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Fulvestrant Mylan : EPAR - Product Information (PDF/458.01 KB)

Fulvestrant Mylan : EPAR - Product Inform … Document details Fulvestrant Mylan : EPAR - Product Information … THE MEDICINAL PRODUCT Fulvestrant Mylan 250 mg solution for …

First published: 02/02/2018
Last updated: 24/02/2023
Bulgarian
(PDF/781.05 KB)

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(PDF/671.28 KB)

Czech
(PDF/566.13 KB)

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(PDF/719.48 KB)

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(PDF/622.05 KB)

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(PDF/846.69 KB)

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(PDF/471.15 KB)

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(PDF/459.55 KB)

German
(PDF/745.25 KB)

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(PDF/547.03 KB)

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(PDF/873.49 KB)

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(PDF/619.01 KB)

Italian
(PDF/672.87 KB)

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(PDF/911.6 KB)

Lithuanian
(PDF/907.11 KB)

Maltese
(PDF/797.79 KB)

Norwegian
(PDF/478.7 KB)

Polish
(PDF/682.98 KB)

Portuguese
(PDF/388.65 KB)

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(PDF/569.69 KB)

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Fulvestrant Mylan : EPAR - All Authorised presentations (PDF/44.53 KB)

Fulvestrant Mylan : EPAR - All Authorised … Document details Fulvestrant Mylan : EPAR - All Authorised … Pack size EU/1/17/1253/001 Fulvestrant Mylan 250 mg Solution for …

First published: 02/02/2018
Last updated: 24/02/2023
Bulgarian
(PDF/72.79 KB)

Croatian
(PDF/71.69 KB)

Czech
(PDF/48 KB)

Danish
(PDF/64.56 KB)

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(PDF/43.24 KB)

Estonian
(PDF/149.78 KB)

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(PDF/44.29 KB)

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(PDF/45.49 KB)

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(PDF/65.33 KB)

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(PDF/42.09 KB)

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(PDF/62.41 KB)

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(PDF/42.04 KB)

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(PDF/62.01 KB)

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(PDF/154.26 KB)

Lithuanian
(PDF/154.07 KB)

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(PDF/35.61 KB)

Norwegian
(PDF/158.03 KB)

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(PDF/40.99 KB)

Portuguese
(PDF/21.43 KB)

Romanian
(PDF/45.71 KB)

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(PDF/79.62 KB)

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(PDF/45.11 KB)

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(PDF/43.97 KB)

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(PDF/48.86 KB)
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Fulvestrant Mylan : EPAR - Public assessment report (PDF/261.21 KB)

Fulvestrant Mylan : EPAR - Public assessment … Document details Fulvestrant Mylan : EPAR - Public assessment … Fulvestrant Mylan; INN fulvestrant 30 Churchill Place …

First published: 02/02/2018
Last updated: 02/02/2018
EMA/CHMP/810299/2017
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Fulvestrant Mylan : EPAR - Summary for the public (PDF/91.63 KB)

Fulvestrant Mylan : EPAR - Summary for … Document details Fulvestrant Mylan : EPAR - Summary for … Fulvestrant Mylan; INN fulvestrant 30 Churchill Place …

First published: 02/02/2018
Last updated: 21/02/2018
EMA/CHMP/810299/2017
Bulgarian
(PDF/109.46 KB)

Croatian
(PDF/102.51 KB)

Czech
(PDF/107.87 KB)

Danish
(PDF/83.63 KB)

Dutch
(PDF/84.11 KB)

Estonian
(PDF/83.02 KB)

Finnish
(PDF/83.57 KB)

French
(PDF/84.6 KB)

German
(PDF/84.98 KB)

Greek
(PDF/112.91 KB)

Hungarian
(PDF/102.1 KB)

Italian
(PDF/83.34 KB)

Latvian
(PDF/104.17 KB)

Lithuanian
(PDF/105.38 KB)

Maltese
(PDF/107.9 KB)

Polish
(PDF/108.48 KB)

