Medicines

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Propofol: List of nationally authorised medicinal products - PSUSA/00002555/201711 (PDF/516.62 KB)

Last updated: 13/09/2018
Active substance: propofol
Procedure number: PSUSA/00002555/201711
Regulatory outcome: Variation
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Celecoxib: List of nationally authorised medicinal products - PSUSA/00000616/201712 (PDF/173.46 KB)

Last updated: 13/09/2018
Active substance: Celecoxib
Procedure number: PSUSA/00000616/201712
Regulatory outcome: Maintenance
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Hypericum perforatum L., herba: List of nationally authorised medicinal products - PSUSA/00001701/201801 (PDF/198.44 KB)

Last updated: 13/09/2018
Active substance: hypericum perforatum L., herba
Procedure number: PSUSA/00001701/201801
Regulatory outcome: Maintenance
List item

Amitriptyline/perphenazine: List of nationally authorised medicinal products - PSUSA/00000170/201801 (PDF/46.5 KB)

Last updated: 13/09/2018
Active substance: perphenazine, amitriptyline
Procedure number: PSUSA/00000170/201801
Regulatory outcome: Maintenance
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Amiodarone: List of nationally authorised medicinal products - PSUSA/00000166/201712 (PDF/141.23 KB)

Last updated: 13/09/2018
Active substance: amiodarone
Procedure number: PSUSA/00000166/201712
Regulatory outcome: Maintenance
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Cefprozil: List of nationally authorised medicinal products - PSUSA/00000605/201712 (PDF/84.44 KB)

Last updated: 13/09/2018
Active substance: cefprozil
Procedure number: PSUSA/00000605/201712
Regulatory outcome: Maintenance
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Naproxen: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002125/201708 (PDF/32.74 KB)

Last updated: 13/09/2018
Active substance: naproxen
Procedure number: PSUSA/00002125/201708
Regulatory outcome: Variation
Bulgarian
(PDF/112.63 KB)

Croatian
(PDF/100.3 KB)

Czech
(PDF/89.6 KB)

Danish
(PDF/38.79 KB)

Dutch
(PDF/32.68 KB)

Estonian
(PDF/39.52 KB)

Finnish
(PDF/36.98 KB)

French
(PDF/58.73 KB)

German
(PDF/34.02 KB)

Greek
(PDF/94.01 KB)

Hungarian
(PDF/86.24 KB)

Icelandic
(PDF/35.57 KB)

Italian
(PDF/39.9 KB)

Latvian
(PDF/96.1 KB)

Lithuanian
(PDF/90.5 KB)

Maltese
(PDF/119.1 KB)

Norwegian
(PDF/34.49 KB)

Polish
(PDF/97.29 KB)

Portuguese
(PDF/38.87 KB)

Romanian
(PDF/90.29 KB)

Slovak
(PDF/95.88 KB)

Slovenian
(PDF/92.68 KB)

Spanish
(PDF/39.2 KB)

Swedish
(PDF/38.61 KB)
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Lubiprostone: List of nationally authorised medicinal products - PSUSA/00010290/201801 (PDF/95.2 KB)

Last updated: 12/09/2018
Active substance: Lubiprostone
Procedure number: PSUSA/00010290/201801
Regulatory outcome: Maintenance
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Cimicifuga racemosa (L.) nutt., rhizome: List of nationally authorised medicinal products - PSUSA/00000755/201801 (PDF/123.44 KB)

Last updated: 12/09/2018
Active substance: cimicifuga racemosa (L.) nutt., rhizoma
Procedure number: PSUSA/00000755/201801
Regulatory outcome: Maintenance
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Tobramycin (nebuliser solution) (apart from centrally authorised product): List of nationally authorised medicinal products - PSUSA/00009316/201712 (PDF/156.43 KB)

Last updated: 11/09/2018
Active substance: Tobramycin
Procedure number: PSUSA/00009316/201712
Regulatory outcome: Maintenance
List item

Cyproheptadine: List of nationally authorised medicinal products - PSUSA/00000902/201712 (PDF/56.47 KB)

Last updated: 11/09/2018
Active substance: cyproheptadine
Procedure number: PSUSA/00000902/201712
Regulatory outcome: Maintenance
List item

Paroxetine: List of nationally authorised medicinal products - PSUSA/00002319/201712 (PDF/348.11 KB)

Last updated: 11/09/2018
Active substance: paroxetine
Procedure number: PSUSA/00002319/201712
Regulatory outcome: Variation
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Paroxetine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002319/201712 (PDF/45.82 KB)

