Tag: CHMP
CHMP Adopts Positive Opinion for Treatment of Acute Angioedema Attacks in Children With Hereditary Angioedema With RUCONEST®

CHMP Adopts Positive Opinion for Treatment of Acute Angioedema Attacks in Children With Hereditary Angioedema With RUCONEST®

LEIDEN, Netherlands, March 27, 2020 /PRNewswire/ -- Pharming announces the Committee for Medicinal Products for Human Use (CHMP), an advisory committee of the European Medicine ...

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EVENITY® (romosozumab) Receives Positive CHMP Opinion for the Treatment of Severe Osteoporosis in Postmenopausal Women at High Risk of Fracture

EVENITY® (romosozumab) Receives Positive CHMP Opinion for the Treatment of Severe Osteoporosis in Postmenopausal Women at High Risk of Fracture

BRUSSELS and THOUSAND OAKS, California, Oct. 18, 2019 /PRNewswire/ -- UCB and Amgen today announced that following a re-examination procedure, the Committee for Medicinal ...

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Kyowa Kirin Announces Mogamulizumab Received Positive CHMP Opinion for the Treatment of Mycosis Fungoides and Sézary Syndrome

Kyowa Kirin Announces Mogamulizumab Received Positive CHMP Opinion for the Treatment of Mycosis Fungoides and Sézary Syndrome

TOKYO, September 21, 2018 /PRNewswire/ -- If approved, mogamulizumab would be the first biologic agent targeting CCR4 to be available for patients in Europe.   Kyowa Hakko ...

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Pelgraz® (pegfilgrastim) van Accord Healthcare krijgt groen licht van CHMP

Pelgraz® (pegfilgrastim) van Accord Healthcare krijgt groen licht van CHMP

HARROW, Engeland, July 27, 2018 /PRNewswire/ -- Pelgraz, - een gepegyleerde G-SCF-biosimilar, is Accord Healthcare's nieuwste aanvulling op zijn gevestigde portefeuille van ...

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Ultragenyx and Kyowa Kirin Announce Burosumab Receives Positive CHMP Opinion for the Treatment of X-Linked Hypophosphatemia in Children

Ultragenyx and Kyowa Kirin Announce Burosumab Receives Positive CHMP Opinion for the Treatment of X-Linked Hypophosphatemia in Children

TOKYO, LONDON, and NOVATO, California, December 15, 2017 /PRNewswire/ -- If approved, burosumab would be the first targeted disease-modifying treatment for XLH   Kyowa Hakko ...

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EMA's CHMP Issues Positive Opinion for Avelumab for the Treatment of Metastatic Merkel Cell Carcinoma

EMA's CHMP Issues Positive Opinion for Avelumab for the Treatment of Metastatic Merkel Cell Carcinoma

DARMSTADT, Germany and NEW YORK, July 21, 2017 /PRNewswire/ -- Not intended for US, Canadian and UK-based media   - If approved, ...

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Cladribine Tablets Receives Positive CHMP Opinion for Treatment of Relapsing Forms of Multiple Sclerosis

Cladribine Tablets Receives Positive CHMP Opinion for Treatment of Relapsing Forms of Multiple Sclerosis

DARMSTADT, Germany, June 23, 2017 /PRNewswire/ -- - Efficacy and safety data support positive benefit/risk assessment from CHMP  - Cladribine Tablets is the ...

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