1626 results
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Withdrawn application: Ibuprofen/Diphenhydramine Hydrochloride Wyeth
date of withdrawal: 07/01/2010, Initial authorisation, Last updated: 20/04/2010Ibuprofen/Diphenhydramine Hydrochloride Wyeth: Withdrawn … authorisation application for Ibuprofen/Diphenhydramine Hydrochloride Wyeth ibuprofen and diphenhydramine hydrochloride … marketing authorisation for Ibuprofen/Diphenhydramine Hydrochloride Wyeth, for … -
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Human medicine European public assessment report (EPAR): Pedea
Ibuprofen, Ductus Arteriosus, Patent
Date of authorisation: 28/07/2004, Revision: 15, Authorised, Last updated: 08/11/2022Authorised ibuprofen Overview This is a summary … medicine. active substance ibuprofen. What is Pedea used for? Pedea … active substance in Pedea, ibuprofen, has been used since the 1960s … -
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Referral: Ibuprofen Kabi 400 mg Infusionslösung and associated names
ibuprofen, associated names: Ibuprofen Fresenius Kabi 400 mg oplossing voor infusie, Ibuprofen Fresenius Kabi 400 mg solution pour perfusion, Ibuprofen Kabi, Ibuprofen Kabi 400 mg oldatos infúzió, Ibuprofen Kabi 400 mg soluţie perfuzabilă, Ibuprofen Kabi 400 mg, Ibuprofen Kabi 400 mg raztopina za infundiranje, Ibuprofeno Kabi 400 mg solución para perfusion, Ibuprofen Kabi 400 mg Solution for Infusion, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 23/07/2020, EC decision date: 15/10/2020, Last updated: 26/10/2020Ibuprofen Kabi 400 mg Infusionslösung … ibuprofen … -
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Referral: Ibuprofen- and dexibuprofen-containing medicines
ibuprofen, dexibuprofen, Article 31 referrals
Status: CMDh final position, opinion/position date: 20/05/2015, Last updated: 14/07/2015Ibuprofen- and dexibuprofen-containing … advice on use of high‑dose ibuprofen … advice on use of high-dose ibuprofen Review confirms small cardiovascular … -
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Orphan designation: Ibuprofen for: Treatment of patent ductus arteriosus
Date of designation: 15/02/2001, Expired, Last updated: 06/03/2015Ibuprofen … opinion on orphan designation Ibuprofen for the treatment of patent … opinion on orphan designation Ibuprofen for the treatment of patent … -
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Orphan designation: Ibuprofen for: Patent ductus arteriosus in premature neonates of less than 34 weeks of gestational age
Date of designation: 06/03/2001, Withdrawn, Last updated: 15/05/2009Ibuprofen Overview This product was … Orphan Europe, France, for ibuprofen for the prevention of patent … medicine expected to work? Ibuprofen is an anti-inflammatory drug … -
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Referral: Paracetamol/Ibuprofen 500 mg/150 mg film-coated tablets
paracetamol, ibuprofen, associated names: Paracomb, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 18/05/2017, EC decision date: 07/08/2017, Last updated: 18/08/2017substances paracetamol and ibuprofen. Both are well known medicines … Combinations of paracetamol and ibuprofen containing 500 mg paracetamol … mg paracetamol and 150 mg ibuprofen or similar doses are already … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: EMEA-002302-PIP01-17, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 16/03/2018, Last updated: 19/06/2018, Compliance check: XKey facts Ibuprofen OtherP/0086/2018EMEA-002302-PIP01-17 … product- specific waiver for ibuprofen (EMEA-002302-PIP01-17) PDF … product specific waiver for ibuprofen (EMEA-002302-PIP01-17 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: EMEA-002017-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release tablet
Decision date: 20/12/2016, Last updated: 30/01/2017, Compliance check: XKey facts Ibuprofen OtherP/0366/2016EMEA-002017-PIP01-16 … product specific waiver for ibuprofen (EMEA-002017-PIP01-16) PDF … product specific waiver for ibuprofen (EMEA-002017-PIP01-16 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-002400-PIP01-18, Route(s) of administration: Topical use, Pharmaceutical form(s): Medicated plaster
Decision date: 07/12/2018, Last updated: 13/02/2019, Compliance check: XKey facts Ibuprofen PainP/0382/2018EMEA-002400-PIP01-18 … product specific waiver for ibuprofen (EMEA-002400-PIP01-18) PDF … Ibuprofen … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen, Famotidine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: Ibuprofen / Famotidine, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 09/10/2009, Last updated: 07/12/2009, Compliance check: XIbuprofen / Famotidine Pain … Ibuprofen / Famotidine … Microsoft Word - Decision ibuprofen famotidine EMEA-000616-PIP01-09 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen, pseudoephedrine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-002102-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral suspension
Decision date: 30/06/2017, Last updated: 24/07/2017, Compliance check: XKey facts Ibuprofen pseudoephedrine Infectious … product specific waiver for ibuprofen / pseudoephedrine (EMEA-002102-PIP01-16 … product specific waiver for ibuprofen / pseudoephedrine (EMEA-002102-PIP01-16 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen, paracetamol
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-002002-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Granules, Tablet
Decision date: 05/10/2016, Last updated: 23/11/2016, Compliance check: XActive substance Ibuprofen paracetamol Therapeutic area … product specific waiver for ibuprofen / paracetamol (EMEA-002002-PIP01-16 … product specific waiver for ibuprofen / paracetamol (EMEA-002002-PIP01-16 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen, Tramadol
