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Botulinum toxin a: List of nationally authorised medicinal products - PSUSA/00000426/201812 (PDF/209.94 KB)

authorised medicinal products - PSUSA/00000426/201812 … authorised medicinal products - PSUSA/00000426/201812 EMA/58116/2019 25/10/2019 …

Last updated: 25/10/2019
Active substance: botulinum toxin a
Procedure number: PSUSA/00000426/201812
Regulatory outcome: Variation
List item

Botulinum toxin a: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000426/201812 (PDF/26.91 KB)

for the implementation - PSUSA/00000426/201812 … for the implementation - PSUSA/00000426/201812 Other languages: hr hu is …

Last updated: 25/10/2019
Active substance: botulinum toxin a
Procedure number: PSUSA/00000426/201812
Regulatory outcome: Variation
(PDF/32.05 KB)

Bulgarian
(PDF/94.79 KB)

Croatian
(PDF/89.49 KB)

Czech
(PDF/101.07 KB)

Danish
(PDF/32.86 KB)

Dutch
(PDF/31.87 KB)

Estonian
(PDF/27.42 KB)

Finnish
(PDF/25.89 KB)

French
(PDF/32.24 KB)

German
(PDF/26.19 KB)

Greek
(PDF/95.57 KB)

Hungarian
(PDF/88.69 KB)

Icelandic
(PDF/24.82 KB)

Italian
(PDF/34.89 KB)

Latvian
(PDF/99.86 KB)

Lithuanian
(PDF/95.89 KB)

Maltese
(PDF/101.42 KB)

Norwegian
(PDF/56.31 KB)

Polish
(PDF/96.67 KB)

Portuguese
(PDF/32.13 KB)

Romanian
(PDF/100.59 KB)

Slovak
(PDF/100.04 KB)

Slovenian
(PDF/96.94 KB)

Spanish
(PDF/29.16 KB)
List item

Botulinum toxin a: List of nationally authorised medicinal products - PSUSA/00000426/201512 (PDF/211.1 KB)

authorised medicinal products - PSUSA/00000426/201512 … authorised medicinal products - PSUSA/00000426/201512 EMA/705701/2016 27/10/2016 … authorised medicinal products - PSUSA/00000426/201512 30 Churchill Place …

Last updated: 27/10/2016
Active substance: botulinum toxin a
Procedure number: PSUSA/00000426/201512
Regulatory outcome: Variation
List item

Botulinum toxin a: CMDh scientific conclusions and grounds for the variation, amendments to the product information, conditions to the MA and timetable for the implementation - PSUSA/00000426/201512 (PDF/589.41 KB)

for the implementation - PSUSA/00000426/201512 … for the implementation - PSUSA/00000426/201512 … for the implementation - PSUSA/00000426/201512 30 Churchill Place …

Last updated: 27/10/2016
Active substance: botulinum toxin a
Procedure number: PSUSA/00000426/201512
Regulatory outcome: Variation
List item

Cefotaxime : List of nationally authorised medicinal products - PSUSA/00000599/201812 (PDF/104.61 KB)

authorised medicinal products - PSUSA/00000599/201812 … authorised medicinal products - PSUSA/00000599/201812 EMA/403947/2019 16/07/2019 …

Last updated: 16/07/2019
Active substance: cefotaxime
Procedure number: PSUSA/00000599/201812
Regulatory outcome: Maintenance
List item

Valaciclovir: List of nationally authorised medicinal products - PSUSA/00003086/201812 (PDF/122.32 KB)

authorised medicinal products - PSUSA/00003086/201812 … authorised medicinal products - PSUSA/00003086/201812 EMA/408177/2019 18/07/2019 …

Last updated: 18/07/2019
Active substance: valaciclovir
Procedure number: PSUSA/00003086/201812
Regulatory outcome: Maintenance
List item

Danaparoid: List of nationally authorised medicinal products - PSUSA/00000923/201812 (PDF/90.65 KB)

authorised medicinal products - PSUSA/00000923/201812 … authorised medicinal products - PSUSA/00000923/201812 EMA/445257/2019 06/08/2019 …

Last updated: 06/08/2019
Active substance: danaparoid
Procedure number: PSUSA/00000923/201812
Regulatory outcome: Maintenance
List item

Azathioprine: List of nationally authorised medicinal products - PSUSA/00000275/201812 (PDF/235.58 KB)

authorised medicinal products - PSUSA/00000275/201812 … authorised medicinal products - PSUSA/00000275/201812 EMA/480512/2019 30/08/2019 …

Last updated: 30/08/2019
Active substance: azathioprine
Procedure number: PSUSA/00000275/201812
Regulatory outcome: Variation
List item

