14376 results
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Referral: Ketabel 100 mg/ml solution for injection and associated names
ketamine, associated names: Ketabel vet. 100 mg/ml solution for injection, Belatamin 100 mg/ml solution for injection, Belatamin vet. 100 mg/ml solution for injection, Article 33
Status: European Commission final decision, opinion/position date: 05/12/2019, EC decision date: 04/03/2020, Last updated: 16/04/2020Ketabel 100 mg/ml solution for injection and … the medicine Ketabel 100 mg/ml solution for injection and … injection and contains 100 mg ketamine as active substance … -
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Referral: Denagard 45%
tiamulin hydrogen fumarate, associated names: Tiamutin 45%, Denagard 450 mg/g, Denagard vet 450 mg/g, Article 34
Status: European Commission final decision, opinion/position date: 12/04/2017, EC decision date: 14/07/2017, Last updated: 11/08/2017drinking water and contains 450 mg tiamulin hydrogen fumarate … Tiamutin 45%, Denagard 450 mg/g and Denagard vet 450 mg/g) is marketed in Austria, Belgium … application/pdf WC500233242_sv.pdf 11/08/2017 11 … -
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Referral: Doxyfar 50%
doxycycline hyclate, associated names: Soludox 500 mg/g, Soludox Vet, Soludox 433 mg/g, Doxy Ort 50%, Article 34
Status: European Commission final decision, opinion/position date: 04/05/2011, EC decision date: 13/07/2011, Last updated: 24/08/2011substance doxycycline hyclate 500 mg/g. The product is indicated … WC500110851_sv.pdf Adopted 23/08/2011 23 08/2011 EMA/512470/2011 Referral … 50%doxycycline hyclate Soludox 500 mg/g Soludox Vet Soludox 433 … -
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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 … decision Overview Prontax 5 mg/ml pour-on solution for cattle … benefit-risk profile of Prontax 5 mg/ml pour-on solution for cattle … -
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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 … decision Overview Prontax 10 mg/ml solution for injection for … benefit-risk profile of Prontax 10 mg/ml solution for injection for … -
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Referral: Zanil and associated names, and generic products thereof
oxyclozanide, associated names: Zanil Suspension, Zanil Fluke Drench, Zanil Fluke Drench 34 mg/ml Oral Suspension, Article 35
Status: European Commission final decision, opinion/position date: 13/07/2017, EC decision date: 28/09/2017, Last updated: 25/10/2017suspensions containing 34 mg oxyclozanide per ml. Oxyclozanide … suspensions containing 34 mg oxyclozanide per ml. Oxyclozanide … 35 - Annexes I-II-III 1/16 Annex I List of the names … -
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Withdrawn application: Ximelagatran 36 mg film coated tablets
date of withdrawal: 14/02/2006, Initial authorisation, Last updated: 16/02/2006Ximelagatran 36 mg film coated tablets: Withdrawn … XIMELAGATRAN ASTRAZENECA 36 MG FILM COATED TABLETS International … authorisation for Ximelagatran 36 mg film coated tablets, for … -
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Opinion/decision on a Paediatric investigation plan (PIP): Human papilloma virus type 16 E6 071-095, human papilloma virus type 16 E6 001-032, human papilloma virus type 16 E6 055-080, human papilloma virus type 16 E6 091-122, Human Papilloma Virus Type 16 E6 109-140, Human Papilloma Virus Type 16 E6 019-050, Human Papilloma Virus Type 16 E6 041-065, Human Papilloma Virus Type 16 E6 085-109, Human Papilloma Virus Type 16 E6 127-158, human papilloma virus type 16 E7 064-098, Human Papilloma Virus Type 16 E7 022-056, Human Papilloma Virus Type 16 E7 001-035
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001055-PIP02-21, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Suspension for injection
Decision date: 09/07/2021, Last updated: 22/07/2022, Compliance check: XHuman papilloma virus type 16 E6 071-095 human papilloma … human papilloma virus type 16 E6 001-032 human papilloma … human papilloma virus type 16 E6 055 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Human papilloma virus type 16 E6 071-095, human papilloma virus type 16 E7 064-098, human papilloma virus type 16 E6 055-080, human papilloma virus type 16 E6 001-032, human papilloma virus type 16 E6 091-122
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001055-PIP01-10, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder for suspension for injection
Decision date: 04/03/2011, Last updated: 08/04/2011, Compliance check: XHuman papilloma virus type 16 E6 071-095 human papilloma … human papilloma virus type 16 E7 064-098 human papilloma … human papilloma virus type 16 E6 055 … -
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Veterinary medicine European public assessment report (EPAR): Coliprotec F4
live non-pathogenic Escherichia coli O8:K87, Pigs
Date of authorisation: 16/03/2015, Revision: 2, Withdrawn, Last updated: 23/11/2021name Escherichia coli, type 08, strain K87 (live) Species … throughout the European Union 16/03/2015 Contact address Geyerspergerstrasse … Union, for Coliprotec F4 on 16 March 2015. Information on … -
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Direct healthcare professional communication (DHPC): RoActemra (tocilizumab): Temporary supply shortage for 162 mg solution for subcutaneous injection and RoActemra 20 mg/mL concentrate for solution for infusion (IV) & recommendations to manage potential risk of disease flare in patient
