Medicines

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Trimetazidine: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/0001 and EMEA/H/N/PSR/J/0002 (PDF/1.26 MB)

Last updated: 04/10/2016
Active substance: trimetazidine
Procedure number: EMEA/H/N/PSR/0001
Regulatory outcome: Variation
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Trimetazidine: List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0002 (PDF/749.78 KB)

Last updated: 04/10/2016
Active substance: trimetazidine
Procedure number: EMEA/H/N/PSR/J/0002
Regulatory outcome: Variation
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Trimetazidine: List of nationally authorised medicinal products - EMEA/H/N/PSR/0001 (PDF/238.84 KB)

Last updated: 04/10/2016
Active substance: trimetazidine
Procedure number: EMEA/H/N/PSR/0001
Regulatory outcome: Variation
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Glycopyrronium bromide (all indications except for chronic obstructive pulmonary disease): List of nationally authorised medicinal products - PSUSA/00001556/201509 (PDF/72.28 KB)

Last updated: 17/10/2016
Active substance: Glycopyrronium bromide
Procedure number: PSUSA/00001556/201509
Regulatory outcome: Variation
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Glycopyrronium / neostigmine: List of nationally authorised medicinal products - PSUSA/00001557/201509 (PDF/65.03 KB)

Last updated: 17/10/2016
Active substance: glycopyrronium, neostigmine
Procedure number: PSUSA/00001557/201509
Regulatory outcome: Variation
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Glycopyrronium bromide (all indications except for chronic obstructive pulmonary disease): CMDh scientific conclusions and grounds for the variation, amendments to the product information, and timetable for the implement... (PDF/645.6 KB)

Last updated: 17/10/2016
Active substance: Glycopyrronium bromide
Procedure number: PSUSA/00001556/201509
Regulatory outcome: Variation
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Glibenclamide / metformin hydrochloride: List of nationally authorised medicinal products - PSUSA/00002002/201506 (PDF/79.87 KB)

Last updated: 17/10/2016
Active substance: glibenclamide, metformin hydrochloride
Procedure number: PSUSA/00002002/201506
Regulatory outcome: Variation
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Glibenclamide / metformin hydrochloride: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - PSUSA/00002002/201506 (PDF/1.82 MB)

Last updated: 17/10/2016
Active substance: glibenclamide, metformin hydrochloride
Procedure number: PSUSA/00002002/201506
Regulatory outcome: Variation
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Glycopyrronium / neostigmine: CMDh Scientific conclusions and grounds for the variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001557/201509 (PDF/607.16 KB)

Last updated: 17/10/2016
Active substance: glycopyrronium, neostigmine
Procedure number: PSUSA/00001557/201509
Regulatory outcome: Variation
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5 Fluorouracil (topical application): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00010000/201412 (PDF/606.15 KB)

Last updated: 17/10/2016
Active substance: 5 fluorouracil
Procedure number: PSUSA/00010000/201412
Regulatory outcome: Variation
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5 Fluorouracil (topical application): List of nationally authorised medicinal products - PSUSA/00010000/201412 (PDF/78.47 KB)

Last updated: 17/10/2016
Active substance: 5 fluorouracil
Procedure number: PSUSA/00010000/201412
Regulatory outcome: Variation
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Perindopril: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - PSUSA/00002354/201510 (PDF/812.41 KB)

Last updated: 17/10/2016
Active substance: perindopril
Procedure number: PSUSA/00002354/201510
Regulatory outcome: Variation
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Paracetamol / tramadol: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - PSUSA/00002310/201508 (PDF/868.33 KB)

Last updated: 17/10/2016
Active substance: paracetamol, Tramadol
Procedure number: PSUSA/00002310/201508
Regulatory outcome: Variation
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Paracetamol / tramadol: List of nationally authorised medicinal products - PSUSA/00002310/201508 (PDF/136.17 KB)

Last updated: 17/10/2016
Active substance: paracetamol, Tramadol
Procedure number: PSUSA/00002310/201508
Regulatory outcome: Variation
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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
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Hydrochlorothiazide, spironolactone: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - PSUSA/00001662/201501 (PDF/1.53 MB)

Last updated: 17/10/2016
Active substance: hydrochlorothiazide, spironolactone
Procedure number: PSUSA/00001662/201501
Regulatory outcome: Variation
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Hydrochlorothiazide, spironolactone: List of nationally authorised medicinal products - PSUSA/00001662/201501 (PDF/63.12 KB)

Last updated: 17/10/2016
Active substance: hydrochlorothiazide, spironolactone
Procedure number: PSUSA/00001662/201501
Regulatory outcome: Variation
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Acitretin: List of nationally authorised medicinal products - PSUSA/00000051/201510 (PDF/84.93 KB)

Last updated: 17/10/2016
Active substance: acitretin
Procedure number: PSUSA/00000051/201510
Regulatory outcome: Variation
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Acitretin: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation- PSUSA/00000051/201510 (PDF/2.63 MB)

