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1748 results

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Ciprofloxacin (systemic use): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00000775/201801 (PDF/53.12 KB)

Last updated: 03/10/2019
Active substance: Ciprofloxacin
Procedure number: PSUSA/00000775/201801
Regulatory outcome: Variation
Bulgarian
(PDF/91.98 KB)

Croatian
(PDF/77.13 KB)

Czech
(PDF/87.25 KB)

Danish
(PDF/50.56 KB)

Dutch
(PDF/51.17 KB)

Estonian
(PDF/45.67 KB)

Finnish
(PDF/49.17 KB)

French
(PDF/50.96 KB)

German
(PDF/52.64 KB)

Greek
(PDF/94.38 KB)

Hungarian
(PDF/79.87 KB)

Icelandic
(PDF/47.02 KB)

Italian
(PDF/52.77 KB)

Latvian
(PDF/88.52 KB)

Lithuanian
(PDF/77.1 KB)

Maltese
(PDF/115.63 KB)

Norwegian
(PDF/50.25 KB)

Polish
(PDF/90.63 KB)

Portuguese
(PDF/45.98 KB)

Romanian
(PDF/93.48 KB)

Slovak
(PDF/85.23 KB)

Slovenian
(PDF/81.33 KB)

Spanish
(PDF/65.36 KB)

Swedish
(PDF/50.93 KB)
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Everolimus (indicated for rejection of transplanted organs) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010269/201807 (PDF/27.04 KB)

Last updated: 17/06/2019
Active substance: everolimus
Procedure number: PSUSA/00010269/201807
Regulatory outcome: Variation
Bulgarian
(PDF/58.96 KB)

Croatian
(PDF/50.28 KB)

Czech
(PDF/53.92 KB)

Danish
(PDF/25.61 KB)

Dutch
(PDF/26.13 KB)

Estonian
(PDF/25.16 KB)

Finnish
(PDF/25.14 KB)

French
(PDF/26.08 KB)

German
(PDF/27.28 KB)

Greek
(PDF/59.4 KB)

Hungarian
(PDF/50.71 KB)

Icelandic
(PDF/27.46 KB)

Italian
(PDF/27.13 KB)

Latvian
(PDF/53.63 KB)

Lithuanian
(PDF/55.6 KB)

Maltese
(PDF/54.4 KB)

Norwegian
(PDF/25.09 KB)

Polish
(PDF/56.26 KB)

Portuguese
(PDF/25.77 KB)

Romanian
(PDF/52.72 KB)

Slovak
(PDF/54.21 KB)

Slovenian
(PDF/50.43 KB)

Spanish
(PDF/25.78 KB)

Swedish
(PDF/25.87 KB)
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Paracetamol / pseudoephedrine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002307/201806 (PDF/69.19 KB)

Last updated: 17/04/2019
Active substance: Paracetamol, pseudoephedrine
Procedure number: PSUSA/00002307/201806
Regulatory outcome: Variation
(PDF/106.92 KB)

Bulgarian
(PDF/116.05 KB)

Croatian
(PDF/104.86 KB)

Czech
(PDF/112.31 KB)

Danish
(PDF/78.6 KB)

Dutch
(PDF/92.13 KB)

Estonian
(PDF/74.16 KB)

Finnish
(PDF/86.84 KB)

French
(PDF/96.05 KB)

German
(PDF/85.54 KB)

Greek
(PDF/96.37 KB)

Hungarian
(PDF/98.3 KB)

Italian
(PDF/134.96 KB)

Latvian
(PDF/110.71 KB)

Lithuanian
(PDF/86.4 KB)

Maltese
(PDF/92.16 KB)

Polish
(PDF/100.74 KB)

Portuguese
(PDF/68.89 KB)

Romanian
(PDF/108.41 KB)

Slovak
(PDF/114.92 KB)

Slovenian
(PDF/84.26 KB)

Spanish
(PDF/81.9 KB)

Swedish
(PDF/67.98 KB)
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Deoxycholic acid: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00010525/201804 (PDF/213.14 KB)

Last updated: 26/02/2019
Active substance: Deoxycholic acid
Procedure number: PSUSA/00010525/201804
Regulatory outcome: Variation
(PDF/212.44 KB)

Bulgarian
(PDF/224.87 KB)

Croatian
(PDF/218.08 KB)

Czech
(PDF/224.85 KB)

Danish
(PDF/258.51 KB)

Dutch
(PDF/216.5 KB)

Finnish
(PDF/207.09 KB)

French
(PDF/225.63 KB)

German
(PDF/238.95 KB)

Greek
(PDF/223.4 KB)

Hungarian
(PDF/447.46 KB)

Icelandic
(PDF/262.37 KB)

Italian
(PDF/298.96 KB)

Latvian
(PDF/288.44 KB)

Lithuanian
(PDF/144.59 KB)

