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Montelukast: List of nationally authorised medicinal products - PSUSA/00002087/201507 (PDF/940.12 KB)

Last updated: 18/10/2016
Active substance: montelukast
Procedure number: PSUSA/00002087/201507
Regulatory outcome: Maintenance
List item

Alendronate: List of nationally authorised medicinal products - PSUSA/00000078/201601 (PDF/375.08 KB)

Spain Acido Alendronico Aurobindo NL/H/2292/001 041256013 … 041256191 $ 041256203 Aurobindo Pharma (Italia) S.R.L. Italy … Italy Acido Alendronico Aurobindo NL/H/2292/002 041256215 …

Last updated: 17/10/2016
Active substance: alendronate
Procedure number: PSUSA/00000078/201601
Regulatory outcome: Maintenance
List item

Bisoprolol: List of nationally authorised medicinal products - PSUSA/00000419/201509 (PDF/310.01 KB)

Legal basis Bisoprolol AUROBINDO 5 mg, comprimé pelliculé … UK/H/1684/001 223 277-2 AUROBINDO PHARMA FRANCE SARL FR Hybrid … 2001/83/EC) Bisoprolol AUROBINDO 5 mg, comprimé pelliculé …

Last updated: 18/10/2016
Active substance: bisoprolol, hydrochlorothiazide
Procedure number: PSUSA/00000419/201509
Regulatory outcome: Maintenance
List item

Lisinopril: List of nationally authorised medicinal products - PSUSA/00001894/201509 (PDF/106.76 KB)

Farmaceutici Spa Italy Lisinopril Aurobindo NL/H/1976/002 040262228/M Aurobindo Pharma (Italia) S.R.L. Italy … S.R.L. Italy Lisinopril Aurobindo NL/H/1976/003 81206.00.00 …

Last updated: 18/10/2016
Active substance: lisinopril
Procedure number: PSUSA/00001894/201509
Regulatory outcome: Maintenance
List item

Acitretin: List of nationally authorised medicinal products - PSUSA/00000051/201510 (PDF/84.93 KB)

Neotigason 027480019 $ 027480021 Aurobindo Pharma (Italia) S.R.L. Italy … Neotigason RVG 13103 $ RVG 13104 Aurobindo Pharma B.V. Netherlands … NAT/H/3089/001- 002 BE144706 Aurobindo Pharma B.V. Belgium Neotigason …

Last updated: 17/10/2016
Active substance: acitretin
Procedure number: PSUSA/00000051/201510
Regulatory outcome: Variation
List item

Furosemide: List of nationally authorised medicinal products - PSUSA/00001491/201501 (PDF/291.08 KB)

Last updated: 18/10/2016
Active substance: Furosemide
Procedure number: PSUSA/00001491/201501
Regulatory outcome: Variation
List item

Candesartan, candesartan / hydrochlorothiazide: List of nationally authorised medicinal products - PSUSA/00000527/201704 (PDF/542.04 KB)

Last updated: 06/03/2018
Active substance: hydrochlorothiazide, Candesartan
Procedure number: PSUSA/00000527/201704
Regulatory outcome: Variation
List item

Nabumetone: List of nationally authorised medicinal products - PSUSA/00002101/201703 (PDF/118.99 KB)

PHARMADAY S.R.L. IT Nabumeton Aurobindo 500 mg, omhulde tabletten … not available RVG 23264 AUROBINDO PHARMA B.V. NL Relifex® …

Last updated: 06/11/2017
Active substance: nabumetone
Procedure number: PSUSA/00002101/201703
Regulatory outcome: Maintenance
List item

Latanoprost (products with paediatric indication): List of nationally authorised medicinal products - PSUSA/00001834/201710 (PDF/235.15 KB)

Last updated: 24/05/2018
Active substance: Latanoprost
Procedure number: PSUSA/00001834/201710
Regulatory outcome: Maintenance
List item

Terbinafine: List of nationally authorised medicinal products - PSUSA/00002896/201709 (PDF/247.53 KB)

LIMITED SI Terbinafine Aurobindo 125 mg tablets NL/H/2399/001 … NL/H/2399/001 MA807/04701 AUROBINDO PHARMA (MALTA) LIMITED MT …

Last updated: 18/05/2018
Active substance: terbinafine
Procedure number: PSUSA/00002896/201709
Regulatory outcome: Maintenance
List item

Benazepril: List of nationally authorised medicinal products - PSUSA/00000313/201511 (PDF/104.43 KB)

is authorised Benazepril Aurobindo 20 mg film-coated tablets … MT/H/0147/002 MA807/02602 AUROBINDO PHARMA (MALTA) LIMITED MT …

Last updated: 18/10/2016
Active substance: benazepril
Procedure number: PSUSA/00000313/201511
Regulatory outcome: Variation
List item