Niflumic acid: List of nationally authorised products - PSUSA/00002157/201812 (PDF/82.75 KB)

nationally authorised products - PSUSA/00002157/201812 … nationally authorised products - PSUSA/00002157/201812 EMA/497073/2019 10/09/2019 …

Last updated: 10/09/2019
Active substance: niflumic acid
Procedure number: PSUSA/00002157/201812
Regulatory outcome: Maintenance
List item

Pentoxyverine: List of nationally authorised medicinal products - PSUSA/00002345/201812 (PDF/68.23 KB)

authorised medicinal products - PSUSA/00002345/201812 … authorised medicinal products - PSUSA/00002345/201812 EMA/496740/2019 11/09/2019 …

Last updated: 11/09/2019
Active substance: pentoxyverine
Procedure number: PSUSA/00002345/201812
Regulatory outcome: Maintenance
List item

Roxithromycin: List of nationally authorised medicinal products - PSUSA/00002669/201812 (PDF/110.27 KB)

authorised medicinal products - PSUSA/00002669/201812 … authorised medicinal products - PSUSA/00002669/201812 EMA/494737/2019 11/09/2019 …

Last updated: 11/09/2019
Active substance: roxithromycin
Procedure number: PSUSA/00002669/201812
Regulatory outcome: Maintenance
List item

Ketamine : List of nationally authorised medicinal products - PSUSA/00001804/201812 (PDF/86.78 KB)

authorised medicinal products - PSUSA/00001804/201812 … authorised medicinal products - PSUSA/00001804/201812 EMA/398958/2019 19/09/2019 …

Last updated: 19/09/2019
Active substance: ketamine
Procedure number: PSUSA/00001804/201812
Regulatory outcome: Variation
List item

Bupropion: List of nationally authorised medicinal products - PSUSA/00000461/201812 (PDF/190.16 KB)

authorised medicinal products - PSUSA/00000461/201812 … authorised medicinal products - PSUSA/00000461/201812 EMA/517429/2019 27/09/2019 …

Last updated: 27/09/2019
Active substance: bupropion
Procedure number: PSUSA/00000461/201812
Regulatory outcome: Maintenance
List item

Ciclosporin (systemic use): List of nationally authorised products - PSUSA/00000745/201812 (PDF/578.14 KB)

nationally authorised products - PSUSA/00000745/201812 … nationally authorised products - PSUSA/00000745/201812 EMA/503045/2019 16/09/2019 …

Last updated: 16/09/2019
Active substance: ciclosporin
Procedure number: PSUSA/00000745/201812
Regulatory outcome: Maintenance
List item

Testosterone (topical use) : List of nationally authorised medicinal products - PSUSA/00002908/201812 (PDF/257.08 KB)

authorised medicinal products - PSUSA/00002908/201812 … authorised medicinal products - PSUSA/00002908/201812 EMA/270645/2015 28/10/2019 …

Last updated: 28/10/2019
Active substance: Testosterone
Procedure number: PSUSA/00002908/201812
Regulatory outcome: Variation
List item

Hydroxycarbamide (except for centrally authorised product): List of nationally authorised medicinal products - PSUSA-00009182-201812 (PDF/92.3 KB)

authorised medicinal products - PSUSA-00009182-201812 … authorised medicinal products - PSUSA-00009182-201812 EMA/401819/2019 15/07/2019 …

Last updated: 15/07/2019
Active substance: hydroxycarbamide
Procedure number: PSUSA-00009182-201812
Regulatory outcome: Maintenance
List item

Yellow fever vaccine (live): List of nationally authorised medicinal products - PSUSA/00003135/201812 (PDF/136.07 KB)

authorised medicinal products - PSUSA/00003135/201812 … authorised medicinal products - PSUSA/00003135/201812 EMA/403921/2019 16/07/2019 …

Last updated: 16/07/2019
Active substance: yellow fever vaccine (live)
Procedure number: PSUSA/00003135/201812
Regulatory outcome: Maintenance
List item

Testosterone (all formulations apart from topical use) : List of nationally authorised medicinal products - PSUSA/00010631/201812 (PDF/262.05 KB)

authorised medicinal products - PSUSA/00010631/201812 … authorised medicinal products - PSUSA/00010631/201812 EMA/270645/2015 29/10/2019 …

Last updated: 29/10/2019
Active substance: Testosterone
Procedure number: PSUSA/00010631/201812
Regulatory outcome: Variation
List item

Botulinum toxin a - haemagglutinin complex : List of nationally authorised medicinal products - PSUSA/00000427/201812 (PDF/143.09 KB)

authorised medicinal products - PSUSA/00000427/201812 … authorised medicinal products - PSUSA/00000427/201812 EMA/590274/2019 30/10/2019 …