Maltese
(PDF/230.19 KB)

Norwegian
(PDF/213.26 KB)

Polish
(PDF/197.11 KB)

Portuguese
(PDF/215.19 KB)

Romanian
(PDF/220.35 KB)

Slovak
(PDF/266.5 KB)

Slovenian
(PDF/217.57 KB)

Spanish
(PDF/214.75 KB)

Swedish
(PDF/213.9 KB)
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Levobupivacaine: List of nationally authorised medicinal products - PSUSA/00001848/201712 (PDF/254.62 KB)

Last updated: 17/09/2018
Active substance: levobupivacaine
Procedure number: PSUSA/00001848/201712
Regulatory outcome: Maintenance
List item

Landiolol: List of nationally authorised medicinal products - PSUSA/00010570/201802 (PDF/122.96 KB)

Last updated: 14/09/2018
Active substance: landiolol
Procedure number: PSUSA/00010570/201802
Regulatory outcome: Maintenance
List item

Hydrochlorothiazide / spironolactone: List of nationally authorised medicinal products - PSUSA/00001662/201801 (PDF/69.12 KB)

Last updated: 13/09/2018
Active substance: spironolactone, hydrochlorothiazide
Procedure number: PSUSA/00001662/201801
Regulatory outcome: Maintenance
List item

Sertindole: List of nationally authorised medicinal products - PSUSA/00002695/201801 (PDF/105.81 KB)

Last updated: 13/09/2018
Active substance: sertindole
Procedure number: PSUSA/00002695/201801
Regulatory outcome: Maintenance
List item

Propofol: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00002555/201711 (PDF/35.38 KB)

Last updated: 13/09/2018
Active substance: propofol
Procedure number: PSUSA/00002555/201711
Regulatory outcome: Variation
Bulgarian
(PDF/62.03 KB)

Croatian
(PDF/56.31 KB)

Czech
(PDF/76.89 KB)

Danish
(PDF/34.11 KB)

Dutch
(PDF/34.69 KB)

Estonian
(PDF/34.11 KB)

Finnish
(PDF/34.02 KB)

French
(PDF/34.98 KB)

German
(PDF/35.06 KB)

Greek
(PDF/61.81 KB)

Hungarian
(PDF/58.15 KB)

Icelandic
(PDF/34.47 KB)

Italian
(PDF/35.54 KB)

Latvian
(PDF/58.65 KB)

Lithuanian
(PDF/63.03 KB)

Maltese
(PDF/60.46 KB)

Norwegian
(PDF/34.07 KB)

Polish
(PDF/61.83 KB)

Portuguese
(PDF/34.1 KB)

Romanian
(PDF/56.9 KB)

Slovak
(PDF/59.23 KB)

Slovenian
(PDF/58.16 KB)

Spanish
(PDF/34.44 KB)

Swedish
(PDF/34.46 KB)
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Haemophilus influenzae / klebsiella ozaenae / klebsiella pneumoniae / moraxella catarrhalis / staphylococcus aureus / streptococcus pneumoniae / streptococcus pyogenes / streptococcus viridans vaccine: List of nationally... (PDF/123.87 KB)

Last updated: 13/09/2018
Active substance: streptococcus viridans vaccine, streptococcus pyogenes, streptococcus pneumoniae, staphylococcus aureus, moraxella catarrhalis, klebsiella pneumoniae, klebsiella ozaenae, haemophilus influenzae
Procedure number: PSUSA/00001582/201712
Regulatory outcome: Maintenance
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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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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
List item

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
List item

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
List item

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

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
List item

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
List item

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
List item

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
List item

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)
List item

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

1748 results

Ciprofloxacin (systemic use): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00000775/201801 (PDF/53.12 KB)

Everolimus (indicated for rejection of transplanted organs) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010269/201807 (PDF/27.04 KB)

Paracetamol / pseudoephedrine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002307/201806 (PDF/69.19 KB)

Deoxycholic acid: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00010525/201804 (PDF/213.14 KB)

Levobupivacaine: List of nationally authorised medicinal products - PSUSA/00001848/201712 (PDF/254.62 KB)

Landiolol: List of nationally authorised medicinal products - PSUSA/00010570/201802 (PDF/122.96 KB)

Hydrochlorothiazide / spironolactone: List of nationally authorised medicinal products - PSUSA/00001662/201801 (PDF/69.12 KB)

Sertindole: List of nationally authorised medicinal products - PSUSA/00002695/201801 (PDF/105.81 KB)

Propofol: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00002555/201711 (PDF/35.38 KB)

Haemophilus influenzae / klebsiella ozaenae / klebsiella pneumoniae / moraxella catarrhalis / staphylococcus aureus / streptococcus pneumoniae / streptococcus pyogenes / streptococcus viridans vaccine: List of nationally... (PDF/123.87 KB)

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

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

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

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

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