Portuguese
(PDF/84.01 KB)

Romanian
(PDF/104.56 KB)

Slovak
(PDF/107.8 KB)

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CHMP summary of positive opinion for Fulvestrant Mylan (PDF/73.46 KB)

summary of positive opinion for Fulvestrant Mylan … summary of positive opinion for Fulvestrant Mylan EMA/CHMP/734315/2017 … Fulvestrant Mylan; INN fulvestrant 30 Churchill Place …

Adopted
First published: 10/11/2017
Last updated: 10/11/2017
EMA/CHMP/734315/2017
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Fulvestrant Mylan : EPAR - Procedural steps taken and scientific information after authorisation (PDF/120.54 KB)

Fulvestrant Mylan : EPAR - Procedural … Document details Fulvestrant Mylan : EPAR - Procedural … 0)88 781 6000 Fulvestrant Mylan Procedural steps taken …

First published: 15/04/2019
Last updated: 24/02/2023
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Ribavirin Teva-H-C-1018-II-11 : EPAR - Assessment Report - Variation (PDF/794.98 KB)

Ribavirin Teva-H-C-1018-II-11 : EPAR - Assessment Report … Document details Ribavirin Teva-H-C-1018-II-11 : EPAR - Assessment Report … Assessment report Ribavirin Teva International non-proprietary …

Adopted
First published: 18/09/2013
Last updated: 09/07/2021
EMA/CHMP/461705/2013
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Ribavirin Teva-H-C-1018-A20-08 : EPAR - Assessment Report - Article 20 (PDF/906.46 KB)

Ribavirin Teva-H-C-1018-A20-08 : EPAR - Assessment Report … Document details Ribavirin Teva-H-C-1018-A20-08 : EPAR - Assessment Report … Assessment report Ribavirin Teva ribavirin Procedure …

Adopted
First published: 12/03/2013
Last updated: 09/07/2021
EMA/12875/2013
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Zoledronic acid Teva-H-C-2439-X-0008 : EPAR - Assessment Report - Extension (PDF/156.55 KB)

Zoledronic acid Teva-H-C-2439-X-0008 : EPAR - Assessment Report … ment details Zoledronic acid Teva-H-C-2439-X-0008 : EPAR - Assessment Report … report Zoledronic acid Teva 4mg/100ml solution for infusion …

Adopted
First published: 02/12/2014
Last updated: 02/12/2014
EMA/631924/2014
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Telmisartan Teva-H-C-1146-A31-0010 : EPAR - Assessment Report - Article 31 (PDF/1.07 MB)

Telmisartan Teva-H-C-1146-A31-0010 : EPAR - Assessment Report … Document details Telmisartan Teva-H-C-1146-A31-0010 : EPAR - Assessment Report … EMEA/H/A-31/1370/C/785/0063, Irbesartan Teva EMEA/H/A- 31/1370/C/1093/0017 …

Adopted
First published: 25/09/2014
Last updated: 25/09/2014
EMA/PRAC/294920/2014
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Irbesartan Teva-H-C-1093-A31-17 : EPAR - Assessment Report - Article 31 (PDF/301.42 KB)

Irbesartan Teva-H-C-1093-A31-17 : EPAR - Assessment Report … Document details Irbesartan Teva-H-C-1093-A31-17 : EPAR - Assessment Report …

Adopted
First published: 01/10/2014
Last updated: 01/10/2014
EMA/PRAC/294920/2014
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Irbesartan Teva-H-C-1093-A31-32 : EPAR - Scientific conclusions (PDF/99.42 KB)

Irbesartan Teva-H-C-1093-A31-32 : EPAR - Scientific conclusio … Document details Irbesartan Teva-H-C-1093-A31-32 : EPAR - Scientific conclusions …

First published: 12/06/2019
Bulgarian
(PDF/136.15 KB)

Croatian
(PDF/125.02 KB)

Czech
(PDF/131.08 KB)

Danish
(PDF/96.12 KB)

Dutch
(PDF/99.3 KB)

