13815 results
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Human medicine European public assessment report (EPAR): Natalizumab Elan Pharma
natalizumab, Crohn Disease
Date of refusal: 11/01/2008, Refused, Last updated: 25/01/2008Natalizumab Elan Pharma Crohn Disease … Refused natalizumab Overview On 19 July 2007 … for the medicinal product Natalizumab Elan Pharma concentrate for … -
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Human medicine European public assessment report (EPAR): Tysabri (updated)
natalizumab, Multiple Sclerosis
Date of authorisation: 27/06/2006, Revision: 34, Authorised, Last updated: 28/04/2021Authorised natalizumab Overview Tysabri is a medicine … medicine. active substance natalizumab. How is Tysabri used? Treatment … active substance in Tysabri, natalizumab, is a monoclonal antibody … -
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Human medicine European public assessment report (EPAR): Moventig
naloxegol oxalate, Constipation, Opioid-Related Disorders
Date of authorisation: 07/12/2014, Revision: 11, Authorised, Last updated: 11/11/2019Authorised naloxegol Overview This is a summary … contains the active substance naloxegol. How is Moventig used? Moventig … active substance in Moventig, naloxegol, is a peripheral mu-opioid-receptor … -
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Human medicine European public assessment report (EPAR): Nyxoid
Naloxone hydrochloride dihydrate, Opioid-Related Disorders
Date of authorisation: 09/11/2017, Revision: 5, Authorised, Last updated: 26/02/2021Authorised naloxone Overview This is a summary … contains the active substance naloxone. Nyxoid is a ‘hybrid medicine’ … While the reference medicine Naloxon HCl B. Braun is given by … -
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Human medicine European public assessment report (EPAR): Starlix
nateglinide, Diabetes Mellitus, Type 2
Date of authorisation: 03/04/2001, Revision: 13, Authorised, Last updated: 11/06/2018Authorised nateglinide Overview This is a summary … containing the active substance nateglinide. It is available as pink … of glucose in the blood. Nateglinide, the active ingredient in … -
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Referral: Tysabri
natalizumab, associated names: Tysabri, Article 20 procedures
Status: European Commission final decision, opinion/position date: 25/02/2016, EC decision date: 25/04/2016, Last updated: 12/05/2016sclerosis medicine Tysabri (natalizumab), and confirmed initial … Tysabri Tysabri natalizumab natalizumab natalizumab … -
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Human medicine European public assessment report (EPAR): Trazec
nateglinide, Diabetes Mellitus, Type 2
Date of authorisation: 03/04/2001, Revision: 5, Withdrawn, Last updated: 24/08/2009Withdrawn nateglinide Overview The marketing authorisation … details >TrazecEMEA/H/C/000383nateglinidenateglinideDiabetes Mellitus, Type 2A10BX03 Publication … diabetes Therapeutic indication Nateglinide is indicated for combination … -
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Human medicine European public assessment report (EPAR): Suboxone
buprenorphine, naloxone, Opioid-Related Disorders
Date of authorisation: 26/09/2006, Revision: 19, Authorised, Last updated: 26/02/2021treat dependence on opioid (narcotic) drugs such as heroin or … substances, buprenorphine and naloxone. How is Suboxone used? Suboxone … 4 mg buprenorphine and 1 mg naloxone. The doctor may increase the … -
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Human medicine European public assessment report (EPAR): Selincro
Nalmefene hydrochloride dihydrate, Alcohol-Related Disorders
Date of authorisation: 24/02/2013, Revision: 11, Authorised, Last updated: 15/05/2019Authorised nalmefene Overview This is a summary … contains the active substance nalmefene. It is available as tablets … active substance in Selincro, nalmefene, attaches to certain opioid … -
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Veterinary medicine European public assessment report (EPAR): Gonazon
azagly-nafarelin, Dogs, Salmonidae (Salmonid fish)
Date of authorisation: 20/07/2003, Revision: 7, Withdrawn, Last updated: 15/08/2012Withdrawn azagly-nafarelin Overview The marketing authorisation … statement on Gonazon (azagly-nafarelin) Withdrawal of the marketing … statement on Gonazon (azagly-nafarelin) Withdrawal of the marketing … -
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Human medicine European public assessment report (EPAR): Mysimba
bupropion hydrochloride, naltrexone hydrochloride, Obesity, Overweight
Date of authorisation: 26/03/2015,
, Revision: 18, Authorised, Last updated: 21/01/2021
Authorised naltrexonebupropion Overview This is a summary … contains the active substances naltrexone and bupropion, which are … tablets containing 7.2 mg naltrexone and 78 mg bupropion and can … -
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Herbal medicinal product: Echinaceae angustifoliae radix
Echinacea angustifolia DC., Narrow-leaved coneflower root, F: Assessment finalised, Last updated: 23/04/2019EMA/HMPC/125289/2018 Page 2/2 The name and contact details of the … evidencing the confidential nature of the data (e.g. that it … Echinaceae angustifoliae radix; narrow- leaved coneflower root … -
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Withdrawn application: Naxcel
ceftiofur, date of withdrawal: 04/02/2010, Post-authorisation, Last updated: 23/06/2010Naxcel: Withdrawn application … Withdrawal assessment report Naxcel Page 1/15 21 April … Withdrawal assessment report Naxcel 200 mg/ml suspension for … -
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Withdrawn application: Tysabri
