Medicines

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Atenolol / chlortalidone: List of nationally authorised medicinal products - PSUSA/00000260/201409 (PDF/124.8 KB)

Last updated: 17/10/2016
Active substance: atenolol, chlortalidone
Procedure number: PSUSA/00000260/201409
Regulatory outcome: Variation
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Atenolol / chlortalidone: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00000260/201409 (PDF/1.09 MB)

Last updated: 17/10/2016
Active substance: atenolol, chlortalidone
Procedure number: PSUSA/00000260/201409
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
List item

Miconazole / hydrocortisone, miconazole nitrate / miconazole nitrate, zinc oxide: CMDh scientific conclusions and grounds for variation, amendments to the product information, and timetable for the implementation -PSUSA/... (PDF/1 MB)

Last updated: 18/10/2016
Active substance: Miconazole, hydrocortisone, miconazole nitrate, zinc oxide
Procedure number: PSUSA/00002052/201410
Regulatory outcome: Variation
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Miconazole / hydrocortisone, miconazole nitrate / miconazole nitrate, zinc oxide: List of nationally authorised medicinal products -PSUSA/00002052/201410 (PDF/129.39 KB)

Last updated: 18/10/2016
Active substance: Miconazole, hydrocortisone, miconazole nitrate, zinc oxide
Procedure number: PSUSA/00002052/201410
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
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Isoniazid: List of nationally authorised medicinal products - PSUSA/00001789/201411 (PDF/70.21 KB)

Last updated: 17/10/2016
Active substance: isoniazid
Procedure number: PSUSA/00001789/201411
Regulatory outcome: Variation
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Prulifloxacin: List of nationally authorised medicinal products -PSUSA/00002569/201410 (PDF/84.38 KB)

Last updated: 17/10/2016
Active substance: prulifloxacin
Procedure number: PSUSA/00002569/201410
Regulatory outcome: Variation
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Prulifloxacin: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation -PSUSA/00002569/201410 (PDF/2.21 MB)

Last updated: 17/10/2016
Active substance: prulifloxacin
Procedure number: PSUSA/00002569/201410
Regulatory outcome: Variation
List item

Tetrabenazine:List of nationally authorised medicinal products-PSUSA/00002911/201410 (PDF/85.26 KB)

Last updated: 19/10/2016
Active substance: tetrabenazine
Procedure number: PSUSA/00002911/201410
Regulatory outcome: Variation
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Tetrabenazine:CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation-PSUSA/00002911/201410 (PDF/639.42 KB)

Last updated: 19/10/2016
Active substance: tetrabenazine
Procedure number: PSUSA/00002911/201410
Regulatory outcome: Variation
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Corticorelin: List of nationally authorised medicinal products - PSUSA/00000876/201410 (PDF/65.84 KB)

Last updated: 17/10/2016
Active substance: corticorelin
Procedure number: PSUSA/00000876/201410
Regulatory outcome: Variation
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Corticorelin: CMDh Scientific conclusions and grounds for variation, amendments to the product information, and timetable for the implementation - PSUSA/00000876/201410 (PDF/497.05 KB)

Last updated: 17/10/2016
Active substance: corticorelin
Procedure number: PSUSA/00000876/201410
Regulatory outcome: Variation
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Calcium carbonate / famotidine / magnesium hydroxide: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001351/201409 (PDF/574.01 KB)

Last updated: 18/10/2016
Active substance: calcium carbonate, Famotidine, magnesium hydroxide
Procedure number: PSUSA/00001351/201409
Regulatory outcome: Variation
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Calcium carbonate / famotidine / magnesium hydroxide: List of nationally authorised medicinal products - PSUSA/00001351/201409 (PDF/72.1 KB)

Last updated: 18/10/2016
Active substance: calcium carbonate, Famotidine, magnesium hydroxide
Procedure number: PSUSA/00001351/201409
Regulatory outcome: Variation
List item

Amiodarone: List of nationally authorised medicinal products -PSUSA/00000166/201412 (PDF/109.87 KB)

Last updated: 17/10/2016
Active substance: amiodarone
Procedure number: PSUSA/00000166/201412
Regulatory outcome: Variation
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Amiodarone: CMDh scientific conclusions and grounds for variation, amendments to the product information, and timetable for the implementation - PSUSA/00000166/201412 (PDF/1.96 MB)

Last updated: 17/10/2016
Active substance: amiodarone
Procedure number: PSUSA/00000166/201412
Regulatory outcome: Variation
List item

Rabbit anti-human thymocyte (powder for solution for infusion): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00010184/201412 (PDF/2.36 MB)