Last updated: 17/10/2016
Active substance: acitretin
Procedure number: PSUSA/00000051/201510
Regulatory outcome: Variation
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Phenylephrine: List of nationally authorised medicinal products - PSUSA/00002378/201501 (PDF/85.47 KB)

Last updated: 17/10/2016
Active substance: phenylephrine
Procedure number: PSUSA/00002378/201501
Regulatory outcome: Variation
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Phenylephrine: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00002378/201501 (PDF/790.25 KB)

Last updated: 17/10/2016
Active substance: phenylephrine
Procedure number: PSUSA/00002378/201501
Regulatory outcome: Variation
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Influenza vaccine (surface antigen, inactivated): List of nationally authorised medicinal products - PSUSA/00001744/201508 (PDF/118.66 KB)

Last updated: 17/10/2016
Active substance: influenza vaccine
Procedure number: PSUSA/00001744/201508
Regulatory outcome: Variation
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Pramiracetam: List of nationally authorised medicinal products - PSUSA/00002492/201409 (PDF/676.57 KB)

Last updated: 17/10/2016
Active substance: pramiracetam
Procedure number: PSUSA/00002492/201409
Regulatory outcome: Variation
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Pramiracetam: CMDh scientific conclusions and grounds for variation, amendments to the product information, and timetable for the implementation - PSUSA/00002492/201409 (PDF/68.2 KB)

Last updated: 17/10/2016
Active substance: pramiracetam
Procedure number: PSUSA/00002492/201409
Regulatory outcome: Variation
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Isoniazid: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001789/201411 (PDF/478.7 KB)

Last updated: 17/10/2016
Active substance: isoniazid
Procedure number: PSUSA/00001789/201411
Regulatory outcome: Variation

994 results

Trimetazidine: CMDh scientific conclusions, amendments to product information and implementation timetable - EMEA/H/N/PSR/0001 and EMEA/H/N/PSR/J/0002 (PDF/1.26 MB)

Trimetazidine: List of nationally authorised medicinal products - EMEA/H/N/PSR/J/0002 (PDF/749.78 KB)

Trimetazidine: List of nationally authorised medicinal products - EMEA/H/N/PSR/0001 (PDF/238.84 KB)

Glycopyrronium bromide (all indications except for chronic obstructive pulmonary disease): List of nationally authorised medicinal products - PSUSA/00001556/201509 (PDF/72.28 KB)

Glycopyrronium / neostigmine: List of nationally authorised medicinal products - PSUSA/00001557/201509 (PDF/65.03 KB)

Glycopyrronium bromide (all indications except for chronic obstructive pulmonary disease): CMDh scientific conclusions and grounds for the variation, amendments to the product information, and timetable for the implement... (PDF/645.6 KB)

Glibenclamide / metformin hydrochloride: List of nationally authorised medicinal products - PSUSA/00002002/201506 (PDF/79.87 KB)

Glibenclamide / metformin hydrochloride: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - PSUSA/00002002/201506 (PDF/1.82 MB)

Glycopyrronium / neostigmine: CMDh Scientific conclusions and grounds for the variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001557/201509 (PDF/607.16 KB)

5 Fluorouracil (topical application): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00010000/201412 (PDF/606.15 KB)

5 Fluorouracil (topical application): List of nationally authorised medicinal products - PSUSA/00010000/201412 (PDF/78.47 KB)

Perindopril: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - PSUSA/00002354/201510 (PDF/812.41 KB)

Paracetamol / tramadol: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - PSUSA/00002310/201508 (PDF/868.33 KB)

Paracetamol / tramadol: List of nationally authorised medicinal products - PSUSA/00002310/201508 (PDF/136.17 KB)

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

Hydrochlorothiazide, spironolactone: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation - PSUSA/00001662/201501 (PDF/1.53 MB)

Hydrochlorothiazide, spironolactone: List of nationally authorised medicinal products - PSUSA/00001662/201501 (PDF/63.12 KB)

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

Acitretin: CMDh scientific conclusions and grounds for the variation, amendments to the product information and timetable for the implementation- PSUSA/00000051/201510 (PDF/2.63 MB)

Phenylephrine: List of nationally authorised medicinal products - PSUSA/00002378/201501 (PDF/85.47 KB)

Phenylephrine: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00002378/201501 (PDF/790.25 KB)

Influenza vaccine (surface antigen, inactivated): List of nationally authorised medicinal products - PSUSA/00001744/201508 (PDF/118.66 KB)

Pramiracetam: List of nationally authorised medicinal products - PSUSA/00002492/201409 (PDF/676.57 KB)

Pramiracetam: CMDh scientific conclusions and grounds for variation, amendments to the product information, and timetable for the implementation - PSUSA/00002492/201409 (PDF/68.2 KB)

Isoniazid: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001789/201411 (PDF/478.7 KB)