967 results
Keyword Diclofenac Teva 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: XMuscoplus Active substance Diclofenac sodium thiocolchicoside Therapeutic … 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: XActive substance Diclofenac (sodium) thiocolchicoside … Diclofenac (sodium) thiocolchicoside … -
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Withdrawn application: Pioglitazone Teva Generics
pioglitazone, date of withdrawal: 26/01/2012, Initial authorisation, Last updated: 03/07/2012Pioglitazone Teva Generics: Withdrawn applicati … Pioglitazone Teva Generics: Withdrawal of the … authorisation) Pioglitazone Teva Generics pioglitazone On … -
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Withdrawn application: Clopidogrel Teva Pharma
clopidogrel, date of withdrawal: 22/04/2009, Initial authorisation, Last updated: 23/04/2009Clopidogrel Teva Pharma: Withdrawn application … Clopidogrel Teva Pharma: Withdrawal of the … application for Clopidogrel Teva Pharma clopidogrel … -
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Human medicine European public assessment report (EPAR): Leflunomide Teva
leflunomide, Arthritis, Rheumatoid
Date of authorisation: 10/03/2011,
, Revision: 6, Withdrawn, Last updated: 18/03/2014
Leflunomide Teva Arthritis, Rheumatoid … Leflunomide Teva … Public statement Leflunomide Teva Cessation of validity of … -
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Human medicine European public assessment report (EPAR): Tevagrastim (updated)
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 15/09/2008,
, Revision: 17, Authorised, Last updated: 24/05/2023
Tevagrastim Agranulocytosis Leukopenia Leukocyte … part of the EPAR). What is Tevagrastim? Tevagrastim is a solution for injection … active substance filgrastim. Tevagrastim is a ‘ A medicine that … -
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Human medicine European public assessment report (EPAR): Nevirapine Teva
nevirapine, HIV Infections
Date of authorisation: 30/11/2009,, Revision: 11, Withdrawn, Last updated: 21/03/2023
Nevirapine Teva Blood-Borne Infections Communicable … Nevirapine Teva … Public statement Nevirapine Teva (nevirapine) Withdrawal … -
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Human medicine European public assessment report (EPAR): Efavirenz Teva
efavirenz, HIV Infections
Date of authorisation: 09/01/2012,, Revision: 12, Authorised, Last updated: 03/03/2023
Efavirenz Teva Blood-Borne Infections Communicable … Efavirenz Teva … for the public Efavirenz Teva efavirenz This is a summary … -
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Human medicine European public assessment report (EPAR): Olanzapine Teva
olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 12/12/2007,, Revision: 29, Authorised, Last updated: 22/11/2022
Olanzapine Teva Schizophrenia Spectrum and … Olanzapine Teva … Olanzapine Teva, INN-olanzapine 7 … -
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Human medicine European public assessment report (EPAR): Lamivudine Teva
lamivudine, Hepatitis B, Chronic
Date of authorisation: 23/10/2009,, Revision: 13, Authorised, Last updated: 17/11/2022
Lamivudine Teva Infections Communicable … Lamivudine Teva … for the public Lamivudine Teva lamivudine This is a summary … -
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Human medicine European public assessment report (EPAR): Levetiracetam Teva
levetiracetam, Epilepsy
Date of authorisation: 25/08/2011,, Revision: 19, Authorised, Last updated: 06/07/2022
Levetiracetam Teva Nervous System Diseases Central … levetiracetam Overview Levetiracetam Teva is an epilepsy medicine … whole brain. Levetiracetam Teva can also be used as an add-on … -
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Human medicine European public assessment report (EPAR): Sildenafil Teva
sildenafil, Erectile Dysfunction
Date of authorisation: 30/11/2009,, Revision: 17, Authorised, Last updated: 04/07/2022
Sildenafil Teva Male Urogenital Diseases Genital … Sildenafil Teva … Sildenafil Teva, INN-sildenafil 7 … -
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Human medicine European public assessment report (EPAR): Imatinib Teva
imatinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic-Myeloproliferative Diseases; Hypereosinophilic Syndrome; Dermatofibrosarcoma
Date of authorisation: 07/01/2013,, Revision: 18, Authorised, Last updated: 09/06/2022
Imatinib Teva Leukemia, Myelogenous, Chronic … Imatinib Teva … Imatinib Teva, INN-imatinib 30 Churchill … -
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Human medicine European public assessment report (EPAR): Temozolomide Teva
temozolomide, Glioma; Glioblastoma
Date of authorisation: 28/01/2010,, Revision: 21, Authorised, Last updated: 18/02/2022
Temozolomide Teva Cancer Neuroectodermal … Temozolomide Teva … Temozolomide Teva, INN: temozolomide EMA/523990/2014 … -
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Human medicine European public assessment report (EPAR): Telmisartan Teva
Telmisartan, Hypertension
Date of authorisation: 25/01/2010,, Revision: 11, Withdrawn, Last updated: 17/09/2021
Telmisartan Teva Hypertension … Telmisartan Teva … Public statement Telmisartan Teva Withdrawal of the marketing … -
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Human medicine European public assessment report (EPAR): Irbesartan Teva
irbesartan, Hypertension
Date of authorisation: 30/10/2009,, Revision: 15, Authorised, Last updated: 06/09/2021
Irbesartan Teva Cardiovascular Diseases Vascular … EPAR). What is Irbesartan Teva? Irbesartan Teva is a medicine that contains … 150 and 300 mg). Irbesartan Teva is a ‘ A generic medicine …