Medicines

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Didanosine: List of nationally authorised medicinal products - PSUSA/00001054/201510 (PDF/105.53 KB)

Last updated: 17/10/2016
Active substance: didanosine
Procedure number: PSUSA/00001054/201510
Regulatory outcome: Maintenance
List item

Dexamfetamine: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000986/201709 (PDF/54.9 KB)

Last updated: 11/06/2018
Active substance: dexamfetamine
Procedure number: PSUSA/00000986/201709
Regulatory outcome: Variation
Bulgarian
(PDF/108.29 KB)

Croatian
(PDF/94.21 KB)

Czech
(PDF/106.37 KB)

Danish
(PDF/52.64 KB)

Dutch
(PDF/38.87 KB)

Estonian
(PDF/40.7 KB)

Finnish
(PDF/38.1 KB)

French
(PDF/38.26 KB)

German
(PDF/51.2 KB)

Greek
(PDF/104.9 KB)

Hungarian
(PDF/95.01 KB)

Icelandic
(PDF/34.98 KB)

Italian
(PDF/42.97 KB)

Latvian
(PDF/98.31 KB)

Lithuanian
(PDF/99.78 KB)

Maltese
(PDF/118.8 KB)

Norwegian
(PDF/36.09 KB)

Polish
(PDF/100.12 KB)

Portuguese
(PDF/45.02 KB)

Romanian
(PDF/104.56 KB)

Slovak
(PDF/99.93 KB)

Slovenian
(PDF/112.07 KB)

Spanish
(PDF/41.18 KB)

Swedish
(PDF/41.42 KB)
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Desflurane: List of nationally authorised medicinal products - PSUSA/00000958/201709 (PDF/195.39 KB)

Last updated: 23/05/2018
Active substance: desflurane
Procedure number: PSUSA/00000958/201709
Regulatory outcome: Maintenance
List item

Clindamycin phosphate / tretinoin: List of nationally authorised medicinal products - PSUSA/00010080/201707 (PDF/94.51 KB)

Last updated: 16/04/2018
Active substance: Tretinoin, Clindamycin phosphate
Procedure number: PSUSA/00010080/201707
Regulatory outcome: Maintenance
List item

Lisdexamfetamine: List of nationally authorised medicinal products - PSUSA/00010289/201508 (PDF/105.19 KB)

Last updated: 18/10/2016
Active substance: lisdexamfetamine
Procedure number: PSUSA/00010289/201508
Regulatory outcome: Maintenance
List item

Influenza vaccine (surface antigen, inactivated): List of nationally authorised medicinal products - PSUSA/00001744/201504 (PDF/89.59 KB)

Last updated: 17/10/2016
Active substance: influenza vaccine
Procedure number: PSUSA/00001744/201504
Regulatory outcome: Maintenance
List item

Amikacin: List of nationally authorised medicinal products - PSUSA/00000143/201706 (PDF/133.26 KB)

Last updated: 06/03/2018
Active substance: amikacin
Procedure number: PSUSA/00000143/201706
Regulatory outcome: Maintenance
List item

Piroxicam: List of nationally authorised medicinal products - PSUSA/00002438/201704 (PDF/200.47 KB)

Last updated: 05/12/2017
Active substance: piroxicam
Procedure number: PSUSA/00002438/201704
Regulatory outcome: Maintenance
List item

Dextromethorphan: List of nationally authorised medicinal products - PSUSA/00001009/201511 (PDF/335.85 KB)

Last updated: 17/10/2016
Active substance: dextromethorphan
Procedure number: PSUSA/00001009/201511
Regulatory outcome: Variation
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Tetanus vaccines: List of nationally authorised medicinal products - PSUSA/00002910/201801 (PDF/103.97 KB)

Last updated: 10/09/2018
Active substance: tetanus vaccines
Procedure number: PSUSA/00002910/201801
Regulatory outcome: Maintenance
List item

Nimesulide (topical formulations): List of nationally authorised medicinal products - PSUSA/00002165/201506 (PDF/83.57 KB)

Last updated: 18/10/2016
Active substance: nimesulide
Procedure number: PSUSA/00002165/201506
Regulatory outcome: Maintenance
List item

Fluocinolone acetonide (intravitreal implant in applicator): List of nationally authorised medicinal products - PSUSA/00010224/201708 (PDF/106.29 KB)