Last updated: 11/09/2018
Active substance: paroxetine
Procedure number: PSUSA/00002319/201712
Regulatory outcome: Variation
Bulgarian
(PDF/194.76 KB)

Croatian
(PDF/76.64 KB)

Czech
(PDF/85.21 KB)

Danish
(PDF/60.1 KB)

Dutch
(PDF/32.46 KB)

Estonian
(PDF/160.5 KB)

Finnish
(PDF/86.04 KB)

French
(PDF/49.91 KB)

German
(PDF/58.14 KB)

Greek
(PDF/96.13 KB)

Hungarian
(PDF/85.51 KB)

Icelandic
(PDF/162.78 KB)

Italian
(PDF/177.21 KB)

Latvian
(PDF/107.22 KB)

Lithuanian
(PDF/155.93 KB)

Maltese
(PDF/90.85 KB)

Norwegian
(PDF/125.64 KB)

Polish
(PDF/171.82 KB)

Portuguese
(PDF/55.85 KB)

Romanian
(PDF/143.38 KB)

Slovak
(PDF/86.64 KB)

Slovenian
(PDF/81.83 KB)

Spanish
(PDF/115.7 KB)

Swedish
(PDF/50.36 KB)
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Acebutolol: List of nationally authorised medicinal products - PSUSA/00000018/201712 (PDF/68.24 KB)

Last updated: 11/09/2018
Active substance: acebutolol
Procedure number: PSUSA/00000018/201712
Regulatory outcome: Maintenance
List item

Felodipine: List of nationally authorised medicinal products - PSUSA/00001356/201712 (PDF/179.53 KB)

Last updated: 11/09/2018
Active substance: felodipine
Procedure number: PSUSA/00001356/201712
Regulatory outcome: Maintenance
List item

Furosemide: List of nationally authorised medicinal products - PSUSA/00001491/201801 (PDF/184.36 KB)

Last updated: 10/09/2018
Active substance: Furosemide
Procedure number: PSUSA/00001491/201801
Regulatory outcome: Maintenance
List item

Betahistine: List of nationally authorised medicinal products - PSUSA/00000389/201712 (PDF/217.94 KB)

Last updated: 10/09/2018
Active substance: betahistine
Procedure number: PSUSA/00000389/201712
Regulatory outcome: Maintenance
List item

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

Lamotrigine : CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001825/201711 (PDF/98.15 KB)

Last updated: 10/09/2018
Active substance: lamotrigine
Procedure number: PSUSA/00001825/201711
Regulatory outcome: Variation
Bulgarian
(PDF/305.37 KB)

Croatian
(PDF/183.53 KB)

Czech
(PDF/211.83 KB)

Danish
(PDF/162.47 KB)

Dutch
(PDF/113.85 KB)

Estonian
(PDF/276.16 KB)

Finnish
(PDF/175.1 KB)

French
(PDF/169.48 KB)

German
(PDF/127.86 KB)

Greek
(PDF/356.94 KB)

Hungarian
(PDF/167.68 KB)

Icelandic
(PDF/266.57 KB)

Italian
(PDF/246.26 KB)

Latvian
(PDF/249.66 KB)

Lithuanian
(PDF/281.89 KB)

Maltese
(PDF/330.08 KB)

Norwegian
(PDF/312.69 KB)

Polish
(PDF/340.26 KB)

Portuguese
(PDF/125.86 KB)

Romanian
(PDF/261.2 KB)

Slovak
(PDF/250.45 KB)

Slovenian
(PDF/323.3 KB)

Spanish
(PDF/212.78 KB)

Swedish
(PDF/190.79 KB)
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Lamotrigine : List of nationally authorised medicinal products - PSUSA/00001825/201711 (PDF/639.41 KB)

Last updated: 10/09/2018
Active substance: lamotrigine
Procedure number: PSUSA/00001825/201711
Regulatory outcome: Variation
List item

Ciprofloxacin hydrochloride / hydrocortisone: List of nationally authorised medicinal products - PSUSA/00000774/201711 (PDF/56.21 KB)

Last updated: 10/09/2018
Active substance: hydrocortisone, ciprofloxacin hydrochloride
Procedure number: PSUSA/00000774/201711
Regulatory outcome: Maintenance
List item

Phenylephrine hydrochloride / tropicamide: List of nationally authorised medicinal products - PSUSA/00010430/201711 (PDF/59.69 KB)

Last updated: 10/09/2018
Active substance: Tropicamide, phenylephrine hydrochloride
Procedure number: PSUSA/00010430/201711
Regulatory outcome: Maintenance
List item

Leuprorelin: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001844/201707 (PDF/31.71 KB)