Last updated: 30/10/2019
Active substance: botulinum toxin a - haemagglutinin complex
Procedure number: PSUSA/00000427/201812
Regulatory outcome: Variation
List item

Azathioprine: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00000275/201812 (PDF/127.05 KB)

implementation timetable - PSUSA/00000275/201812 … implementation timetable - PSUSA/00000275/201812 Other languages: bg cs da …

Last updated: 30/08/2019
Active substance: azathioprine
Procedure number: PSUSA/00000275/201812
Regulatory outcome: Variation
Bulgarian
(PDF/321.97 KB)

Croatian
(PDF/146.33 KB)

Czech
(PDF/285.15 KB)

Danish
(PDF/372.44 KB)

Dutch
(PDF/129.25 KB)

Estonian
(PDF/152.53 KB)

Finnish
(PDF/126.19 KB)

French
(PDF/139.26 KB)

German
(PDF/90.2 KB)

Greek
(PDF/149.87 KB)

Hungarian
(PDF/243.5 KB)

Icelandic
(PDF/162.32 KB)

Italian
(PDF/130.04 KB)

Latvian
(PDF/176.85 KB)

Lithuanian
(PDF/101.46 KB)

Maltese
(PDF/262.18 KB)

Norwegian
(PDF/105.6 KB)

Polish
(PDF/126.4 KB)

Portuguese
(PDF/155.26 KB)

Romanian
(PDF/244.45 KB)

Slovak
(PDF/209.44 KB)

Slovenian
(PDF/145.73 KB)

Spanish
(PDF/180.56 KB)

Swedish
(PDF/129.99 KB)
List item

Botulinum neurotoxin type a (150 kD) free from complexing proteins: List of nationally authorised medicinal products - PSUSA/00009084/201812 (PDF/262.02 KB)

authorised medicinal products - PSUSA/00009084/201812 … authorised medicinal products - PSUSA/00009084/201812 EMA/583348/2019 28/10/2019 …

Last updated: 28/10/2019
Active substance: botulinum neurotoxin type a (150 kd) free from complexing proteins
Procedure number: PSUSA/00009084/201812
Regulatory outcome: Variation
List item

Amino acid combinations / glucose / triglyceride combinations / with or without electrolytes / mineral compounds - only for the drug Numeta: List of nationally authorised medicinal products - PSUSA/00010190/201812 (PDF/106.33 KB)

authorised medicinal products - PSUSA/00010190/201812 … authorised medicinal products - PSUSA/00010190/201812 EMA/408522/2019 18/07/2019 …

Last updated: 18/07/2019
Active substance: amino acid combinations, glucose, triglyceride combinations
Procedure number: PSUSA/00010190/201812
Regulatory outcome: Maintenance
List item

Camellia sinensis, Leaf, Dry extract refined (derived from Camellia sinensis, L. O.KUNTZE) (topical use): List of nationally authorised products - PSUSA/00010569/201812

nationally authorised products - PSUSA/00010569/201812 … nationally authorised products - PSUSA/00010569/201812 EMA/503050/2019 16/09/2019 …

Last updated: 16/09/2019
Active substance: Camellia sinensis
Procedure number: PSUSA/00010569/201812
Regulatory outcome: Maintenance
List item

Ketamine : CMDh Scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001804/201812 (PDF/81.7 KB)

for the implementation - PSUSA/00001804/201812 … for the implementation - PSUSA/00001804/201812 Other languages: lv mt nl …

Last updated: 19/09/2019
Active substance: ketamine
Procedure number: PSUSA/00001804/201812
Regulatory outcome: Variation
Bulgarian
(PDF/72.74 KB)

Croatian
(PDF/73.54 KB)

Czech
(PDF/81.69 KB)

Danish
(PDF/84.26 KB)

Dutch
(PDF/87.44 KB)

Estonian
(PDF/70.04 KB)

Finnish
(PDF/76.26 KB)

French
(PDF/87.92 KB)

German
(PDF/97.63 KB)

Greek
(PDF/75.3 KB)

Hungarian
(PDF/86.06 KB)

Italian
(PDF/90.51 KB)

Latvian
(PDF/90.06 KB)

Lithuanian
(PDF/83.33 KB)

Maltese
(PDF/91.84 KB)

Norwegian
(PDF/75.22 KB)

Polish
(PDF/78.55 KB)

Portuguese
(PDF/84.71 KB)

Romanian
(PDF/79.37 KB)

Slovak
(PDF/79.69 KB)

Slovenian
(PDF/76.55 KB)

Spanish
(PDF/76.82 KB)