Last updated: 16/04/2018
Active substance: Fluocinolone acetonide
Procedure number: PSUSA/00010224/201708
Regulatory outcome: Maintenance
List item

Atomoxetine: List of nationally authorised medicinal products - PSUSA/00000262/201411 (PDF/112.97 KB)

Last updated: 17/10/2016
Active substance: atomoxetine
Procedure number: PSUSA/00000262/201411
Regulatory outcome: Maintenance
List item

Doxazosin: CMDh Scientific conclusions and grounds for the variation, amendments to the product information, and timetable for the implementation - PSUSA/00001169/201512 (PDF/677.58 KB)

Last updated: 19/10/2016
Active substance: doxazosin
Procedure number: PSUSA/00001169/201512
Regulatory outcome: Variation
List item

Diphtheria / tetanus / pertussis (acellular, component) / haemophilus type b conjugate vaccine (adsorbed): List of nationally authorised medicinal products - PSUSA/00001121/201710 (PDF/72.8 KB)

Last updated: 15/06/2018
Active substance: haemophilus type b conjugate vaccine, pertussis (acellular, component), tetanus, diphtheria vaccine
Procedure number: PSUSA/00001121/201710
Regulatory outcome: Maintenance
List item

Ethinylestradiol / gestodene (transdermal application): List of nationally authorised medicinal products - PSUSA/00010145/201708 (PDF/119.78 KB)

Last updated: 16/04/2018
Active substance: ethinylestradiol, gestodene
Procedure number: EMA/235952/2018
Regulatory outcome: Maintenance
List item

Influenza vaccine (surface antigen, inactivated, virosome): List of nationally authorised medicinal products - PSUSA/00001746/201504 (PDF/72.88 KB)

Last updated: 17/10/2016
Active substance: influenza vaccine
Procedure number: PSUSA/00001746/201504
Regulatory outcome: Maintenance
List item

Testosterone (all formulations apart from topical use and testosterone undecanoate injection): CMDh Scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementa... (PDF/38.69 KB)

Last updated: 07/11/2016
Active substance: Testosterone, testosterone undecanoate
Procedure number: PSUSA/00002907/201512
Regulatory outcome: Variation
Bulgarian
(PDF/175.11 KB)

Croatian
(PDF/170.83 KB)

Czech
(PDF/146.77 KB)

Danish
(PDF/168.39 KB)

Dutch
(PDF/45.27 KB)

Estonian
(PDF/45.39 KB)

Finnish
(PDF/164.47 KB)

French
(PDF/49.36 KB)

German
(PDF/45.11 KB)

Greek
(PDF/159.98 KB)

Hungarian
(PDF/147 KB)

Icelandic
(PDF/169.02 KB)

Italian
(PDF/168.98 KB)

Latvian
(PDF/176.27 KB)

Lithuanian
(PDF/181.62 KB)

Maltese
(PDF/176.37 KB)

Norwegian
(PDF/43.29 KB)

Polish
(PDF/176.17 KB)

Portuguese
(PDF/168.8 KB)

Romanian
(PDF/166.83 KB)

Slovak
(PDF/141.35 KB)

Slovenian
(PDF/146.61 KB)

Spanish
(PDF/45.38 KB)

Swedish
(PDF/164.62 KB)
List item

Flunarizine: List of nationally authorised medicinal products - PSUSA/00001416/201505 (PDF/73.16 KB)

Last updated: 18/10/2016
Active substance: flunarizine
Procedure number: PSUSA/00001416/201505
Regulatory outcome: Maintenance
List item

Ethinylestradiol / gestodene (transdermal application): List of nationally authorised medicinal products - PSUSA/00010145/201702 (PDF/107.06 KB)

Last updated: 17/11/2017
Active substance: ethinylestradiol, gestodene
Procedure number: PSUSA/00010145/201702
Regulatory outcome: Variation
List item

Solifenacin/tamsulosine: List of nationally authorised medicinal products - PSUSA/00010285/201507 (PDF/124.98 KB)

Last updated: 18/10/2016
Active substance: tamsulosin, solifenacin
Procedure number: PSUSA/00010285/201507
Regulatory outcome: Maintenance
List item

Naltrexone: List of nationally authorised medicinal products - PSUSA/00002117/201511 (PDF/88.64 KB)