Cabergoline: List of nationally authorised medicinal products - PSUSA/00000477/201503 (PDF/122.25 KB)

United Kingdom Cabergoline Aurobindo UK/H/0955/001 RVG 34200 Aurobindo Pharma B.V. Netherlands Cabergoline …

Last updated: 18/10/2016
Active substance: cabergoline
Procedure number: PSUSA/00000477/201503
Regulatory outcome: Maintenance
List item

Metformin: List of nationally authorised medicinal products - PSUSA/00002001/201504 (PDF/113.77 KB)

Last updated: 18/10/2016
Active substance: Metformin
Procedure number: PSUSA/00002001/201504
Regulatory outcome: Maintenance
List item

Gabapentin: List of nationally authorised medicinal products - PSUSA/00001499/201602 (PDF/172.26 KB)

United Kingdom Gabapentin ”aurobindo” UK/H/1165/001 41673 Aurobindo Pharma Limited Denmark Gabapentine …

Last updated: 29/11/2016
Active substance: gabapentin
Procedure number: PSUSA/00001499/201602
Regulatory outcome: Variation
List item

Isotretinoin: List of nationally authorised medicinal products - PSUSA/00001795/201505 (PDF/163.12 KB)

Last updated: 20/10/2016
Active substance: isotretinoin
Procedure number: PSUSA/00001795/201505
Regulatory outcome: Maintenance
List item

Latanoprost (products with paediatric indication): List of nationally authorised medicinal products - PSUSA/00001834/201604 (PDF/267.04 KB)

PTC EHF. PL Latanoprost Aurobindo 50 microgram/ml, oogdruppels … PL/H/0386/001 RVG 101423 AUROBINDO PHARMA B.V. NL Latanoprost …

Last updated: 04/11/2016
Active substance: Latanoprost
Procedure number: PSUSA/00001834/201604
Regulatory outcome: Maintenance
List item

Annexes - 2017 annual report of the European Medicines Agency (PDF/1.42 MB)

First published: 02/05/2018
Last updated: 02/05/2018
List item

Didanosine Article-29 referral - Assessment report (PDF/195.32 KB)

INN: didanosine Applicant: Aurobindo Pharma (Malta) Limited Procedure … CMD(h) 60 day procedure Aurobindo Pharma (Malta) Limited submitted …

Adopted
First published: 10/12/2013
Last updated: 10/12/2013
EMA/686289/2013
List item

Ibuprofen and dexibuprofen Article-31 referral - Annex I (PDF/2.57 MB)

First published: 20/06/2014
Last updated: 20/06/2014
EMA/373842/2014
Bulgarian
(PDF/4.85 MB)

Croatian
(PDF/5.78 MB)

Czech
(PDF/4.34 MB)

Danish
(PDF/4.38 MB)

Dutch
(PDF/3.66 MB)

Estonian
(PDF/4.22 MB)

Finnish
(PDF/4.08 MB)

French
(PDF/3.55 MB)

German
(PDF/4.04 MB)

Greek
(PDF/4.72 MB)

Hungarian
(PDF/4.09 MB)

Icelandic
(PDF/4.38 MB)

Italian
(PDF/4.62 MB)

Latvian
(PDF/3.61 MB)

Lithuanian
(PDF/4.93 MB)

Maltese
(PDF/5.66 MB)

Norwegian
(PDF/4.08 MB)

Polish
(PDF/3.59 MB)

Portuguese
(PDF/4.1 MB)

Romanian
(PDF/5.82 MB)

Slovak
(PDF/3.56 MB)

Slovenian
(PDF/3.56 MB)

Spanish
(PDF/4.15 MB)

Swedish
(PDF/5.55 MB)
List item

Perindopril: List of nationally authorised medicinal products - PSUSA/00002354/201510 (PDF/439.31 KB)

Last updated: 17/10/2016
Active substance: perindopril
Procedure number: PSUSA/00002354/201510
Regulatory outcome: Variation
List item

Flecainide: List of nationally authorised medicinal products - PSUSA/00001396/201706 (PDF/175.82 KB)

NL/H/2428/001 MA80705301 AUROBINDO PHARMA (MALTA) LIMITED MT …

Last updated: 13/03/2018
Active substance: flecainide
Procedure number: PSUSA/00001396/201706
Regulatory outcome: Maintenance
List item

Performance of the Agency’s scientific procedures: Survey 2010 for medicinal products for human use - Management Board meeting 17 March 2011 (PDF/543.01 KB)

First published: 29/03/2011
Last updated: 29/03/2011
EMA/MB/66833/2011
List item

Latanoprost (products with paediatric indication): List of nationally authorised medicinal products - PSUSA/00001834/201510 (PDF/193.38 KB)