Swedish
(PDF/80.5 KB)
List item

Testosterone (topical use) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002908/201812 (PDF/31.63 KB)

for the implementation - PSUSA/00002908/201812 … for the implementation - PSUSA/00002908/201812 Other languages: nl no pl …

Last updated: 28/10/2019
Active substance: Testosterone
Procedure number: PSUSA/00002908/201812
Regulatory outcome: Variation
(PDF/34.9 KB)

Bulgarian
(PDF/117.28 KB)

Croatian
(PDF/119.57 KB)

Czech
(PDF/123.95 KB)

Danish
(PDF/56.41 KB)

Dutch
(PDF/32.38 KB)

Estonian
(PDF/38.65 KB)

Finnish
(PDF/31.48 KB)

French
(PDF/31.64 KB)

German
(PDF/31.89 KB)

Greek
(PDF/109.57 KB)

Hungarian
(PDF/101.82 KB)

Icelandic
(PDF/31.44 KB)

Italian
(PDF/36.4 KB)

Latvian
(PDF/119.51 KB)

Lithuanian
(PDF/123.51 KB)

Norwegian
(PDF/30.74 KB)

Polish
(PDF/145.8 KB)

Portuguese
(PDF/35.34 KB)

Romanian
(PDF/120.86 KB)

Slovak
(PDF/104.35 KB)

Slovenian
(PDF/99.63 KB)

Spanish
(PDF/37.27 KB)

Swedish
(PDF/34.9 KB)

2186 results

Botulinum toxin a: List of nationally authorised medicinal products - PSUSA/00000426/201812 (PDF/209.94 KB)

Botulinum toxin a: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000426/201812 (PDF/26.91 KB)

Botulinum toxin a: List of nationally authorised medicinal products - PSUSA/00000426/201512 (PDF/211.1 KB)

Botulinum toxin a: CMDh scientific conclusions and grounds for the variation, amendments to the product information, conditions to the MA and timetable for the implementation - PSUSA/00000426/201512 (PDF/589.41 KB)

Cefotaxime : List of nationally authorised medicinal products - PSUSA/00000599/201812 (PDF/104.61 KB)

Valaciclovir: List of nationally authorised medicinal products - PSUSA/00003086/201812 (PDF/122.32 KB)

Danaparoid: List of nationally authorised medicinal products - PSUSA/00000923/201812 (PDF/90.65 KB)

Azathioprine: List of nationally authorised medicinal products - PSUSA/00000275/201812 (PDF/235.58 KB)

Niflumic acid: List of nationally authorised products - PSUSA/00002157/201812 (PDF/82.75 KB)

Pentoxyverine: List of nationally authorised medicinal products - PSUSA/00002345/201812 (PDF/68.23 KB)

Roxithromycin: List of nationally authorised medicinal products - PSUSA/00002669/201812 (PDF/110.27 KB)

Ketamine : List of nationally authorised medicinal products - PSUSA/00001804/201812 (PDF/86.78 KB)

Bupropion: List of nationally authorised medicinal products - PSUSA/00000461/201812 (PDF/190.16 KB)

Ciclosporin (systemic use): List of nationally authorised products - PSUSA/00000745/201812 (PDF/578.14 KB)

Testosterone (topical use) : List of nationally authorised medicinal products - PSUSA/00002908/201812 (PDF/257.08 KB)

Hydroxycarbamide (except for centrally authorised product): List of nationally authorised medicinal products - PSUSA-00009182-201812 (PDF/92.3 KB)

Yellow fever vaccine (live): List of nationally authorised medicinal products - PSUSA/00003135/201812 (PDF/136.07 KB)

Testosterone (all formulations apart from topical use) : List of nationally authorised medicinal products - PSUSA/00010631/201812 (PDF/262.05 KB)

Botulinum toxin a - haemagglutinin complex : List of nationally authorised medicinal products - PSUSA/00000427/201812 (PDF/143.09 KB)

Azathioprine: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00000275/201812 (PDF/127.05 KB)

Botulinum neurotoxin type a (150 kD) free from complexing proteins: List of nationally authorised medicinal products - PSUSA/00009084/201812 (PDF/262.02 KB)

Amino acid combinations / glucose / triglyceride combinations / with or without electrolytes / mineral compounds - only for the drug Numeta: List of nationally authorised medicinal products - PSUSA/00010190/201812 (PDF/106.33 KB)

Camellia sinensis, Leaf, Dry extract refined (derived from Camellia sinensis, L. O.KUNTZE) (topical use): List of nationally authorised products - PSUSA/00010569/201812

Ketamine : CMDh Scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001804/201812 (PDF/81.7 KB)

Testosterone (topical use) : CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002908/201812 (PDF/31.63 KB)