8192 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 … Tiamutin 45% Denagard 450 mg/g Denagard vet 450 … -
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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 … 50%doxycycline hyclate Soludox 500 mg/g Soludox Vet Soludox 433 mg/g Doxy Ort 50% EMA/512470/2011 … substance doxycycline hyclate 500 mg/g. The product is indicated … -
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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: 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 … cattle, sheep and goats, e.g. cattle meat and offal from … suspensions containing 34 mg oxyclozanide per ml. Oxyclozanide … -
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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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Opinion/decision on a Paediatric investigation plan (PIP): EGFR-cMET bispecific antibody
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002573-PIP01-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion, Solution for injection
Decision date: 16/08/2019, Last updated: 20/11/2019, Compliance check: XKey facts EGFR-cMET bispecific antibody OncologyP/0289/2019EMEA-002573-PIP01-19 … product specific waiver for EGFR-cMET bispecific antibody (EMEA-002573-PIP01-19 … EGFR-cMET bispecific antibody … -
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Withdrawn application: Egranli
date of withdrawal: 04/11/2014, Initial authorisation, Last updated: 16/02/2015Egranli: Withdrawn application … Egranli, INN-balugrastim 30 … initial authorisation) Egranli balugrastim On 25 September … -
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Withdrawn application: Egrifta
date of withdrawal: 21/06/2012, Initial authorisation, Last updated: 18/07/2012Egrifta: Withdrawn application … authorisation application for Egrifta (tesamorelin) On 21 June … marketing authorisation for Egrifta, for the treatment of excess … -
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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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Human medicine European public assessment report (EPAR): Humenza
split influenza virus, inactivated, containing antigen*: A/California/7/2009 (H1N1)v like strain (X-179A)*propagated in eggs., Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 08/06/2010,
, Withdrawn, Last updated: 30/06/2011
strain (X-179A)*propagated in eggs.pandemic influenza vaccine (H1N1 … as ovalbumin (a protein in egg white egg or chicken proteins, neomycin … strain (X-179A)*propagated in eggs. … -
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Human medicine European public assessment report (EPAR): Arepanrix
split influenza virus, inactivated, containing antigen*: A/California/7/2009 (H1N1)v like strain (X-179A)*propagated in eggs., Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 23/03/2010,, Revision: 1, Withdrawn, Last updated: 25/10/2011
strain (X-179A)*propagated in eggs.pandemic influenza vaccine (H1N1)v … in the vaccine, such as egg or chicken protein, ovalbumin … protein, ovalbumin (a protein in egg white), formaldehyde and … -
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Orphan designation: Refusal of orphan designation for the treatment of poisoning by local anaesthetics
Date of refusal of designation: 03/04/2017, Negative, Last updated: 15/05/2017of 20% soybean oil, 1.2% egg yolk phospholipids, 2.25 … of 20% soybean oil, 1.2% egg yolk phospholipids, 2.25 … of 20% soybean oil, 1.2% egg yolk phospholipids, 2.25 … -
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Human medicine European public assessment report (EPAR): Daronrix
Whole virion, inactivated, containing antigen*: A/Vietnam/1194/2004 (H5N1)* produced in eggs, Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 21/03/2007,
, Withdrawn, Last updated: 02/07/2013
A/Vietnam/1194/2004 (H5N1)* produced in eggspandemic influenza vaccine (whole … in the vaccine, such as eggs, chicken protein or gentamicin … A/Vietnam/1194/2004 (H5N1)* produced in eggs … -
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Opinion/decision on a Paediatric investigation plan (PIP): Humenza, Split influenza virus, inactivated containing antigen equivalent to A/California/7/2009 (H1N1)-like strain (A/California/7/2009 (NYMC X-179A)), adjuvanted
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000669-PIP01-09-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension and emulsion for injection
Decision date: 04/01/2019, Last updated: 21/09/2021, Compliance check: V, 26/04/2019strain (X-179A)*propagated in eggs. … -
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Opinion/decision on a Paediatric investigation plan (PIP): Arepanrix, Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted), containing antigen equivalent to Influenza A/California/7/2009
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000687-PIP01-09-M02, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension and emulsion for emulsion for injection
Decision date: 09/08/2010, Last updated: 07/10/2010, Compliance check: V, 12/12/2014strain (X-179A)*propagated in eggs. … -
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Orphan designation: Adeno-associated virus serotype rh74 containing the human micro-dystrophin gene for: Treatment of Duchenne muscular dystrophy
Date of designation: 28/02/2020, Positive, Last updated: 22/10/2020EU/3/20/2250 … orphan designation EU/3/20/2250 was granted by the European … -
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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: 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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National expert: Iveta Eglite, State Agency Of Medicines (updated)
- Declaration of interests - 79.78 KB | PDF
- Curriculum Vitae - 16.93 KB | PDF
Iveta Eglite … Iveta Eglite … Vitae PERSONAL INFORMATION Iveta Eglite WORK EXPERIENCE March 2021 … -
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National expert: Egle Daniuleviciute, State Medicines Control Agency (updated)
- Declaration of interests - 79.85 KB | PDF
- Curriculum Vitae - 17.85 KB | PDF
Egle Daniuleviciute … Egle Daniuleviciute … Vitae PERSONAL INFORMATION Egle Daniuleviciute WORK EXPERIENCE … -
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National expert: Egle Audova, State Agency Of Medicines (updated)
- Declaration of interests - 79.79 KB | PDF
- Curriculum Vitae - 16.3 KB | PDF
Egle Audova … Egle Audova … Vitae PERSONAL INFORMATION Egle Audova WORK EXPERIENCE October … -
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National expert: Egberdina Botjes, European Medicines Agency (updated)
- Declaration of interests - 79.85 KB | PDF
- Curriculum Vitae - 16.47 KB | PDF
Egberdina Botjes … Egberdina Botjes … Vitae PERSONAL INFORMATION Egberdina Botjes WORK EXPERIENCE January … -
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National expert: Egbert Flory, Paul Ehrlich Institute (updated)
- Declaration of interests - 80.04 KB | PDF
- Curriculum Vitae - 22.08 KB | PDF
Egbert Flory … Egbert Flory … Vitae PERSONAL INFORMATION Egbert Flory WORK EXPERIENCE … -
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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 … referral for Lansopon 15 mg and 30 mg International Non-Proprietary …