35113 Arrow Génériques (Aurobindo) France Latanoprost Arrow …

Last updated: 17/10/2016
Active substance: Latanoprost
Procedure number: PSUSA/00001834/201510
Regulatory outcome: Maintenance
List item

Start of community reviews - CHMP meeting of 18-21 March 2013 (PDF/69.08 KB)

and associated names from Aurobindo Pharma Limited. The procedure …

First published: 22/03/2013
Last updated: 22/03/2013
EMA/177209/2013
List item

Questions and answers on Didanosine and associated names (didanosine, gastro-resistant capsules, 200, 250 and 400 mg) (PDF/65.38 KB)

was Didanosine reviewed? Aurobindo Pharma (Malta) Limited submitted …

First published: 20/09/2013
Last updated: 10/12/2013
EMA/562334/2013 Rev.1
Bulgarian
(PDF/93.77 KB)

Croatian
(PDF/86.61 KB)

Czech
(PDF/89.29 KB)

Danish
(PDF/65.25 KB)

Dutch
(PDF/65.73 KB)

Estonian
(PDF/65.06 KB)

Finnish
(PDF/65.52 KB)

French
(PDF/66.34 KB)

German
(PDF/66.86 KB)

Greek
(PDF/91.19 KB)

Hungarian
(PDF/78.57 KB)

Italian
(PDF/87.94 KB)

Latvian
(PDF/87.24 KB)

Lithuanian
(PDF/87.65 KB)

Maltese
(PDF/88.88 KB)

Polish
(PDF/87.12 KB)

Portuguese
(PDF/88.48 KB)

Romanian
(PDF/84.16 KB)

Slovak
(PDF/87.12 KB)

Slovenian
(PDF/84.77 KB)

Spanish
(PDF/66.25 KB)

Swedish
(PDF/65.49 KB)

64 results

Montelukast: List of nationally authorised medicinal products - PSUSA/00002087/201507 (PDF/940.12 KB)

Alendronate: List of nationally authorised medicinal products - PSUSA/00000078/201601 (PDF/375.08 KB)

Bisoprolol: List of nationally authorised medicinal products - PSUSA/00000419/201509 (PDF/310.01 KB)

Lisinopril: List of nationally authorised medicinal products - PSUSA/00001894/201509 (PDF/106.76 KB)

Acitretin: List of nationally authorised medicinal products - PSUSA/00000051/201510 (PDF/84.93 KB)

Furosemide: List of nationally authorised medicinal products - PSUSA/00001491/201501 (PDF/291.08 KB)

Candesartan, candesartan / hydrochlorothiazide: List of nationally authorised medicinal products - PSUSA/00000527/201704 (PDF/542.04 KB)

Nabumetone: List of nationally authorised medicinal products - PSUSA/00002101/201703 (PDF/118.99 KB)

Latanoprost (products with paediatric indication): List of nationally authorised medicinal products - PSUSA/00001834/201710 (PDF/235.15 KB)

Terbinafine: List of nationally authorised medicinal products - PSUSA/00002896/201709 (PDF/247.53 KB)

Benazepril: List of nationally authorised medicinal products - PSUSA/00000313/201511 (PDF/104.43 KB)

Cabergoline: List of nationally authorised medicinal products - PSUSA/00000477/201503 (PDF/122.25 KB)

Metformin: List of nationally authorised medicinal products - PSUSA/00002001/201504 (PDF/113.77 KB)

Gabapentin: List of nationally authorised medicinal products - PSUSA/00001499/201602 (PDF/172.26 KB)

Isotretinoin: List of nationally authorised medicinal products - PSUSA/00001795/201505 (PDF/163.12 KB)

Latanoprost (products with paediatric indication): List of nationally authorised medicinal products - PSUSA/00001834/201604 (PDF/267.04 KB)

Annexes - 2017 annual report of the European Medicines Agency (PDF/1.42 MB)

Didanosine Article-29 referral - Assessment report (PDF/195.32 KB)

Ibuprofen and dexibuprofen Article-31 referral - Annex I (PDF/2.57 MB)

Perindopril: List of nationally authorised medicinal products - PSUSA/00002354/201510 (PDF/439.31 KB)

Flecainide: List of nationally authorised medicinal products - PSUSA/00001396/201706 (PDF/175.82 KB)

Performance of the Agency’s scientific procedures: Survey 2010 for medicinal products for human use - Management Board meeting 17 March 2011 (PDF/543.01 KB)

Latanoprost (products with paediatric indication): List of nationally authorised medicinal products - PSUSA/00001834/201510 (PDF/193.38 KB)

Start of community reviews - CHMP meeting of 18-21 March 2013 (PDF/69.08 KB)

Questions and answers on Didanosine and associated names (didanosine, gastro-resistant capsules, 200, 250 and 400 mg) (PDF/65.38 KB)