Last updated: 17/10/2016
Active substance: rabbit anti-human thymocyte
Procedure number: PSUSA/00010184/201412
Regulatory outcome: Variation
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Rabbit anti-human thymocyte (powder for solution for infusion): List of nationally authorised medicinal products - PSUSA/00010184/201412 (PDF/76.52 KB)

Last updated: 17/10/2016
Active substance: rabbit anti-human thymocyte
Procedure number: PSUSA/00010184/201412
Regulatory outcome: Variation
List item

Rabbit anti-human thymocyte (powder for solution for infusion): List of nationally authorised medicinal products - PSUSA/00010184/201412 (PDF/76.52 KB)

Last updated: 17/10/2016
Active substance: rabbit anti-human thymocyte
Procedure number: PSUSA/00010184/201412
Regulatory outcome: Variation
List item

Rabbit anti-human thymocyte (powder for solution for infusion): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00010184/201412 (PDF/2.36 MB)

Last updated: 17/10/2016
Active substance: rabbit anti-human thymocyte
Procedure number: PSUSA/00010184/201412
Regulatory outcome: Variation
List item

Testosterone undecylate (injection): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation-PSUSA/00010161/201411 (PDF/693.98 KB)

Last updated: 19/10/2016
Active substance: testosterone undecylat
Procedure number: PSUSA/00010161/201411
Regulatory outcome: Variation
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Testosterone undecylate (injection): List of nationally authorised medicinal products-PSUSA/00010161/201411 (PDF/90.51 KB)

Last updated: 19/10/2016
Active substance: testosterone undecylat
Procedure number: PSUSA/00010161/201411
Regulatory outcome: Variation
List item

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

994 results

Atenolol / chlortalidone: List of nationally authorised medicinal products - PSUSA/00000260/201409 (PDF/124.8 KB)

Atenolol / chlortalidone: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00000260/201409 (PDF/1.09 MB)

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)

Miconazole / hydrocortisone, miconazole nitrate / miconazole nitrate, zinc oxide: CMDh scientific conclusions and grounds for variation, amendments to the product information, and timetable for the implementation -PSUSA/... (PDF/1 MB)

Miconazole / hydrocortisone, miconazole nitrate / miconazole nitrate, zinc oxide: List of nationally authorised medicinal products -PSUSA/00002052/201410 (PDF/129.39 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)

Isoniazid: List of nationally authorised medicinal products - PSUSA/00001789/201411 (PDF/70.21 KB)

Prulifloxacin: List of nationally authorised medicinal products -PSUSA/00002569/201410 (PDF/84.38 KB)

Prulifloxacin: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation -PSUSA/00002569/201410 (PDF/2.21 MB)

Tetrabenazine:List of nationally authorised medicinal products-PSUSA/00002911/201410 (PDF/85.26 KB)

Tetrabenazine:CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation-PSUSA/00002911/201410 (PDF/639.42 KB)

Corticorelin: List of nationally authorised medicinal products - PSUSA/00000876/201410 (PDF/65.84 KB)

Corticorelin: CMDh Scientific conclusions and grounds for variation, amendments to the product information, and timetable for the implementation - PSUSA/00000876/201410 (PDF/497.05 KB)

Calcium carbonate / famotidine / magnesium hydroxide: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001351/201409 (PDF/574.01 KB)

Calcium carbonate / famotidine / magnesium hydroxide: List of nationally authorised medicinal products - PSUSA/00001351/201409 (PDF/72.1 KB)

Amiodarone: List of nationally authorised medicinal products -PSUSA/00000166/201412 (PDF/109.87 KB)

Amiodarone: CMDh scientific conclusions and grounds for variation, amendments to the product information, and timetable for the implementation - PSUSA/00000166/201412 (PDF/1.96 MB)

Rabbit anti-human thymocyte (powder for solution for infusion): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00010184/201412 (PDF/2.36 MB)

Rabbit anti-human thymocyte (powder for solution for infusion): List of nationally authorised medicinal products - PSUSA/00010184/201412 (PDF/76.52 KB)

Rabbit anti-human thymocyte (powder for solution for infusion): List of nationally authorised medicinal products - PSUSA/00010184/201412 (PDF/76.52 KB)

Rabbit anti-human thymocyte (powder for solution for infusion): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00010184/201412 (PDF/2.36 MB)

Testosterone undecylate (injection): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation-PSUSA/00010161/201411 (PDF/693.98 KB)

Testosterone undecylate (injection): List of nationally authorised medicinal products-PSUSA/00010161/201411 (PDF/90.51 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)