315 results
Keyword Diclofenac Remove keyword
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Referral: Diclofenac-containing medicines
diclofenac, Article 31 referrals
Status: European Commission final decision, opinion/position date: 26/06/2013, EC decision date: 25/09/2013, Last updated: 27/11/2013Diclofenac-containing medicines … New safety advice for diclofenac … EMA/592685/2013 New safety advice for diclofenac New measures aim to minimise … -
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Referral: Diclofenac epolamine 50 mg tablets
diclofenac, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 25/02/2016, EC decision date: 22/09/2016, Last updated: 10/10/2016Diclofenac epolamine 50 mg tablets … authorisation of the medicine diclofenac epolamine (50 mg tablets … France and Slovakia. What is diclofenac epolamine (50 mg tablets … -
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Referral: Diclofenac Sodium Spray Gel 4%
diclofenac sodium, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 15/11/2018, EC decision date: 18/01/2019, Last updated: 14/02/2019Diclofenac Sodium Spray Gel 4 … Agency completed a review of Diclofenac Sodium Spray Gel 4% following … marketing authorisation. What is Diclofenac Sodium Spray Gel 4 Diclofenac Sodium Spray Gel 4% contains … -
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Referral: Diotop capsules
diclofenac, omeprazole, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 15/11/2018, EC decision date: 31/01/2019, Last updated: 15/02/2019is already controlled by diclofenac and omeprazole, the two active … Diotop have different effects. Diclofenac is a nonsteroidal anti-inflammatory … acid the stomach makes. Both diclofenac and omeprazole have been … -
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Opinion/decision on a Paediatric investigation plan (PIP): Diclofenac (sodium)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-002132-PIP01-17, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Cutaneous solution
Decision date: 09/08/2017, Last updated: 28/09/2017, Compliance check: XKey facts Pennsaid Diclofenac (sodium) PainP/0203/2017EMEA-002132-PIP01-17 … product specific waiver for diclofenac (sodium) (Pennsaid), (EMEA-002132-PIP01 … product specific waiver for diclofenac (sodium) (Pennsaid), (EMEA-002132-PIP01-17 … -
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Opinion/decision on a Paediatric investigation plan (PIP): diclofenac, Levomenthol
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: EMEA-001536-PIP01-13, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Gel
Decision date: 24/01/2014, Last updated: 20/02/2014, Compliance check: XActive substance diclofenac Levomenthol Therapeutic area … granting of a waiver for diclofenac / levomenthol (EMEA-001536-PIP01-13 … granting of a waiver for diclofenac / levomenthol (EMEA-001536-PIP01-13 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Diclofenac (sodium), capsaicin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-001861-PIP01-15, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Gel
Decision date: 20/05/2016, Last updated: 18/07/2016, Compliance check: XKey facts Diclofenac (sodium) capsaicin PainP/0142/2016EMEA-001861-PIP01-15 … product specific waiver for diclofenac (sodium) / capsaicin (EMEA-001861-PIP01-15 … product specific waiver for diclofenac (sodium) / capsaicin (EMEA-001861-PIP01-15 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Diclofenac sodium, thiocolchicoside
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-001558-PIP02-14, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Cutaneous patch
Decision date: 25/11/2014, Last updated: 12/12/2014, Compliance check: XKey facts Diclofenac sodium thiocolchicoside PainP/0311/2014EMEA-001558-PIP02-14 … product specific waiver for diclofenac sodium / thiocolchicoside … paediatric investigation plan: Diclofenac sodium/thiocolchicoside for … -
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Opinion/decision on a Paediatric investigation plan (PIP): Diclofenac sodium, thiocolchicoside
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-001558-PIP01-13, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 07/03/2014, Last updated: 16/04/2014, Compliance check: XKey facts Muscoplus Diclofenac sodium thiocolchicoside PainP/0056/2014EMEA-001558-PIP01-13 … product specific waiver for diclofenac sodium / thiocolchicoside … product specific waiver for diclofenac sodium / thiocolchicoside … -
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Opinion/decision on a Paediatric investigation plan (PIP): Diclofenac sodium, omeprazole
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: P/117/2010, Route(s) of administration: Oral use, Pharmaceutical form(s): Modified release capsule
Decision date: 07/07/2010, Last updated: 29/07/2010, Compliance check: XKey facts Diclofenac sodium omeprazole Immunology-Rheumatology-TransplantationP/117/2010P/117/2010 … product specific waiver for diclofenac sodium / omeprazole (EMEA-000820-PIP01-09 … product specific waiver for diclofenac sodium / omeprazole (EMEA-000820-PIP01-09 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Diclofenac (sodium), thiocolchicoside
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-002580-PIP01-19, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 04/12/2019, Last updated: 03/04/2020, Compliance check: XKey facts Diclofenac (sodium) thiocolchicoside … product specific waiver for diclofenac (sodium) / thiocolchicoside … Diclofenac (sodium) thiocolchicoside … -
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News: Is diclofenac a threat to European vultures?
