735 results
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Orphan designation: Lactobacillus acidophilus and Bifidobacterium bifidum for: Prevention of necrotising enterocolitis
Date of first decision: 16/01/2014, Positive, Last updated: 23/01/2014Italy, for Lactobacillus acidophilus and Bifidobacterium bifidum … expected to work? Lactobacillus acidophilus and Bifidobacterium bifidum … designation Lactobacillus acidophilus and Bifidobacterium bifidum … -
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Withdrawn application: Pioglitazone ratiopharm
pioglitazone, date of withdrawal: 03/02/2012, Initial authorisation, Last updated: 30/04/2012Pioglitazone ratiopharm: Withdrawn application … authorisation) Pioglitazone ratiopharm pioglitazone On 21 July … medicinal product Pioglitazone ratiopharm 15, 30, 45 mg tablet intended … -
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Withdrawn application: Pioglitazone ratiopharm GmbH
pioglitazone, date of withdrawal: 03/02/2012, Initial authorisation, Last updated: 30/04/2012Pioglitazone ratiopharm GmbH: Withdrawn application … authorisation) Pioglitazone ratiopharm GmbH pioglitazone On 21 … medicinal product Pioglitazone ratiopharm GmbH 15, 30, 45 mg tablet … -
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Human medicine European public assessment report (EPAR): Levetiracetam ratiopharm (updated)
levetiracetam, Epilepsy
Date of authorisation: 26/08/2011,
, Revision: 11, Authorised, Last updated: 22/02/2021
Levetiracetam ratiopharm Epilepsy … EPAR) for Levetiracetam ratiopharm. It explains how the Committee … of use for Levetiracetam ratiopharm. What is Levetiracetam ratiopharm? Levetiracetam ratiopharm is a medicine that contains … -
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Human medicine European public assessment report (EPAR): Desloratadine ratiopharm (updated)
desloratadine, Rhinitis, Allergic, Perennial, Urticaria, Rhinitis, Allergic, Seasonal
Date of authorisation: 13/01/2012,, Revision: 9, Authorised, Last updated: 03/02/2021
Desloratadine ratiopharm Rhinitis, Allergic, Perennial Urticaria Rhinitis … desloratadine Overview Desloratadine ratiopharm is a medicine used in adults … is unknown. Desloratadine ratiopharm contains the active substance … -
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Human medicine European public assessment report (EPAR): Rasagiline ratiopharm
rasagiline, Parkinson Disease
Date of authorisation: 12/01/2015, Revision: 7, Authorised, Last updated: 22/10/2020Rasagiline ratiopharm Parkinson Disease … Rasagiline ratiopharm … for the public Rasagiline ratiopharm rasagiline This is a summary … -
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Human medicine European public assessment report (EPAR): Sildenafil ratiopharm
sildenafil, Erectile Dysfunction
Date of authorisation: 23/12/2009,, Revision: 17, Authorised, Last updated: 06/10/2020
Sildenafil ratiopharm Erectile Dysfunction … Sildenafil ratiopharm … Sildenafil ratiopharm, INN-sildenafil 7 … -
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Human medicine European public assessment report (EPAR): Leflunomide ratiopharm
leflunomide, Arthritis, Rheumatoid
Date of authorisation: 28/11/2010,, Revision: 14, Authorised, Last updated: 11/09/2020
Leflunomide ratiopharm Arthritis, Rheumatoid … Leflunomide ratiopharm … the public Leflunomide ratiopharm leflunomide This is a … -
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Human medicine European public assessment report (EPAR): Clopidogrel ratiopharm
clopidogrel, Peripheral Vascular Diseases, Stroke, Myocardial Infarction
Date of authorisation: 23/09/2009,, Revision: 5, Withdrawn, Last updated: 12/12/2013
Clopidogrel ratiopharm Peripheral Vascular Diseases Stroke Myocardial … Clopidogrel ratiopharm … Clopidogrel ratiopharm - public statement 06 … -
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Human medicine European public assessment report (EPAR): Filgrastim ratiopharm
filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer
Date of authorisation: 15/09/2008,
, Revision: 1, Withdrawn, Last updated: 20/07/2011
Filgrastim ratiopharm Neutropenia Hematopoietic … Filgrastim ratiopharm … Filgrastim ratiopharm, INN-filgrastim 7 Westferry … -
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Human medicine European public assessment report (EPAR): Memantine ratiopharm
memantine hydrochloride, Alzheimer Disease
Date of authorisation: 12/06/2013,, Revision: 6, Authorised, Last updated: 15/08/2018
Memantine ratiopharm Alzheimer Disease … Memantine ratiopharm … for the public Memantine ratiopharm memantine hydrochloride … -
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Human medicine European public assessment report (EPAR): Clopidogrel ratiopharm GmbH
clopidogrel, Peripheral Vascular Diseases, Acute Coronary Syndrome, Myocardial Infarction, Stroke
Date of authorisation: 28/07/2009,, Revision: 12, Withdrawn, Last updated: 25/01/2021
Clopidogrel ratiopharm GmbH Peripheral Vascular … Clopidogrel ratiopharm GmbH … Public statement Clopidogrel ratiopharm GmbH Withdrawal of the marketing … -
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Human medicine European public assessment report (EPAR): Clopidogrel ratiopharm
clopidogrel (as hydrogen sulfate), Myocardial Infarction, Acute Coronary Syndrome, Peripheral Vascular Diseases, Stroke
Date of authorisation: 18/02/2015,, Revision: 9, Authorised, Last updated: 30/03/2020