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-001887-PIP01-15, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Solution for infusion, Granules for oral solution, Concentrate for solution for infusion
Decision date: 14/06/2016, Last updated: 26/08/2016, Compliance check: XKey facts Ibuprofen Tramadol PainP/0153/2016EMEA-001887-PIP01-15 … product specific waiver for ibuprofen / tramadol (EMEA-001887-PIP01-15 … product specific waiver for ibuprofen / tramadol (EMEA-001887-PIP01-15 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen, Codeine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-001713-PIP02-14, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 01/04/2015, Last updated: 06/07/2015, Compliance check: XKey facts Ibuprofen Codeine PainP/0078/2015EMEA-001713-PIP02-14 … product-specific waiver for ibuprofen/codeine (EMEA-001713-PIP02-14) PDF … product-specific waiver: Ibuprofen / codeine for treatment of … -
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Opinion/decision on a Paediatric investigation plan (PIP): Caffeine, Ibuprofen
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-001537-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 22/01/2014, Last updated: 20/02/2014, Compliance check: XKey facts Caffeine Ibuprofen PainP/0024/2014EMEA-001537-PIP01-13 … product-specific waiver for caffeine / ibuprofen (EMEA-001537-PIP01-13) PDF … specific waiver for caffeine / ibuprofen (EMEA-001537-PIP01-13) in … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen, paracetamol
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: P/12/2009, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 27/01/2009, Last updated: 23/04/2009, Compliance check: XKey facts Ibuprofen paracetamol PainP/12/2009P/12/2009 … product specific waiver for ibuprofen, paracetamol, (EMEA-000313-PIP01-08 … product specific waiver for ibuprofen, paracetamol, (EMEA-000313-PIP01-08 … -
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Opinion/decision on a Paediatric investigation plan (PIP): paracetamol, Ibuprofen
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-000564-PIP01-09, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, suspension
Decision date: 23/12/2009, Last updated: 25/01/2010, Compliance check: XKey facts paracetamol Ibuprofen PainP/259/2009EMEA-000564-PIP01-09 … waiver for paracetamol / ibuprofen (EMEA-000564-PIP01-09) in … waiver for paracetamol / ibuprofen (EMEA-000564-PIP01- 09) in … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen, paracetamol
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-002002-PIP02-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral suspension
Decision date: 07/05/2018, Last updated: 27/11/2018, Compliance check: XKey facts Ibuprofen paracetamol PainP/0135/2018EMEA-002002-PIP02-17 … product-specific waiver for ibuprofen / paracetamol (EMEA-002002-PIP02-17 … Ibuprofen paracetamol … -
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Orphan designation: Refusal of orphan designation for the treatment of patent ductus arteriosus in premature neonates of less than 34 week gestational age
Date of refusal of designation: 24/06/2005, Negative, Last updated: 11/10/2005Ibuprofen L-Lysinate (salt) Overview … on orphan designation of ibuprofen L-lysinate for the treatment … has not been provided that ibuprofen L-lysinate may be of significant … -
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Orphan designation: Refusal of orphan designation for the prevention of patent ductus arteriosus in premature neonates of less than 34 week of gestational age
Date of refusal of designation: 07/07/2005, Negative, Last updated: 11/10/2005Ibuprofen L-Lysinate (salt) Overview … on orphan designation of ibuprofen L-lysinate for the prevention … the application. Key facts Ibuprofen L-Lysinate (salt)Prevention … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen, diphenhydramine hydrochloride
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: Ibuprofen, diphenhydramine hydrochloride, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, soft
Decision date: 01/12/2008, Last updated: 29/01/2009, Compliance check: XIbuprofen, diphenhydramine hydrochloride … Key facts Ibuprofen diphenhydramine hydrochloride … hydrochloride PainP/118/2008Ibuprofen, diphenhydramine hydrochloride … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen (sodium dihydrate)
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-001599-PIP01-13, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 30/09/2014, Last updated: 05/11/2014, Compliance check: XKey facts Ibuprofen (sodium dihydrate) OtherP/0255/2014EMEA-001599-PIP01-13 … granting of a waiver for ibuprofen (sodium dihydrate), (EMEA-001599-PIP01-13 … paediatric investigation plan: Ibuprofen (sodium dihydrate) for treatment … -
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Opinion/decision on a Paediatric investigation plan (PIP): Acetylcysteine, Ibuprofen (sodium dihydrate)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oto-rhino-laryngology; Pneumology-allergology
PIP number: EMEA-002561-PIP02-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Granules for oral suspension
Decision date: 27/01/2021, Last updated: 29/09/2021, Compliance check: XKey facts Acetylcysteine Ibuprofen (sodium dihydrate) Oto-rhino-laryngologyPneumology-allergologyP/0054/2021EMEA-002561-PIP02-20 … waiver for acetylcysteine / ibuprofen (sodium dihydrate) (EMEA-002561-PIP02-20 … waiver for acetylcysteine / ibuprofen (sodium dihydrate) (EMEA-002561-PIP02-20 … -
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Referral: Tibolona Aristo and Tibocina and associated names
tibolone, associated names: Tibolon Aristo, Tibolinia, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/12/2013, EC decision date: 05/03/2014, Last updated: 08/04/2014Tibolona Aristo and Tibocina and associated … of the medicines Tibolona Aristo and Tibocina. The Agency's … the benefits of Tibolona Aristo and Tibocina outweigh their …