CVMP, Last updated: 12/09/2014Is diclofenac a threat to European vultures … veterinary medicines containing diclofenac to vultures and other necrophagous … Diclofenac - Art. 30(3) - Consultation … -
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Press release: Diclofenac use in animals poses a risk to European vultures
CVMP, Last updated: 12/12/2014Diclofenac use in animals poses a risk … at risk due to residues of diclofenac if they feed on carcasses … be exposed to residues of diclofenac in the EU and, for each scenario … -
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Press release: New safety advice for diclofenac – CMDh endorses PRAC recommendation
CMDh, Last updated: 28/06/2013New safety advice for diclofenac – CMDh endorses PRAC recomm … majority new safety advice for diclofenac-containing medicines that are given … that the effects of systemic diclofenac on the heart and circulation … -
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Press release: PRAC recommends the same cardiovascular precautions for diclofenac as for selective COX-2 inhibitors
PRAC, Last updated: 14/06/2013cardiovascular precautions for diclofenac as for selective COX-2 inhibi … cardiovascular precautions for diclofenac as for selective COX-2 inhibi … cardiovascular precautions for diclofenac as for selective COX-2 inhibitors … -
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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: 14/07/2015including COX-2 inhibitors and diclofenac. No increase in cardiovascular … including COX-2 inhibitors and diclofenac. For diclofenac, the risk was estimated at … every 1,000 patients taking diclofenac for a year. Use of high-dose … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29-31 October 2012
PRAC, Last updated: 31/10/2012Review of diclofenac-containing medicines started … -
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Referral: Arcoxia
etoricoxib, Article 6(12) referrals (prior to January 2010)
Status: European Commission final decision, opinion/position date: 26/06/2008, EC decision date: 09/09/2008, Last updated: 21/11/2008similar CV thrombotic risk like diclofenac and some degree of upper … advantage over naproxen and diclofenac (though no particular lower … drugs (NSAIDs) other than diclofenac and naproxen. It was therefore … -
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Press release: European Medicines Agency finalises review of recent published data on cardiovascular safety of NSAIDs
CHMP, Last updated: 19/10/2012updated treatment advice for diclofenac in follow-on review … updated treatment advice for diclofenac in follow-on review The … most widely used NSAIDs – diclofenac, ibuprofen and naproxen. In … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 June 2013
PRAC, Last updated: 14/06/2013PRAC recommendation on diclofenac … -
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Press release: Pharmacovigilance Risk Assessment Committee: one year of public-health promotion and protection
PRAC, Last updated: 19/07/2013contraindication for the painkiller diclofenac. The PRAC found that the effects … found that the effects of diclofenac on the heart and circulation … should also be applied to diclofenac. The PRAC's full range of … -
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Press release: Updated advice on use of high-dose ibuprofen
CMDh, Last updated: 22/05/2015including COX-2 inhibitors and diclofenac. No increase in cardiovascular … including COX-2 inhibitors and diclofenac. No increase in cardiovascular … including COX-2 inhibitors and diclofenac. For diclofenac, the risk was estimated at … -
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Referral: Nimesulide
nimesulide, Article 31 referrals
Status: European Commission final decision, opinion/position date: 23/06/2011, EC decision date: 20/01/2012, Last updated: 19/04/2012NSAID pain killers such as diclofenac, ibuprofen and naproxen. In … NSAID pain killers such as diclofenac, ibuprofen and naproxen … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 November 2018
CHMP, Last updated: 16/11/2018Name of medicine Diclofenac sodium spray gel 4% INN diclofenac List item … -
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Press release: PRAC recommends updating advice on use of high-dose ibuprofen
PRAC, Last updated: 13/04/2015including COX-2 inhibitors and diclofenac. No increase in cardiovascular … including COX-2 inhibitors and diclofenac. No increase in cardiovascular … that of COX-2 inhibitors and diclofenac. The review was conducted …