Last updated: 10/09/2018
Active substance: leuprorelin
Procedure number: PSUSA/00001844/201707
Regulatory outcome: Variation
Bulgarian
(PDF/99.03 KB)

Croatian
(PDF/93.95 KB)

Czech
(PDF/121.91 KB)

Danish
(PDF/36.42 KB)

Dutch
(PDF/35.33 KB)

Estonian
(PDF/36.2 KB)

Finnish
(PDF/29.9 KB)

French
(PDF/35.75 KB)

German
(PDF/31.31 KB)

Greek
(PDF/104.04 KB)

Hungarian
(PDF/95.61 KB)

Icelandic
(PDF/30.14 KB)

Italian
(PDF/38.66 KB)

Latvian
(PDF/100.35 KB)

Lithuanian
(PDF/101.02 KB)

Maltese
(PDF/101.79 KB)

Norwegian
(PDF/27.21 KB)

Polish
(PDF/95.31 KB)

Portuguese
(PDF/32.58 KB)

Romanian
(PDF/100.31 KB)

Slovak
(PDF/98.74 KB)

Spanish
(PDF/37.09 KB)

Swedish
(PDF/33.33 KB)
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Azelastine: List of nationally authorised medicinal products - PSUSA/00000277/201712 (PDF/220.2 KB)

Last updated: 10/09/2018
Active substance: azelastine
Procedure number: PSUSA/00000277/201712
Regulatory outcome: Maintenance
List item

Hydrochlorothiazide / ramipril: List of nationally authorised medicinal products - PSUSA/00001660/201801 (PDF/272.5 KB)

Last updated: 10/09/2018
Active substance: Ramipril, hydrochlorothiazide
Procedure number: PSUSA/00001660/201801
Regulatory outcome: Maintenance

2574 results

Propofol: List of nationally authorised medicinal products - PSUSA/00002555/201711 (PDF/516.62 KB)

Celecoxib: List of nationally authorised medicinal products - PSUSA/00000616/201712 (PDF/173.46 KB)

Hypericum perforatum L., herba: List of nationally authorised medicinal products - PSUSA/00001701/201801 (PDF/198.44 KB)

Amitriptyline/perphenazine: List of nationally authorised medicinal products - PSUSA/00000170/201801 (PDF/46.5 KB)

Amiodarone: List of nationally authorised medicinal products - PSUSA/00000166/201712 (PDF/141.23 KB)

Cefprozil: List of nationally authorised medicinal products - PSUSA/00000605/201712 (PDF/84.44 KB)

Naproxen: CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002125/201708 (PDF/32.74 KB)

Lubiprostone: List of nationally authorised medicinal products - PSUSA/00010290/201801 (PDF/95.2 KB)

Cimicifuga racemosa (L.) nutt., rhizome: List of nationally authorised medicinal products - PSUSA/00000755/201801 (PDF/123.44 KB)

Tobramycin (nebuliser solution) (apart from centrally authorised product): List of nationally authorised medicinal products - PSUSA/00009316/201712 (PDF/156.43 KB)

Cyproheptadine: List of nationally authorised medicinal products - PSUSA/00000902/201712 (PDF/56.47 KB)

Paroxetine: List of nationally authorised medicinal products - PSUSA/00002319/201712 (PDF/348.11 KB)

Paroxetine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002319/201712 (PDF/45.82 KB)

Acebutolol: List of nationally authorised medicinal products - PSUSA/00000018/201712 (PDF/68.24 KB)

Felodipine: List of nationally authorised medicinal products - PSUSA/00001356/201712 (PDF/179.53 KB)

Furosemide: List of nationally authorised medicinal products - PSUSA/00001491/201801 (PDF/184.36 KB)

Betahistine: List of nationally authorised medicinal products - PSUSA/00000389/201712 (PDF/217.94 KB)

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

Lamotrigine : CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001825/201711 (PDF/98.15 KB)

Lamotrigine : List of nationally authorised medicinal products - PSUSA/00001825/201711 (PDF/639.41 KB)

Ciprofloxacin hydrochloride / hydrocortisone: List of nationally authorised medicinal products - PSUSA/00000774/201711 (PDF/56.21 KB)

Phenylephrine hydrochloride / tropicamide: List of nationally authorised medicinal products - PSUSA/00010430/201711 (PDF/59.69 KB)

Leuprorelin: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001844/201707 (PDF/31.71 KB)

Azelastine: List of nationally authorised medicinal products - PSUSA/00000277/201712 (PDF/220.2 KB)

Hydrochlorothiazide / ramipril: List of nationally authorised medicinal products - PSUSA/00001660/201801 (PDF/272.5 KB)