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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Glipizide: List of nationally authorised medicinal products - PSUSA/00001535/201601 (PDF/90.76 KB)

Last updated: 17/10/2016
Active substance: glatiramer
Procedure number: PSUSA/00001535/201601
Regulatory outcome: Maintenance
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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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Tiludronic acid: List of nationally authorised medicinal products - PSUSA/00002959/201502 (PDF/66.71 KB)

Last updated: 17/10/2016
Active substance: tiludronic acid
Procedure number: PSUSA/00002959/201502
Regulatory outcome: Maintenance
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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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Glatiramer: List of nationally authorised medicinal products - PSUSA/00001529/201411 (PDF/108.16 KB)

Last updated: 17/10/2016
Active substance: glatiramer
Procedure number: PSUSA/00001529/201411
Regulatory outcome: Maintenance
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Paracetamol (IV formulation): List of nationally authorised medicinal products - PSUSA/00002311/201505 (PDF/149.67 KB)

Last updated: 17/10/2016
Active substance: paracetamol
Procedure number: PSUSA/00002311/201505
Regulatory outcome: Maintenance
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(18f) Fludeoxyglucose: List of nationally authorised medicinal products - PSUSA/00001437/201411 (PDF/88.88 KB)

Last updated: 17/10/2016
Active substance: fludeoxyglucose (18F)
Procedure number: PSUSA/00001437/201411
Regulatory outcome: Maintenance
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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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5 Fluorouracil (i.v. application): List of nationally authorised medicinal products - PSUSA/00000007/201412 (PDF/223.55 KB)

Last updated: 17/10/2016
Active substance: 5 fluorouracil
Procedure number: PSUSA/00000007/201412
Regulatory outcome: Maintenance
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5 Fluorouracil, salicylic acid: List of nationally authorised medicinal products - PSUSA/00000008/201505 (PDF/76.42 KB)

Last updated: 17/10/2016
Active substance: 5 fluorouracil, salicylic acid
Procedure number: PSUSA/00000008/201505
Regulatory outcome: Maintenance
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Acarbose: List of nationally authorised medicinal products - PSUSA/00000017/201503 (PDF/121.24 KB)

Last updated: 17/10/2016
Active substance: acarbose
Procedure number: PSUSA/00000017/201503
Regulatory outcome: Maintenance
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Acetylcysteine: List of nationally authorised medicinal products - PSUSA/00000034/201509 (PDF/146.92 KB)

Last updated: 17/10/2016
Active substance: Acetylcysteine
Procedure number: PSUSA/00000034/201509
Regulatory outcome: Maintenance
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Acetylsalicylic acid / bisoprolol: List of nationally authorised medicinal products - PSUSA/00010287/201505 (PDF/89.79 KB)

Last updated: 17/10/2016
Active substance: Acetylsalicylic acid, bisoprolol
Procedure number: PSUSA/00010287/201505
Regulatory outcome: Maintenance
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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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Paraffin liquid: List of nationally authorised medicinal products - PSUSA/00009251/201510 (PDF/129.55 KB)

Last updated: 17/10/2016
Procedure number: PSUSA/00009251/201510
Regulatory outcome: Maintenance

2491 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)

Glipizide: List of nationally authorised medicinal products - PSUSA/00001535/201601 (PDF/90.76 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)

Tiludronic acid: List of nationally authorised medicinal products - PSUSA/00002959/201502 (PDF/66.71 KB)

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)

Glatiramer: List of nationally authorised medicinal products - PSUSA/00001529/201411 (PDF/108.16 KB)

Paracetamol (IV formulation): List of nationally authorised medicinal products - PSUSA/00002311/201505 (PDF/149.67 KB)

(18f) Fludeoxyglucose: List of nationally authorised medicinal products - PSUSA/00001437/201411 (PDF/88.88 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)

5 Fluorouracil (i.v. application): List of nationally authorised medicinal products - PSUSA/00000007/201412 (PDF/223.55 KB)

5 Fluorouracil, salicylic acid: List of nationally authorised medicinal products - PSUSA/00000008/201505 (PDF/76.42 KB)

Acarbose: List of nationally authorised medicinal products - PSUSA/00000017/201503 (PDF/121.24 KB)

Acetylcysteine: List of nationally authorised medicinal products - PSUSA/00000034/201509 (PDF/146.92 KB)

Acetylsalicylic acid / bisoprolol: List of nationally authorised medicinal products - PSUSA/00010287/201505 (PDF/89.79 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)

Paraffin liquid: List of nationally authorised medicinal products - PSUSA/00009251/201510 (PDF/129.55 KB)