Estonian
(PDF/94.4 KB)

Finnish
(PDF/97.12 KB)

French
(PDF/97.56 KB)

German
(PDF/100.2 KB)

Greek
(PDF/142.79 KB)

Hungarian
(PDF/119.82 KB)

Italian
(PDF/95.54 KB)

Latvian
(PDF/130.68 KB)

Lithuanian
(PDF/130.84 KB)

Maltese
(PDF/133.78 KB)

Polish
(PDF/130.65 KB)

Portuguese
(PDF/96.47 KB)

Romanian
(PDF/128.25 KB)

Slovak
(PDF/119.14 KB)

Slovenian
(PDF/124.14 KB)

Spanish
(PDF/98.31 KB)

Swedish
(PDF/96.85 KB)
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Budesonide/Formoterol Teva-H-C-3951-A31-14165: EPAR - Assessment Report - Article 31 (PDF/228.27 KB)

Budesonide/Formoterol Teva-H-C-3951-A31-14165: EPAR - Assessment Report … details Budesonide/Formoterol Teva-H-C-3951-A31-14165: EPAR - Assessment Report …

Adopted
First published: 15/07/2016
Last updated: 15/07/2016
EMA/330021/2016
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Irbesartan/Hydrochlorothiazide Teva-H-C-1112-A31-0019 : EPAR - Assessment Report - Article 31 (PDF/301.42 KB)

besartan/Hydrochlorothiazide Teva-H-C-1112-A31-0019 : EPAR - Assessment Report … Irbesartan/Hydrochlorothiazide Teva-H-C-1112-A31-0019 : EPAR - Assessment Report …

Adopted
First published: 02/10/2014
Last updated: 02/10/2014
EMA/PRAC/294920/2014
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Ibandronic Acid Teva-H-C-1195-A20-0001 : EPAR - Assessment Report - Article-20 (PDF/124.65 KB)

Ibandronic Acid Teva-H-C-1195-A20-0001 : EPAR - Assessment Report … ment details Ibandronic Acid Teva-H-C-1195-A20-0001 : EPAR - Assessment Report … report Ibandronic Acid Teva ibandronic acid Procedure …

Adopted
First published: 13/09/2011
Last updated: 13/09/2011
EMA/543436/2011
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Capecitabine Teva-H-C-2362-A31-1481-C-2362-31 : EPAR - Assessement report - Article 31 (PDF/983.27 KB)

Capecitabine Teva-H-C-2362-A31-1481-C-2362-31 : EPAR - Assessement report … Capecitabine Teva-H-C-2362-A31-1481-C-2362-31 : EPAR - Assessement report …

Adopted
First published: 29/07/2020
EMA/274404/2020
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Desloratadine Teva-H-C-PSUSA-00000962-201607 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/101.36 KB)

Desloratadine Teva-H-C-PSUSA-00000962-201607 : EPAR - Scientific conclusions … cument details Desloratadine Teva-H-C-PSUSA-00000962-201607 : EPAR - Scientific conclusions …

First published: 07/06/2017
Last updated: 07/06/2017
EMA/333803/2017
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Dimethyl fumarate Teva: EPAR - Public Assessment Report (PDF/2.13 MB)

Dimethyl fumarate Teva: EPAR - Public Assessment … details Dimethyl fumarate Teva: EPAR - Public Assessment … report Dimethyl fumarate Teva International non-proprietary …

First published: 21/12/2022
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Dimethyl fumarate Teva: EPAR - Product information (PDF/695.18 KB)

Dimethyl fumarate Teva: EPAR - Product information … details Dimethyl fumarate Teva: EPAR - Product information … PRODUCT Dimethyl fumarate Teva 120 mg gastro-resistant hard …

First published: 21/12/2022
Bulgarian
(PDF/780.36 KB)

Croatian
(PDF/720.1 KB)

Czech
(PDF/718.57 KB)

Danish
(PDF/642.67 KB)

Dutch
(PDF/634.29 KB)

Estonian
(PDF/652.23 KB)

