1921 results
Keyword Ditralia - Film Remove keyword
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Withdrawn application: Ximelagatran 36 mg film coated tablets
date of withdrawal: 14/02/2006, Initial authorisation, Last updated: 16/02/2006Ximelagatran 36 mg film coated tablets: Withdrawn … XIMELAGATRAN ASTRAZENECA 36 MG FILM COATED TABLETS International … authorisation for Ximelagatran 36 mg film coated tablets, for the prevention … -
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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: 18/08/2017amol/Ibuprofen 500 mg/150 mg film-coated tablets … Paracetamol/ibuprofen 500mg/150mg film-coated tablets. The Agency's Committee … Paracetamol/ibuprofen 500mg/150mg film-coated tablets outweigh its risks … -
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Press release: AstraZeneca withdraws its application for Ximelagatran 36-mg film-coated tablets
Last updated: 16/02/2009application for Ximelagatran 36-mg film-coated tablets … authorisation for ximelagatran 36-mg film-coated tablets. AstraZeneca submitted … withdrawal, ximelagatran 36-mg film-coated tablets were under review … -
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Direct healthcare professional communication (DHPC): Venclyxto - (venetoclax) film coated tablets: Updated recommendations on tumour lysis syndrome (TLS) in CLL patients
Active substance: Venetoclax, DHPC type: Type II variation, Last updated: 10/06/2021Venclyxto - (venetoclax) film coated tablets: Updated … Venclyxto - (venetoclax) film coated tablets: Updated recommendations … Venclyxto ▼ (venetoclax) film coated tablets: Updated … -
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Human medicine European public assessment report (EPAR): Exjade
deferasirox, beta-Thalassemia; Iron Overload
Date of authorisation: 28/08/2006,
, Revision: 51, Authorised, Last updated: 22/12/2022
overload. It is available as film-coated tablets, dispersible tablets … tablets and granules. The film-coated tablets are to be swallowed … minutes before food), and the film-coated tablets and granules can … -
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Veterinary medicine European public assessment report (EPAR): Apoquel
oclacitinib maleate, Dogs
Date of authorisation: 12/09/2013, Revision: 8, Authorised, Last updated: 21/01/2022prescription; it is available as film-coated tablets and chewable tablets … comparing the effects of Apoquel film-coated tablets against pruritus … dogs, the effects of Apoquel film-coated tablets against pruritus … -
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Human medicine European public assessment report (EPAR): Levitra
vardenafil, Erectile Dysfunction
Date of authorisation: 06/03/2003, Revision: 32, Authorised, Last updated: 24/11/2021vardenafil. It is available as film-coated tablets (5, 10 and 20 mg … without liquid. If Levitra film-coated tablets are taken with a … delayed. The dose of the film-coated tablets may be increased … -
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Human medicine European public assessment report (EPAR): Darunavir Krka d.d.
darunavir, HIV Infections
Date of authorisation: 18/01/2018,
, Revision: 8, Withdrawn, Last updated: 03/02/2023
400mg and 800 mg Film-coated Tablets … -
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Human medicine European public assessment report (EPAR): Tracleer
bosentan (as monohydrate), Scleroderma, Systemic; Hypertension, Pulmonary
Date of authorisation: 14/05/2002, Revision: 42, Authorised, Last updated: 13/02/2023sclerosis. It is available as film-coated tablets (62.5 mg; 125 mg … Patients should take the film-coated tablets with water. The dispersible … patients who cannot swallow the film-coated tablets. The dispersible … -
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Human medicine European public assessment report (EPAR): Tenofovir disoproxil Mylan
tenofovir disoproxil, HIV Infections
Date of authorisation: 08/12/2016,, Revision: 18, Authorised, Last updated: 20/09/2022
Tenofovir disoproxil 245 mg film-coated tablets are indicated in … -
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Human medicine European public assessment report (EPAR): Thymanax
Agomelatine, Depressive Disorder, Major
Date of refusal: 16/01/2007, Refused, Last updated: 27/07/2006Valdoxan/Thymanax, 25 mg film-coated tablets intended for the … -
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Human medicine European public assessment report (EPAR): Viread
tenofovir disoproxil fumarate, Hepatitis B, Chronic; HIV Infections
Date of authorisation: 04/02/2002, Revision: 58, Authorised, Last updated: 04/01/2023Viread 123 mg film coated tablets are indicated … -
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Human medicine European public assessment report (EPAR): Valdoxan
Agomelatine, Depressive Disorder, Major
