19519 results
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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: 24/08/2011the treatment of certain infections of the respiratory tract … administered and withdrawal periods concerning the authorisation … associated names: Background information PDF icon application/pdf … -
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Orphan designation: Eculizumab for: Treatment myasthenia gravis
Date of designation: 29/07/2014, Positive, Last updated: 20/11/2019been authorised in the EU as Soliris since 14 August 2017. The … 10,000. This is based on the information provided by the sponsor and … thymus gland (thymectomy) was performed in some patients. The sponsor … -
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Orphan designation: Eculizumab for: Treatment of neuromyelitis optica spectrum disorders
Date of designation: 05/08/2013, Positive, Last updated: 20/11/2019been authorised in the EU as Soliris since 26 August 2019. The … optica spectrum disorders are inflammatory disorders that affect mostly … 10,000. This is based on the information provided by the sponsor and … -
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Opinion/decision on a Paediatric investigation plan (PIP): Diphtheria toxoid, tetanus toxoid, pertussis toxoid, pertussis filamentous haemagglutinin, pertactin
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Infectious diseases
PIP number: EMEA-002343-PIP01-18, Route(s) of administration: Intramuscular use,
Decision date: 16/07/2019, Last updated: 13/11/2019, Compliance check: XEMEA-002343-PIP01-18 Infectious diseases … Diphtheria toxoid tetanus toxoid pertussis toxoid pertussis filamentous haemagglutinin pertactin … eria toxoid tetanus toxoid pertussis toxoid pertussis filamentous haemagglutinin pertactin … -
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Orphan designation: Eculizumab for: Treatment of atypical haemolytic uraemic syndrome (aHUS)
Date of designation: 24/07/2009, Positive, Last updated: 20/11/2019been authorised in the EU as Soliris since 24 November 2011. The … occur in children after an infection with gut bacteria, atypical … adults, and is not caused by an infection. More than half of the cases … -
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Herbal medicinal product: Solidaginis virgaureae herba
Solidago virgaurea L., European Goldenrod, F: Assessment finalised, Last updated: 29/11/2020Solidaginis virgaureae herba Urinary … currently developing this information. Key facts Solidaginis virgaureae herbaEuropean … the assessment report on Solidago virgaurea L., herba EMA/HMPC/637909/2018Adopted … -
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Herbal medicinal product: Solani dulcamarae stipites
Solanum dulcamara L., Woody nightshade stem, F: Assessment finalised, Last updated: 21/12/2020Solani dulcamarae stipites Skin … Abbreviated as HMPC. More information can be found under 'Committee … herbal medicines. More information can be found under Committee … -
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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 associated … medicine Ketabel 100 mg/ml solution for injection and associated … UK during the transition period. What is Ketabel? Ketabel … -
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Referral: Dectomax injectable solution and its associated names
doramectin, associated names: Dectomax 1% Injektionslösung für Rinder und Schafe, Dectomax Vet, Dectomax 1%, Dectomax 1% Injectable Solution, Prontax, Dectomax solution injectable, Dectomax Injectable Solution for Cattle and Sheep, Article 34
Status: European Commission final decision, opinion/position date: 08/12/2004, EC decision date: 29/03/2005, Last updated: 13/08/2014Dectomax injectable solution and its associated names … Overview Dectomax injectable solution and its associated names … active substance at 10 mg per ml. Doramectin is a semi-synthetic … -
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Withdrawn application: Solumarv
insulin human, date of withdrawal: 15/11/2012, Initial authorisation, Last updated: 14/12/2012Solumarv: Withdrawn application … 0)20 7523 7129 E-mail info@ema.europa.eu Website www.ema.europa.eu … authorisation application for Solumarv (human insulin) On 15 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Bordetella pertussis antigen: Filamentous Haemagglutinin, Bordetella pertussis antigen: Pertactin, Bordetella pertussis antigen: Pertussis toxoid, Inactivated poliovirus: type 1 (Mahoney strain), Inactivated poliovirus: type 2 (MEF-1 strain), Inactivated poliovirus: type 3 (Saukett strain), tetanus toxoid
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases; Vaccines
PIP number: EMEA-003066-PIP01-21, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection in pre-filled syringe
Decision date: 03/12/2021, Last updated: 13/03/2023, Compliance check: XEMEA-003066-PIP01-21 Infectious diseases Vaccines … Key facts Bordetella pertussis antigen: Filamentous Haemagglutinin … Haemagglutinin Bordetella pertussis antigen Pertactin Bordetella pertussis antigen … -
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Orphan designation: Autologous tumour-derived immunoglobulin idiotype coupled to keyhole limpet hemocyanin for: Treatment of follicular lymphoma
Date of designation: 28/08/2006, Positive, Last updated: 14/06/2012idiotype coupled to keyhole limpet haemocyanin for the treatment … subsequently to Biovest Europe Limited, United Kingdom, in September … system and helps fighting infections. It is a complex system made … -
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Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000876-PIP05-15-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 11/03/2022, Last updated: 30/06/2023, Compliance check: V, 14/10/2022Invented name Soliris Active substance Eculizumab … Pharmaceutical form(s) Concentrate for solution for infusion Condition(s) / indication(s … investigation plan for eculizumab (Soliris), (EMEA-000876-PIP05-15-M05 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000876-PIP02-11-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 21/12/2012, Last updated: 02/03/2018, Compliance check: V, 02/06/2015Invented name Soliris Active substance Eculizumab … Pharmaceutical form(s) Concentrate for solution for infusion Condition(s) / indication(s … an agreed PIP Decision perez Typewritten Text Signature … -