Finnish
(PDF/644.1 KB)

French
(PDF/662.09 KB)

German
(PDF/658.46 KB)

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(PDF/815.82 KB)

Hungarian
(PDF/761.33 KB)

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(PDF/668.49 KB)

Italian
(PDF/652.28 KB)

Latvian
(PDF/716.37 KB)

Lithuanian
(PDF/738.67 KB)

Maltese
(PDF/749.48 KB)

Norwegian
(PDF/659.59 KB)

Polish
(PDF/731.17 KB)

Portuguese
(PDF/670.77 KB)

Romanian
(PDF/759.72 KB)

Slovak
(PDF/744.42 KB)

Slovenian
(PDF/676.87 KB)

Spanish
(PDF/636.45 KB)

Swedish
(PDF/685.52 KB)
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Dimethyl fumarate Teva: EPAR - Medicine overview (PDF/144.22 KB)

Dimethyl fumarate Teva: EPAR - Medicine overview … details Dimethyl fumarate Teva: EPAR - Medicine overview … EMEA/H/C/005963 Dimethyl fumarate Teva (dimethyl fumarate) An overview …

First published: 21/12/2022
EMEA/H/C/005963
Bulgarian
(PDF/157.27 KB)

Croatian
(PDF/153.39 KB)

Czech
(PDF/155.13 KB)

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(PDF/134.64 KB)

Dutch
(PDF/135.04 KB)

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(PDF/123.35 KB)

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(PDF/132.84 KB)

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(PDF/137.01 KB)

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(PDF/138.18 KB)

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(PDF/159.25 KB)

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(PDF/156.5 KB)

Italian
(PDF/133.32 KB)

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(PDF/173.15 KB)

Lithuanian
(PDF/155.11 KB)

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(PDF/158.25 KB)

Polish
(PDF/157.89 KB)

Portuguese
(PDF/135.73 KB)

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(PDF/154 KB)

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(PDF/154.75 KB)

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(PDF/152.46 KB)

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(PDF/135.32 KB)

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(PDF/133.34 KB)
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Dimethyl fumarate Teva: EPAR - All authorised presentations (PDF/27.94 KB)

Dimethyl fumarate Teva: EPAR - All authorised present … details Dimethyl fumarate Teva: EPAR - All authorised presentations … EU/1/22/1702/001 Dimethyl fumarate Teva 120 mg Gastro-resistant …

First published: 21/12/2022
Bulgarian
(PDF/85.88 KB)

Croatian
(PDF/47.98 KB)

Czech
(PDF/37.85 KB)

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(PDF/27.82 KB)

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(PDF/28.97 KB)

Estonian
(PDF/28.14 KB)

Finnish
(PDF/27.81 KB)

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(PDF/28.33 KB)

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(PDF/28.7 KB)

Greek
(PDF/54.2 KB)

Hungarian
(PDF/47.47 KB)

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(PDF/28.61 KB)

Italian
(PDF/28.12 KB)

Latvian
(PDF/52.11 KB)

Lithuanian
(PDF/52.52 KB)

Maltese
(PDF/50.16 KB)

Norwegian
(PDF/22.99 KB)

Polish
(PDF/49.81 KB)

Portuguese
(PDF/29.5 KB)

Romanian
(PDF/50.23 KB)

Slovak
(PDF/47.29 KB)

Slovenian
(PDF/36.66 KB)

Spanish
(PDF/28.77 KB)

Swedish
(PDF/23.8 KB)
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Desloratadine Teva-H-C-PSUSA-00000962-202107 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/128.84 KB)

Desloratadine Teva-H-C-PSUSA-00000962-202107 : EPAR - Scientific conclusions … cument details Desloratadine Teva-H-C-PSUSA-00000962-202107 : EPAR - Scientific conclusions …

First published: 09/06/2022
EMA/567651/2022
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Dimethyl fumarate Teva: EPAR - Risk management plan summary (PDF/367.16 KB)