Date of refusal: 16/01/2007, Refused, Last updated: 27/07/2006Valdoxan/Thymanax, 25 mg film-coated tablets in tended for the … -
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Human medicine European public assessment report (EPAR): Eliquis
Apixaban, Arthroplasty; Venous Thromboembolism
Date of authorisation: 18/05/2011, Revision: 31, Authorised, Last updated: 21/12/2022Eliquis 2.5 mg film-coated tablets … -
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Human medicine European public assessment report (EPAR): Olanzapine Apotex
olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 10/06/2010,, Revision: 13, Authorised, Last updated: 09/03/2023
available as white, round film-coated tablets (2.5, 5, 7.5 and … available as white, round film-coated tablets (2.5, 5, 7.5 and … -
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Human medicine European public assessment report (EPAR): Suboxone
buprenorphine, naloxone, Opioid-Related Disorders
Date of authorisation: 26/09/2006, Revision: 21, Authorised, Last updated: 17/01/2023Suboxone is available as a film to be placed either under … on a maintenance dose the film may also be placed inside … 2 mg/0.5 mg Sublingual film Buccal use, Sublingual use … -
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Summary of opinion: Prolevare
oclacitinib maleate, opinion date: 15/02/2023, Positive, Last updated: 17/02/2023medicinal product Prolevare film-coated tablets for dogs. The applicant … medicinal product Prolevare film-coated tablets for dogs. The applicant … -
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Human medicine European public assessment report (EPAR): Vizarsin
sildenafil, Erectile Dysfunction
Date of authorisation: 21/09/2009,, Revision: 19, Authorised, Last updated: 24/02/2023
sildenafil. It is available as film-coated tablets (25, 50 and 100 mg … sildenafil. It is available as film-coated tablets (25, 50 and 100 … sildenafil. It is available as film-coated tablets (25, 50 and 100 … -
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Human medicine European public assessment report (EPAR): Stayveer
bosentan (as monohydrate), Hypertension, Pulmonary; Scleroderma, Systemic
Date of authorisation: 24/06/2013, Revision: 15, Authorised, Last updated: 13/02/2023Stayveer is available as film-coated tablets (62.5 mg and 125 … EU/1/13/832/001 Stayveer 62.5 mg Film-coated tablet Oral use blister (PVC/PE/PVDC/alu … EU/1/13/832/002 Stayveer 125 mg Film-coated tablet Oral use blister (PVC/PE/PVDC/alu … -
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Human medicine European public assessment report (EPAR): Dificlir
fidaxomicin, Clostridium Infections
Date of authorisation: 05/12/2011, Revision: 17, Authorised, Last updated: 22/12/2022Therapeutic indication Dificlir film-coated tablets is indicated for … EU/1/11/733/003 Dificlir 200 mg Film-coated tablet Oral use blister (alu/alu … EU/1/11/733/004 Dificlir 200 mg Film-coated tablet Oral use blister (alu/alu … -
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Human medicine European public assessment report (EPAR): Iasibon
ibandronic acid, Hypercalcemia; Fractures, Bone; Neoplasm Metastasis; Breast Neoplasms
Date of authorisation: 21/01/2011,, Revision: 11, Authorised, Last updated: 14/11/2022
Film-coated Tablets … -
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Summary of opinion: Jaypirca
pirtobrutinib, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023available as 50 mg and 100 mg film-coated tablets. The The substance … available as 50 mg and 100 mg film-coated tablets. The active substance … -
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Summary of opinion: Sitagliptin / Metformin hydrochloride Sun
sitagliptin, metformin hydrochloride, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023mg/1000 mg and 50 mg/850 mg film‑coated tablets. The The substance … mg/1000 mg and 50 mg/850 mg film-coated tablets. The active substances … -
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Human medicine European public assessment report (EPAR): Imatinib Koanaa
imatinib mesilate, Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic-Myeloproliferative Diseases; Hypereosinophilic Syndrome; Dermatofibrosarcoma; Gastrointestinal Stromal Tumors
Date of authorisation: 22/09/2021,, Authorised, Last updated: 01/10/2021
medicine, Glivec, is available as film-coated tablets, Imatinib Koanaa … -
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Human medicine European public assessment report (EPAR): Deferasirox Accord
deferasirox, Iron Overload; beta-Thalassemia
Date of authorisation: 09/01/2020,, Revision: 4, Authorised, Last updated: 08/05/2023
Deferasirox Accord is available as film-coated tablets (90 mg, 180 mg … Deferasirox Accord 90 mg film-coated tablets Deferasirox Accord … Deferasirox Accord 180 mg film-coated tablets Deferasirox Accord …