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Opinion/decision on a Paediatric investigation plan (PIP): Aclasta, zoledronic acid

Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-000057-PIP01-07-M07, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 17/01/2020, Last updated: 11/06/2020, Compliance check: X

Invented name Aclasta Active substance zoledronic … Aclasta Aclasta zoledronic acid zoledronic …
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Human medicine European public assessment report (EPAR): Aclasta

zoledronic acid, Osteoporosis, Osteitis Deformans, Osteoporosis, Postmenopausal
Date of authorisation: 15/04/2005, Revision: 27, Authorised, Last updated: 12/06/2020

summary for the public Aclasta zoledronic acid This document … Assessment Report (EPAR) for Aclasta. It explains how the Committee … the conditions of use for Aclasta. What is …
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Aclasta-H-C-595-P46-036 : EPAR - Assessment Report (PDF/373.13 KB)

Aclasta-H-C-595-P46-036 : EPAR - Assessment Report … Aclasta-H-C-595-P46-036 : EPAR - Assessment Report …

Adopted
First published: 18/12/2018
EMA/873947/2018
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Aclasta-H-C-595-A20-0026 : EPAR - Assessment Report - Article 20 (PDF/123.56 KB)

Assessment report Aclasta zoledronic acid Procedure … impact on the benefit/risk for Aclasta, and to give its opinion on … safe and effective use of Aclasta, and on whether the marketing …

Adopted
First published: 13/09/2011
Last updated: 13/09/2011
EMA/543438/2011
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Aclasta-H-C-595-II-0017 : EPAR - Assessment Report - Variation (PDF/363.4 KB)

ASSESSMENT REPORT FOR Aclasta International non-proprietary … worldwide under the trade name Aclasta as of 15 June 2007 in 61 … States. In July 2007, Aclasta received a positive CHMP …

First published: 08/07/2009
Last updated: 08/07/2009
EMEA/CHMP/358213/2009
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Aclasta-H-C-595-II-0016 : EPAR - Assessment Report - Variation (PDF/684.77 KB)

ASSESSMENT REPORT Aclasta International non-proprietary … nature deleted. Aclasta-H-535-II-16-AR 2 SCIENTIFIC DISCUSSION … worldwide under the trade name Aclasta as of 15 June 2007 in over …

First published: 21/10/2008
Last updated: 21/10/2008
EMEA/CHMP/483357/2008
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Aclasta-H-C-595-II-10 : EPAR - Scientific Discussion - Variation (PDF/296.41 KB)

http://www.emea.europa.eu Product Name: Aclasta Procedure number: EMEA-H-595-II-10-AR … approved under the trade name Aclasta in 50 countries as of 30 … the US and Australia. Aclasta is presented as ready to …

Adopted
First published: 23/10/2007
Last updated: 23/10/2007
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Aclasta-H-C-PSUSA-00009334-201408 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/61.59 KB)

Aclasta-H-C-PSUSA-00009334-201408 : EPAR - Scientific conclusions … Aclasta-H-C-PSUSA-00009334-201408 : EPAR - Scientific conclusions …

First published: 28/07/2015
Last updated: 28/07/2015
EMA/CHMP/373034/2015
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Aclasta-H-C-595-PSUV-0047 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/66.39 KB)

Products for Human Use (CHMP) Aclasta Scientific conclusions and … Assessment Report on the PSUR for Aclasta, the scientific conclusions … sections 4.4 and 4.8 of the Aclasta SmPC are endorsed. As …

First published: 05/12/2014
Last updated: 05/12/2014
EMA/CHMP/753938/2014
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Aclasta: further measures to minimise risk of osteonecrosis of the jaw with bisphosphonate medicine (PDF/81.54 KB)

completed a periodic review1 of Aclasta (zoledronic acid), one of … the recommendations for Aclasta, following a review by the … Information for patients Aclasta is used to treat osteoporosis …

First published: 27/03/2015
Last updated: 27/03/2015
EMA/206916/2015
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Aclasta: Product Information as approved by the CHMP on 26 March 2015, pending endorsement by the European Commission (PDF/250.81 KB)

THE MEDICINAL PRODUCT Aclasta 5 mg solution for infusion … prior to administration of Aclasta. This is especially important … recommended in association with Aclasta administration. Osteoporosis …