Dimethyl fumarate Teva: EPAR - Risk management plan … details Dimethyl fumarate Teva: EPAR - Risk management plan … Plan for DIMETHYL FUMARATE TEVA 120 mg and 240 mg gastro-resistant …

First published: 21/12/2022
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Mycophenolate mofetil Teva-PSUSA-00010550-201705 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/68.8 KB)

Mycophenolate mofetil Teva-PSUSA-00010550-201705 : EPAR - Scientific conclusions … details Mycophenolate mofetil Teva-PSUSA-00010550-201705 : EPAR - Scientific conclusions … Mycophenolate Mofetil Teva, INN-mycophenolate mofetil …

First published: 05/04/2018
Last updated: 05/04/2018
EMA/187794/2018
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Mycophenolate mofetil Teva-H-C-PSUSA-00010550-202105 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/125.33 KB)

Mycophenolate mofetil Teva-H-C-PSUSA-00010550-202105 : EPAR - Scientific conclusions … details Mycophenolate mofetil Teva-H-C-PSUSA-00010550-202105 : EPAR - Scientific conclusions …

First published: 02/03/2022
EMA/45415/2022

1894 results

Fulvestrant Mylan : EPAR - Product Information (PDF/458.01 KB)

Fulvestrant Mylan : EPAR - All Authorised presentations (PDF/44.53 KB)

Fulvestrant Mylan : EPAR - Public assessment report (PDF/261.21 KB)

Fulvestrant Mylan : EPAR - Summary for the public (PDF/91.63 KB)

CHMP summary of positive opinion for Fulvestrant Mylan (PDF/73.46 KB)

Fulvestrant Mylan : EPAR - Procedural steps taken and scientific information after authorisation (PDF/120.54 KB)

Ribavirin Teva-H-C-1018-II-11 : EPAR - Assessment Report - Variation (PDF/794.98 KB)

Ribavirin Teva-H-C-1018-A20-08 : EPAR - Assessment Report - Article 20 (PDF/906.46 KB)

Zoledronic acid Teva-H-C-2439-X-0008 : EPAR - Assessment Report - Extension (PDF/156.55 KB)

Telmisartan Teva-H-C-1146-A31-0010 : EPAR - Assessment Report - Article 31 (PDF/1.07 MB)

Irbesartan Teva-H-C-1093-A31-17 : EPAR - Assessment Report - Article 31 (PDF/301.42 KB)

Irbesartan Teva-H-C-1093-A31-32 : EPAR - Scientific conclusions (PDF/99.42 KB)

Budesonide/Formoterol Teva-H-C-3951-A31-14165: EPAR - Assessment Report - Article 31 (PDF/228.27 KB)

Irbesartan/Hydrochlorothiazide Teva-H-C-1112-A31-0019 : EPAR - Assessment Report - Article 31 (PDF/301.42 KB)

Ibandronic Acid Teva-H-C-1195-A20-0001 : EPAR - Assessment Report - Article-20 (PDF/124.65 KB)

Capecitabine Teva-H-C-2362-A31-1481-C-2362-31 : EPAR - Assessement report - Article 31 (PDF/983.27 KB)

Desloratadine Teva-H-C-PSUSA-00000962-201607 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/101.36 KB)

Dimethyl fumarate Teva: EPAR - Public Assessment Report (PDF/2.13 MB)

Dimethyl fumarate Teva: EPAR - Product information (PDF/695.18 KB)

Dimethyl fumarate Teva: EPAR - Medicine overview (PDF/144.22 KB)

Dimethyl fumarate Teva: EPAR - All authorised presentations (PDF/27.94 KB)

Desloratadine Teva-H-C-PSUSA-00000962-202107 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/128.84 KB)

Dimethyl fumarate Teva: EPAR - Risk management plan summary (PDF/367.16 KB)

Mycophenolate mofetil Teva-PSUSA-00010550-201705 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/68.8 KB)

Mycophenolate mofetil Teva-H-C-PSUSA-00010550-202105 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation (PDF/125.33 KB)