18928 results
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Withdrawn application: Graspa
asparaginase, date of withdrawal: 22/06/2018, Initial authorisation, Last updated: 23/01/2019application for Graspa (L-asparaginase) On 22 June 2018, Erytech … contains the active substance L-asparaginase that has been enclosed in … enclosed in red blood cells. Asparaginase has been used to treat cancer … -
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Orphan designation: Asciminib for: Treatment of chronic myeloid leukaemia
Date of designation: 24/03/2020, Positive, Last updated: 07/09/2022Asciminib … Scemblix Scemblix asciminib Asciminib asciminib hydrochloride … application/pdf orphan medicine assessment report . … -
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Summary of opinion: Tremelimumab AstraZeneca
tremelimumab, opinion date: 15/12/2022, Positive, Last updated: 16/12/2022Tremelimumab AstraZeneca: Pending EC decision … Tremelimumab AstraZeneca … authorisation) Tremelimumab AstraZeneca tremelimumab On 15 December … -
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Human medicine European public assessment report (EPAR): Ryzodeg
insulin aspart, insulin degludec, Diabetes Mellitus
Date of authorisation: 21/01/2013, Revision: 13, Authorised, Last updated: 23/09/2021Active substance insulin aspart insulin degludec International … insulin degludec insulin aspart Therapeutic area (MeSH) Diabetes … Marketing-authorisation holder Novo Nordisk A/S Revision 13 Date of issue … -
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Opinion/decision on a Paediatric investigation plan (PIP): Sycrest, Asenapine maleate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Psychiatry
PIP number: EMEA-000228-PIP01-08-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Sublingual tablet
Decision date: 24/11/2014, Last updated: 02/03/2018, Compliance check: V, 18/08/2017Sycrest Active substance Asenapine maleate Therapeutic area … paediatric investigation plan for asenapine (maleate) (Sycrest) (EMEA-000228-PIP01-08-M04 … paediatric investigation plan for asenapine (maleate) (Sycrest) (EMEA-000228-PIP01-08-M04 … -
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Orphan designation: Asp-Arg-Val-Tyr-Ile-His-Pro for: Treatment of acute lung Injury
Date of designation: 10/10/2012, Withdrawn, Last updated: 19/01/2016Asp-Arg-Val-Tyr-Ile-His-Pro Overview Please note that … Pharmaceuticals Limited, Cyprus, for Asp-Arg-Val-Tyr-Ile-His-Pro for the treatment of acute … transferred to Gregory Fryer Associates Ltd, United Kingdom, in June … -
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Human medicine European public assessment report (EPAR): Trizivir
abacavir (as sulfate), lamivudine, zidovudine, HIV Infections
Date of authorisation: 27/12/2000, Revision: 42, Authorised, Last updated: 27/09/2022abacavir (as sulfate) / lamivudine / zidov … contains 300 mg of abacavir (as sulfate), 150 mg lamivudine … section 4.4). Therefore, as dose adjustments of these … -
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Human medicine European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca)
ChAdOx1-SARS-COV-2, COVID-19 virus infection
Date of authorisation: 29/01/2021,
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, Revision: 25, Authorised, Last updated: 30/11/2022
previously COVID-19 Vaccine AstraZeneca) Myelitis Respiratory Tract … previously COVID-19 Vaccine AstraZeneca) … EMA/205598/2021 Pharmacovigilance Risk Assessment Committee (PRAC) Signal assessment report on embolic and thrombotic … -
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Human medicine European public assessment report (EPAR): Spherox (updated)
spheroids of human autologous matrix-associated chondrocytes, Cartilage Diseases
Date of authorisation: 10/07/2017, Revision: 7, Authorised, Last updated: 16/01/2023of human autologous matrix-associated chondrocytes Overview Spherox … experiencing symptoms (such as pain and problems moving … used? Spherox is available as a suspension for implantation … -
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Opinion/decision on a Paediatric investigation plan (PIP): Strensiq, asfotase alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000987-PIP01-10-M04, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 15/05/2019, Last updated: 21/09/2021, Compliance check: V, 18/10/2019Strensiq Active substance asfotase alfa Therapeutic area Endocrinology … Strensiq Strensiq asfotase alfa asfotase alfa asfotase alfa … -
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Direct healthcare professional communication (DHPC): Vaxzevria (previously COVID-19 Vaccine AstraZeneca): risk of thrombocytopenia (including immune thrombocytopenia) with or without associated bleeding
Active substance: ChAdOx1-SARS-COV-2, DHPC type: Safety signal, Last updated: 13/10/2021previously COVID-19 Vaccine AstraZeneca): risk of thrombocytopenia … thrombocytopenia) with or without associated bleeding COVID-19 virus … previously COVID-19 Vaccine AstraZeneca): risk of thrombocytopenia … -
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Direct healthcare professional communication (DHPC): Vaxzevria/COVID-19 Vaccine AstraZeneca: Risk of thrombosis in combination with thrombocytopenia - Updated information
Active substance: ChAdOx1-SARS-COV-2, DHPC type: Type II variation, Last updated: 02/06/2021Vaxzevria/COVID-19 Vaccine AstraZeneca: Risk of thrombosis in combination … Vaxzevria/COVID-19 Vaccine AstraZeneca: Risk of thrombosis in combination … VAXZEVRIA/COVID-19 Vaccine AstraZeneca: Risk of thrombosis in combination … -
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Direct healthcare professional communication (DHPC): Vaxzevria (previously COVID-19 Vaccine AstraZeneca): contraindication in individuals with previous capillary leak syndrome