Last updated: 18/10/2016
Active substance: Naltrexone
Procedure number: PSUSA/00002117/201511
Regulatory outcome: Maintenance
List item

Lidocaine / prilocaine (not centrally authorised product): List of nationally authorised medicinal products - PSUSA/00001867/201703 (PDF/197.83 KB)

Last updated: 08/12/2017
Active substance: lidocaine, prilocaine
Procedure number: PSUSA/00001867/201703
Regulatory outcome: Maintenance
List item

Lovastatin: List of nationally authorised medicinal products - PSUSA/00010051/201607 (PDF/73.1 KB)

Last updated: 10/03/2017
Active substance: lovastatin
Procedure number: PSUSA/00010051/201607
Regulatory outcome: Maintenance
List item

Mifepristone: List of nationally authorised medicinal products - PSUSA/00002060/201705 (PDF/131.25 KB)

Last updated: 16/01/2018
Active substance: mifepristone
Procedure number: PSUSA/00002060/201705
Regulatory outcome: Maintenance

2520 results

Didanosine: List of nationally authorised medicinal products - PSUSA/00001054/201510 (PDF/105.53 KB)

Dexamfetamine: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000986/201709 (PDF/54.9 KB)

Desflurane: List of nationally authorised medicinal products - PSUSA/00000958/201709 (PDF/195.39 KB)

Clindamycin phosphate / tretinoin: List of nationally authorised medicinal products - PSUSA/00010080/201707 (PDF/94.51 KB)

Lisdexamfetamine: List of nationally authorised medicinal products - PSUSA/00010289/201508 (PDF/105.19 KB)

Influenza vaccine (surface antigen, inactivated): List of nationally authorised medicinal products - PSUSA/00001744/201504 (PDF/89.59 KB)

Amikacin: List of nationally authorised medicinal products - PSUSA/00000143/201706 (PDF/133.26 KB)

Piroxicam: List of nationally authorised medicinal products - PSUSA/00002438/201704 (PDF/200.47 KB)

Dextromethorphan: List of nationally authorised medicinal products - PSUSA/00001009/201511 (PDF/335.85 KB)

Tetanus vaccines: List of nationally authorised medicinal products - PSUSA/00002910/201801 (PDF/103.97 KB)

Nimesulide (topical formulations): List of nationally authorised medicinal products - PSUSA/00002165/201506 (PDF/83.57 KB)

Fluocinolone acetonide (intravitreal implant in applicator): List of nationally authorised medicinal products - PSUSA/00010224/201708 (PDF/106.29 KB)

Atomoxetine: List of nationally authorised medicinal products - PSUSA/00000262/201411 (PDF/112.97 KB)

Doxazosin: CMDh Scientific conclusions and grounds for the variation, amendments to the product information, and timetable for the implementation - PSUSA/00001169/201512 (PDF/677.58 KB)

Diphtheria / tetanus / pertussis (acellular, component) / haemophilus type b conjugate vaccine (adsorbed): List of nationally authorised medicinal products - PSUSA/00001121/201710 (PDF/72.8 KB)

Ethinylestradiol / gestodene (transdermal application): List of nationally authorised medicinal products - PSUSA/00010145/201708 (PDF/119.78 KB)

Influenza vaccine (surface antigen, inactivated, virosome): List of nationally authorised medicinal products - PSUSA/00001746/201504 (PDF/72.88 KB)

Testosterone (all formulations apart from topical use and testosterone undecanoate injection): CMDh Scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementa... (PDF/38.69 KB)

Flunarizine: List of nationally authorised medicinal products - PSUSA/00001416/201505 (PDF/73.16 KB)

Ethinylestradiol / gestodene (transdermal application): List of nationally authorised medicinal products - PSUSA/00010145/201702 (PDF/107.06 KB)

Solifenacin/tamsulosine: List of nationally authorised medicinal products - PSUSA/00010285/201507 (PDF/124.98 KB)

Naltrexone: List of nationally authorised medicinal products - PSUSA/00002117/201511 (PDF/88.64 KB)

Lidocaine / prilocaine (not centrally authorised product): List of nationally authorised medicinal products - PSUSA/00001867/201703 (PDF/197.83 KB)

Lovastatin: List of nationally authorised medicinal products - PSUSA/00010051/201607 (PDF/73.1 KB)

Mifepristone: List of nationally authorised medicinal products - PSUSA/00002060/201705 (PDF/131.25 KB)