First published: 27/03/2015
Last updated: 27/03/2015
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Aclasta : EPAR - Product Information (PDF/922.13 KB)

Aclasta : EPAR - Product Information … Document details Aclasta : EPAR - Product Information …

First published: 08/07/2009
Last updated: 12/06/2020
Bulgarian
(PDF/1.14 MB)

Croatian
(PDF/1014.5 KB)

Czech
(PDF/970.96 KB)

Danish
(PDF/969.1 KB)

Dutch
(PDF/1.06 MB)

Estonian
(PDF/924.21 KB)

Finnish
(PDF/933.12 KB)

French
(PDF/969.77 KB)

German
(PDF/1.07 MB)

Greek
(PDF/1.11 MB)

Hungarian
(PDF/1.03 MB)

Icelandic
(PDF/961.04 KB)

Italian
(PDF/946.06 KB)

Latvian
(PDF/958.53 KB)

Lithuanian
(PDF/965.61 KB)

Maltese
(PDF/1007.14 KB)

Norwegian
(PDF/1004.2 KB)

Polish
(PDF/1.01 MB)

Portuguese
(PDF/1004.04 KB)

Romanian
(PDF/1.11 MB)

Slovak
(PDF/1.02 MB)

Slovenian
(PDF/957.38 KB)

Spanish
(PDF/1.04 MB)

Swedish
(PDF/1.1 MB)
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Reminder card for Aclasta (PDF/22.94 KB)

Reminder card for Aclasta … Reminder card for Aclasta …

First published: 27/03/2015
Last updated: 27/03/2015
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Aclasta : EPAR - Scientific Discussion (PDF/218.27 KB)

Marketing Authorisation for Aclasta for the proposed indication … The active substance of Aclasta, zoledronic acid (zoledronate)is … aspects Introduction Aclasta contains zoledronic acid …

First published: 03/04/2006
Last updated: 03/04/2006
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Aclasta : EPAR - All Authorised presentations (PDF/60.3 KB)

Package size EU/1/05/308/001 Aclasta 5 mg/100 ml Solution for … bottle EU/1/05/308/002 Aclasta 5 mg/100 ml Solution for … Aclasta : EPAR - All Authorised prese …

First published: 18/04/2006
Last updated: 18/04/2006
Bulgarian
(PDF/78.4 KB)

Czech
(PDF/81.06 KB)

Danish
(PDF/61.02 KB)

Dutch
(PDF/59.7 KB)

Estonian
(PDF/58.92 KB)

Finnish
(PDF/57.86 KB)

French
(PDF/59.79 KB)

German
(PDF/63.37 KB)

Greek
(PDF/75.6 KB)

Hungarian
(PDF/80.24 KB)

Italian
(PDF/57.35 KB)

Latvian
(PDF/82.09 KB)

Lithuanian
(PDF/80.78 KB)

Maltese
(PDF/81.31 KB)

Polish
(PDF/83.33 KB)

Portuguese
(PDF/58.23 KB)

Romanian
(PDF/76.99 KB)

Slovak
(PDF/81.34 KB)

Slovenian
(PDF/60.48 KB)

Spanish
(PDF/58.69 KB)

Swedish
(PDF/59.87 KB)
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Aclasta : EPAR - Summary for the public (PDF/85.67 KB)

summary for the public Aclasta zoledronic acid This document … Assessment Report (EPAR) for Aclasta. It explains how the Committee … the conditions of use for Aclasta. What is …

First published: 08/07/2009
Last updated: 28/07/2015
Bulgarian
(PDF/116.88 KB)

Croatian
(PDF/109.97 KB)

Czech
(PDF/116.59 KB)

Danish
(PDF/86.36 KB)

Dutch
(PDF/87.5 KB)

Estonian
(PDF/85.11 KB)

Finnish
(PDF/85.62 KB)

French
(PDF/88.99 KB)

German
(PDF/89.48 KB)

Greek
(PDF/121.43 KB)

Hungarian
(PDF/110.49 KB)

Italian
(PDF/87.1 KB)

Latvian
(PDF/111.78 KB)

Lithuanian
(PDF/111.91 KB)

Maltese
(PDF/119.71 KB)

Polish
(PDF/115.14 KB)

