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List of all PMRs. Only registered members have access to PMR details. 2364 post-marketing requirements

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Have you ever wondered

  • Which post-marketing studies have been requested for competitive products over the past several years?
  • What post-marketing requirements have been requested by the FDA for antineoplastic agents, for example?
  • Which kind of post-marketing study is most frequently requested by European health authorities?

Post-marketing surveillance for adverse effects has become an essential element in the worldwide development of new drugs. Many parameters must be evaluated in real-world studies by population profiles, drug-to-drug interactions, specific populations (pediatrics, diabetics, pregnant women, etc.), to name a few. The new PMR database will help you anticipate regulatory requests and optimize your marketing strategies. For more information on PMRs, please consider signing up for a yearly subscription.


Nov 19


Requirements from PMDA and TGA & links to studies performed to fulfill requirements now available in the PMR Database. 

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Nov 12

Late Phase Leaders Forum

Meet with Mapi Experts at the 5th Annual Late Phase Leaders Forum

12th – 14th November, 2013 (Next Level Pharma, Brussels, Belgium)



VALCHLOR is an alkylating drug indicated for the topical treatment of Stage IA and IB mycosis fungoides‐type cutaneous T‐cell lymphoma in patients who have received prior skin‐directed therapy

Date of request: Aug 23, 2013


Trokendi XR™ is an antiepileptic drug indicated for: • Partial Onset Seizure and Primary Generalized Tonic-Clonic Seizures - initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures and...

Date of request: Aug 16, 2013


Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Date of request: Jul 25, 2013


Lojuxta is indicated as an adjunct to a low‑fat diet and other lipid‑lowering medicinal products with or without low-density-lipoprotein (LDL) apheresis in adult patients with homozygous familial hypercholesterolaemia (HoFH) Genetic confirmation of...

Date of request: Jul 25, 2013