Overview
The marketing authorisation for Pregabalin Mylan Pharma has been withdrawn at the request of the marketing-authorisation holder.
Pregabalin Mylan Pharma : EPAR - Summary for the public
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Pregabalin Mylan Pharma : EPAR - Risk-management-plan summary
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Product information
Pregabalin Mylan Pharma : EPAR - Product Information
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português (PT) (1.13 MB - PDF)
română (RO) (1.16 MB - PDF)
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slovenščina (SL) (2.17 MB - PDF)
Suomi (FI) (1.05 MB - PDF)
svenska (SV) (1.05 MB - PDF)
Latest procedure affecting product information: WS/2006
14/01/2021
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Pregabalin Mylan Pharma : EPAR - All Authorised presentations
English (EN) (629.49 KB - PDF)
български (BG) (794.06 KB - PDF)
español (ES) (633.98 KB - PDF)
čeština (CS) (710.54 KB - PDF)
dansk (DA) (632.7 KB - PDF)
Deutsch (DE) (633.33 KB - PDF)
eesti keel (ET) (635.71 KB - PDF)
ελληνικά (EL) (733.45 KB - PDF)
français (FR) (638.81 KB - PDF)
hrvatski (HR) (663.87 KB - PDF)
íslenska (IS) (628.15 KB - PDF)
italiano (IT) (631.47 KB - PDF)
latviešu valoda (LV) (710.56 KB - PDF)
lietuvių kalba (LT) (674.65 KB - PDF)
magyar (HU) (695.47 KB - PDF)
Malti (MT) (718.63 KB - PDF)
Nederlands (NL) (631.35 KB - PDF)
norsk (NO) (630.24 KB - PDF)
polski (PL) (683.04 KB - PDF)
português (PT) (643.45 KB - PDF)
română (RO) (648.99 KB - PDF)
slovenčina (SK) (690.69 KB - PDF)
slovenščina (SL) (717.93 KB - PDF)
Suomi (FI) (632.1 KB - PDF)
svenska (SV) (633.74 KB - PDF)
Product details
- Name of medicine
- Pregabalin Mylan Pharma
- Active substance
- pregabalin
- International non-proprietary name (INN) or common name
- pregabalin
- Therapeutic area (MeSH)
- Anxiety Disorders
- Neuralgia
- Epilepsy
- Anatomical therapeutic chemical (ATC) code
- N03AX16
Pharmacotherapeutic group
AntiepilepticsTherapeutic indication
Epilepsy
Pregabalin Mylan Pharma is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Generalised Anxiety Disorder
Pregabalin Mylan Pharma is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
Authorisation details
- EMA product number
- EMEA/H/C/003962
Generic
This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.
- Marketing authorisation holder
- Mylan S.A.S.
117 Allee des Parcs
69800 Saint-Priest
France - Opinion adopted
- 23/04/2015
- Marketing authorisation issued
- 25/06/2015
- Revision
- 7
Assessment history
Pregabalin Mylan Pharma : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (776.51 KB - PDF)
Pregabalin Mylan Pharma : EPAR - Public assessment report
English (EN) (1.3 MB - PDF)
CHMP summary of positive opinion for Pregabalin Mylan Pharma
English (EN) (661.89 KB - PDF)
News on Pregabalin Mylan Pharma
More information on Pregabalin Mylan Pharma
Questions and answers on generic medicines
English (EN) (66.45 KB - PDF)
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čeština (CS) (87.71 KB - PDF)
dansk (DA) (66.79 KB - PDF)
Deutsch (DE) (67.55 KB - PDF)
eesti keel (ET) (65.21 KB - PDF)
ελληνικά (EL) (91.29 KB - PDF)
français (FR) (68.35 KB - PDF)
hrvatski (HR) (87.8 KB - PDF)
italiano (IT) (67.62 KB - PDF)
latviešu valoda (LV) (111.81 KB - PDF)
lietuvių kalba (LT) (86.76 KB - PDF)
magyar (HU) (85.76 KB - PDF)
Malti (MT) (89.35 KB - PDF)
Nederlands (NL) (66.81 KB - PDF)
polski (PL) (88.51 KB - PDF)
português (PT) (68.32 KB - PDF)
română (RO) (86.9 KB - PDF)
slovenčina (SK) (87.73 KB - PDF)
slovenščina (SL) (84.8 KB - PDF)
Suomi (FI) (66.21 KB - PDF)
svenska (SV) (67.11 KB - PDF)
Related information
Public statement on Pregabalin Mylan Pharma : Withdrawal of the marketing authorisation in the European Union
English (EN) (124.88 KB - PDF)