Portuguese
(PDF/110.33 KB)

Romanian
(PDF/112 KB)

Slovak
(PDF/114.22 KB)

Slovenian
(PDF/106.87 KB)

Spanish
(PDF/88.01 KB)

Swedish
(PDF/85.62 KB)
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Aclasta : EPAR - Procedural steps taken before authorisation (PDF/17.84 KB)

Medicinal Products (EMEA) for Aclasta, through the centralised … Marketing Authorisation to Aclasta on 20 January 2005. The applicant … Aclasta : EPAR - Procedural steps …

First published: 03/04/2006
Last updated: 03/04/2006
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Aclasta : EPAR - Procedural steps taken and scientific information after authorisation (PDF/291.65 KB)

Aclasta : EPAR - Procedural steps … Document details Aclasta : EPAR - Procedural steps …

First published: 08/07/2009
Last updated: 12/06/2020
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CHMP post-authorisation summary of positive opinion for Aclasta (PDF/46.57 KB)

opinion1 (post authorisation) Aclasta Zoledronic acid On 15 … for the medicinal product Aclasta. The marketing authorisation … full contraindication(s) for Aclasta will be as follows2: “4.3 …

Adopted
First published: 16/12/2011
Last updated: 16/12/2011
EMA/CHMP/966950/2011
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Aclasta : EPAR - Conditions imposed on member states for safe and effective use - Annex IV (PDF/148.09 KB)

expected to prescribe/use Aclasta in the authorised indications … creatinine before treatment with Aclasta o Contraindication in patients … patient o Need to infuse Aclasta slowly over a period of no …

First published: 08/07/2009
Last updated: 07/06/2012
Bulgarian
(PDF/155.14 KB)

Czech
(PDF/164.81 KB)

Danish
(PDF/146.33 KB)

Dutch
(PDF/148.14 KB)

Estonian
(PDF/145.14 KB)

Finnish
(PDF/143.68 KB)

French
(PDF/153.38 KB)

German
(PDF/152.78 KB)

Greek
(PDF/152.88 KB)

Hungarian
(PDF/150.67 KB)

Icelandic
(PDF/147.96 KB)

Italian
(PDF/147.92 KB)

Latvian
(PDF/150.22 KB)

Lithuanian
(PDF/152 KB)

Maltese
(PDF/155.33 KB)

Norwegian
(PDF/146.25 KB)

Polish
(PDF/152.33 KB)

Portuguese
(PDF/148.11 KB)

Romanian
(PDF/150.56 KB)

Slovak
(PDF/154.61 KB)

Slovenian
(PDF/147.85 KB)

Spanish
(PDF/146.13 KB)

Swedish
(PDF/144.88 KB)
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CHMP post-authorisation summary of positive opinion for Aclasta on 24 July 2008 (PDF/30.95 KB)

POSITIVE OPINION* for ACLASTA International Nonproprietary … for the medicinal product Aclasta. The Marketing Authorisation … the full indications for Aclasta will be as follows …

Adopted
First published: 24/07/2008
Last updated: 24/07/2008
EMEA/CHMP/391587/2008
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P/0140/2013: EMA decision of 3 July 2013 on the acceptance of a modification of an agreed paediatric investigation plan for zoledronic acid (Aclasta), (EMEA-000057-PIP01-07-M05) (PDF/91.52 KB)

plan for zoledronic acid (Aclasta), (EMEA-000057-PIP01-07-M05 … plan for zoledronic acid (Aclasta), (EMEA-000057-PIP01-07-M05 … plan for zoledronic acid (Aclasta), (EMEA-000057-PIP01-07-M05 …

Adopted
First published: 08/08/2013
Last updated: 08/08/2013
EMA/331252/2013
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P/0169/2012: EMA decision of 27 July 2012 on the refusal of a modification of an agreed paediatric investigation plan for zoledronic acid (Aclasta) (EMEA-000057-PIP01-07-M04) (PDF/149.6 KB)

plan for zoledronic acid (Aclasta) (EMEA-000057-PIP01-07-M04) 7 … plan for zoledronic acid (Aclasta) (EMEA-000057-PIP01-07-M04 … plan for zoledronic acid (Aclasta) (EMEA-000057-PIP01-07-M04 …

