Dynastat

parecoxib

Overview
Authorisation details
Product information
Assessment history

Authorised

This medicine is authorised for use in the European Union.

Overview

Dynastat is a painkilling medicine for use in adults for the short-term relief of pain after an operation.

It contains the active substance parecoxib.

: Dynastat is available as an injection and it can only be obtained with a prescription.

Dynastat can be given into a vein or a muscle. The first dose of 40 mg is followed by further doses of 20 or 40 mg every 6 to 12 hours, up to a maximum total dose of 80 mg a day.

For more information about using Dynastat, see the package leaflet or contact your doctor or pharmacist.

: The active substance in Dynastat, parecoxib, is converted to valdecoxib in the body. Valdecoxib is a non‑steroidal anti‑inflammatory drug (NSAID) that belongs to the group of medicines called cyclo‑oxygenase‑2 (COX‑2) inhibitors. It blocks the COX‑2 enzyme, resulting in reduced production of prostaglandins, substances that are involved in inflammation. By reducing prostaglandins, Dynastat helps to reduce the symptoms of inflammation, including pain.

: Dynastat was studied in over 2,500 adults who had surgical procedures including dental, orthopaedic (bone) and gynaecological surgery (surgery on the female reproductive system). Dynastat was compared with placebo (a dummy treatment) as well as with other painkillers such as ibuprofen, ketorolac, morphine, tramadol and valdecoxib. Dynastat was generally more effective than placebo and as effective as other painkillers. Dynastat also reduced the need for morphine.

: The most common side effect with Dynastat (which may affect more than 1 in 10 people) is nausea (feeling sick). The most serious side effects (which may affect fewer than 1 in 100 people) include myocardial infarction (heart attack), severe reduction in blood pressure and allergic reactions.

Dynastat must not be used in patients who have had a serious allergic reaction to a medicine, have allergies to a class of medicines called sulfonamides or have certain illnesses including those affecting the gastrointestinal system, liver and heart. Women must not be given Dynastat during the last 3 months of pregnancy or if they are breast-feeding. It must not be used to relieve pain after certain types of heart surgery.

For the full list of side effects and restrictions of Dynastat, see the package leaflet.

: Dynastat was found effective for relieving pain after surgery and its side effects are manageable.

The European Medicines Agency therefore decided that Dynastat’s benefits are greater than its risks and it can be authorised for use in the EU.

: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dynastat have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Dynastat are continuously monitored. Side effects reported with Dynastat are carefully evaluated and any necessary action taken to protect patients.

: Dynastat received a marketing authorisation valid throughout the EU on 22 March 2002.

List item

Dynastat : EPAR - Medicine overview (PDF/159.13 KB)

First published: 15/04/2009
Last updated: 13/07/2020
EMA/344077/2020
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More detail is available in the summary of product characteristics

This EPAR was last updated on 13/07/2020

Authorisation details

Product details
Name	Dynastat
Agency product number	EMEA/H/C/000381
Active substance	parecoxib sodium
International non-proprietary name (INN) or common name	parecoxib
Therapeutic area (MeSH)	Pain, Postoperative
Anatomical therapeutic chemical (ATC) code	M01AH04

Publication details
Marketing-authorisation holder	Pfizer Europe MA EEIG
Revision	30
Date of issue of marketing authorisation valid throughout the European Union	22/03/2002
Contact address	Boulevard de la Plaine 17 1050 Bruxelles Belgium

Product information

07/05/2020 Dynastat - EMEA/H/C/000381 - II/0077

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Dynastat : EPAR - Product Information (PDF/591.21 KB)

First published: 08/01/2010
Last updated: 13/07/2020
- Bulgarian
  (PDF/418.17 KB)
- Croatian
  (PDF/385.85 KB)
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  (PDF/396.13 KB)
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  (PDF/355.06 KB)
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  (PDF/386.71 KB)
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  (PDF/366.87 KB)
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  (PDF/393.82 KB)
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  (PDF/402.74 KB)
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  (PDF/417.34 KB)
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  (PDF/447.33 KB)
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  (PDF/386.19 KB)
- Icelandic
  (PDF/362.29 KB)
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  (PDF/398.8 KB)
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  (PDF/407.89 KB)
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  (PDF/345.7 KB)
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  (PDF/441.22 KB)
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  (PDF/363.7 KB)
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  (PDF/381.87 KB)
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  (PDF/387 KB)
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  (PDF/361.9 KB)
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  (PDF/394.26 KB)
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  (PDF/372.25 KB)
- Spanish
  (PDF/382.33 KB)
- Swedish
  (PDF/351.77 KB)