natalizumab, date of withdrawal: 14/05/2013, Post-authorisation, Last updated: 31/05/2013authorisation for Tysabri (natalizumab) On 14 May 2013, Elan … contains the active substance natalizumab. It is already used to treat … active substance in Tysabri, natalizumab, is a monoclonal antibody … -
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Opinion/decision on a Paediatric investigation plan (PIP): Tysabri, natalizumab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neurology
PIP number: EMEA-001095-PIP02-12, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 19/10/2012, Last updated: 27/11/2012, Compliance check: V, 16/12/2016Invented name Tysabri Active substance natalizumab Therapeutic area Neurology … granting of a waiver for natalizumab (Tysabri) (EMEA-001095-PIP02-12 … granting of a waiver for natalizumab (Tysabri) (EMEA-001095-PIP02-12 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Tysabri, natalizumab
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Neurology
PIP number: EMEA-001095-PIP03-19, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection in pre-filled syringe
Decision date: 18/03/2020, Last updated: 28/07/2020, Compliance check: XInvented name Tysabri Active substance natalizumab Therapeutic area Neurology … Tysabri Tysabri natalizumab natalizumab natalizumab … -
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Direct healthcare professional communication (DHPC): Suboxone sublingual tablets (buprenorphine / naloxone): inaccurate Braille information on the carton for HU/CZ/SK pack
Active substance: buprenorphine, naloxone, DHPC type: Quality defect, Last updated: 18/06/2020tablets (buprenorphine / naloxone): inaccurate Braille information … tablets (buprenorphine / naloxone): inaccurate Braille information … ne Suboxone buprenorphine naloxone buprenorphine naloxone buprenorphine naloxone … -
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Opinion/decision on a Paediatric investigation plan (PIP): Moventig, Naloxegol
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001146-PIP01-11-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Age-appropriate oral liquid dosage form
Decision date: 04/12/2019, Last updated: 01/04/2020, Compliance check: XKey facts Moventig Naloxegol Gastroentology-HepatologyP/0381/2019EMEA-001146-PIP01-11-M05 … paediatric investigation plan for naloxegol (Moventig) (EMEA-001146-PIP01-11-M05 … Moventig Moventig naloxegol Naloxegol naloxegol oxalate … -
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Human medicine European public assessment report (EPAR): Zubsolv
Buprenorphine hydrochloride, Naloxone hydrochloride dihydrate, Opioid-Related Disorders
Date of authorisation: 10/11/2017, Revision: 5, Authorised, Last updated: 27/01/2021treat dependence on opioid (narcotic) drugs such as heroin or … substances buprenorphine and naloxone. Zubsolv is a ‘hybrid medicine’ … but less powerfully), and naloxone, an opioid antagonist (it … -
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Orphan designation: Adeno-associated viral vector containing the human NADH-dehydrogenase-4 gene for: Treatment of Leber's hereditary optic neuropathy
Date of first decision: 13/05/2011, Positive, Last updated: 11/04/2016vector containing the human NADH-dehydrogenase-4 gene for treatment of Leber's … vector containing the human NADH-dehydrogenase-4 gene is a medicine that works … gene for an enzyme called 'NADH dehydrogenase 4'. Patients … -
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Opinion/decision on a Paediatric investigation plan (PIP): Mysimba, bupropion hydrochloride, naltrexone hydrochloride
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001373-PIP01-12-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release tablet
Decision date: 01/12/2017, Last updated: 02/03/2018, Compliance check: XMysimba bupropion hydrochloride naltrexone hydrochloride OtherP/0365/2017EMEA-001373-PIP01-12-M03 … paediatric investigation plan for naltrexone (hydrochloride) / bupropion … paediatric investigation plan for naltrexone (hydrochloride) / bupropion … -
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Human medicine European public assessment report (EPAR): Foclivia
influenza virus surface antigens, inactivated: A/Viet Nam/1194/2004 (H5N1), Influenza, Human, Immunization, Disease Outbreaks
Date of authorisation: 18/10/2009,
, Revision: 11, Authorised, Last updated: 10/03/2021
immune system (the body’s natural defences) to defend itself … Foclivia Common Name: A/Viet Nam/1194/2004 (H5N1) virus surface inactivated … commercially confidential nature deleted. Page 2 of … -
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Human medicine European public assessment report (EPAR): Rizmoic
Naldemedine tosilate, Constipation
Date of authorisation: 18/02/2019,, Revision: 5, Authorised, Last updated: 24/03/2021
Authorised naldemedine Overview Rizmoic is a medicine … contains the active substance naldemedine. How is Rizmoic used? Rizmoic … active substance in Rizmoic, naldemedine, works by attaching to and … -
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Orphan designation: Mexiletine hydrochloride for: Treatment of myotonic disorders
Date of first decision: 19/11/2014, Positive, Last updated: 13/06/2018been authorised in the EU as Namuscla since 18 December 2018. What … the orphan designation of Namuscla at the time of marketing … Namuscla Namuscla mexiletine hcl Mexiletine … -
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Orphan designation: Recombinant human parathyroid hormone for: Treatment of hypoparathyroidism
Date of first decision: 16/01/2014, Positive, Last updated: 26/04/2017been authorised in the EU as Natpar since 24 April 2017. Expand … identical to the hormone naturally produced by the body. This … identical to the hormone naturally produced by the body. This …