199 results
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Human medicine European public assessment report (EPAR): Enzepi
pancreas powder, Exocrine Pancreatic Insufficiency
Date of authorisation: 29/06/2016,
, Revision: 1, Withdrawn, Last updated: 17/02/2021
monitoring . Publication details >Allergan Pharmaceuticals International … marketing authorisation holder, Allergan Pharmaceuticals International … -
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Human medicine European public assessment report (EPAR): Truberzi
eluxadoline, Irritable Bowel Syndrome; Diarrhea
Date of authorisation: 19/09/2016,, Revision: 6, Withdrawn, Last updated: 25/02/2021
Marketing-authorisation holder Allergan Pharmaceuticals International … marketing authorisation holder, Allergan Pharmaceuticals International … -
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Opinion/decision on a Paediatric investigation plan (PIP): Xydalba, dalbavancin hydrochloride (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000016-PIP01-07-M08, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 03/12/2021, Last updated: 14/03/2023, Compliance check: Xinfections Intravenous use Allergan Pharmaceuticals International … application submitted by Allergan Pharmaceuticals International … decision is addressed to Allergan Pharmaceuticals International … -
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Opinion/decision on a Paediatric investigation plan (PIP): Constella, linaclotide
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-000927-PIP01-10-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 08/06/2021, Last updated: 28/04/2022, Compliance check: XContact for public enquiries Allergan Pharmaceuticals International … application submitted by Allergan Pharmaceuticals International … decision is addressed to Allergan Pharmaceuticals International … -
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Opinion/decision on a Paediatric investigation plan (PIP): Relamorelin
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-002323-PIP02-19, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Age-appropriate oral dosage form, Solution for injection
Decision date: 09/09/2020, Last updated: 12/01/2023, Compliance check: XContact for public enquiries Allergan Pharmaceuticals International … from interested parties: Allergan Limited Telephone … application submitted by Allergan Pharmaceuticals International … -
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Opinion/decision on a Paediatric investigation plan (PIP): Cenicriviroc
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001999-PIP02-17-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral liquid dosage form, Film-coated tablet
Decision date: 09/09/2020, Last updated: 01/07/2021, Compliance check: Xsteatohepatitis (NASH) Oral use Allergan Pharmaceuticals International … 3152-301-002) study. Allergan confirms that the termination … from interested parties: Allergan Medinfo Telephone: +44(0)1628 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Pilocarpine (hydrochloride), Oxymetazoline hydrochloride
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Ophthalmology
PIP number: EMEA-002181-PIP01-17, Route(s) of administration: Ophthalmic use, Pharmaceutical form(s): Eye drops, solution, Solution
Decision date: 31/10/2017, Last updated: 12/02/2018, Compliance check: Xpresbyopia Ophthalmic use Allergan Pharmaceuticals International … application submitted by Allergan Pharmaceuticals International … decision is addressed to Allergan Pharmaceuticals International … -
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Opinion/decision on a Paediatric investigation plan (PIP): Testosterone
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Ophthalmology
PIP number: EMEA-001873-PIP01-15, Route(s) of administration: Ocular use, Pharmaceutical form(s): Eye drops, solution
Decision date: 18/03/2016, Last updated: 25/04/2016, Compliance check: Xdry eye disease Ocular use Allergan Pharmaceuticals International … application submitted by Allergan Pharmaceuticals Ireland on … decision is addressed to Allergan Pharmaceuticals Ireland … -
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Opinion/decision on a Paediatric investigation plan (PIP): ciclosporin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Ophthalmology
PIP number: EMEA-001007-PIP02-15, Route(s) of administration: Ocular use, Pharmaceutical form(s): Eye drops, solution
Decision date: 27/10/2015, Last updated: 17/12/2015, Compliance check: Xdry eye disease Ocular use Allergan Pharmaceuticals International … application submitted by Allergan Pharmaceuticals Ireland on … decision is addressed to Allergan Pharmaceuticals Ireland … -
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Opinion/decision on a Paediatric investigation plan (PIP): Truberzi, eluxadoline
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001579-PIP01-13-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral liquid dosage form
Decision date: 18/03/2020, Last updated: 04/08/2020, Compliance check: Xirritable bowel Syndrome Oral use Allergan Pharmaceuticals International … -
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Opinion/decision on a Paediatric investigation plan (PIP): ciclosporin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Ophthalmology
PIP number: EMEA-001007-PIP01-10, Route(s) of administration: Ocular use, Pharmaceutical form(s): Eye drops, solution, Solution
Decision date: 06/07/2011, Last updated: 09/08/2011, Compliance check: Xkeratoconjunctivitis Ocular use Allergan Pharmaceuticals International … application submitted by Allergan Pharmaceuticals Ireland on … decision is addressed to Allergan Pharmaceuticals Ireland … -
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Opinion/decision on a Paediatric investigation plan (PIP): dexamethasone
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Ophthalmology
PIP number: EMEA-000198-PIP04-10, Route(s) of administration: Intravitreal use, Pharmaceutical form(s): Intravitreal implant in applicator
Decision date: 30/07/2010, Last updated: 26/08/2010, Compliance check: Xmacular oedema Intravitreal use Allergan Pharmaceuticals International … application submitted by Allergan Pharmaceuticals Ireland on … decision is addressed to Allergan Pharmaceuticals Ireland … -