Annex I - Summary of product characteristics
Annex IIA - Manufacturing-authorisation holder responsible for batch release
Annex IIB - Conditions of the marketing authorisation
Annex IIIA - Labelling
Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

List item

Dynastat : EPAR - All Authorised presentations (PDF/74.59 KB)

First published: 15/11/2005
Last updated: 24/08/2012
- Bulgarian
  (PDF/89.92 KB)
- Czech
  (PDF/94.3 KB)
- Danish
  (PDF/83.96 KB)
- Dutch
  (PDF/78.77 KB)
- Estonian
  (PDF/66.74 KB)
- Finnish
  (PDF/64.8 KB)
- French
  (PDF/88.99 KB)
- German
  (PDF/88.1 KB)
- Greek
  (PDF/68.39 KB)
- Hungarian
  (PDF/93.96 KB)
- Icelandic
  (PDF/62.05 KB)
- Italian
  (PDF/84.8 KB)
- Latvian
  (PDF/78.83 KB)
- Lithuanian
  (PDF/134.53 KB)
- Maltese
  (PDF/92.09 KB)
- Norwegian
  (PDF/63.24 KB)
- Polish
  (PDF/101.75 KB)
- Portuguese
  (PDF/77.41 KB)
- Romanian
  (PDF/80.07 KB)
- Slovak
  (PDF/95.31 KB)
- Slovenian
  (PDF/63.1 KB)
- Spanish
  (PDF/87.19 KB)
- Swedish
  (PDF/64.21 KB)

Pharmacotherapeutic group

Antiinflammatory and antirheumatic products
Coxibs

Therapeutic indication

For the short-term treatment of postoperative pain in adults.

Assessment history

Changes since initial authorisation of medicine

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Dynastat : EPAR - Procedural steps taken and scientific information after authorisation (PDF/316.91 KB)

First published: 08/01/2010
Last updated: 13/07/2020
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Dynastat-H-C-381-II-0032 : EPAR - Scientific Discussion - Variation (PDF/629.1 KB)

Adopted

First published: 08/05/2009
Last updated: 08/05/2009
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Dynastat : EPAR - Steps taken after authorisation when a cutoff date has been used (PDF/93.65 KB)

First published: 15/11/2005
Last updated: 15/11/2005
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Dynastat-H-C-381-A18-20 : EPAR - Scientific Conclusion (PDF/102.91 KB)

First published: 15/11/2005
Last updated: 15/11/2005
- Czech
  (PDF/140.39 KB)
- Danish
  (PDF/108.97 KB)
- Dutch
  (PDF/102.22 KB)
- Estonian
  (PDF/94.96 KB)
- Finnish
  (PDF/98.47 KB)
- French
  (PDF/98.87 KB)
- German
  (PDF/104.48 KB)
- Greek
  (PDF/151.2 KB)
- Hungarian
  (PDF/122.15 KB)
- Italian
  (PDF/103.2 KB)
- Latvian
  (PDF/142.16 KB)
- Lithuanian
  (PDF/135.26 KB)
- Polish
  (PDF/136.63 KB)
- Portuguese
  (PDF/107.21 KB)
- Slovak
  (PDF/113.47 KB)
- Slovenian
  (PDF/123.74 KB)
- Spanish
  (PDF/101.91 KB)
- Swedish
  (PDF/104.13 KB)

Dynastat

Table of contents

Overview

Dynastat : EPAR - Medicine overview (PDF/159.13 KB)

Authorisation details

Product information

Dynastat : EPAR - Product Information (PDF/591.21 KB)

Contents

Dynastat : EPAR - All Authorised presentations (PDF/74.59 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Dynastat : EPAR - Procedural steps taken and scientific information after authorisation (PDF/316.91 KB)

Dynastat-H-C-381-II-0032 : EPAR - Scientific Discussion - Variation (PDF/629.1 KB)

Dynastat : EPAR - Steps taken after authorisation when a cutoff date has been used (PDF/93.65 KB)

Dynastat-H-C-381-A18-20 : EPAR - Scientific Conclusion (PDF/102.91 KB)

Initial marketing-authorisation documents

Dynastat : EPAR - Scientific Discussion (PDF/286.8 KB)

Dynastat : EPAR - Procedural steps taken before authorisation (PDF/88.79 KB)

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