Active substance: ChAdOx1-SARS-COV-2, DHPC type: Safety signal, Last updated: 23/06/2021previously COVID-19 Vaccine AstraZeneca): contraindication in individuals … previously COVID-19 Vaccine AstraZeneca): contraindication in individuals … VAXZEVRIA/COVID-19 Vaccine AstraZeneca: contraindication in individuals … -
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Direct healthcare professional communication (DHPC): Vaxzevria (previously COVID-19 Vaccine AstraZeneca): link between the vaccine and the occurrence of thrombosis in combination with thrombocytopenia
Active substance: ChAdOx1-SARS-COV-2, DHPC type: Safety signal, Last updated: 13/04/2021previously COVID-19 Vaccine AstraZeneca): link between the vaccine … previously COVID-19 Vaccine AstraZeneca): link between the vaccine … VAXZEVRIA/COVID-19 Vaccine AstraZeneca: link between the vaccine … -
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Herbal medicinal product: Centellae asiaticae herba
Centella asiatica (L.) Urb., Centella, F: Assessment finalised, Last updated: 02/09/2022Centellae asiaticae herba Skin disorders and … information. Key facts Centellae asiaticae herbaCentellaCentella asiatica (L.) Urb. Skin disorders … disorders and minor woundsF: Assessment finalised 31/10/2007 08/05/2008 … -
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Orphan designation: L-asparaginase encapsulated in erythrocytes for: Treatment of acute lymphoblastic leukaemia
Date of designation: 27/10/2006, Positive, Last updated: 29/07/2008L-asparaginase encapsulated in erythrocytes … ORPHAN DESIGNATION OF L-asparaginase encapsulated in erythrocytes … Pharma S.A., France, for L-asparaginase encapsulated in erythrocytes … -
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Summary of opinion: Frontpro (previously known as Afoxolaner Merial)
afoxolaner, opinion date: 09/09/2021, Positive, Last updated: 10/09/2021Frontpro (previously known as Afoxolaner Merial): Pending … Frontpro (previously known as Afoxolaner Merial … Frontpro is currently authorised as chewable tablets for use … -
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Referral: Cefuroximaxetil
cefuroxime (as axetil), Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 26/04/2007, EC decision date: 22/08/2007, Last updated: 24/09/2007by Pharmacovigilance Risk Assessment Committee Opinion provided … Overview Cefuroximaxetil and associated names, 125 mg, 250 mg and … susceptible to cefuroxime, such as: upper respiratory tract infections … -
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Direct healthcare professional communication (DHPC): Cetrorelix acetate - Cetrotide 0.25 mg Powder and solvent for injection: Temporary Shortage
Active substance: cetrorelix (as acetate), DHPC type: Medicine shortage, Last updated: 09/08/2022Active substance cetrorelix (as acetate) Therapeutic area … followed by oocyte pick-up and assisted reproductive techniques … and your continued support as we work to resolve this with as little disruption to you … -
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Opinion/decision on a Paediatric investigation plan (PIP): Vaxzevria (previously COVID-19 Vaccine AstraZeneca), COVID-19 vaccine (ChAdOx1-S [recombinant]) (AZD1222)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002862-PIP01-20-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 07/07/2021, Last updated: 18/07/2022, Compliance check: Xpreviously COVID-19 Vaccine AstraZeneca) Active substance COVID-19 … Contact for public enquiries AstraZeneca AB Tel. +46 855324400 … application submitted by AstraZeneca AB on 22 March 2021 under … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ryzodeg, insulin degludec, insulin aspart
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000479-PIP01-08-M03, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 06/03/2015, Last updated: 13/11/2015, Compliance check: V, 11/09/2015insulin degludec insulin aspart Therapeutic area Endocrinology … public enquiries Novo Nordisk A/S Denmark Tel. +45 3075 8242 … insulin degludec / insulin aspart (Ryzodeg), (EMEA-000479-PIP01-08-M03 … -
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Orphan designation: Recombinant human tissue non-specific alkaline phosphatase - Fc - deca-aspartate fusion protein for: Treatment of hypophosphatasia
Date of designation: 04/12/2008, Positive, Last updated: 20/11/2019alkaline phosphatase - Fc - deca-aspartate fusion protein … phosphatase - Fc - deca-aspartate fusion protein for the for … phosphatase - Fc - deca-aspartate fusion protein for the treatment … -
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Orphan designation: Genetically modified adeno-associated viral vector serotype 9 expressing shRNA as well as a codon-optimised shRNA-insensitive wildtype PABPN1 for: Treatment of oculopharyngeal muscular dystrophy
Date of designation: 12/01/2017, Positive, Last updated: 11/07/2017Genetically modified adeno-associated viral vector serotype 9 expressing … serotype 9 expressing shRNA as well as a codon-optimised shRNA-insensitive … genetically modified adeno-associated viral vector serotype 9 expressing … -
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Direct healthcare professional communication (DHPC): Vaxzevria (previously COVID-19 Vaccine AstraZeneca): Risk of thrombocytopenia and coagulation disorders
Active substance: Chimpanzee Adenovirus encoding the SARS CoV 2 Spike glycoprotein (ChAdOx1-S), DHPC type: Safety signal, Last updated: 24/03/2021previously COVID-19 Vaccine AstraZeneca): Risk of thrombocytopenia … previously COVID-19 Vaccine AstraZeneca): Risk of thrombocytopenia … COVID-19 Vaccine AstraZeneca: Risk of thrombocytopenia … -
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Human medicine European public assessment report (EPAR): Aspaveli
Pegcetacoplan, Hemoglobinuria, Paroxysmal
Date of authorisation: 13/12/2021,, 
, Revision: 3, Authorised, Last updated: 06/09/2022
Aspaveli Hemoglobinuria, Paroxysmal … Aspaveli … EMA/603278/2021 EMEA/H/C/005553 Aspaveli (pegcetacoplan) An overview …