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Opinion/decision on a Paediatric investigation plan (PIP): dexamethasone
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Ophthalmology
PIP number: Dexamethasone, Route(s) of administration: Intravitreal use, Pharmaceutical form(s): Intravitreal implant in applicator
Decision date: 23/03/2009, Last updated: 18/05/2009, Compliance check: Xuveitis Intravitreal use Allergan Pharmaceuticals International … application submitted by Allergan Pharmaceuticals Ireland on … decision is addressed to Allergan Pharmaceuticals Ireland … -
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Opinion/decision on a Paediatric investigation plan (PIP): dexamethasone
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Ophthalmology
PIP number: Dexamethasone, Route(s) of administration: Intravitreal use, Pharmaceutical form(s): Intravitreal implant in an applicator
Decision date: 15/08/2008, Last updated: 18/09/2008, Compliance check: Xocclusion Intravitreal use Allergan Pharmaceuticals International … application submitted by Allergan Pharmaceuticals Ireland on … decision is addressed to Allergan Pharmaceuticals Ireland … -
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Orphan designation: Adeno-associated viral vector serotype 2/2 containing a gene encoding the channelrhodopsin-2 protein for: Treatment of retinitis pigmentosa
Date of designation: 14/10/2016, Withdrawn, Last updated: 11/06/2021sponsorship was transferred to Allergan Pharmaceuticals International … -
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Opinion/decision on a Paediatric investigation plan (PIP): Botulinum toxin type A
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Dermatology
PIP number: EMEA-002521-PIP01-18, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 16/08/2019, Last updated: 20/11/2019, Compliance check: Xwrinkling Intramuscular use Allergan Pharmaceuticals International … -
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Opinion/decision on a Paediatric investigation plan (PIP): Botulinum toxin type A
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002628-PIP01-19, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 10/09/2020, Last updated: 25/03/2020, Compliance check: Xsurgery Intramuscular use Allergan Pharmaceutical International … -
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Opinion/decision on a Paediatric investigation plan (PIP): Lumigan, bimatoprost
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-000917-PIP01-10-M04, Route(s) of administration: Ocular use, Cutaneous use, Intraocular use, Pharmaceutical form(s): Eye drops, solution, Cutaneous solution, Ophthalmic insert
Decision date: 30/10/2014, Last updated: 09/12/2014, Compliance check: XContact for public enquiries Allergan Pharmaceuticals International … application submitted by Allergan Pharmaceuticals Ireland on … decision is addressed to Allergan Pharmaceuticals Ireland … -
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Opinion/decision on a Paediatric investigation plan (PIP): Lumigan, bimatoprost
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Dermatology
PIP number: EMEA-000917-PIP02-11, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Cutaneous solution
Decision date: 29/05/2012, Last updated: 25/06/2012, Compliance check: XContact for public enquiries Allergan Pharmaceuticals International … application submitted by Allergan Pharmaceuticals Ireland on … decision is addressed to Allergan Pharmaceuticals Ireland … -
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Opinion/decision on a Paediatric investigation plan (PIP): atogepant
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pain
PIP number: EMEA-002530-PIP01-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Age-appropriate oral solid dosage form
Decision date: 29/01/2020, Last updated: 09/06/2020, Compliance check: XContact for public enquiries Allergan Pharmaceuticals International … -
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Orphan designation: dexamethasone for: Treatment of non-infectious uveitis affecting the posterior segment of the eye
Date of designation: 04/08/2010, Withdrawn, Last updated: 19/11/2010the European Commission to Allergan Pharmaceuticals Ireland … European Commission to Allergan Pharmaceuticals Ireland … Sponsor’s contact details: Allergan Pharmaceuticals Ireland Castlebar … -
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Orphan designation: ciclosporin for: Treatment of atopic keratoconjunctivitis
Date of designation: 24/07/2009, Positive, Last updated: 11/09/2009the European Commission to Allergan Pharmaceuticals Ireland … the European Commission to Allergan Pharmaceuticals Ireland … Sponsor’s contact details: Allergan Pharmaceuticals Ireland Carrowbar … -
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Orphan designation: ciclosporin for: Treatment of atopic keratoconjunctivitis
Date of designation: 14/04/2004, Withdrawn, Last updated: 22/01/2008the European Commission to Allergan Pharmaceuticals Ireland … the European Commission to Allergan Pharmaceuticals Ireland … Sponsor’s contact details: Allergan Pharmaceuticals Ireland Carrowbar … -
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Opinion/decision on a Paediatric investigation plan (PIP): Proteinase, metallo- (synthetic nociceptin receptor-binding) 1290102-81-6 (AGN214868)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pain
PIP number: EMEA-001200-PIP01-11, Route(s) of administration: Intradermal use, Intramuscular use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 26/02/2013, Last updated: 23/04/2013, Compliance check: XIntradermal use Intramuscular use Allergan Pharmaceuticals Ireland Ireland … application submitted by Allergan Pharmaceuticals Ireland on … -
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Human medicine European public assessment report (EPAR): Lumigan
bimatoprost, Glaucoma, Open-Angle; Ocular Hypertension
Date of authorisation: 08/03/2002, Revision: 37, Authorised, Last updated: 20/07/2022European Union for Lumigan to Allergan Pharmaceuticals Ireland on … European Union for Lumigan to Allergan Pharmaceuticals Ireland on … the dossier The applicant Allergan Sales Ltd submitted on 11 …