Active substance: tocilizumab, DHPC type: Medicine shortage, Last updated: 02/09/2021Temporary supply shortage for 162 mg solution for subcutaneous … injection and RoActemra 20 mg/mL concentrate for solution … Temporary supply shortage for 162 mg solution for subcutaneous … -
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Referral: Dinolytic 12.5 mg/ml and 5 mg/ml solutions for injection and associated names, and generic products thereof
dinoprost, Article 35
Status: European Commission final decision, opinion/position date: 18/06/2020, EC decision date: 16/09/2020, Last updated: 06/10/2020Dinolytic 12.5 mg/ml and 5 mg/ml solutions for injection and … -
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Referral: Paracetamol/Ibuprofen 500 mg/150 mg film-coated tablets
paracetamol, ibuprofen, associated names: Paracomb, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 18/05/2017, EC decision date: 07/08/2017, Last updated: 18/08/2017Paracetamol/Ibuprofen 500 mg/150 mg film-coated tablets … Paracetamol/ibuprofen 500mg/150mg film-coated tablets. The … Paracetamol/ibuprofen 500mg/150mg film-coated tablets outweigh … -
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Direct healthcare professional communication (DHPC): Nulojix (belatacept): Risk of medication errors due to change in maintenance dose from 5 mg/kg to 6 mg/kg
Active substance: belatacept, DHPC type: Medication error, Last updated: 12/09/2022in maintenance dose from 5 mg/kg to 6 mg/kg Graft Rejection Kidney … in maintenance dose from 5 mg/kg to 6 mg/kg … maintenance dose from 5 mg/kg to 6 mg/kg Dear Healthcare professional … -
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Referral: Fluconazol Tiefenbacher 50mg, 100mg, 150mg, 200mg capsules, hard
fluconazole, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 24/07/2003, EC decision date: 01/12/2003, Last updated: 11/02/2004Fluconazol Tiefenbacher 50mg, 100 mg, 150 mg, 200 mg capsules, hard … Fluconazol Tiefenbacher 50mg, 100 mg, 150 mg, 200 mg capsules, hard … Fluconazol Tiefenbacher 50 mg, 100 mg, 150 mg, 200 mg capsules, hard, INN-Fluconazole … -
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Referral: Betamox LA 150 mg/ml suspension for injection and associated names, and generics products thereof
Amoxicillin trihydrate, Article 35
Status: European Commission final decision, opinion/position date: 16/07/2020, EC decision date: 12/10/2020, Last updated: 12/11/2020Betamox LA 150 mg/ml suspension for injection … final decision Overview On 16 July 2020, the European Medicines … -
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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 … cells incubated ex-vivo with 16, 16-dimethyl prostaglandin E2dexamethasone … orphan designation (EU/3/16/1774) was granted by the … -
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Referral: Strenzen 500/125-mg/g powder
amoxicillin, clavulanic acid, Article 33
Status: European Commission final decision, opinion/position date: 10/04/2013, EC decision date: 12/08/2013, Last updated: 19/09/2013Strenzen 500/125-mg/g powder … Overview Strenzen 500/125-mg/g powder for use in drinking … procedure for Strenzen 500/125-mg/g powder for use in drinking … -
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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 for the … treated with a chemical called '16,16-dimethyl prostaglandin E2' (dmPGE2 … Regulation (EC) No 141/2000 of 16 December 1999, the COMP adopted … -
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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 Overview … cells treated ex vivo with 16,16-dimethyl prostaglandin E2 for the … treated with a chemical called '16,16-dimethyl prostaglandin E2' (dmPGE2 … -
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Referral: Ecomectin 18.7mg/g Oral Paste for Horses
ivermectin, Article 33
Status: European Commission final decision, opinion/position date: 08/11/2007, EC decision date: 17/01/2008, Last updated: 07/12/2011Ecomectin 18.7mg/g Oral Paste for Horses … decision Overview Ecomectin 18.7 mg/g Oral Paste for Horses is … endectocides. Ecomectin 18.7 mg/g Oral Paste for Horses is … -
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Referral: Lansopon 15 mg and 30 mg
Lansoprazole, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 23/06/2005, EC decision date: 15/09/2005, Last updated: 13/10/2005Lansopon 15 mg and 30 mg … Authorisation for Lansopon (15 mg and 30 mg) was previously granted to … Procedure was started on 16 September 2004.The Reference … -
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Referral: Lansoprazol HEXAL 15 mg and 30 mg
Lansoprazole, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 23/06/2005, EC decision date: 15/09/2005, Last updated: 15/09/2005Lansoprazol HEXAL 15 mg and 30 mg … for Lansoprazol HEXAL (15 mg and 30 mg) was previously granted to … Procedure was started on 16 September 2004. The Reference … -
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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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Referral: Solamocta 697 mg/g powder for use in drinking water for chickens, ducks and turkeys
Amoxicillin trihydrate, Article 33
Status: European Commission final decision, opinion/position date: 04/11/2015, EC decision date: 07/01/2016, Last updated: 05/02/2016Solamocta 697 mg/g powder for use in drinking … medicinal product Solamocta 697 mg/g Powder for Use in Drinking … information. What is Solamocta 697 mg/g Powder for Use in Drinking …