970 results
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Orphan designation: Lactobacillus acidophilus and Bifidobacterium bifidum for: Prevention of necrotising enterocolitis
Date of designation: 16/01/2014, Positive, Last updated: 23/01/2014Lactobacillus acidophilus and Bifidobacterium bifidum … Italy, for Lactobacillus acidophilus and Bifidobacterium bifidum … expected to work? 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Withdrawn application: Pioglitazone ratiopharm
pioglitazone, date of withdrawal: 03/02/2012, Initial authorisation, Last updated: 30/04/2012Pioglitazone ratiopharm: Withdrawn application … Pioglitazone ratiopharm: Withdrawal of the marketing … authorisation) Pioglitazone ratiopharm pioglitazone On 21 July … -
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Withdrawn application: Pioglitazone ratiopharm GmbH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date of withdrawal: 03/02/2012, Initial authorisation, Last updated: 30/04/2012Pioglitazone ratiopharm GmbH: Withdrawn application … Pioglitazone ratiopharm GmbH: Withdrawal of the marketing … authorisation) Pioglitazone ratiopharm GmbH pioglitazone On 21 … -
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Human medicine European public assessment report (EPAR): Levetiracetam ratiopharm
levetiracetam, Epilepsy
Date of authorisation: 26/08/2011,
, Revision: 14, Authorised, Last updated: 10/06/2022
Levetiracetam ratiopharm Nervous System Diseases Central … EPAR) for Levetiracetam ratiopharm. It explains how the Committee … of use for Levetiracetam ratiopharm. What is Levetiracetam ratiopharm and what is it used for … -
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Human medicine European public assessment report (EPAR): Sildenafil ratiopharm
sildenafil, Erectile Dysfunction
Date of authorisation: 23/12/2009,, Revision: 19, Authorised, Last updated: 24/06/2022
Sildenafil ratiopharm Male Urogenital Diseases Genital … sildenafil. What is Sildenafil ratiopharm? Sildenafil ratiopharm is a medicine that contains … 50 and 100 mg). Sildenafil ratiopharm is a ‘ A generic medicine … -
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Human medicine European public assessment report (EPAR): Leflunomide ratiopharm
leflunomide, Arthritis, Rheumatoid
Date of authorisation: 28/11/2010,, Revision: 16, Authorised, Last updated: 17/05/2022
Leflunomide ratiopharm Musculoskeletal Diseases Joint … Leflunomide ratiopharm … the public Leflunomide ratiopharm leflunomide This is a … -
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Human medicine European public assessment report (EPAR): Desloratadine ratiopharm
desloratadine, Rhinitis, Allergic, Perennial; Urticaria; Rhinitis, Allergic, Seasonal
Date of authorisation: 13/01/2012,, Revision: 12, Authorised, Last updated: 24/06/2022
Desloratadine ratiopharm Respiratory Tract Diseases Nose … 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: 8, Authorised, Last updated: 05/11/2021Rasagiline ratiopharm Nervous System Diseases Central … Rasagiline ratiopharm … for the public Rasagiline ratiopharm rasagiline This is a summary … -
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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 … authorisation for Clopidogrel ratiopharm has been withdrawn at the … Summary documents Clopidogrel ratiopharm : EPAR - Summary for the … -
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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: 8, Authorised, Last updated: 30/06/2022
Memantine ratiopharm Nervous System Diseases Central … report (EPAR) for Memantine ratiopharm. It explains how the European … advice on how to use Memantine ratiopharm. For practical information … -
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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 … authorisation for Clopidogrel Ratiopharm GmbH has been withdrawn at … Summary documents Clopidogrel ratiopharm GmbH : EPAR - Summary for … -
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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: 14, Authorised, Last updated: 15/11/2022
Clopidogrel ratiopharm Cardiovascular Diseases Vascular … report (EPAR) for Clopidogrel ratiopharm. It explains how the Agency … on how to use Clopidogrel ratiopharm. For practical information … -
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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 … 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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Human medicine European public assessment report (EPAR): Sibnayal
Potassium citrate monohydrated, Potassium hydrogen carbonate, Acidosis, Renal Tubular
Date of authorisation: 30/04/2021, Revision: 1, Authorised, Last updated: 26/04/2022Diseases Acid-Base Imbalance Acidosis Acidosis, Renal Tubular … with distal renal tubular acidosis (dRTA), a disease in which … with distal renal tubular acidosis (dRTA), a disease in which … -
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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 medicines for the treatment … require a warning about lactic acidosis. … -
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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 … not known. Trimetazidine Ratiopharm is a generic medicine based … Trimetadizine-ratiopharm reviewed? ratiopharm GmbH submitted Trimetazidine-ratiopharm … -
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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 … company that markets Valproat Ratiopharm Chrono, a generic medicine … medicines, including Valproat Ratiopharm Chrono. Because bipolar disorder … -
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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: 14/12/2007only with opioid analgesics. Ratiopharm GmbH submitted applications … with opioid analgesics. Ratiopharm GmbH submitted applications … favourable for Fentanyl- ratiopharm 25/50/75/100 µg/h Matrixpflaster … -
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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: 14/12/2007only with opioid analgesics. Ratiopharm GmbH submitted applications … with opioid analgesics. Ratiopharm GmbH submitted applications … favourable for Fentanyl- ratiopharm 25/50/75/100 µg/h TTS and … -
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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 … was previously granted to ratiopharm GmbH in Finland on 7 November … administration Lansoprazol "ratiopharm" 15 mg Kapseln 15 mg Gastro-resistant … -
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Human medicine European public assessment report (EPAR): Bondenza (previously Ibandronic Acid Roche)
ibandronic acid, Osteoporosis, Postmenopausal
Date of authorisation: 23/02/2004, Revision: 16, Withdrawn, Last updated: 13/05/2013Roche)EMEA/H/C/000502ibandronic acidibandronic acidOsteoporosis, PostmenopausalM05BA06 Publication … -
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Orphan designation: tripotassium citrate monohydrate, Potassium hydrogen carbonate for: Treatment of distal renal tubular acidosis
Date of designation: 20/06/2017, Withdrawn, Last updated: 03/05/2021treatment of distal renal tubular acidosis. The sponsor’s address was … 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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Human medicine European public assessment report (EPAR): Ebymect
dapagliflozin propanediol monohydrate, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 15/11/2015, Revision: 17, Authorised, Last updated: 28/01/2022any form of acute metabolic acidosis (build up of acid in the … called ketones) or lactic acidosis (build-up of lactic acid … increase the risk of lactic acidosis (see section 4.4) should … -
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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: 18, Authorised, Last updated: 28/01/2022any form of acute metabolic acidosis (build up of acid in the … ‘ketones’) or lactic acidosis (build-up of lactic acid …