Clopidogrel ratiopharm Myocardial Infarction Acute … Clopidogrel ratiopharm … authorisation) Clopidogrel ratiopharm clopidogrel On 18 December … -
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Opinion/decision on a Paediatric investigation plan (PIP): 2,6-Bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2,6-diamino-hexanoylamino)-2,6-diamino-hexanoic acid (diphenylmethyl)-amide, polysodium salt
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Other
PIP number: EMEA-001354-PIP01-12, Route(s) of administration: Vaginal use, Pharmaceutical form(s): Vaginal gel
Decision date: 26/02/2013, Last updated: 23/04/2013, Compliance check: X2,6-Bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2,6-diamino-hexanoylamino)-2,6-diamino-hexanoic … 2,6-Bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2,6-diamino-hexanoylamino)-2,6-diamino-hexanoic … 2,6-Bis-{(1- napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2,6-diamino-hexanoylamino)- 2,6-diamino-hexanoic … -
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Press release: Updated advice on body fat changes and lactic acidosis with HIV medicines
CHMP, Last updated: 23/10/2015body fat changes and lactic acidosis with HIV medicines … body fat changes and lactic acidosis with HIV medicines … body fat changes and lactic acidosis with HIV medicines 23 … -
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Referral: Trimetadizine ratiopharm
trimetazidine, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 22/01/2009, EC decision date: 19/03/2009, Last updated: 22/01/2009Trimetadizine ratiopharm … Trimetadizine ratiopharm … not known. Trimetazidine Ratiopharm is a generic medicine based … -
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Referral: Valproat Ratiopharm Chrono
valproic acid / valproate, Article 6(12) referrals (prior to January 2010)
Status: European Commission final decision, opinion/position date: 25/05/2010, EC decision date: 26/05/2010, Last updated: 23/07/2012Valproat Ratiopharm Chrono … Valproat Ratiopharm Chrono … company that markets Valproat Ratiopharm Chrono, a generic medicine … -
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Referral: Fentanyl-ratiopharm Matrixpflaster
fentanyl, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/07/2007, EC decision date: 23/10/2007, Last updated: 14/12/2007with opioid analgesics. Ratiopharm GmbH submitted applications … favourable for Fentanyl- ratiopharm 25/50/75/100 µg/h Matrixpflaster … concentration) Germany ratiopharm GmbH Graf-Arco-Str. 3, 89079 … -
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Referral: Fentanyl-ratiopharm_TTS
fentanyl, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/07/2007, EC decision date: 23/10/2007, Last updated: 14/12/2007with opioid analgesics. Ratiopharm GmbH submitted applications … favourable for Fentanyl- ratiopharm 25/50/75/100 µg/h TTS and … concentration) Germany ratiopharm GmbH Graf-Arco-Str. 3, 89079 … -
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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: 25/02/2006was previously granted to ratiopharm GmbH in Finland on 7 November … administration Lansoprazol "ratiopharm" 15 mg Kapseln 15 mg Gastro-resistant … hard Oral use Austria - ratiopharm Arzneimittel Vertriebs -GmbH … -
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Orphan designation: tripotassium citrate monohydrate, Potassium hydrogen carbonate for: Treatment of distal renal tubular acidosis
Date of first decision: 20/06/2017, Positive, Last updated: 17/07/2017treatment of distal renal tubular acidosis. Expand section Collapse section … What is distal renal tubular acidosis? Distal renal tubular acidosis is a kidney disease in which … type of distal renal tubular acidosis, usually first detected in … -
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Orphan designation: Sodium (4-{(E)-3-(4-fluorophenyl)-3-[4-(3-morpholin-4-yl-prop1ynyl)phenyl]allyloxy}-2-methylphenoxy)acetate for: Treatment of mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes
Date of first decision: 21/08/2020, Positive, Last updated: 25/11/2020encephalomyopathy, lactic acidosis, and stroke-like episodes … encephalomyopathy, lactic acidosis, and stroke-like episodes … encephalomyopathy, lactic acidosis, and stroke-like episodes … -
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Human medicine European public assessment report (EPAR): Ratiograstim
filgrastim, Neutropenia, Hematopoietic Stem Cell Transplantation, Cancer
Date of authorisation: 15/09/2008,, Revision: 12, Authorised, Last updated: 19/10/2020
the EU for Ratiograstim to ratiopharm GmbH on 15 September 2008 … -
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Human medicine European public assessment report (EPAR): Xigduo
metformin hydrochloride, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2
Date of authorisation: 16/01/2014, Revision: 16, Authorised, Last updated: 12/02/2020any form of acute metabolic acidosis (build up of acid in the … ‘ketones’) or lactic acidosis (build-up of lactic acid … -
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Orphan designation: (S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2-carboxamide hydrochloride for: Treatment of mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes
Date of first decision: 10/08/2015, Positive, Last updated: 02/10/2015encephalomyopathy, lactic acidosis, and stroke-like episodes … encephalomyopathy, lactic acidosis, and stroke-like episodes … encephalomyopathy, lactic acidosis, and stroke-like episodes …