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Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000876-PIP03-14-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 22/12/2020, Last updated: 23/09/2021, Compliance check: XInvented name Soliris Active substance Eculizumab … Pharmaceutical form(s) Concentrate for solution for infusion Condition(s) / indication(s … investigation plan for eculizumab (Soliris), (EMEA-000876-PIP03-14-M05 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000876-PIP07-15, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 01/09/2016, Last updated: 27/10/2016, Compliance check: XInvented name Soliris Active substance Eculizumab … Pharmaceutical form(s) Concentrate for solution for infusion Condition(s) / indication(s … delayed graft function after solid organ transplantation Route(s … -
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Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000876-PIP01-10-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 24/10/2014, Last updated: 02/03/2017, Compliance check: XInvented name Soliris Active substance Eculizumab … Pharmaceutical form(s) Concentrate for solution for infusion Condition(s) / indication(s … investigation plan for eculizumab (Soliris) (EMEA-000876-PIP01-10-M01 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000876-PIP06-15, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 28/07/2016, Last updated: 20/04/2018, Compliance check: XInvented name Soliris Active substance Eculizumab … Pharmaceutical form(s) Concentrate for solution for infusion Condition(s) / indication(s … graft rejection following solid organ transplantation Route(s … -
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Opinion on medicine for use outside EU: Globorix
Diphtheria toxoid, Tetanus toxoid, Bordetella pertussis (inactivated), Haemophilus influenzae type b polysaccharide, Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid, hepatitis B surface antigen, Immunization; Hepatitis B; Diphtheria-Tetanus-Pertussis Vaccine; Bordetella pertussis; Haemophilus influenzae type b; Neisseria meningitidis, Serogroup A; Neisseria meningitidis, Serogroup C, ATC code: J07CA09 Opinion number: H/W/848, Withdrawn application , Last updated: 05/07/2018B Diphtheria-Tetanus-Pertussis Vaccine Bordetella pertussis Haemophilus influenzae type b Neisseria meningitidis … Abbreviated as CHMP. More information can be found under 'Committee … concerning human medicines. More information can be found under 'Committee … -
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Human medicine European public assessment report (EPAR): Soliris
Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 20/06/2007,
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, Revision: 36, Authorised, Last updated: 21/08/2023
Soliris Cancer Neoplasms Hemic … Soliris is a medicine used to treat … clot) and kidney failure. Soliris is used to treat adults and … -
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Veterinary medicine European public assessment report (EPAR): Respiporc Flu3
inactivated influenza-A virus / swine, Pigs
Date of authorisation: 14/01/2010, Revision: 5, Authorised, Last updated: 16/02/2021different strains of swine influenza A virus which have been inactivated … of 56 days against swine influenza in order to help them clinically … the piglets against swine influenza for at least 33 days after … -
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Veterinary medicine European public assessment report (EPAR): Solensia
frunevetmab, Cats
Date of authorisation: 17/02/2021, Authorised, Last updated: 25/06/2020Solensia … Solensia is a veterinary medicinal … osteoarthritis. For more information, see the package leaflet … -
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Opinion/decision on a Paediatric investigation plan (PIP): Purified Tetanus Toxoid, Inactivated Type 1 Poliovirus (Mahoney), Inactivated Type 2 Poliovirus (MEF-1), Inactivated Type 3 Poliovirus (Saukett), polyribosylribitol phosphate (PRP) from Haemophilus influenzae type b as prp-ompc, hepatitis B surface antigen recombinant, Purified Filamentous Haemagglutinin, purified pertussis toxoid, purified fimbriae types 2 and 3, purified pertactin, purified diphtheria toxoid
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-000394-PIP01-08-M01, Route(s) of administration: Intramuscular route, Pharmaceutical form(s): Suspension for injection, Suspension for injection in pre-filled syringe
Decision date: 03/02/2012, Last updated: 15/03/2012, Compliance check: V, 10/10/2014phosphate (PRP) from Haemophilus influenzae type b as prp-ompc hepatitis B … Filamentous Haemagglutinin purified pertussis toxoid purified fimbriae … fimbriae types 2 and 3 purified pertactin purified diphtheria toxoid … -
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Human medicine European public assessment report (EPAR): Inflectra
infliximab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Psoriasis; Crohn Disease; Arthritis, Rheumatoid
Date of authorisation: 10/09/2013,
, Revision: 29, Authorised, Last updated: 12/05/2022
Inflectra Musculoskeletal Diseases Joint … Diseases Intestinal Diseases Inflammatory Bowel Diseases Gastroenteritis Colitis Colonic … assessment report (EPAR) for Inflectra. It explains how the European … -
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Human medicine European public assessment report (EPAR): Pergoveris
follitropin alfa, lutropin alfa, Infertility, Female
Date of authorisation: 25/06/2007, Revision: 15, Authorised, Last updated: 31/05/2023Pergoveris Female Urogenital Diseases … Diseases Genital Diseases, Female Infertility Infertility, Female … assessment report (EPAR) for Pergoveris. It explains how the Agency …