-mg dose of rosuvastatin together … -
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Human medicine European public assessment report (EPAR): Gardasil
human papillomavirus type 6 L1 protein, human papillomavirus type 11 L1 protein, human papillomavirus type 16 L1 protein, human papillomavirus type 18 L1 protein, Papillomavirus Infections; Uterine Cervical Dysplasia; Condylomata Acuminata; Immunization
Date of authorisation: 20/09/2006, Revision: 48, Authorised, Last updated: 08/11/2022papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed … papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed … papillomavirus (types 6, 11, 16 and 18). It is available …