Adopted
First published: 21/08/2012
Last updated: 21/08/2012
EMA/485855/2012
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P/289/2011: EMA decision of 2 December 2011 on the acceptance of a modification of an agreed paediatric investigation plan for zoledronic acid (Aclasta) (EMEA-000057-PIP01-07-M03) (PDF/149.58 KB)

plan for zoledronic acid (Aclasta) (EMEA-000057-PIP01-07-M03 … plan for zoledronic acid (Aclasta) (EMEA-000057-PIP01-07-M03 … plan for zoledronic acid (Aclasta), solution for infusion …

Adopted
First published: 18/01/2012
Last updated: 18/01/2012
EMA/915429/2011
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P/151/2010: EMA decision of 16 August 2010 on the acceptance of a modification of an agreed paediatric investigation plan for zoledronic acid (Aclasta) (EMEA-000057-PIP01-07-M02) (PDF/96.02 KB)

plan for zoledronic acid (Aclasta), (EMEA-000057-PIP01-07-M02 … plan for zoledronic acid (Aclasta), (EMEA-000057-PIP01-07-M02 … plan for zoledronic acid (Aclasta), solution for infusion …

Adopted
First published: 07/10/2010
Last updated: 07/10/2010
EMA/500538/2010

178 results

Opinion/decision on a Paediatric investigation plan (PIP): Aclasta, zoledronic acid

Human medicine European public assessment report (EPAR): Aclasta

Aclasta-H-C-595-P46-036 : EPAR - Assessment Report (PDF/373.13 KB)

Aclasta-H-C-595-A20-0026 : EPAR - Assessment Report - Article 20 (PDF/123.56 KB)

Aclasta-H-C-595-II-0017 : EPAR - Assessment Report - Variation (PDF/363.4 KB)

Aclasta-H-C-595-II-0016 : EPAR - Assessment Report - Variation (PDF/684.77 KB)

Aclasta-H-C-595-II-10 : EPAR - Scientific Discussion - Variation (PDF/296.41 KB)

Aclasta-H-C-PSUSA-00009334-201408 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/61.59 KB)

Aclasta-H-C-595-PSUV-0047 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/66.39 KB)

Aclasta: further measures to minimise risk of osteonecrosis of the jaw with bisphosphonate medicine (PDF/81.54 KB)

Aclasta: Product Information as approved by the CHMP on 26 March 2015, pending endorsement by the European Commission (PDF/250.81 KB)

Aclasta : EPAR - Product Information (PDF/922.13 KB)

Reminder card for Aclasta (PDF/22.94 KB)

Aclasta : EPAR - Scientific Discussion (PDF/218.27 KB)

Aclasta : EPAR - All Authorised presentations (PDF/60.3 KB)

Aclasta : EPAR - Summary for the public (PDF/85.67 KB)

Aclasta : EPAR - Procedural steps taken before authorisation (PDF/17.84 KB)

Aclasta : EPAR - Procedural steps taken and scientific information after authorisation (PDF/291.65 KB)

CHMP post-authorisation summary of positive opinion for Aclasta (PDF/46.57 KB)

Aclasta : EPAR - Conditions imposed on member states for safe and effective use - Annex IV (PDF/148.09 KB)

CHMP post-authorisation summary of positive opinion for Aclasta on 24 July 2008 (PDF/30.95 KB)

P/0140/2013: EMA decision of 3 July 2013 on the acceptance of a modification of an agreed paediatric investigation plan for zoledronic acid (Aclasta), (EMEA-000057-PIP01-07-M05) (PDF/91.52 KB)

P/0169/2012: EMA decision of 27 July 2012 on the refusal of a modification of an agreed paediatric investigation plan for zoledronic acid (Aclasta) (EMEA-000057-PIP01-07-M04) (PDF/149.6 KB)

P/289/2011: EMA decision of 2 December 2011 on the acceptance of a modification of an agreed paediatric investigation plan for zoledronic acid (Aclasta) (EMEA-000057-PIP01-07-M03) (PDF/149.58 KB)

P/151/2010: EMA decision of 16 August 2010 on the acceptance of a modification of an agreed paediatric investigation plan for zoledronic acid (Aclasta) (EMEA-000057-PIP01-07-M02) (PDF/96.02 KB)